ADOPTED RULES An agency may take final action on a section 30 days after a proposal has been published in the Texas Register. The section becomes effective 20 days after the agency files the correct document with the Texas Register, unless a later date is specified or unless a federal statute or regulation requires implementation of the action on shorter notice. If an agency adopts the section without any changes to the proposed text, only the preamble of the notice and statement of legal authority will be published. If an agency adopts the section with changes to the proposed text, the proposal will be republished with the changes. TITLE 7. BANKING AND SECURITIES Part VI. Credit Union Department Chapter 91. Chartering, Operations, Mergers, Liquidations Reserves and Dividends 7 TAC sec.91.901 The Credit Union Commission adopts an amendment to sec.91.901, concerning reserving requirements, without changes to the proposed text as published in the December 9, 1994, issue of the Texas Register (19 TexReg 9710). The rule is amended to extend the maturities of assets to be exempted from the calculation of risk assets from three years to five years. The effect of the rule will be to avoid conflicting reserving requirements with those of the share insurer. No comments were received regarding adoption of the amendment. The amendment is adopted under Texas Civil Statutes, Article 2461-11.07, which provide the Credit Union Commission with the authority to adopt reasonable rules necessary for the administration of the Texas Credit Union Department. This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Issued in Austin, Texas, on February 24, 1995. TRD-9502391 Robert W. Rogers Commissioner Credit Union Department Effective date: March 17, 1995 Proposal publication date: December 9, 1994 For further information, please call: (512) 837-9236 TITLE 16. ECONOMIC REGULATION Part VIII. Texas Racing Commission Chapter 305. Licenses for Pari-mutuel Racing Subchapter B. Individual Licenses General Provisions 16 TAC sec.305.35 The Texas Racing Commission adopts an amendment to sec.305.35, concerning license fees, without changes to the proposed text as published in the December 30, 1994, issue of the Texas Register (19 TexReg 10409). The amendment is adopted to make the commission's licensing program operate efficiently and effectively. The amendment deletes the licensing category of stable registration. No comments were received regarding adoption of the amendment. The amendment is adopted under Texas Civil Statutes, Article 179e, sec.3.02, which authorize the commission to adopt rules for conducting racing with wagering and for administering the Texas Racing Act; sec.5.01, which authorizes the commission to prescribe reasonable license fees for each category of license issued under the Act; sec.7.02, which authorizes the commission to adopt categories of occupational licenses; and sec.7.05, which authorizes the commission to adopt a fee schedule for occupational licenses. This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's authority. Issued in Austin, Texas, on February 21, 1995. TRD-9502250 Paula Cochran Carter General Counsel Texas Racing Commission Effective date: March 15, 1995 Proposal publication date: December 30, 1994 For further information, please call: (512) 794-8461 Specific Licensees 16 TAC sec.305.49 The Texas Racing Commission adopts an amendment to sec.305.49, concerning emergency licenses, without changes to the proposed text as published in the December 30, 1994, issue of the Texas Register (19 TexReg 10409). The amendment is adopted to ensure the commission's licensing program will operate efficiently and effectively. The amendment permits a licensee to obtain only one emergency license per year. No comments were received regarding adoption of the amendment. The amendment is adopted under Texas Civil Statutes, Article 179e, sec.3.02, which authorize the commission to adopt rules for conducting racing with wagering and for administering the Texas Racing Act; sec.7.02, which authorizes the commission to adopt categories of occupational licenses and to establish the criteria for those licenses. This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's authority. Issued in Austin, Texas, on February 21, 1995. TRD-9502251 Paula Cochran Carter General Counsel Texas Racing Commission Effective date: March 15, 1995 Proposal publication date: December 30, 1994 For further information, please call: (512) 794-8461 Subchapter E. Renewal of Licenses 16 TAC sec.305.263 The Texas Racing Commission adopts the repeal of sec.305.263, concerning license badges for renewed occupational licenses, without changes to the proposed text as published in the December 30, 1994, issue of the Texas Register (19 TexReg 10409). The repeal is adopted to ensure that the commission's licensing program will operate efficiently and effectively. The repeal deletes the requirement that a new badge be issued on renewal of an occupational license. No comments were received regarding adoption of the repeal. The repeal is adopted under Texas Civil Statutes, Article 179e, sec.3.02, which authorize the commission to adopt rules for conducting racing with wagering and for administering the Texas Racing Act; sec.7.02, which authorizes the commission to adopt categories of occupational licenses and to establish the criteria for those licenses. This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's authority. Issued in Austin, Texas, on February 21, 1995. TRD-9502252 Paula Cochran Carter General Counsel Texas Racing Commission Effective date: March 15, 1995 Proposal publication date: December 30, 1994 For further information, please call: (512) 794-8461 Chapter 309. Operation of Racetracks Subchapter A. General Provisions Operations 16 TAC sec.309.65 The Texas Racing Commission adopts an amendment to sec.309.65, concerning loans to racetracks, without changes to the proposed text as published in the December 30, 1994, issue of the Texas Register (19 TexReg 10409). The amendment is adopted to ensure that the commission is regularly informed regarding the fiscal status of racetrack licensees. The amendment requires a racetrack to disclose information to the commission regarding all loans it receives of anything valued at $500 or more. No comments were received regarding adoption of the amendment. The amendment is adopted under Texas Civil Statutes, Article 179e, sec.3.02, which authorize the commission to adopt rules for conducting racing with wagering and for administering the Texas Racing Act; and sec.6.06, which authorizes the commission to adopt rules relating to all aspects regarding the operation of racetracks. This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's authority. Issued in Austin, Texas, on February 21, 1995. TRD-9502253 Paula Cochran Carter General Counsel Texas Racing Commission Effective date: March 15, 1995 Proposal publication date: December 30, 1994 For further information, please call: (512) 794-8461 Chapter 311. Conduct and Duties of Individual Licensees Subchapter A. General Provisions 16 TAC sec.311.11 The Texas Racing Commission adopts an amendment to sec.311.11, concerning weapons prohibited at racetracks, without changes to the proposed text as published in the December 30, 1994, issue of the Texas Register (19 TexReg 10409). The amendment is adopted to ensure that pari-mutuel racing will be safe for its licensees. The amendment clarifies which weapons are prohibited on the grounds of licensed pari-mutuel racetracks. No comments were received regarding adoption of the amendment. The amendment is adopted under Texas Civil Statutes, Article 179e, sec.3.02, which authorize the commission to adopt rules for conducting racing with wagering and for administering the Texas Racing Act; and sec.6.06, which authorizes the commission to adopt rules relating to all aspects regarding the operation of racetracks. This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's authority. Issued in Austin, Texas, on February 21, 1995. TRD-9502254 Paula Cochran Carter General Counsel Texas Racing Commission Effective date: March 15, 1995 Proposal publication date: December 30, 1994 For further information, please call: (512) 794-8461 Subchapter B. Specific Licenses Licensees for Horse Racing 16 TAC sec.311.152 The Texas Racing Commission adopts an amendment to sec.311.152, concerning trainer employees, without changes to the proposed text as published in the December 30, 1994, issue of the Texas Register (19 TexReg 10409). The amendment is adopted to ensure that the commission's licensing and enforcement programs will function efficiently and effectively. The amendment deletes the requirement that a licensed trainer maintain a current employee list in the commission offices at a racetrack. No comments were received regarding adoption of the amendment. The amendment is adopted under Texas Civil Statutes, Article 179e, sec.3.02, which authorize the commission to adopt rules for conducting racing with wagering and for administering the Texas Racing Act; sec.6.06, which authorizes the commission to adopt rules relating to all aspects regarding the operation of racetracks; and sec.7.02, which authorizes the commission to set the qualifications for licensing in various categories. This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's authority. Issued in Austin, Texas, on February 21, 1995. TRD-9502255 Paula Cochran Carter General Counsel Texas Racing Commission Effective date: March 15, 1995 Proposal publication date: December 30, 1994 For further information, please call: (512) 794-8461 16 TAC sec.311.158 The Texas Racing Commission adopts an amendment to sec.311.158, concerning restrictions on the ability of certain persons to race horses at a pari-mutuel racetrack, without changes to the proposed text as published in the December 30, 1994, issue of the Texas Register (19 TexReg 10409). The amendment is adopted to ensure that the pari-mutuel racing will be of the utmost integrity and the public's perception of the integrity of racing will be protected. The amendment removes the prohibition against the owners of a racetrack running horses at the racetrack and instead prohibits certain employees of the racetrack from running horses as an owner or trainer at that racetrack. No comments were received regarding adoption of the amendment. The amendment is adopted under Texas Civil Statutes, Article 179e, sec.3.02, which authorize the commission to adopt rules for conducting racing with wagering and for administering the Texas Racing Act; and sec.6.06, which authorizes the commission to adopt rules relating to all aspects regarding the operation of racetracks; and sec.7.02, which authorizes the commission to set the qualifications for licensing in various categories. This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's authority. Issued in Austin, Texas, on February 21, 1995. TRD-9502256 Paula Cochran Carter General Counsel Texas Racing Commission Effective date: March 15, 1995 Proposal publication date: December 30, 1994 For further information, please call: (512) 794-8461 Licensees for Greyhound Racing 16 TAC sec.311.171 The Texas Racing Commission adopts an amendment to sec.311.171, concerning kennel owners, without changes to the proposed text as published in the December 30, 1994, issue of the Texas Register (19 TexReg 10409). The amendment is adopted to ensure that the commission's rules will be consistent with applicable state law. The amendment deletes the requirement that kennel owners provide workers' compensation insurance for their employees. No comments were received regarding adoption of the amendment. The amendment is adopted under Texas Civil Statutes, Article 179e, sec.3.02, which authorize the commission to adopt rules for conducting racing with wagering and for administering the Texas Racing Act; and sec.7.02, which authorizes the commission to set the qualifications for licensing in various categories. This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's authority. Issued in Austin, Texas, on February 21, 1995. TRD-9502257 Paula Cochran Carter General Counsel Texas Racing Commission Effective date: March 15, 1995 Proposal publication date: December 30, 1994 For further information, please call: (512) 794-8461 Chapter 313. Officials and Rules of Horse Racing Subchapter D. Running of the Race Pre-race Procedure 16 TAC sec.313.422 The Texas Racing Commission adopts an amendment to sec.313.422, concerning saddling, without changes to the proposed text as published in the December 30, 1994, issue of the Texas Register (19 TexReg 10409). The amendment requires a horse to race with the appropriate equipment and requires all equipment to be used consistently on a horse. The amendment is adopted to ensure that the pari-mutuel racing will be of the utmost integrity. No comments were received regarding adoption of the amendment. The amendment is adopted under Texas Civil Statutes, Article 179e, sec.3.02, which authorize the commission to adopt rules for conducting racing with wagering and for administering the Texas Racing Act; and sec.6.06, which authorizes the commission to adopt rules relating to all aspects regarding the operation of racetracks. This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's authority. Issued in Austin, Texas, on February 21, 1995. TRD-9502258 Paula Cochran Carter General Counsel Texas Racing Commission Effective date: March 15, 1995 Proposal publication date: December 30, 1994 For further information, please call: (512) 794-8461 Chapter 319. Veterinary Practices and Drug Testing Subchapter B. Treatment of Horses 16 TAC sec.319.111 The Texas Racing Commission adopts an amendment to sec.319.111, concerning the program for bleeders and Lasix administration, without changes to the proposed text as published in the December 30, 1994, issue of the Texas Register (19 TexReg 10409). The amendment is adopted to ensure that pari-mutuel racing will be safe for the race horses. The amendment changes the time after a race or workout during which a horse must bleed to be certified as a bleeder. No comments were received regarding adoption of the amendment. The amendment is adopted under Texas Civil Statutes, Article 179e, sec.3.02, which authorize the commission to adopt rules for conducting racing with wagering and for administering the Texas Racing Act; sec.6.06, which authorizes the commission to adopt rules relating to all aspects regarding the operation of racetracks; and sec.14.03, which authorizes the commission to adopt rules relating to the use of medication on race horses. This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's authority. Issued in Austin, Texas, on February 21, 1995. TRD-9502259 Paula Cochran Carter General Counsel Texas Racing Commission Effective date: March 15, 1995 Proposal publication date: December 30, 1994 For further information, please call: (512) 794-8461 TITLE 19. EDUCATION Part I. Texas Higher Education Coordinating Board Chapter 7. Texas State Postsecondary Review Program Subchapter C. State Review Standards and Procedures 19 TAC sec.7.42 The Texas Higher Education Coordinating Board adopts new Subchapter C, sec.7.42, concerning Texas State Postsecondary Review Program (State Review Standards and Procedures), with changes to the proposed text as published in the November 15, 1994, issue of the Texas Register (19 TexReg 8915). The new rules are necessary to implement the State Postsecondary Review Program (a federal program) and establish the guidelines under which the State Postsecondary Review Entity will review institutions of higher education in the state. The rules will guide the activities of the State Postsecondary Review Entity in its review of institutions of higher education. They will also establish the standards developed in consultation with affected schools. The rules will eliminate fraud and abuse in Title IV, HEA programs, reduce loss resulting from high defaults in student loan program, and increase overall quality of education in the state. The possible economic cost to persons who are required to comply with the rule as proposed will be contingent on the degree of non-compliance with the standards. Refusal to bring an institution into compliance could result in the recommendation to terminate the institutions participation in Title IV, HEA programs. Comments were received from the following institutions on the review standards: Abilene Christian University; Amarillo College; Brazosport College; Cisco Junior College; Court Reporting Institute of Dallas; Executive Secretarial School; Our Lady of the Lake University; Southwest School of Electronics; Southwest Texas State University; Sul Ross State University; University of North Texas; University of Texas Health Science Center-San Antonio; University of Texas-Pan American; University of Texas-Tyler. The comments have been summarized by standard number as follows: Standard Number 1. One institution stated that standard number 1 would not apply to them as they had no course cancellation policy and did not drop courses once they were placed on the schedule. Standard Number 8. One institution wanted to ensure that the transfer of credit was a policy of the receiving institution and not automatic as the standard implied. Staff agreed with comments and changed the standard. Standard Number 9. Four institutions commented on this standard. One institution objected to the use of "average remuneration" and requested the use of "median earnings" and also objected to the use of state-verified NOICC employment data. Two other institutions objected to the government setting the "absolute level of tuition" and thought that establishing an "absolute level of tuition charge" was beyond the scope of the federal law and complained of educational mediocrity enforced by the Department of Education policy. The fourth institution was concerned that the stature of its certificate programs would be diminished if they were labeled "vocational." Staff disagreed with the comments objecting to use of NOICC data because use of NOICC data is federally mandated. Standard Number 10. Three institutions commented on standard number 10. One suggested the inclusion of geographic factors in "employment opportunities. Staff disagreed because, as stated, there are no limits to geographic employment opportunities in the standard; thus, regional opportunities could also be accommodated. Another thought that clarification was needed on what would be included in the definition of a "professional" program. Staff agreed and incorporated the definition by reference. A third thought that standard number 10 forced a market orientation upon professional programs by tying them to employment opportunities. They did not believe that faculty should be expected to teach to employment opportunities-not in universities. Standard Number 11. Three institutions commented on standard number 11. One thought that the standard would infringe upon the students by requiring them to complete a program within a specified period of time. The other two objected to the government setting the absolute level of course and program length, prohibiting proprietors from responding to the demands of the free market. Staff disagreed with comments because the federal intent is not to set a single standard for maximum program length but to provide a safeguard against course stretching. They also disagreed because the standard relates to credit or clock hours required for a program, not the actual time a student takes to complete it. Standard Number 14. One institution commented that the term "program" was not specific and could be interpreted as academic, student support or even administrative. Staff agreed but made no change because the standard merely calls for the existence of an institutional complaints procedure. Standard Number 17. Twelve institutions commented on various aspects of standard number 17. Eight institutions thought the completion graduation rates were unreasonable. One institution expressed concerns on the use of Student Right to Know language. Staff disagreed because SRK will become the norm as soon as Final Regulations for it are drafted. One institution objected to the 70% placement in the equal to or less than 600 clock hour programs. Staff disagreed because this percentage is already a federal mandate. One institution thought a withdrawal rate less than 33% does not necessarily describe a good school. One institution stated that the licensure exam passage rate will penalize rural institutions, minority-rich institutions and institutions with probationally- admitted students since they will tend to be below national or state passage rates. Staff disagreed since license and passage rates only apply to completers of programs and thus would be a fair comparison on a state or national level. Another thought the licensure exam passage rate for dental school graduates would be difficult to apply with current problems regarding certification. Two institutions offered general comments. One related to reiterating the scope of the program within the standards subsection. The second thought that the Coordinating Board should function as an investigative body and not as a regulatory body. The new rule is adopted under 42 United States Code, sec.1099 a-1 and Texas Education Code, Chapter 61, sec.61.927, which provides the Texas Higher Education Coordinating Board with the authority to adopt rules concerning State Postsecondary Review Program (State Review Standards and Procedures. sec.7.42. State Review Standards. If an institution has been identified for review based on referral by the Secretary or selection by the Board, it shall be reviewed on the basis of the following standards, compliance guidelines, and referenced regulations. (1) Catalogs and Other Documents. (A) Review Standard Number 1. The institution shall publish and make available to prospective and enrolled students catalogs and other appropriate documents which provide accurate and current information regarding, but not necessarily limited to, clearly stated admissions requirements; academic calendar; program and course descriptions; schedules of tuition and fees; course cancellation policies; financial aid; refunds; withdrawals; policies for academic progress and dismissal; standards of student conduct including student rights and responsibilities; disciplinary procedures; rules and regulations of the institution that relate to students; enrollment agreements as applicable; and institutional and state complaint procedures. (B) Compliance Guideline Number 1. The institution shall be considered in compliance if the information required by Review Standard Number 1 is documented in the catalog or other form, and it is available for distribution to prospective and enrolled students. (C) References. See paragraph (2)(C) of this section (Review Standard Number 2). (2) Courses and Programs. (A) Review Standard Number 2. The institution's course and program descriptions shall represent actual course and program content. (B) Compliance Guideline Number 2. The institution's description of its courses and educational programs will be considered accurate unless there is evidence to the contrary. (C) References. 34 Code of Federal Regulation, sec.668.14(b)(9)(10)(i) (59 FedReg 22426 (1994)); 34 Code of Federal Regulation, Subpart D, sec.sec.668.41- 668. 44 (1993); 34 Code of Federal Regulation, Subpart F, sec.sec.668.71-668.74 (1993); and 20 United States Code, sec.1092(a) (1994) (HEA, Part G, sec.485(a)). (3) Admissions Standards. (A) Review Standard Number 3. The institution shall publish its general standards for admission and the standards for admission to specific programs if they differ from general admission requirements, and shall consistently apply its published standards. The standards shall be designed to identify students likely to be able to complete successfully the course of study for which he or she has applied. The standards shall include one or more of the following: (i) a high school transcript, diploma, or high school equivalency diploma; (ii) an official academic transcript from an accredited institution of higher education; (iii) passing scores on independently administered tests approved by the Secretary of Education; or (iv) by satisfying other appropriate admissions requirements and/or placement standards. (B) Compliance Guideline Number 3. The institution shall be considered in compliance if its records show its admissions decisions are based on its published admissions policy, which must include one or more of subparagraph (A)(i)-(iv) of this paragraph. (C) References. 34 Code of Federal Regulation, sec.668.7(b) (1993); 34 Code of Federal Regulation, sec.600.5 (59 FedReg 22337 (1994)); and 34 Code of Federal Regulation, sec.600.7 (59 FedReg 22339 (1994)). (4) Academic Progress. (A) Review Standard Number 4. The institution shall have a written policy that defines acceptable academic progress and at least once in an academic year shall review the progress of all regular students to determine whether standards of academic progress are being achieved. The policy shall specify the range of actions the institution may take if satisfactory academic progress is not achieved. (B) Compliance Guideline Number 4. The institution shall be considered in compliance if it has a written policy defining acceptable academic progress and all regular students are reviewed in accordance with this policy at least once in an academic year. (C) References. 34 Code of Federal Regulation, sec.667.21(b)(3) (9 FedReg 22295 (1994)); 34 Code of Federal Regulation, sec.668.7(c) (1993); and 34 Code of Federal Regulation, sec.668.16(e) (59 FedReg 22431 (1994)). (5) Student Records. (A) Review Standard Number 5. The institution shall maintain records for each student that include: (i) transcripts that contain a student's name, address, and social security number; (ii) dates of attendance and completion or termination; (iii) a copy of the enrollment agreement (if any); (iv) a record of all courses (including remedial courses) taken at the institution; (v) a record of any credit granted; (vi) the total number of credit or clock hours of instruction received; (vii) grades and dates of enrollment for each course or unit of instruction; (viii) cumulative grade for completed work; (ix) an explanation of the grading system; (x) financial aid records; and (xi) other such student records as prescribed by federal laws and regulations. (B) Compliance Guideline Number 5. The institution shall be considered in compliance if it has records for each student that contain the information required in Review Standard Number 5. (C) References. 34 Code of Federal Regulation, sec.667.21(b)(3) (9 FedReg 22295 (1994)); 34 Code of Federal Regulation, sec.668.23(h)(1) to sec.668.24 (59 FedReg 22440-22441 (1994)); and 34 Code of Federal Regulation, sec.668.36 (1993). (6) Safety. (A) Review Standard Number 6. The institution shall certify and maintain its compliance with applicable safety, health, fire, building, and sanitation regulations. (B) Compliance Guideline Number 6. The institution shall be considered in compliance if it provides current certification that there are no citations, or if cited, there is a plan for coming into compliance that has been accepted by the citing authority. (C) References. None are cited. (7) Financial and Administrative Adequacy. (A) Review Standard Number 7. The institution shall maintain evidence of current financial, administrative, and other resources which are adequate to ensure satisfactory conduct of its programs and the achievement of its stated educational goals. (B) Compliance Guideline Number 7. The institution's financial and administrative capacity and resources to conduct its programs shall be considered in compliance if they meet or exceed the requirements of the U.S. Department of Education. (C) References. 34 Code of Federal Regulation, sec.668.15 (59 FedReg 22428- 22431 (1994)); 34 Code of Federal Regulation, sec.668.16 (59 FedReg 22431-22433 (1994)); 34 Code of Federal Regulation, sec.668.23 (59 FedReg 22439 (1994)); and 34 Code of Federal Regulation, sec.668.82 (59 FedReg 22444 (1994)). (8) Closure Plan. (A) Review Standard Number 8. If, in accordance with Review Standard Number 7, the institution is determined to be financially at risk, it shall present a written plan acceptable to the Board staff which provides for the retention of and accessibility to its academic and financial aid records in the event of institutional closure. The institution shall make reasonable efforts to identify opportunities for students to transfer to alternative programs of instruction and present a written plan for informing students of their options. (B) Compliance Guideline Number 8. The institution shall be considered in compliance if it has a written plan acceptable to Board staff which (i) provides for retention of and accessibility to its academic and financial aid records in event of institutional closure; (ii) identifies reasonable opportunities for students to transfer to alternative programs; and (iii) contains evidence of assurance of financial and educational protection of the students. (C) References. 34 Code of Federal Regulation, sec.668.15(d)-(e) (59 FedReg 22428 (1994)). (9) Cost Benefits. (A) Review Standard Number 9. This standard applies to vocational programs with certificates or degrees less than a baccalaureate degree, obtainable through courses of study less than four years in length, which have as their objective preparing students for gainful employment in specific recognized occupations. For each of these programs, the institution shall obtain and make available to students information regarding the total costs of tuition and fees for completing the program and the average remuneration an employee earns in the occupation for which the program is designed to prepare the student. (i) The tuition and fees charged a student shall be reasonable. (ii) See Review Standard Number 11 for length of course; see Review Standard Number 17 for placement rates. (B) Compliance Guideline Number 9. The institution shall be considered in compliance if the sum of tuition and fees charged to complete the program is not greater than two-thirds of the average earnings for the occupation based on state or regional data. For programs one year or less, the earnings period shall be one year. For programs longer than one year, the earnings period shall be the same length as the vocational program. (C) References. 34 Code of Federal Regulation, sec.600.2 (59 FedReg 22336 (1994)); 34 Code of Federal Regulation, sec. sec.600.4-600.6 (59 FedReg 22337- 22341 (1994)); and 34 Code of Federal Regulation, sec.668.14(b)(26) (59 FedReg 22427 (1994)). (10) Occupational Information. (A) Review Standard Number 10. The institution shall publish and provide to all prospective and enrolled students in occupational, professional, and vocational programs information showing employment opportunities in recognized occupations for which those programs were designed. The institution shall publish and make available to prospective and enrolled students information that identifies courses necessary for state licensure in its specific occupational, professional, and vocational programs. This information shall also specify the relationship of the institution's programs and courses to specific Texas licensure requirements. (B) Compliance Guideline Number 10. The institution shall be considered in compliance if: (i) it publishes and provides to all prospective and enrolled students in occupational, professional, and vocational programs information showing employment opportunities in recognized occupations for which those programs were designed; (ii) it publishes and provides to all prospective and enrolled students information that identifies courses designed to meet the requirements for state licensure in its specific occupational, professional, and vocational programs; and (iii) the information specifies the content and skills relationship of the institution's programs and courses to specific Texas licensure requirements. (C) References. 34 Code of Federal Regulation, sec.668.14(b)(10)(i)-(ii) (59 FedReg 22426 (1994)). (11) Program Length. (A) Review Standard Number 11. The number of credit or clock hours required for the completion of any program shall be consistent with: (i) common practice in similar postsecondary education programs; (ii) state licensing or certification standards; and (iii) accrediting agency requirements. (B) The institution shall maintain and publish information specifying the length of its programs. See also Review Standard Number 12. (C) Compliance Guideline Number 11. The institution shall be considered in compliance if: (i) the number of credit or clock hours required for the completion of any program is consistent with: (I) common practice in similar postsecondary education programs in that the length is not more than 10% above the median of similar programs in the state or region preparing students for the same occupation; (II) state licensing or certification standards; and (III) accrediting agency requirements; and (ii) it maintains and publishes information specifying the length of its programs. (D) References. 34 Code of Federal Regulation, sec.668.8(a)-(e)(iv) and sec.668.8(k)-(l) (59 FedReg 22421 (1994)). (12) 600-Clock Hour Programs. (A) Review Standard Number 12. The 600-clock hour courses shall be of appropriate length that is consistent with: (i) applicable accrediting or credentialing requirements; (ii) available industry standards; and (iii) the length of similar programs in the state or region (by CIP code). See also Review Standard Number 11. (B) Compliance Guideline Number 12. The institution shall be considered in compliance if the length of each 600-clock hour program is consistent with applicable accrediting or credentialing requirements and available industry standards. In the absence of such standards then the length shall be comparable to the length of similar programs in the state or region (by CIP code). (C) References. 34 Code of Federal Regulation, sec.668.8(d)-(e)(iv) (59 FedReg 22421 (1994)). (13) Legal Qualifications. (A) Review Standard Number 13. The institution shall not have an owner, chief executive officer, member of a governing board, or shareholder (if applicable) who has been: (i) convicted of, or pled nolo contendere or guilty to, a crime involving the misappropriation, misuse, acquisition, or expenditure of funds; or (ii) judicially determined to have committed fraud involving funds; or (iii) found liable in a civil proceeding for misappropriation or misuse of funds. (B) Compliance Guideline Number 13. The institution shall be considered in compliance if it provides current notarized certification that no owner, chief executive officer, shareholder or board member has been either convicted of, or pled nolo contendere or guilty to, a crime involving the misappropriation, misuse, acquisition, use, or expenditure of funds; judicially determined to have committed fraud involving funds; or found liable in a civil proceeding for misappropriation or misuse of funds. (C) References. 34 Code of Federal Regulation, sec.600.7(a)(3) (59 FedReg 22339 (1994)); 34 Code of Federal Regulation, sec.600.30(a)(7) (59 FedReg 22343 (1994)); 34 Code of Federal Regulation, sec.668.14(b)(18) (59 FedReg 22426 (1994)); 34 Code of Federal Regulation, sec.668.15(c)-(d) (59 FedReg 22428 (1994)); and 34 Code of Federal Regulation, sec.668.82(a)-(c) (59 FedReg 22450 (1994)). (14) Institutional Complaints Procedures. (A) Review Standard Number 14. The institution shall publish and consistently administer internal procedures to receive, investigate, and formally respond to student complaints. At a minimum, the complaints procedure should process complaints concerning the management or conduct of its programs or concerning misleading advertisement and promotion of those programs. (B) Compliance Guideline Number 14. The institution shall be considered in compliance if it has a procedure for receiving, investigating, and resolving student complaints which at a minimum, processes complaints concerning the management or conduct of its programs or concerning misleading advertisement or promotion of those programs. (C) References. 34 Code of Federal Regulation, sec.667.21(b)(3) (59 FedReg 22295 (1994)). (15) Advertising, Promotion, and Recruitment. (A) Review Standard Number 15. Advertising, promotion, or student recruitment practices conducted by or on behalf of an institution shall not be false or misleading. (B) Compliance Guideline Number 15. The institution shall be considered in compliance if information provided to prospective and enrolled students is specific and accurate with respect to the costs of attendance, conditions, and benefits of the institution and its programs. (C) References. 34 Code of Federal Regulation, sec. sec.668.71-668.74 (1993); 34 Code of Federal Regulation, sec.668.14(b)(10) (59 FedReg 22426 (1994)); and 34 Code of Federal Regulation, sec.668.14(b)(22) (59 FedReg 22427 (1994)). (16) Refund Policies. (A) Review Standard Number 16. The institution shall publish and consistently administer fair and equitable refund policies that include procedures for official student withdrawal. (B) Compliance Guideline Number 16. The institution shall be considered in compliance if its refund policy complies with sec.484B of the HEA and the relevant implementing regulations with regard to students who receive Title IV financial aid. For non-Title IV students, the institution shall be in compliance if the refund policy complies with appropriate accrediting agency guidelines andor other state and federal regulations. (C) References. 34 Code of Federal Regulation, sec.668.22 (59 FedReg 22436 (1994)); and 34 Code of Federal Regulation, Appendix A to Part 668 (59 FedReg 22453 (1994)). (17) Success Standards. (A) Review Standard Number 17. The institution's educational programs shall be successful as measured by its completiongraduation, withdrawal, placement, and licensure examination passage rates. (B) Compliance Guideline Number 17. (i) Compliance Guideline (Completion Graduation). (I) With regard to programs equal to or less than 600 clock hours, the reviewed institution shall be considered in compliance if its most recently calculated completiongraduation rate meets or exceeds the Secretary's requirements. (II) With regard to Coordinating Board approved associate degree and Coordinating Board approved certificate programs greater than 600 clock hours, the reviewed institution shall be in compliance if its most recently calculated completiongraduation rate meets or exceeds the standards established in the Coordinating Board's Performance Measures and Core Standards for Postsecondary Technical Education Programs, as revised. (III) With regard to all other programs, the reviewed institution shall be considered in compliance if its most recently calculated completiongraduation rate is equal to or greater than 85% of the median of similar institutions in the state or region, as classified by the Coordinating Board. (ii) Compliance Guideline (Withdrawal). The institution shall be considered in compliance if its withdrawal rate is in compliance with federal requirements, which currently is equal to or less than 33%. (iii) Compliance Guideline (Placement Rate). The institution shall be considered in compliance if, with respect to its vocational and professional programs, the placement rate of graduates in occupations related to their educational programs is equal to or greater than the following: (I) Programs greater than 600 clock hours-60%; and Programs equal to or less than 600 clock hours-70%. Related programs and occupations will be determined by reference to the Texas-verified NOICC Master Crosswalk. (iv) Compliance Guideline (Licensure Examination Pass Rate). The institution shall be considered in compliance if, for appropriate programs of study, the licensure examination pass rate for two of the past three years equals or exceeds national or state rates for the examination. (C) References. 34 Code of Federal Regulation, sec.668.8(e)-(h) (59 FedReg 22421 (1994)); 34 Code of Federal Regulation, sec.668.16(l) (59 FedReg 22431 (1994)); and 20 Code of Federal Regulation, sec.1092(a) (1994) Student Right-to- Know Act of 1990, as amended {HEA, Part G, sec.485(a)). This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Issued in Austin, Texas, on February 21, 1995. TRD-9502284 James McWhorter Assistant Commissioner for Administration Texas Higher Education Coordinating Board Effective date: March 16, 1995 Proposal publication date: December 20, 1994 For further information, please call: (512) 483-6160 Chapter 9. Public Junior Colleges Subchapter E. Operational Provisions 19 TAC sec.9.103 The Texas Higher Education Coordinating Board adopts an amendment to sec.9. 103, concerning Operational Provisions (Reporting for State Reimbursement), without changes to the proposed text as published in the December 20, 1994, issue of the Texas Register (19 TexReg 10063). The Coordinating Board's rules for refund of tuition and fees at public community and technical colleges have been found to be unnecessary because refunds to students who receive any federal Title IV student aid must be handled according to federal regulations, which differ from the Board's regulations. A high percentage of students enrolled at the community and technical colleges receive Title IV aid. In addition, the Texas Education Code does not require the Board to regulate refunds at community and technical colleges. The proposed amendment will eliminate the Board's regulation of the refund of tuition and fees. Refund policies will become institutional policy decisions rather than governance by Coordinating Board rules. No comments were received as a result of the proposed rule change. The amendment is adopted under Texas Education Code, Subchapter 61, Subchapter C, sec.61.062(c), which provides the Texas Higher Education Coordinating Board with the authority to adopt rules concerning Operational Provisions (Reporting for State Reimbursement). This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Issued in Austin, Texas, on February 21, 1995. TRD-9502287 James McWhorter Assistant Commissioner for Administration Texas Higher Education Coordinating Board Effective date: March 16, 1995 Proposal publication date: December 20, 1994 For further information, please call: (512) 483-6160 Chapter 21. Student Services Subchapter A. General Provisions 19 TAC sec.21.3 The Texas Higher Education Coordinating Board adopts an amendment to sec.21.3, concerning Loan Repayment Deferral and Loan Forgiveness for Emergency Tuition Loans Made Under Texas Education Code, sec.56.051, without changes to the proposed text as published in the December 20, 1994, issue of the Texas Register (19 TexReg 10063). The amendment is being made to give better guidance to institutions for audit compliance. Institutions will have been notified of audit requirements. The amendment will make it better able to comply with criteria of auditors. No comments were received as a result of the rule change. The amendment is adopted under Texas Education Code, sec.56.055, which provides the Texas Higher Education Coordinating Board with the authority to adopt rules concerning Loan Repayment Deferral and Loan Forgiveness for Emergency Tuition Loans Made Under Texas Education Code, sec.56.051. This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Issued in Austin, Texas, on February 21, 1995. TRD-9502275 James McWhorter Assistant Commissioner for Administration Texas Higher Education Coordinating Board Effective date: March 16, 1995 Proposal publication date: December 20, 1994 For further information, please call: (512) 483-6160 19 TAC sec.21.4 The Texas Higher Education Coordinating Board adopts new sec.21.4, concerning Collection of Tuition, without changes to the proposed text as published in the December 20, 1994, issue of the Texas Register (19 TexReg 10064). The new section is being made to give better guidance to institutions for audit compliance. Institutions will have been notified of audit requirements. The amendments will make it better able to comply with criteria of auditors. No comments were received as a result of the new section. The new section is adopted under Texas Education Code, sec.61.051(a), which provides the Texas Higher Education Coordinating Board with the authority to adopt rules concerning Collection of Tuition. This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Issued in Austin, Texas, on February 21, 1995. TRD-9502276 James McWhorter Assistant Commissioner for Administration Texas Higher Education Coordinating Board Effective date: March 16, 1995 Proposal publication date: December 20, 1994 For further information, please call: (512) 483-6160 Subchapter J. The Physician Education Loan Repayment Program 19 TAC sec.sec.21.254, 21.255, 21.257, 21.261 The Texas Higher Education Coordinating Board adopts amendments to sec.sec.21. 254, 21.255, 21.257, and 21.261, concerning the Physician Education Loan Repayment Program, without changes to the proposed text as published in the December 20, 1994, issue of the Texas Register (19 TexReg 10064). The amendments are being made to comply with changes in federal statutes. The amendments change terminology to be consistent with federal statutes. No comments were received as a result of the rule changes. The amendments are adopted under Texas Education Code, sec.61.537, which provides the Texas Higher Education Coordinating Board with the authority to adopt rules concerning the Physician Education Loan Repayment Program. This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Issued in Austin, Texas, on February 21, 1995. TRD-9502273 James McWhorter Assistant Commissioner for Administration Texas Higher Education Coordinating Board Effective date: March 16, 1995 Proposal publication date: December 20, 1994 For further information, please call: (512) 483-6160 Subchapter L. Paul Douglas Teacher Scholarship Program 19 TAC sec.sec.21.307, 21.309, 21.311, 21.312, 21.320, 21.323, 21.335 The Texas Higher Education Coordinating Board adopts amendments to sec.sec.21. 307, 21.309, 21.311, 21.312, 21.320, 21.323, and 21.325, without changes to the proposed text as published in the December 20, 1994, issue of the Texas Register (19 TexReg 10065). The amendments are being made to comply with changes in federal statutes. The amendments change eligibility criteria. More students may qualify for the program benefits. No comments were received as a result of the rule changes. The amendments are adopted under Texas Education Code, sec.61.068, which provides the Texas Higher Education Coordinating Board with the authority to adopt rules concerning the Physician Education Loan Repayment Program. This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Issued in Austin, Texas, on February 21, 1995. TRD-9502274 James McWhorter Assistant Commissioner for Administration Texas Higher Education Coordinating Board Effective date: March 16, 1995 Proposal publication date: December 20, 1994 For further information, please call: (512) 483-6160 TITLE 22. EXAMINING BOARDS Part XV. Texas State Board of Pharmacy Chapter 291. Pharmacies Community Pharmacy (Class A) 22 TAC sec.291.36 The Texas State Board of Pharmacy adopts an amendment to sec.291.36, concerning Class A Pharmacies Compounding Sterile Pharmaceuticals, with changes to the proposed text as published in the August 26, 1994, issue of the Texas Register (19 TexReg 6699). These rules will specify minimum requirements for the operation of Class A Pharmacies Compounding Sterile Pharmaceuticals and implement the recommendations of the Task Force on Class C Pharmacy Practice. As a part of its recommendations, the Task Force on Class C Pharmacy Practice recommended that the rules for Class A Pharmacies Compounding Sterile Pharmaceuticals be amended to match the sterile products requirements proposed in the Class C rules including training of technicians and duties of technicians. A public hearing on the proposed rules was held on October 25, 1995, at which time comments were received from ten persons. In addition, the agency received written comments from seven persons on the proposed rules. The Texas Pharmacy Association recommended that clarification be made regarding the type of on-the-job training that would be allowed for technicians and that technicians be allowed to obtain their training from an approved provider. The Board agrees with these comments and has modified the rules to specify that the on-the-job training should be a structured program that is not transferable to another pharmacy and to allow technicians to receive their training from an approved provider. Specifically, the comments and the Board's response to these comments are as follows: (b) Definitions: Several persons indicated that the definition of batch preparation (definition 7) was unclear-the Board agreed and has amended the definition to clarify that batch preparation/compounding does not include the preparation of multiple sterile-product units pursuant to medication orders; several persons indicated that it was unclear what products should be included in each Risk Level-the Board agrees and has eliminated the definitions of Risk Levels 1, 2, and 3 (definitions 48, 49, and 50) and deleted the definition of closed-system transfer (definition 13) since it is no longer needed. (c) Personnel: In (1)(B)(ii) the reference to subsection (c)(3) has been corrected to (d)(3); one person commented that "handling of cytotoxic and hazardous drug" should be added to the list of training subjects in (4)(A)(i) - the Board agreed and has amended the rules; several persons disagreed with allowing on-the-job training for pharmacists and supportive personnel in (4)(B) and (C)-the Board disagrees with this comment and believes that on-the-job training has been effectively used in Class C pharmacy practice for many years; however, the Board has amended the language to specify that on-the-job training is not transferable from one facility to another whereas the training received from colleges of pharmacy and approved providers is transferable; in addition, the Board has delayed implementation of this requirement until March 1, 1996; several persons commented regarding the requirement for annual continuing education for pharmacists and pharmacy supportive personnel in (4) (B) and (C)- the Board agrees with these comments and has eliminated this provision; several persons suggested that supportive personnel be given the option to obtain their training through a course presented by an approved provider-the Board agrees with the suggestion and has amended the rules to allow supportive personnel receive their training from an approved provider; and several persons questioned the need and practicality for the subparagraph on the training of personnel to clean the controlled area (4)(D)-the Board agreed and has eliminated this subparagraph. (d)(2) Environment. Several persons commented in opposition to the multi-tier levels of sterile pharmaceuticals-the Board agrees with this comment and has eliminated the risk levels and the different environmental standards for those levels, resulting in one set of standards for the environment; several persons commented that pre-filters did not need to be changed every time they were inspected-the Board agreed and has modified the section to require periodic inspection of the filter with changing as needed; several persons commented that a vertical flow hood should be allowed to be used to compound other sterile products, not just cytotoxic drugs-the Board agreed and has modified the section to allow the vertical flow hood to be used for other products if it is properly cleaned. (d)(4) Pharmaceutical care services. The reference to medication order in (A)(ii) has been corrected to prescription drug order; one person commented that the requirement that a pharmacist contact the prescribing practitioner to resolve any questions discovered during the drug regimen review was eliminated from clause (i) and should be included-the Board agrees and has added this requirement as a new subclause (II). (d)(6) Equipment and supplies. Several persons commented that the subparagraph regarding the temperature monitoring required for a refrigerator was not clear- the Board agreed and has modified the subparagraph to clarify. (d)(7) Library. Several persons commented that the title of the American Hospital Formulary Service has changed and that a pharmacy should not be required to have the Federal Current Good Manufacturing Practices for Finished Pharmaceuticals (CGMPFP)-the Board agreed and has corrected the reference to the AHFS Drug Information and deleted the requirement for the CGMPFP. (d)(10) Sterile pharmaceuticals. One person commented on the requirements for the master and preparation work sheets by indicating that subclauses (XI) storage requirements and (XII) specific equipment used during aseptic preparation should be moved from the preparation work sheet to the master work sheet-the Board agreed and has modified the rules accordingly; in addition, all references to the risk levels has been eliminated; the reference to the risk levels has also been eliminated from the Quality Control subparagraph (D). The amendment is adopted under the Texas Pharmacy Act (Article 4542a-1, Texas Civil Statutes), sec.4, which specifies that the purpose of the Act is to protect the public through the effective control and regulation of the practice of pharmacy; sec.16(a), which gives the Board the authority to adopt rules for the proper administration and enforcement of the Act; sec.17(b)(2) and (3), which gives the Board the authority to specify minimum standards for: professional environment, technical equipment, and security in the prescription dispensing area, drug storage, maintenance of prescription drug records and procedures for the delivery, dispensing in a suitable container appropriately labeled, providing of prescription drugs or devices, monitoring of drug therapy, and counseling of patients on proper use of prescription drugs and devices within the practice of pharmacy; and sec.17(o), which gives the Board the authority to establish rules for the use of supportive personnel and the duties of those personnel in pharmacies licensed by the Board. sec.291.36. Class A Pharmacies Compounding Sterile Pharmaceuticals. (a) (No change.) (b) Definitions. The following words and terms, when used in this section, shall have the following meanings unless the context clearly indicates otherwise. (1)-(2) (No change.) (3) Airborne particulate cleanliness class-The level of cleanliness specified by the maximum allowable number of particles per cubic foot of air as specified in Federal Standard 209 E, et seq. For example: (A) Class 100 is an atmospheric environment which contains less than 100 particles 0.5 microns in diameter per cubic foot of air; (B) Class 10,000 is an atmospheric environment which contains less than 10,000 particles 0.5 microns in diameter per cubic foot of air; and (C) Class 100,000 is an atmospheric environment which contains less than 100,000 particles 0.5 microns in diameter per cubic foot of air. (4) Ancillary supplies-Supplies necessary for the administration of compounded sterile pharmaceuticals. (5) Aseptic preparation-The technique involving procedures designed to preclude contamination of drugs, packaging, equipment, or supplies by microorganisms during processing. (6) Automated compounding or drug dispensing system -An automated device that compounds, measures, counts and/or packages a specified quantity of dosage units for a designated drug product. (7) Batch preparation compounding-Compounding of multiple sterile-product units, in a single discrete process, by the same individual(s), carried out during one limited time period. Batch preparation/compounding does not include the preparation of multiple sterile-product units pursuant to patient specific medication orders. (8) Biological Safety Cabinet-Containment unit suitable for the preparation of low to moderate risk agents where there is a need for protection of the product, personnel, and environment, according to National Sanitation Foundation (NSF) Standard 49. (9) Board-The Texas State Board of Pharmacy. (10) Carrying out a prescription drug order-To complete a prescription drug order presigned by the delegating physician by providing the following information: (A)-(F) (No change.) (11) Clean-room-A room in which the concentration of airborne particles is controlled and there are one or more clean zones according to Federal Standard 209E, et seq. (12) Clean zone-A defined space in which the concentration of airborne particles is controlled to meet a specified airborne particulate cleanliness class. (13) Compounding-The preparation, mixing, assembling, packaging, or labeling of a drug or device: (A) as the result of a practitioner's prescription drug or medication order or initiative based on the practitioner-patient pharmacist relationship in the course of professional practice; (B) in anticipation of prescription drug or medication orders based on routine, regularly observed prescribing patterns; or (C) for the purpose of or as an incident to research, teaching, or chemical analysis and not for sale or dispensing. (14) Confidential record-Any health related record maintained by a pharmacy or pharmacist such as a patient medication record, prescription drug order, or medication drug order. (15) Controlled area-A controlled area is the area designated for preparing sterile pharmaceuticals. (16) Controlled substance-A drug, immediate precursor, or other substance listed in Schedules I-V or Penalty Groups 1-4 of the Texas Controlled Substances Act, as amended, or a drug, immediate precursor, or other substance included in Schedule I, II, III, IV, or V of the Federal Comprehensive Drug Abuse Prevention and Control Act of 1970, as amended (Public Law 91-513). (17) Critical areas-Any area in the controlled area where products or containers are exposed to the environment. (18) Cytotoxic-A pharmaceutical that has the capability of killing living cells. (19) Dangerous drug-Any drug or device that is not included in Penalty Groups 1-4 of the Controlled Substances Act and that is unsafe for self-medication or any drug or device that bears or is required to bear the legend: (A)-(B) (No change.) (20) Deliver or delivery-The actual, constructive, or attempted transfer of a prescription drug or device or controlled substance from one person to another, whether or not for a consideration. (21) Designated agent- (A) a licensed nurse, physician assistant, pharmacist, or other individual designated by a practitioner, and for whom the practitioner assumes legal responsibility, who communicates prescription drug orders to a pharmacist; (B) a licensed nurse, physician assistant, or pharmacist employed in a health care facility to whom the practitioner communicates a prescription drug order; or (C) a registered nurse or physician assistant authorized by a practitioner to carry out a prescription drug order for dangerous drugs under, Medical Practice Act, Article 4459b, sec.3.06(d)(5). (22) Device-An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component part or accessory, that is required under federal or state law to be ordered or prescribed by a practitioner. (23) Dispense-Preparing, packaging, compounding, or labeling for delivery a prescription drug or device in the course of professional practice to an ultimate user or his agent by or pursuant to the lawful order of a practitioner. (24) Distribute-The delivery of a prescription drug or device other than by administering or dispensing. (25) Downtime-Period of time during which a data processing system is not operable. (26) Drug regimen review-An evaluation of prescription drug or medication orders and patient medication records for: (A) known allergies; (B) rational therapy-contraindications; (C) reasonable dose and route of administration; (D) reasonable directions for use; (E) duplication of therapy; (F) drug-drug interactions; (G) drug-food interactions; (H) drug-disease interactions; (I) adverse drug reactions; and (J) proper utilization, including overutilization or underutilization. (27) Expiration date-The date (and time, when applicable) beyond which a product should not be used. (28) Facsimile (FAX) prescription drug order-A prescription drug order which is transmitted by an electronic device which sends an exact image to the receiver (pharmacy) over telephone lines. (29) Full-time pharmacist-A pharmacist who works in a pharmacy from 30 to 40 hours per week or if the pharmacy is open less than 60 hours per week, one-half of the time the pharmacy is open. (30) Hard-copy-A physical document that is readable without the use of a special device (i.e., cathode ray tube (CRT), microfiche reader, etc). (31) Medical Practice Act-The Texas Medical Practice Act, Texas Civil Statutes, Article 4495b, as amended. (32) New prescription drug order-A prescription drug order for a drug not previously self administered by the patient. A new prescription includes a discharge prescription drug order but not a furlough prescription drug order. (33) Original prescription-The: (A)-(C) (No change.) (34) Part-time pharmacist-A pharmacist who works less than full-time. (35) Patient counseling-Communication by the pharmacist of information to the patient or patient's agent, in order to improve therapy by ensuring proper use of drugs and devices. (36) Pharmacist-in-charge-The pharmacist designated on a pharmacy license as the pharmacist who has the authority or responsibility for a pharmacy's compliance with laws and rules pertaining to the practice of pharmacy. (37) Pharmaceutical care-The provision of drug therapy and other pharmaceutical services intended to assist in the cure or prevention of a disease, elimination or reduction of a patient symptoms, or arresting or slowing of a disease process. (38) Physician assistant-A physician assistant recognized by the Texas State Board of Medical Examiners as having the specialized education and training required under the Medical Practice Act, sec.3.06(d), and issued an identification number by the Texas State Board of Medical Examiners. (39) Practitioner- (A)-(D) (No change.) (40) Prepackaging-The act of repackaging and relabeling quantities of drug products from a manufacturer's original commercial container into a prescription container for dispensing by a pharmacist to the ultimate consumer. (41) Prescription drug- (A)-(C) (No change.) (42) Prescription drug order- (A) An order from a practitioner or a practitioner's designated agent to a pharmacist for a drug or device to be dispensed; or (B) An order pursuant to the Medical Practice Act, sec.3.06(d)(5). (43) Process validation-Documented evidence providing a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes. (44) Quality assurance-The set of activities used to assure that the process used in the preparation of sterile drug products lead to products that meet predetermined standards of quality. (45) Quality control-The set of testing activities used to determine that the ingredients, components (e.g., containers), and final sterile pharmaceuticals prepared meet predetermined requirements with respect to identity, purity, non- pyrogenicity, and sterility. (46) Registered Nurse-A registered nurse recognized by the Texas State Board of Nurse Examiners as having the specialized education and training necessary to carry out a prescription drug order and issued an identification number by the Texas State Board of Nurse Examiners. (47) Sample-A prescription drug which is not intended to be sold and is intended to promote the sale of the drug. (48) Sterile pharmaceutical-A dosage form free from living micro-organisms. (49) Supportive personnel-Those individuals utilized in pharmacies whose responsibility it shall be to provide technical services that do not require professional judgement concerned with the preparation and distribution of drugs under the direct supervision of and responsible to a pharmacist. (50) Texas Controlled Substances Act-The Texas Controlled Substances Act, Health and Safety Code, Chapter 481, as amended. (51) Unit-dose packaging-The ordered amount of drug in a dosage form ready for administration to a particular patient, by the prescribed route at the prescribed time, and properly labeled with name, strength, and expiration date of the drug. (52) Unusable drugs-Drugs or devices that are unusable for reasons such as, they are adulterated, misbranded, expired, defective, or recalled. (c) Personnel. (1) Pharmacist-in-charge. (A) (No change.) (B) Responsibilities. The pharmacist-in-charge shall have the responsibility for, at a minimum, the following: (i) developing a system to assure that drugs and/or devices are dispensed and delivered safely and accurately to the patient for whom they are prescribed; (ii) that a pharmacist communicates to the patient or the patient's agent information about the prescription drug or device which in the exercise of the pharmacist's professional judgment, the pharmacist deems significant as specified in subsection (d)(3) of this section; (iii) assuring that a pharmacist communicates to the patient or the patient's agent on his or her request, information concerning any prescription drugs dispensed to the patient by the pharmacy; (iv) assuring that a reasonable effort is made to obtain, record, and maintain patient medication records; (v) developing a system to assure that all pharmacy personnel responsible for compounding and/or supervising the compounding of sterile pharmaceuticals within the pharmacy receive appropriate education and training and competency evaluation; (vi) establishing policies for procurement of drugs and devices and storage of all pharmaceutical materials including pharmaceuticals, components used in the compounding of pharmaceuticals, and drug delivery devices; (vii) developing a system for the disposal and distribution of drugs from the Class A pharmacy; (viii) developing a system for bulk compounding or batch preparation of drugs; (ix) developing a system for the compounding, sterility assurance, quality assurance and quality control sterile pharmaceutical; (x) participating in those aspects of the patient care evaluation program relating to pharmaceutical material utilization and effectiveness; (xi) implementing the policies and decisions relating to pharmaceutical services; (xii) maintaining records of all transactions of the Class A pharmacy necessary to maintain accurate control over and accountability for all pharmaceutical materials required by applicable state and federal laws and rules; (xiii) developing a system to assure the maintenance of effective controls against the theft or diversion of prescription drugs, and records for such drugs; (xiv) assuring that records in a data processing system such that the data processing system is in compliance with this section; (xv) assuring that the pharmacy has a system to dispose of cytotoxic waste in a manner so as not to endanger the public health; and (xvi) legal operation of the pharmacy, including meeting all inspection and other requirements of all state and federal laws or rules governing the practice of pharmacy. (2) Pharmacists. (A) General. (i)-(iv) (No change.) (v) A pharmacist shall be accessible at all times to respond to patients' and other health professionals' questions and needs. Such access may be through a telephone which is answered 24 hours a day. (B) Duties. Duties which may only be performed by a pharmacist are as follows: (i) receiving verbal prescription drug orders and reducing these orders to writing, either manually or electronically; (ii) interpreting and evaluating prescription drug orders; (iii) (No change.) (iv) performing drug regimen reviews; (v)-(viii) (No change.) (3) Supportive personnel. (A) Qualifications. Supportive personnel shall possess the education and training necessary to carry out their responsibilities and shall be qualified to perform the tasks assigned to them. (B) Duties. (i)-(ii) (No change.) (C) (No change.) (D) Training. (i)-(ii) (No change.) (iii) A written record of initial and in-service training of supportive personnel shall be maintained and contain the following information: (I)-(V) (No change.) (4) Special education, training, and evaluation requirements for pharmacy personnel compounding or responsible for the direct supervision of pharmacy personnel compounding sterile pharmaceuticals. (A) General. (i) All pharmacy personnel preparing sterile pharmaceuticals shall receive didactic and experiential training and competency evaluation through demonstration, testing (written or practical) as outlined by the pharmacist-in- charge and described in the policy and procedure or training manual. Such training shall include instruction and experience in the following areas: (I) aseptic technique; (II) critical area contamination factors; (III) environmental monitoring; (IV) facilities; (V) equipment and supplies; (VI) sterile pharmaceutical calculations and terminology; (VII) sterile pharmaceutical compounding documentation; (VIII) quality assurance procedures; (IX) aseptic preparation procedures including proper gowning and gloving technique; (X) handling of cytotoxic and hazardous drugs, if applicable; and (XI) general conduct in the controlled area. (ii) The aseptic technique of each person compounding or responsible for the direct supervision of personnel compounding sterile pharmaceuticals shall be observed and evaluated as satisfactory through written or practical tests and process validation and such evaluation documented. (iii) No product intended for patient use shall be compounded by an individual until the process validation test indicates that the individual can competently perform aseptic procedures. (iv) Process validation procedures for assessing the preparation of a specific risk level sterile pharmaceuticals shall be representative of all types of manipulations, products, and batch sizes that personnel preparing that risk level are likely to encounter. (v) The pharmacist-in-charge shall assure continuing competency of pharmacy personnel through in-service education, training, and process validation to supplement initial training. Personnel competency shall be evaluated: (I) during orientation and training prior to the regular performance of those tasks; (II) whenever the quality assurance program yields an unacceptable result; (III) whenever unacceptable techniques are observed; and (IV) at least on an annual basis. (B) Pharmacists. (i) All pharmacists who compound sterile pharmaceuticals or supervise supportive personnel compounding sterile pharmaceuticals shall: (I) effective March 1, 1996, complete a minimum of 20 hours of instruction and experience in the areas listed in subparagraph (A) of this paragraph. Such training may be through: (-a-) completion of a structured on-the-job didactic and experiential training program at this pharmacy (not transferable to another pharmacy) which provides 20 hours of instruction and experience in the areas listed in paragraph (1) of this subsection; or (-b-) completion of a recognized course in an accredited college of pharmacy or a course sponsored by an American Council on Pharmaceutical Education approved provider which provides 20 hours of instruction and experience in the areas listed in subparagraph (A) of this paragraph; and (II) possess knowledge about: (-a-) aseptic processing; (-b-) quality control and quality assurance as related to environmental, component, and end-product testing; (-c-) chemical, pharmaceutical, and clinical properties of drugs; (-d-) container, equipment, and closure system selection; and (-e-) sterilization techniques. (ii) discontinue preparation of sterile pharmaceuticals if the training specified in clause (i) of this subparagraph is not completed by March 1, 1996. Such pharmacists may continue to compound sterile pharmaceuticals and supervise supportive personnel compounding sterile pharmaceuticals during the interim between the effective date of these rules and March 1, 1996, if they comply with the previous requirements of these rules and maintain documentation of completion of 20 hours of on-the-job training in the preparation, sterilization, and admixture of sterile pharmaceuticals. (C) Supportive personnel. All supportive personnel who compound sterile pharmaceuticals shall: (i) have a high school or equivalent education; and (ii) either: (I) complete a minimum of 40 hours of instruction and experience in the areas listed in paragraph (1) of this subsection. Such training may be obtained through the: (-a-) completion of a structured on-the-job didactic and experiential training program at this pharmacy (not transferable to another pharmacy) which provides 40 hours of instruction and experience in the areas listed in subparagraph (A) of this paragraph; or (-b-) completion of a course sponsored by an ACPE approved provider which provides 40 hours of instruction and experience in the areas listed in subparagraph (A) of this paragraph; or (II) completion of a training program which is accredited by the American Society of Health-System Pharmacists (formerly the American Society of Hospital Pharmacists). (D) Documentation of Training. A written record of initial and in-service training and the results of written or practical testing and process validation of pharmacy personnel shall be maintained and contain the following information: (i) name of the person receiving the training or completing the testing or process validation; (ii) date(s) of the training, testing, or process validation; (iii) general description of the topics covered in the training or testing or of the process validated; (iv) name of the person supervising the training, testing, or process validation; and (v) signature (first initial and last name or full signature) of the person receiving the training or completing the testing or process validation and the pharmacist-in-charge or other pharmacist employed by the pharmacy and designated by the pharmacist-in-charge as responsible for training, testing, or process validation of personnel. (5) Identification of pharmacy personnel. Pharmacy personnel shall be identified as follows. (A)-(B) (No change.) (d) Operational standards. (1) Licensing requirements. (A)-(I) (No change.) (J) A Class A Pharmacy, licensed under the provisions of the Act, sec.29(b)(1) which would otherwise be required to be licensed under the Act, sec.29(b)(6) (relating to Class F Pharmacy), is not required to secure a license for such other type of pharmacy; provided, however: (i) such licensee is required to comply with the provisions of sec.291.111 of this title (relating to Purpose), sec.291.112 of this title (relating to Definitions), sec.291.113 of this title (relating to Personnel), sec.291.114 (relating to Operational Standards), and sec.291.115 of this title (relating to Records), contained in Home and Community Support Services Pharmacy (Class F), to the extent such rules are applicable to the operation of the pharmacy; and (ii) the Class A Pharmacy and the Home and Community Support Services Agency licensed under Health and Safety Code, Chapter 142, whose patients the Class F Pharmacy provides services are at the same location and under common control and ownership; (iii) the pre-labeled drugs for the Class F Pharmacy are maintained in such a manner that a person accessing these pre-labeled drugs does not have access to other drugs in the Class A Pharmacy. (2) Environment. (A) (No change.) (B) Special requirements for the compounding of sterile pharmaceuticals. When the pharmacy compounds sterile pharmaceuticals, the following is applicable. (i) Aseptic environment control device(s). The pharmacy shall prepare sterile pharmaceuticals in an appropriate aseptic environmental control device(s) or area, such as a laminar air flow hood, biological safety cabinet,or clean room which is capable of maintaining at least Class 100 conditions during normal activity. The aseptic environmental control device(s) shall: (I) be certified by an independent contractor according to Federal Standard 209E, et seq, for operational efficiency at least every six months or when it is relocated; and (II) have pre-filters inspected periodically and replaced as needed, in accordance with written policies and procedures, and the inspection and/or replacement date documented. (ii) Controlled area. The pharmacy shall have a designated controlled area for the compounding of sterile pharmaceuticals that is functionally separate from areas for the preparation of non-sterile pharmaceuticals and is constructed to minimize the opportunities for particulate and microbial contamination. This controlled area for the preparation of sterile pharmaceuticals shall: (I) have a controlled environment that is aseptic or contains an aseptic environmental control device(s); (II) be clean, well lighted, and of sufficient size to support sterile compounding activities; (III) be used only for the compounding of sterile pharmaceuticals; (IV) be designed to avoid outside traffic and air flow; (V) have non-porous and washable floors or floor covering to enable regular disinfection; (VI) be ventilated in a manner not interfering with aseptic environmental control conditions; (VII) have hard cleanable walls and ceilings (acoustical ceiling tiles that are coated with an acrylic paint are acceptable); (VIII) have drugs and supplies stored on shelving areas above the floor to permit adequate floor cleaning; (IX) contain only the appropriate compounding supplies and not be used for bulk storage for supplies and materials. (iii) End-product evaluation. (I) The responsible pharmacist shall verify that the sterile pharmaceutical was compounded accurately with respect to the use of correct ingredients, quantities, containers, and reservoirs. (II) end product sterility testing according to policies and procedures, which include a statistically valid sampling plan and acceptance criteria for the sampling and testing, shall be performed if deemed appropriate by the pharmacist-in-charge. (III) the pharmacist-in-charge shall establish a mechanism for recalling all products of a specific batch if end-product testing procedures yield unacceptable results. (iv) Automated compounding device(s). If automated compounding device(s) are used, the pharmacy shall have a method to calibrate and verify the accuracy of automated compounding devices used in aseptic processing and document the calibration and verification on a routine basis. (v) Cytotoxic drugs. In addition to the requirements specified in clause (i) of this subparagraph, if the product is also cytotoxic, the following is applicable. (I) General. (-a-) All personnel involved in the compounding of cytotoxic products shall wear appropriate protective apparel, such as masks, gloves, and gowns or coveralls with tight cuffs. (-b-) Appropriate safety and containment techniques for compounding cytotoxic drugs shall be used in conjunction with aseptic techniques required for preparing sterile pharmaceuticals. (-c-) Disposal of cytotoxic waste shall comply with all applicable local, state, and federal requirements. (-d-) Prepared doses of cytotoxic drugs must be dispensed, labeled with proper precautions inside and outside, and distributed in a manner to minimize patient contact with cytotoxic agents. (II) Aseptic environment control device(s). (-a-) Cytotoxic drugs must be prepared in a vertical flow biological safety cabinet. (-b-) If the vertical flow biological safety cabinet is also used to prepare non-cytotoxic sterile pharmaceuticals, the cabinet must be thoroughly cleaned prior to its use to prepare non-cytotoxic sterile pharmaceuticals. (C) (No change.) (3) Prescription dispensing and delivery. (A) Patient counseling and provision of drug information. (i) (No change.) (ii) Such communication: (I) shall be provided with each new prescription drug order, once yearly on maintenance medications, and if the pharmacist deems appropriate, with prescription drug order refills. (For the purposes of this clause, maintenance medications are defined as any medication the patient has taken for 1 year or longer); (II)-(III) (No change.) (IV) may be reinforced with written information when deemed appropriate by the pharmacist. Beginning September 1, 1993, the communication shall be reinforced with written information. The following is applicable concerning this written information. (-a-) Written information designed for the consumer such as the USP DI Patient Information Leaflets shall be provided. (-b-) When a compounded product is dispensed, information shall be provided for the major active ingredient(s), if available. (-c-) For new drug entities, if no written information is initially available, the pharmacist is not required to provide information until such information is available, provided: (-1-) the pharmacist informs the patient or the patient's agent that the product is a new drug entity and written information is not available; (-2-) the pharmacist documents the fact that no written information was provided; and (-3-) if the prescription is refilled after written information is available, such information is provided to the patient or patient's agent. (iii)-(vi) (No change.) (B) (No change.) (C) Labeling. (i) At the time of delivery of the drug, the dispensing container of a sterile pharmaceutical shall bear a label with at least the following information: (I) name, address and phone number of the pharmacy, including a phone number which is answered 24 hours a day; (II) date dispensed; (III) name of prescribing practitioner; (IV) name of patient; (V) directions for use, including infusion rate and directions to the patient for the addition of additives, if applicable; (VI) unique identification number of the prescription; (VII) name and amount of the base solution and of each drug added unless otherwise directed by the prescribing practitioner; (VIII) name or initials of the person preparing the product and the pharmacist who checked and released the final product; (IX) expiration date of the preparation based on published data; (X) appropriate ancillary instructions, such as storage instructions or cautionary statements, including cytotoxic/biohazardous warning labels where applicable; (XI) if the prescription is for a Schedule II-IV controlled substance, the statement Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed; (XII) if the pharmacist has selected a generically equivalent drug pursuant to the provisions of the Act, sec.40, the statement Substituted for Brand Prescribed or "Substituted for 'Brand Name" where "Brand Name" is the actual name of the brand name product prescribed; and (XIII) the name of the registered nurse or physician assistant, if the prescription is carried out by a registered nurse or physician assistant in compliance with the Medical Practice Act, sec.3.06(d). (ii) The dispensing container is not required to bear the label specified in subparagraph (A) of this paragraph if: (I) the drug is prescribed for administration to an ultimate user who is institutionalized in a licensed health care facility (e.g., nursing home, hospice, hospital); (II) no more than a 34-day supply or 100 dosage units, whichever is less, is dispensed at one time; (III) the drug is not in the possession of the ultimate user prior to administration; (IV) the pharmacist-in-charge has determined that the institution: (-a-) maintains medication administration records which include adequate directions for use for the drug(s) prescribed; (-b-) maintains records of ordering, receipt, and administration of the drug(s); and (-c-) provides for appropriate safeguards for the control and storage of the drug(s); (V) the system employed by the pharmacy in dispensing the prescription drug order adequately identifies the: (-a-) pharmacy by name and address; (-b-) unique identification number of the prescription; (-c-) name and strength of the drug dispensed (-d-) the name of the patient; (-e-) name of the prescribing practitioner; and (VI) the system employed by the pharmacy in dispensing the prescription drug order adequately sets forth the directions for use and cautionary statements, if any, contained on the prescription drug order or required by law. (4) Pharmaceutical care services. (A) The following pharmaceutical care services shall be provided by pharmacists of the pharmacy. (i) Drug utilization review. A systematic ongoing process of drug utilization review shall be designed, followed, and documented to increase the probability of desired patient outcomes and decrease the probability of undesired outcomes from drug therapy. (ii) Drug regimen review. (I) For the purpose of promoting therapeutic appropriateness, a pharmacist shall evaluate prescription drug orders and patient medication records for: (-a-) known allergies; (-b-) rational therapy-contraindications; (-c-) reasonable dose and route of administration; (-d-) reasonable directions for use; (-e-) duplication of therapy; (-f-) drug-drug interactions; (-g-) drug-food interactions; (-h-) drug-disease interactions; (-i-) adverse drug reactions; (-j-) proper utilization, including overutilization or underutilization; and (-k-) clinical laboratory or clinical monitoring methods to monitor and evaluate drug effectiveness, side effects, toxicity, or adverse effects, and appropriateness to continued use of the drug in its current regimen. (II) Upon identifying any clinically significant conditions, situations, or items listed in subclause (I) of this clause, the pharmacist shall take appropriate steps to avoid or resolve the problem including consultation with the prescribing practitioner. (iii) Patient care guidelines. (I) Primary provider. There shall be a designated physician primarily responsible for the patient's medical care. There shall be a clear understanding between the physician, the patient, and the pharmacy of the responsibilities of each in the areas of the delivery of care, and the monitoring of the patient. This shall be documented in the patient medication record (PMR). (II) Patient training. The pharmacist-in-charge shall develop policies that assure that the patient and/or patient's caregiver receives information regarding drugs and their safe and appropriate use, including instruction regarding: (-a-) appropriate disposition of hazardous solutions and ancillary supplies; (-b-) proper disposition of controlled substances in the home; (-c-) self-administration of drugs, where appropriate; (-d-) emergency procedures, including how to contact an appropriate individual in the event of problems or emergencies related to drug therapy; and (-e-) if the patient or patient's caregiver prepares sterile preparations in the home, the following additional information shall be provided: (-1-) safeguards against microbial contamination, including aseptic techniques for compounding intravenous admixtures and aseptic techniques for injecting additives to premixed intravenous solutions; (-2-) appropriate storage methods, including storage durations for sterile pharmaceuticals and expirations of self-mixed solutions; (-3-) handling and disposition of premixed and self-mixed intravenous admixtures; and (-4-) proper disposition of intravenous admixture compounding supplies such as syringes, vials, ampules, and intravenous solution containers. (III) Pharmacist-patient relationship. It is imperative that a pharmacist- patient relationship be established and maintained throughout the patient's course of therapy. This shall be documented in the patient's medication record (PMR). (IV) Patient monitoring. The pharmacist-in-charge shall develop policies to ensure that: (-a-) the patient's response to drug therapy is monitored and conveyed to the appropriate health care provider; and (-b-) the first dose of any new drug therapy is administered in the presence of an individual qualified to monitor for and respond to adverse drug reactions. (B) Other pharmaceutical care services which may be provided by pharmacists include, but are not limited to, the following: (i) managing drug therapy as delegated by a practitioner as allowed under the provisions of the Medical Practice Act, sec.3.06(d); (ii) managing patient compliance programs; (iii) providing preventative health care services; and (iv) providing case management of patients who are being treated with high- risk or high-cost drugs, or who are considered "high risk" due to their age, medical condition, family history, or related concern. (5) Equipment and supplies. Class A pharmacies compounding sterile pharmaceuticals shall have the following equipment and supplies: (A) (No change.) (B) refrigerator and, if sterile pharmaceuticals are stored in the refrigerator, a system or device (i.e., thermometer) to monitor the temperature daily to ensure that proper storage requirements are met; (C)-(I) (No change.) (J) all necessary supplies, including: (i)-(v) (No change.) (vi) cytotoxic spill kits, if applicable; and (vii) masks, caps, coveralls or gowns with tight cuffs, shoe covers, and gloves, as applicable. (6) Library. A reference library shall be maintained which includes the following in hard-copy or electronic format: (A) (No change.) (B) at least one current or updated reference from each of the following categories: (i) (No change.) (ii) Drug interactions. A reference text on drug interactions, such as Hansten's and Horn's Drug Interactions. (iii) General information. (I)-(III) (No change.) (IV) AHFS Drug Information with current supplements; or (V) Micromedex. (iv) Sterile Pharmaceuticals. A current or updated reference text on injectable drug products, such as Handbook on Injectable Drug Products; (C) a specialty reference appropriate for the scope of pharmacy services provided by the pharmacy, e.g., if the pharmacy prepares cytotoxic drugs, a reference text on the preparation of cytotoxic drugs, such as Procedures for Handling Cytotoxic Drugs; (D)-(E) (No change.) (7) Drugs. (A) Procurement and storage. (i)-(ii) (No change.) (iii) All drugs shall be stored at the proper temperature, as defined by the following terms. (I) cold Any temperature not exceeding 8 degrees Centigrade (46 degrees Fahrenheit). A refrigerator is a cold place in which the temperature is maintained thermostatically between 2 and 8 degrees Centigrade (36 and 46 degrees Fahrenheit). A freezer is a cold place in which the temperature is maintained thermostatically between -20 and -10 degrees Centigrade (-4 and -14 degrees Fahrenheit). (II) cool Any temperature between 8 and 15 degrees Centigrade (46 and 59 degrees Fahrenheit). An article for which storage in a cool place is directed may, alternatively, be stored in a refrigerator unless otherwise specified in the labeling. (III) room temperature The temperature prevailing in a working area. Controlled room temperature is a temperature thermostatically between 15 and 30 degrees Centigrade (59 and 86 degrees Fahrenheit). (IV) warm Any temperature between 30 and 40 degrees Centigrade (86 and 104 degrees Fahrenheit). (V) excessive heat Temperature above 40 degrees Centigrade (104 degrees Fahrenheit). (VI) protection from freezing where, in addition to the risk of breakage of the container, freezing subjects a product to loss of strength or potency, or to destructive alteration of the dosage form, the container label bears an appropriate instruction to protect the product from freezing. (B) Out-of-date and other unusable drugs or devices. (i) (No change.) (ii) Outdated and other unusable drugs or devices shall be removed from dispensing stock and shall be quarantined together until such drugs or devices are disposed of properly. (C) Class A Pharmacies may not sell, purchase, trade or possess prescription drug samples, unless the pharmacy meets all of the following conditions: (i) the pharmacy is owned by a charitable organization described in the Internal Revenue Code of 1986, or by a city, state or county government; (ii) the pharmacy is a part of a health care entity which provides health care primarily to indigent or low income patients at no or reduced cost; (iii) the samples are for dispensing or provision at no charge to patients of such health care entity; and (iv) the samples are possessed in compliance with the federal Prescription Drug Marketing Act of 1986. (8) Prepackaging of drugs and loading bulk drugs into automated compounding or drug dispensing systems. (A) Prepackaging of drugs. (i) (No change.) (ii) The label of a prepackaged unit shall indicate: (I) (No change.) (II) facility's unique lot number; (III) expiration date based on currently available literature; and (IV) (No change.) (iii) Records of prepackaging shall be maintained to show: (I) (No change.) (II) facility's unique lot number; (III)-(VIII) (No change.) (IX) name, initials, or electronic signature of the prepacker; and (X) name, initials, or electronic signature of the responsible pharmacist. (iv) (No change.) (B) Loading bulk drugs into automated compounding or drug dispensing systems. (i) Automated compounding or drug dispensing systems may be loaded with bulk drugs only by a pharmacist or by supportive personnel under the direction and direct supervision of a pharmacist. (ii) The label of an automated compounding or drug dispensing system container shall indicate the brand name and strength of the drug; or if no brand name, then the generic name, strength, and name of the manufacturer or distributor. (iii) Records of loading bulk drugs into an automated compounding or drug dispensing system shall be maintained to show: (I)-(IV) (No change.) (V) quantity added to the automated compounding or drug dispensing system; (VI) (No change.) (VII) name, initials, or electronic signature of the person loading the automated compounding or drug dispensing system; and (VIII) name, initials, or electronic signature of the responsible pharmacist. (iv) The automated compounding or drug dispensing system shall not be used until a pharmacist verifies that the system is properly loaded and affixes his or her signature or electronic signature to the record specified in clause (iii) of this subparagraph. (9) Sterile pharmaceuticals. (A) Batch preparation. (i) Master work sheet. A master work sheet shall be developed and approved by a pharmacist for each batch of sterile pharmaceuticals to be prepared. Once approved, a duplicate of the master work sheet shall be used as the preparation work sheet from which each batch is prepared and on which all documentation for that batch occurs. The master work sheet shall contain at a minimum: (I) the formula; (II) the components; (III) the compounding directions; (IV) a sample label; and (V) evaluation and testing requirements. (VI) sterilization method(s); (VII) specific equipment used during aseptic preparation (e.g., specific automated compounding device); and (VIII) storage requirements (ii) Preparation work sheet. The preparation work sheet for each batch of sterile pharmaceuticals shall document the following; (I) identity of all solutions and ingredients and their corresponding amounts, concentrations, or volumes; (II) manufacturer lot number for each component; (III) component manufacturer or suitable identifying number; (IV) container specifications (e.g., syringe, pump cassette); (V) unique lot or control number assigned to batch; (VI) expiration date of batch-prepared products; (VII) date of preparation; (VIII) name, initials, or electronic signature of the person(s) involved in the preparation; (IX) name, initials, or electronic signature of the responsible pharmacist; (X) end-product evaluation and testing specifications, if applicable; and (XI) comparison of actual yield to anticipated yield, when appropriate. (iii) Label. The label of each batch prepared sterile pharmaceutical shall bear at a minimum: (I) the unique lot number assigned to the batch; (II) all solution and ingredient names, amounts, strengths, and concentrations, when applicable; (III) quantity; (IV) expiration date and time, when applicable; (V) appropriate ancillary instructions, such as storage instructions or cautionary statements, including cytotoxic warning labels where appropriate; and (VI) device-specific instructions, when appropriate. (C) Expiration date. (i) The expiration date assigned shall be based on currently available drug stability information and sterility considerations or appropriate in house or contract service stability testing. (ii) Sources of drug stability information shall include the following: (I) references (e.g., Remington's Pharmaceutical Sciences, Handbook on Injectable Drugs); (II) manufacturer recommendations; and (III) reliable, published research. (iii) When interpreting published drug stability information, the pharmacist shall consider all aspects of the final sterile product being prepared (e.g., drug reservoir, drug concentration, storage conditions). (iv) Methods used for establishing expiration dates shall be documented. (D) Quality control. There shall be a documented, ongoing quality control program that monitors and evaluates personnel performance, equipment and facilities. Procedures shall be in place to assure that the pharmacy is capable of consistently preparing pharmaceuticals which are sterile and stable. Quality control procedures shall include, but are not limited to, the following: (i)-(iii) (No Change.) (iv) documentation of aseptic environmental control device(s) certification at least every six months and the regular replacement of pre-filters as necessary; and (v) a process to evaluate and confirm the quality of the prepared pharmaceutical product. (E) Quality assurance. (i)-(iv) (No change.) (e) Records. (1) (No change.) (2) Prescriptions. (A)-(D) (No change.) (E) Authorization for generic substitution. (i)-(iv) (No change.) (F) Substitution of dosage form. A pharmacist may dispense, with the patient's consent and notification to the practitioner, a dosage form of a drug product different from that prescribed, such as a tablet instead of a capsule or liquid instead of tablets, provided the dosage form so dispensed: (i) contains the identical amount of the active ingredients as the dosage prescribed for the patient; (ii) is not an enteric-coated or time release product; and (iii) does not alter desired clinical outcomes. (G) Original prescription drug order records. (i)-(iv) (No change.) (H) Prescription drug order information. (i)-(iv) (No change.) (I) Refills. (i)-(iv) (No change.) (v) A pharmacist may exercise his professional judgment in refilling a prescription drug order for a drug, other than a controlled substance listed in Schedule II, without the authorization of the prescribing practitioner, provided: (I) failure to refill the prescription might result in an interruption of a therapeutic regimen or create patient suffering; (II) either: (-a-) a natural or manmade disaster has occurred which prohibits the pharmacist from being able to contact the practitioner; or (-b-) the pharmacist is unable to contact the practitioner after a reasonable effort; (III) the quantity of prescription drug dispensed does not exceed a 72-hour supply; (IV) the pharmacist informs the patient or the patient's agent at the time of dispensing that the refill is being provided without such authorization and that authorization of the practitioner is required for future refills; and (V) the pharmacist informs the practitioner of the emergency refill at the earliest reasonable time. (3)-(5) (No change.) (6) Policy and procedure manual. A policy and procedure manual as it relates to the sterile pharmaceuticals shall be maintained at the pharmacy and be available for inspection. The manual shall include policies and procedures for: (A) pharmaceutical care services; (B) (No change.) (C) disposal of unusable drugs, supplies, and returns; (D)-(P) (No change.) (Q) duties and education and training of professional and nonprofessional staff; and (R) emergency preparedness plan, to include continuity of patient and public safety. (7) (No change.) (8) Distribution of controlled substances to another registrant. A pharmacy may distribute controlled substances to a practitioner, another pharmacy or other registrant, without being registered to distribute, under the following conditions: (A)-(C) (No change.) (D) If the distribution is for a Schedule I or II controlled substance, the following is applicable: (i) The pharmacy, practitioner or other registrant who is receiving the controlled substances shall issue copy 1 and copy 2 of a DEA order form (DEA 222) to the distributing pharmacy. (ii) The distributing pharmacy shall: (I) complete the area on the DEA order form (DEA 222) titled TO BE FILLED IN BY SUPPLIER; (II) maintain copy 1 of the DEA order form (DEA 222) at the pharmacy for two years; and (III) forward copy 2 of the DEA order form (DEA 222) to the divisional office of the Drug Enforcement Administration at the close of the month during which the order is filled. (9) Other records. Other records to be maintained by a pharmacy: (A) (No change.) (B) copy 3 of DEA order form (DEA 222) which has been properly dated, initialed, and filed, and all copies of each unaccepted or defective order form and any attached statements or other documents; (C) a hard-copy of the power of attorney to sign DEA 222 order forms (if applicable); (D)-(I) (No change.) (10) (No change.) (11) Confidentiality. (A) A pharmacist shall provide adequate security of prescription drug order and patient medication records to prevent indiscriminate or unauthorized access to confidential health information. (B) Confidential records are privileged and may be released only to: (i) the patient or the patient's agent; (ii) practitioners and other pharmacists when, in the pharmacist's professional judgement, such release is necessary to protect the patient's health and well-being; (iii) other persons, the board, or other state or federal agencies authorized by law to receive such information; (iv) a law enforcement agency engaged in investigation of suspected violations of the Controlled Substances Act or the Dangerous Drug Act; (v) a person employed by any state agency which licenses a practitioner as defined in the Act if such person is engaged in the performance of the person's official duties; or (vi) an insurance carrier or other third party payor authorized by a patient to receive such information. (f) Triplicate prescription requirements. (1)-(4) (No change.) (5) Partial dispensing of Schedule II controlled substances. (A) If unable to supply the full quantity called for in a written or emergency oral prescription for a Schedule II controlled substance, the pharmacist may partially dispense the prescription and complete the prescription under the following conditions. (i) The pharmacist notes the initial partial quantity dispensed on the face of the written prescription or emergency oral prescription. (ii) The remaining portion of the prescription is dispensed within 72 hours of the first partial dispensing. No further quantity may be dispensed beyond 72 hours without a new prescription. (iii) If the remaining portion of the prescription is not or cannot be dispensed within the 72-hour period, the pharmacist shall notify the prescribing practitioner. (B) A pharmacist may dispense a prescription for a Schedule II controlled substance in partial quantities to include individual dosage units, for a patient in a long-term facility (LTCF) or for a patient with a medical diagnosis documenting a terminal illness under the following conditions. (i) The pharmacist must record on the prescription whether the patient is terminally ill or an LTCF patient. A prescription that is partially filled and does not contain the notation terminally ill or LTCF patient shall be deemed to have been filled in violation of the Texas Controlled Substances Act. (ii) If there is any question about whether a patient may be classified as having a terminal illness, the pharmacist must contact the practitioner prior to partially filling the prescription. Both the pharmacist and the practitioner have a corresponding responsibility to assure that the controlled substance is for a terminally ill patient. (iii) For each partial dispensing, the dispensing pharmacist shall record on the back of Copy 1 and Copy 2 of the prescription the: (I) date of the partial dispensing; (II) quantity dispensed; (III) remaining quantity authorized to be dispensed; and (IV) identification of the dispensing pharmacist. (iv) Prior to any subsequent partial dispensing, the pharmacist must determine that the additional partial dispensing is necessary. (v) The total quantity of the Schedule II controlled substances dispensed in all partial dispensings must not exceed the total quantity prescribed. (vi) Schedule II prescriptions for patients in a long-term care facility or patients with a medical diagnosis documenting a terminal illness shall be valid for a period not to exceed 30 days from the issue date unless sooner terminated by discontinuance of the medication. (6) Exceptions to use of triplicate prescriptions. (A)-(B) (No change.) (7) Pharmacist responsibilities. (A)-(E) (No change.) This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Issued in Austin, Texas, on February 23, 1995. TRD-9502335 Fred S. Brinkley, Jr., R.Ph., M.B.A. Executive Director/Secretary Texas State Board of Pharmacy Effective date: March 16, 1995 Proposal publication date: August 26, 1994 For further information, please call: (512) 832-0661 Institutional Pharmacy (Class C) 22 TAC sec.sec.291.71-291.75 The Texas State Board of Pharmacy adopts amendments to sec.sec.291.71-291.75, concerning Purpose, Definitions, Personnel, Operational Standards, and Records in a Class C Pharmacy. Sections 291.72-291.75 are adopted with changes to the proposed text as published in the August 23, 1994, issue of the Texas Register (19 TexReg 6637). Section 291.71 is adopted without changes and will not be republished. The amendments: implement the recommendations of the Board's Task Force on Class C Pharmacy Practice; provide a method for a Class C Pharmacy to operate a Class F Pharmacy without obtaining a separate license; add the language from Chapter 291 regarding the possession of samples by a Class C Pharmacy to the Class C rules; and amend definitions to incorporate the changes passed during the 73rd Legislative session. A public hearing on the proposed rules was held on October 25, 1995, at which time comments were received from ten persons. In addition, the agency received written comments from 32 persons on the proposed rules. Written comments were received from the following organizations: Texas Hospital Association (THA), Texas Society of Hospital Pharmacists (TSHP), and American Society of Health System Pharmacists (ASHP). The Texas Hospital Association recommended: that the definitions of risk levels be revised to include specific examples and by adding a statement to allow pharmacists to exercise their professional judgement in deciding which risk level applies to a specific product; the deletion of the continuing education provision for supportive personnel; that the environmental requirements for pharmacies compounding risk level 2 sterile pharmaceuticals be deleted; the deletion of the end-product testing requirements for risk level 2 and 3 sterile pharmaceuticals; the rules be amended to allow a vertical flow hood to be used for both cytotoxic drugs and non-cytotoxic sterile pharmaceutical if the hood is properly maintained and cleaned; that the language that allows a physician to telephone an order for a drug to be supplied to a patient who has been admitted to the hospital emergency room not be deleted; and if the Board adopts the rules as proposed, the effective date for the requirements should be two years from the date of adoption to provide adequate time for hospital pharmacies to budget for the required changes. The Texas Society of Hospital Pharmacists: stated in its comments that it cannot support the practice of incorporating a technical advisory bulletin (which was prepared to provide for maximum professional outcomes); asked that, if these rules are adopted, the Board delay enforcement for five years to allow hospitals to budget for the capital expenditures required to bring their pharmacies into compliance, and to provide the requisite education and training for their personnel that prepare sterile pharmaceutical products; and expressed concern about the multiple risk levels and the confusion about which products fell within each of the risk levels. The American Society of Health System Pharmacists expressed concerns that standards established in its Technical Assistance Bulletin on Quality Assurance for Pharmacy-Prepared Sterile Products were being used as a base for minimum standards for Class C Pharmacies. The Board agrees with most of these comments and has amended the rules to: eliminate the risk levels and set one standard for the preparation of sterile products; eliminate the annual continuing education requirement for pharmacists and supportive personnel; allow the vertical flow hood to be used when mixing other products; and delay the effective date for the training requirements until March 1, 1996. Specifically, the comments and the Board's response to these comments are as follows: 291.72. Definitions: Several persons indicated that the definition of batch preparation was unclear-the Board agreed and has amended the definition to clarify that batch preparation/compounding does not include the preparation of multiple sterile-product units pursuant to medication orders; as previously mentioned, several persons indicated that it was unclear what products should be included in each Risk Level-the Board agrees and has eliminated the definitions of Risk Levels 1, 2, and 3 and deleted the definition of closed-system transfer since it is no longer needed. In addition, all references to these levels has been eliminated from the other sections of the rules. 291.73. Personnel: one person commented that the method for 24 hour access of the pharmacist in (a)(3) should be left to the discretion of the facility-the Board intended for this to be the case and has amended the paragraph to clarify this issue; one person commented that "handling of cytotoxic and hazardous drug" should be added to the list of training subjects in (f)(1)(A) -the Board agreed and has amended the rules; several persons disagreed with allowing on-the-job training for pharmacists and supportive personnel in (f)(2) and (3)-the Board disagrees with this comment and believes that on-the-job training has been effectively used in Class C pharmacy practice for many years; however, the Board has amended the language to specify that on-the-job training is not transferable from one facility to another, whereas the training received from colleges of pharmacy and approved providers is transferable; in addition, the Board has delayed implementation of this requirement until March 1, 1996; several persons commented regarding the requirement for annual continuing education for pharmacists and pharmacy supportive personnel in (f)(2) and (3)-the Board agrees with these comments and has eliminated this provision; several persons suggested that supportive personnel be given the option to obtain their training through a course presented by an approved provider-the Board agrees with the suggestion and has amended the rules to allow supportive personnel receive their training from an approved provider; and several persons questioned the need and practicality for the paragraph on the training of personnel to clean the controlled area (f)(5)-the Board agreed and has eliminated this paragraph. 291.74. Operational standards: as previously mentioned, several persons commented in opposition to the multi-tier levels of sterile pharmaceuticals-the Board agrees with this comment and has eliminated the risk levels and the different environment standards for those levels. The result is one set of standards for the environment; several persons commented that pre-filters did not need to be changed every time they were inspected-the Board agreed and has modified the section to require periodic inspection of the filter with changing as needed; several persons commented that a vertical flow hood should be allowed to be used to compound other sterile products, not just cytotoxic drugs-the Board agreed and has modified the section to allow the vertical flow hood to be used for other products if it is properly cleaned; several persons commented that the subparagraph regarding the temperature monitoring required for a refrigerator was not clear -the Board agreed and has modified the subparagraph to clarify; several persons commented that the title of the American Hospital Formulary Service reference has changed and that the pharmacy should not be required to have the Federal Current Good Manufacturing Practices for Finished Pharmaceuticals (CGMPFP)-the Board agreed and has corrected the reference to the AHFS Drug Information and deleted the requirement for the CGMPFP; one person commented on the requirements for the master and preparation work sheets by indicating that subclauses (XI) storage requirements and (XII) specific equipment used during aseptic preparation should be moved from the preparation work sheet to the master work sheet -the Board agreed and has modified the rules accordingly; in addition, all references to the risk levels has been eliminated; the reference to the risk levels has also been eliminated from the Quality Control paragraph; one person commented that the reference under the subparagraph (f)(6)(A)"Medication Orders" to subsections (d) and (f) in Section 40 of the Pharmacy Act was incorrect-the Board agreed and has corrected the reference to (e) and (g); a comment suggested that education and training of staff should be added to the policy and procedure requirements in (f)(6)(B)-the Board agreed and has added this to subclause (XXXIV); several persons commented that subparagraph (h)(2)(B) should not be deleted-the Board agrees and has not deleted this subparagraph in the adopted version. 291.75. Records. The proposed addition of the phrase "(first initial and last name or full signature)" has been deleted in (c)(1)(A)(v). The amendments are adopted under the Texas Pharmacy Act (Article 4542a-1, Texas Civil Statutes), sec.4, which specifies that the purpose of the Act is to protect the public through the effective control and regulation of the practice of pharmacy; sec.16(a), which gives the Board the authority to adopt rules for the proper administration and enforcement of the Act; sec.17(b)(2) and (3), which gives the Board the authority to specify minimum standards for: professional environment, technical equipment, and security in the prescription dispensing area, drug storage, maintenance of prescription drug records and procedures for the delivery, dispensing in a suitable container appropriately labeled, providing of prescription drugs or devices, monitoring of drug therapy, and counseling of patients on proper use of prescription drugs and devices within the practice of pharmacy; and sec.17(o), which gives the Board the authority to establish rules for the use of supportive personnel and the duties of those personnel in pharmacies licensed by the Board. sec.291.72. Definitions. The following words and terms, when used in these sections, shall have the following meanings, unless the context clearly indicates otherwise. Airborne particulate cleanliness class-The level of cleanliness specified by the maximum allowable number of particles per cubic foot of air as specified in Federal Standard 209E et seq. For example: (A) Class 100 is an atmospheric environment which contains less than 100 particles 0.5 microns in diameter per cubic foot of air; (B) Class 10,000 is an atmospheric environment which contains less than 10,000 particles 0.5 microns in diameter per cubic foot of air; and (C) Class 100,000 is an atmospheric environment which contains less than 100, 000 particles 0.5 microns in diameter per cubic foot of air. Administer-The direct application of a prescription drug by injection, inhalation, ingestion, or any other means to the body of a patient by: (A) a practitioner, an authorized agent under his supervision, or other person authorized by law; or (B) the patient at the direction of a practitioner. Automated compounding or drug dispensing system -An automated device that compounds, measures, counts and/or packages a specified quantity of dosage units for a designated drug product. Aseptic preparation -The technique involving procedures designed to preclude contamination of drugs, packaging, equipment, or supplies by microorganisms during processing. Batch preparation/compounding -Compounding of multiple sterile-product units, in a single discrete process, by the same individual(s), carried out during one limited time period. Batch preparation does not include the preparation of multiple sterile-product units pursuant to medication orders. Biological Safety Cabinet-Containment unit suitable for the preparation of low to moderate risk agents where there is a need for protection of the product, personnel, and environment, according to National Sanitation Foundation (NSF) Standard 49. Clean-room-A room in which the concentration of airborne particles is controlled and there are one or more clean zones according to Federal Standard 209E et seq. Clean zone-A defined space in which the concentration of airborne particles is controlled to meet a specified airborne particulate cleanliness class. Compounding-The preparation, mixing, assembling, packaging, or labeling of a drug or device: (A) as the result of a practitioner's prescription drug or medication order or initiative based on the practitioner-patient-pharmacist relationship in the course of professional practice; (B) in anticipation of prescription drug or medication orders based on routine, regularly observed prescribing patterns; or (C) for the purpose of, or as an incident to research, teaching, or chemical analysis and not for sale or dispensing. Controlled area -A controlled area is the area designated for preparing sterile pharmaceuticals. Critical areas -Any area in the controlled area where products or containers are exposed to the environment. Cytotoxic-A pharmaceutical that has the capability of killing living cells. Device-An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component part or accessory, that is required under federal or state law to be ordered or prescribed by a practitioner. Expiration date -The date (and time, when applicable) beyond which a product should not be used. Formulary-List of drugs approved for use in the facility by the committee which performs the pharmacy and therapeutics function for the facility. Part-time pharmacist -A pharmacist either employed or under contract, who routinely works less than full-time. Pharmaceutical care -The provision of drug therapy and other pharmaceutical services intended to assist in the cure or prevention of a disease, elimination or reduction of patient symptoms, or arresting or slowing of a disease process. Pharmacy and therapeutics function-Committee of the medical staff in the facility which assists in the formulation of broad professional policies regarding the evaluation, selection, distribution, handling, use, and administration, and all other matters relating to the use of drugs and devices in the facility. Pre-packaging-The act of re-packaging and re-labeling quantities of drug products from a manufacturer's original container into unit-dose packaging or a multiple dose container for distribution within the facility. Process validation -Documented evidence providing a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes. Quality assurance -The set of activities used to assure that the process used in the preparation of sterile drug products lead to products that meet predetermined standards of quality. Quality control -The set of testing activities used to determine that the ingredients, components (e.g., containers), and final sterile pharmaceuticals prepared meet predetermined requirements with respect to identity, purity, non- pyrogenicity, and sterility. Sample-A prescription drug which is not intended to be sold and is intended to promote the sale of the drug. Sterile pharmaceutical -A dosage form free from living micro-organisms. Supportive personnel/pharmacy technicians-Those individuals utilized in institutional pharmacies whose responsibility it shall be to provide technical services that do not require professional judgement concerned with the preparation and distribution of drugs under the direct supervision of and responsible to a pharmacist. Unit-dose packaging -The ordered amount of drug in a dosage form ready for administration to a particular patient, by the prescribed route at the prescribed time, and properly labeled with name, strength, and expiration date of the drug. Unusable drugs -Drugs or devices that are unusable for reasons, such as they are adulterated, misbranded, expired, defective, or recalled. sec.291.73. Personnel. (a) Requirements for pharmacist services. (1)-(2) (No change.) (3) A pharmacist shall be accessible at all times to respond to other health professional's questions and needs. Such access may be through a telephone which is answered 24 hours a day, e.g., answering or paging service, a list of phone numbers where the pharmacist may be reached, or any other system which accomplishes this purpose. (b) Pharmacist-in-charge. (1) General. (A)-(B) (No change.) (C) The pharmacist-in-charge shall be assisted by additional pharmacists and pharmacy supportive personnel commensurate with the scope of services provided. (D) If the pharmacist-in-charge is employed on a part-time or consulting basis, a written agreement shall exist between the facility and the pharmacist, and a copy of the written agreement shall be made available to the board upon request. (2) Responsibilities. The pharmacist-in-charge shall have the responsibility for, at a minimum, the following: (A) providing the appropriate level of pharmaceutical care services to patients of the facility; (B) developing a system to assure that drugs and/or devices are dispensed and distributed safely and accurately to the patient for whom they are prescribed; (C) developing a system for the compounding, sterility assurance, quality assurance and quality control of sterile pharmaceuticals compounded within the institutional pharmacy; (D) developing a system to assure that all pharmacy personnel responsible for compounding and/or supervising the compounding of sterile pharmaceuticals within the pharmacy receive appropriate education and training and competency evaluation; (E) providing written guidelines and approval of the procedure to assure that all pharmaceutical requirements are met when any part of preparing, sterilizing, and labeling of sterile pharmaceuticals is not performed under direct pharmacy supervision; (F) developing a system for bulk compounding or batch preparation of drugs; (G) establishing specifications for procurement and storage of all pharmaceutical materials including pharmaceuticals, components used in the compounding of pharmaceuticals, and drug delivery devices; (H) participating in the development of a formulary for the facility, subject to approval of the appropriate committee of the facility; (I) developing a system to assure that drugs to be administered to inpatients are distributed pursuant to an original or direct copy of the practitioner's medication order; (J) developing a system for the filling and labeling of all containers from which drugs are to be distributed or dispensed; (K) assuring that the pharmacy maintains and makes available a sufficient inventory of antidotes and other emergency drugs as well as current antidote information, telephone numbers of regional poison control center and other emergency assistance organizations, and such other materials and information as may be deemed necessary by the appropriate committee of the facility; (L) maintaining records of all transactions of the institutional pharmacy as may be required by applicable law, state and federal, and as may be necessary to maintain accurate control over and accountability for all pharmaceutical materials including pharmaceuticals, components used in the compounding of pharmaceuticals, and drug delivery devices; (M) participating in those aspects of the facility's patient care evaluation program which relate to pharmaceutical utilization and effectiveness; (N) participating in teaching and/or research programs in the facility; (O) implementing the policies and decisions of the appropriate committee(s) relating to pharmaceutical services of the facility; (P) providing effective and efficient messenger or delivery service to connect the institutional pharmacy with appropriate areas of the facility on a regular basis throughout the normal workday of the facility; (Q) developing a system for the labeling, storage, and distribution of investigational new drugs, including maintenance of information in the pharmacy and nursing station where such drugs are being administered, concerning the dosage form, route of administration, strength, actions, uses, side effects, adverse effects, interactions and symptoms of toxicity of investigational new drugs; (R) assuring that records in a data processing system are maintained such that the data processing system is in compliance with Class C (Institutional) pharmacy requirements; (S) assuring that a reasonable effort is made to obtain, record, and maintain patient medication records; and (T) assuring the legal operation of the pharmacy, including meeting all inspection and other requirements of all state and federal laws or rules governing the practice of pharmacy. (c) (No change.) (d) Pharmacists. (1) (No change.) (2) Duties. Duties of all pharmacists shall include, but need not be limited to the following: (A) providing those acts or services necessary to provide pharmaceutical care; (B) receiving, interpreting, and evaluating prescription drug orders, and reducing verbal medication orders to writing either manually or electronically; (C) participating in drug and/or device selection as authorized by law, drug and/or device supplier selection, drug administration, drug regimen review, or drug or drug-related research; (D) accepting the responsibility for: (i) distributing drugs and devices pursuant to medication orders; (ii) compounding and labeling of drugs and devices; (iii) proper and safe storage of drugs and devices; and (iv) maintaining proper records for drugs and devices. (e) Supportive personnel/pharmacy technicians. (1) (No change.) (2) Duties. Duties may include, but need not be limited to, the following functions under the direct supervision of and responsible to a pharmacist: (A) pre-packing and labeling unit and multiple dose packages, provided a pharmacist supervises and conducts in-process and final checks and affixes his or her signature (first initial and last name or full signature) or electronic signature to the appropriate quality control records; (B) (No change.) (C) compounding sterile pharmaceuticals pursuant to medication orders providing a pharmacist supervises and conducts in-process and final checks and affixes his or her initials to the label or if batch prepared, to the appropriate quality control records (The initials are not required on the label if it is maintained in a permanent record of the pharmacy); (D) bulk compounding or batch preparation provided a pharmacist supervises and conducts in-process and final checks and affixes his or her initials to the appropriate quality control records; (E)-(F) (No change.) (G) loading bulk unlabeled drugs into an automated compounding or drug dispensing system provided a pharmacist supervises, verifies that the system was properly loaded prior to use, and affixes his or her signature (first initial and last name or full signature) or electronic signature to the appropriate quality control records. (3) (No change.) (4) Training. (A) Supportive personnel shall complete initial training as outlined by the pharmacist-in-charge and described in the policy and procedure manual or training manual, which includes on-the-job training and related education commensurate with the tasks they are to perform, prior to the regular performance of those tasks. (B) The pharmacist-in-charge shall assure continuing competency of supportive personnel through in-service education and training to supplement initial training. (C) A written record of initial and in-service training of supportive personnel shall be maintained and contain the following information: (i)-(iv) (No change.) (v) signature (first initial and last name or full signature) of the supportive person and the pharmacist-in-charge or other pharmacist employed by the pharmacy and designated by the pharmacist-in-charge as responsible for training of supportive personnel. (f) Special education, training, and evaluation requirements for pharmacy personnel compounding or responsible for the direct supervision of pharmacy personnel compounding sterile pharmaceuticals. (1) General. (A) All pharmacy personnel preparing sterile pharmaceuticals shall receive didactic and experiential training and competency evaluation through demonstration, testing (written or practical) as outlined by the pharmacist-in- charge and described in the policy and procedure or training manual. Such training shall include instruction and experience in the following areas: (i) aseptic technique; (ii) critical area contamination factors; (iii) environmental monitoring; (iv) facilities; (v) equipment and supplies; (vi) sterile pharmaceutical calculations and terminology; (vii) sterile pharmaceutical compounding documentation; (viii) quality assurance procedures; (ix) aseptic preparation procedures, including proper gowning and gloving technique; (x) the handling of cytotoxic and hazardous drugs; and (xi) general conduct in the controlled area. (B) The aseptic technique of each person compounding or responsible for the direct supervision of personnel compounding sterile pharmaceuticals shall be observed and evaluated as satisfactory through written or practical tests and process validation and such evaluation documented. (C) No product intended for patient use shall be compounded by an individual until the process validation test indicates that the individual can competently perform aseptic procedures. (D) Process validation procedures for assessing the preparation of specific types of sterile pharmaceuticals shall be representative of all types of manipulations, products, and batch sizes that personnel preparing that type of pharmaceutical are likely to encounter. (E) The pharmacist-in-charge shall assure continuing competency of pharmacy personnel through in-service education, training, and process validation to supplement initial training. Personnel competency shall be evaluated: (i) during orientation and training prior to the regular performance of those tasks; (ii) whenever the quality assurance program yields an unacceptable result; (iii) whenever unacceptable techniques are observed; and (iv) at least on an annual basis. (2) Pharmacists. (A) All pharmacists who compound sterile pharmaceuticals or supervise supportive personnel compounding sterile pharmaceuticals shall: (i) effective March 1, 1996, complete a minimum 20 hours of instruction and experience in the areas listed in paragraph (1) of this subsection. Such training may be evidenced by either: (I) completion of a structured on-the-job didactic and experiential training program at this pharmacy (not transferable to another pharmacy) which provides 20 hours of instruction and experience in the areas listed in paragraph (1) of this subsection; or (II) completion of a recognized course in an accredited college of pharmacy or a course sponsored by an American Council on Pharmaceutical Education approved provider which provides 20 hours of instruction and experience in the areas listed in paragraph (1) of this subsection; and (ii) possess knowledge about: (I) aseptic processing; (II) quality control and quality assurance as related to environmental, component, and end-product testing; (III) chemical, pharmaceutical, and clinical properties of drugs; (IV) container, equipment, and closure system selection; and (V) sterilization techniques. (B) discontinue preparation of sterile pharmaceuticals if the training specified in subparagraph (B) of this paragraph is not completed by March 1, 1996. Such pharmacists may continue to compound sterile pharmaceuticals and supervise supportive personnel compounding sterile pharmaceuticals if they comply with the previous requirements of these rules and maintain documentation of completion of 20 hours of on-the-job training in the preparation, sterilization, and admixture of sterile pharmaceuticals. (3) Supportive personnel. All supportive personnel who compound sterile pharmaceuticals shall: (A) have a high school or equivalent education; and (B) either: (i) complete a minimum of 40 hours of instruction and experience in the areas listed in paragraph (1) of this subsection. Such training may be obtained through the: (I) completion of a structured on-the-job didactic and experiential training program at this pharmacy (not transferable to another pharmacy) which provides 40 hours of instruction and experience in the areas listed in paragraph (1) of this subsection; or (II) completion of a course sponsored by an ACPE approved provider which provides 40 hours of instruction and experience in the areas listed in paragraph (1) of this subsection; or (ii) complete of a training program which is accredited by the American Society of Health-System Pharmacists (formerly American Society of Hospital Pharmacists). (C) discontinue preparation of sterile pharmaceuticals if the training specified in subparagraphs (A)-(B) of this paragraph is not completed by March 1, 1996. Such supportive personnel may continue to compound sterile pharmaceuticals during the interim between the effective date of these rules and March 1, 1996, if they comply with the previous requirements of these rules and maintain documentation of completion of 40 hours of on-the-job training in the preparation, sterilization, and admixture of sterile pharmaceuticals. (4) Documentation of Training. A written record of initial and in-service training and the results of written or practical testing and process validation of pharmacy personnel shall be maintained and contain the following information: (A) name of the person receiving the training or completing the testing or process validation; (B) date(s) of the training, testing, or process validation; (C) general description of the topics covered in the training or testing or of the process validated; (D) name of the person supervising the training, testing, or process validation; and (E) signature (first initial and last name or full signature) of the person receiving the training or completing the testing or process validation and the pharmacist-in-charge or other pharmacist employed by the pharmacy and designated by the pharmacist-in-charge as responsible for training, testing, or process validation of personnel. (g) Identification of pharmacy personnel. All pharmacy personnel shall wear an identification tag or badge which bears the person's name and identifies him or her by title or function. sec.291.74. Operational Standards. (a) Licensing requirements. (1)-(8) (No change.) (9) A Class C pharmacy, licensed under the Act sec.29(b)(3) which also operates another type of pharmacy which would otherwise be required to be licensed under the Act sec.29(b)(1), (Community Pharmacy (Class A)) or the Act sec.29(b)(2) (Nuclear Pharmacy (Class B)), is not required to secure a license for the such other type of pharmacy; provided, however, such licensee is required to comply with the provisions of sec.291.31 of this title (relating to Definitions), sec.291.32 of this title (relating to Personnel), sec.291.33 of this title (relating to Operational Standards), sec.291.34 of this title (relating to Records), sec.291.35 of this title (relating to Triplicate Prescription Records), and sec.291.36 of this title (relating to Class A Pharmacies Compounding Sterile Pharmaceuticals), contained in Community Pharmacy (Class A), or sec.291.51 of this title (relating to Definitions), sec.291.52 of this title (relating to Personnel), sec.291.53 of this title (relating to Operational Standards), and sec.291.54 of this title (relating to Records), contained in Nuclear Pharmacy (Class B), to the extent such rules are applicable to the operation of the pharmacy. (10) A Class C pharmacy engaged in non-sterile compounding of drug products for inpatients of the hospital shall comply with the provisions of sec.sec.291.31-291.34 of this title (relating to Definitions, Personnel, Operational Standards, and Records for Class A (Community) Pharmacies) to the extent such rules are applicable to non-sterile compounding of drug products. (11) A Class C Pharmacy, licensed under the provisions of the Act, sec.29(b)(3) which would otherwise be required to be licensed under the Act, sec.29(b)(6) (relating to Class F Pharmacy), is not required to secure a license for such other type of pharmacy; provided, however: (A) such licensee is required to comply with the provisions of sec.291.111 of this title (relating to Purpose), sec.291.112 of this title (relating to Definitions), sec.291.113 of this title (relating to Personnel), sec.291.114 of this title (relating to Operational Standards), and sec.291.115 of this title (relating to Records), contained in Home and Community Support Services Pharmacy (Class F), to the extent such rules are applicable to the operation of the pharmacy; (B) the Class C Pharmacy and the Home and Community Support Services Agency licensed under Health and Safety Code, Chapter 142, whose patients the Class F Pharmacy provides services, are at the same location and under common control and ownership; and (C) the pre-labeled drugs for the Class F Pharmacy are maintained in such a manner that a person accessing these pre-labeled drugs does not have access to other drugs in the Class C Pharmacy. (b) Environment. (1) General requirements. (A)-(F) (No change.) (G) If the institutional pharmacy has flammable materials, the pharmacy shall have a designated area for the storage of flammable materials. Such area shall meet the requirements set by local and state fire laws. (H) The institutional pharmacy shall store antiseptics, other drugs for external use, and disinfectants separately from internal and injectable medications. (2) Special requirements for the compounding of sterile pharmaceuticals in the institutional pharmacy. (A) If the institutional pharmacy compounds sterile pharmaceuticals, the following is applicable. (i) Aseptic environment control device(s) . The institutional pharmacy shall prepare sterile pharmaceuticals in an appropriate aseptic environmental control device(s) or area, such as a laminar air flow hood, biological safety cabinet, or clean room, which is capable of maintaining at least Class 100 conditions during normal activity. Such aseptic environmental control device(s) shall: (I) be certified by an independent contractor according to Federal Standard 209E et seq for operational efficiency at least every six months or when it is relocated; and (II) have pre-filters inspected periodically and replaced as needed, in accordance with written policies and procedures, and the inspection and/or replacement date documented. (ii) Controlled area. The institutional pharmacy shall have a designated controlled area for the compounding of sterile pharmaceuticals that is functionally separate from areas for the preparation of non-sterile pharmaceuticals and is constructed to minimize the opportunities for particulate and microbial contamination. This controlled area for the preparation of sterile pharmaceuticals shall: (I) have a controlled environment that is aseptic or contains an aseptic environmental control device(s); (II) be clean, well lighted, and of sufficient size to support sterile compounding activities; (III) be used only for the compounding of sterile pharmaceuticals; (IV) be designed to avoid outside traffic and air flow and be ventilated in a manner not interfering with aseptic environmental control conditions; (V) have drugs and supplies stored on shelving areas above the floor to permit adequate floor cleaning; (VI) have non-porous and washable floors or floor covering to enable regular disinfection; (VII) have hard cleanable walls and ceilings (acoustical ceiling tiles that are coated with an acrylic paint are acceptable); and (VIII) contain only the appropriate compounding supplies and not be used for bulk storage for supplies and materials. (iii) End-product evaluation. (I) The responsible pharmacist shall verify that the sterile pharmaceutical was compounded accurately with respect to the use of correct ingredients, quantities, containers, and reservoirs. (II) End product sterility testing according to policies and procedures, which include a statistically valid sampling plan and acceptance criteria for the sampling and testing, shall be performed if deemed appropriate by the pharmacist-in-charge. (III) The pharmacist-in-charge shall establish a mechanism for recalling all products of a specific batch if end-product testing procedures yield unacceptable results. (iv) Automated compounding device(s). If automated compounding device(s) are used, the pharmacy shall have a method to calibrate and verify the accuracy of automated compounding devices used in aseptic processing and document the calibration and verification on a routine basis. (B) Cytotoxic drugs. In addition to the requirements specified in subparagraph (A) of this subsection, the product is also cytotoxic, the following is applicable. (i) General. (I) All personnel involved in the compounding of cytotoxic products shall wear appropriate protective apparel, such as masks, gloves, and gowns or coveralls with tight cuffs. (II) Appropriate safety and containment techniques for compounding cytotoxic drugs shall be used in conjunction with aseptic techniques required for preparing sterile pharmaceuticals. (III) Disposal of cytotoxic waste shall comply with all applicable local, state, and federal requirements. (IV) Prepared doses of cytotoxic drugs must be dispensed, labeled with proper precautions inside and outside, and distributed in a manner to minimize contact with cytotoxic agents. (ii) Aseptic environment control device(s). (I) Cytotoxic drugs must be prepared in a vertical flow biological safety cabinet. (II) If the vertical flow biological safety cabinet is also used to prepare non-cytotoxic sterile pharmaceuticals, the cabinet must be thoroughly cleaned prior to its use to prepare non-cytotoxic sterile pharmaceuticals. (3) Security requirements. (A)-(B) (No change.) (C) The institutional pharmacy shall have locked storage for Schedule II controlled substances and other drugs requiring additional security. (c) Equipment and supplies. (1) Institutional pharmacies distributing medication orders shall have the following equipment: (A) typewriter or comparable equipment; and (B) refrigerator and a system or device (e.g., thermometer) to monitor the temperature daily to ensure that proper storage requirements are met. (2) If the institutional pharmacy compounds medication orders which require the use of a balance, a Class A prescription balance or analytical balance with weights. Such balance shall be properly maintained and inspected at least every three years by the appropriate authority as prescribed by local, state, or federal law or regulations. (3) If the institutional pharmacy compounds sterile pharmaceuticals, the pharmacy shall have the following equipment. (A) appropriate disposal containers for used needles, syringes, etc., and if applicable, cytotoxic waste from the preparation of chemotherapeutic agents, cytotoxic waste; (B) infusion devices, if applicable; (C) all necessary supplies, including: (i) disposable needles, syringes, and other supplies for aseptic mixing; (ii) disinfectant cleaning solutions; (iii) hand washing agents with bacteriocidal action; (iv) disposable, lint free towels or wipes; (v) appropriate filters and filtration equipment; (vi) cytotoxic spill kits, if applicable; and (vii) masks, caps, coveralls or gowns with tight cuffs, shoe covers, and gloves, as applicable. (d) Library. A reference library shall be maintained which includes the following in hard-copy or electronic format: (1) (No change.) (2) at least one current or updated reference from each of the following categories: (A) Drug interactions. A reference text on drug interactions, such as Hansten's and Horn's Drug Interactions. (B) General information. (i)-(ii) (No change.) (iii) AHFS Drug Information with current supplements; (iv) Remington's Pharmaceutical Sciences; or (v) Micromedex. (3)-(4) (No change.) (5) If the pharmacy compounds sterile pharmaceuticals: (A) American Society of Hospital Pharmacists' Technical Assistance Bulletin on Quality Assurance for Pharmacy-Prepared Sterile Products; and (B) specialty reference appropriate for the scope of services provided by the pharmacy, e.g., if the pharmacy prepares cytotoxic drugs, a reference text on the preparation of cytotoxic drugs, such as Procedures for Handling Cytotoxic Drugs. (6) Metric-apothecary weight and measure conversion charts. (e) Absence of a pharmacist. (1) Medication orders. (A) In facilities with a full-time pharmacist, if a practitioner orders a drug for administration to a bona fide patient of the facility when the pharmacy is closed, the following is applicable. (i)-(ii) (No change.) (iii) A record shall be made at the time of withdrawal by the authorized person removing the drugs and devices. The record shall contain the following information: (I)-(V) (No change.) (VI) signature (first initial and last name or full signature) or electronic signature of person making withdrawal. (iv) (No change.) (v) The pharmacist shall verify the withdrawal and perform a drug regimen review as specified in subsection (g)(1)(B) of this section as soon as practical, but in no event more than 72 hours from the time of such withdrawal. (B) In facilities with a part-time or consultant pharmacist, if a practitioner orders a drug for administration to a bona fide patient of the facility when the pharmacist is not on duty, or when the pharmacy is closed, the following is applicable. (i)-(iii) (No change.) (iv) The pharmacist shall verify the withdrawal and perform a drug regimen review as specified in subsection (g)(1)(B) of this section after a reasonable interval, but in no event may such interval exceed seven days. (2) Floor stock. In facilities using a floor stock method of drug distribution, the following is applicable. (A)-(B) (No change.) (C) A record shall be made at the time of withdrawal by the authorized person removing the drug or device; the record shall contain the following information: (i)-(iv) (No change.) (v) signature (first initial and last name or full signature) or electronic signature of person making the withdrawal. (D) The pharmacist shall verify the withdrawal after a reasonable interval, but in no event may such interval exceed seven days. (f) Drugs. (1) Procurement, preparation and storage. (A)-(B) (No change.) (C) Institutional pharmacies may not sell, purchase, trade or possess prescription drug samples, unless the pharmacy meets all of the following conditions: (i) the pharmacy is owned by a charitable organization described in the Internal Revenue Code of 1986, or by a city, state or county government; (ii) the pharmacy is a part of a health care entity which provides health care primarily to indigent or low income patients at no or reduced cost; (iii) the samples are for dispensing or provision at no charge to patients of such health care entity; and (iv) the samples are possessed in compliance with the federal Prescription Drug Marketing Act of 1986. (D) All drugs shall be stored at the proper temperatures, as defined by the following: (i) cold Any temperature not exceeding 8 degrees Centigrade (46 degrees Fahrenheit). A refrigerator is a cold place in which the temperature is maintained thermostatically between 2 and 8 degrees Centigrade (36 and 46 degrees Fahrenheit). A freezer is a cold place in which the temperature is maintained thermostatically between -20 and -10 degrees Centigrade (-4 and -14 degrees Fahrenheit). (ii) cool Any temperature between 8 and 15 degrees Centigrade (46 and 59 degrees Fahrenheit). An article for which storage in a cool place is directed may, alternatively, be stored in a refrigerator unless otherwise specified in the labeling. (iii) room temperature The temperature prevailing in a working area. Controlled room temperature is a temperature thermostatically between 15 and 30 degrees Centigrade (59 and 86 degrees Fahrenheit). (iv) warm Any temperature between 30 and 40 degrees Centigrade (86 and 104 degrees Fahrenheit). (v) excessive heat Any temperature above 40 degrees Centigrade (104 degrees Fahrenheit). (vi) protection from freezing where, in addition to the risk of breakage of the container, freezing subjects a product to loss of strength or potency, or to destructive alteration of the dosage form, the container label bears an appropriate instruction to protect the product from freezing. (E) Any drug bearing an expiration date may not be distributed beyond the expiration date of the drug. (F) Outdated and other unusable drugs shall be removed from stock and shall be quarantined together until such drugs are disposed of properly. (2) Formulary. (A) A formulary shall be developed by the facility committee performing the pharmacy and therapeutics function for the facility. (B) The pharmacist-in-charge or pharmacist designated by the pharmacist-in- charge shall be a full voting member of the committee performing the pharmacy and therapeutics function for the facility, when such committee is performing the pharmacy and therapeutics function. (3) Prepackaging of drugs and loading bulk or unlabeled drugs into automated compounding or drug dispensing systems. (A) Pre-packaging of drugs. (i) (No change.) (ii) The label of a pre-packaged unit shall indicate: (I) (No change.) (II) facility's unique lot number; (III) expiration date based on currently available literature; and (IV) (No change.) (iii) Records of pre-packaging shall be maintained to show: (I) (No change.) (II) facility's unique lot number; (III)-(IX) (No change.) (X) name, initials, or electronic signature of the responsible pharmacist. (iv) (No change.) (B) Loading bulk or unlabeled drugs into automated compounding or drug dispensing systems. (i) Automated compounding or drug dispensing systems may be loaded with bulk or unlabeled drugs only by a pharmacist or by supportive personnel under the direction and direct supervision of a pharmacist. (ii) The label of an automated compounding or drug dispensing system container shall indicate the brand name and strength of the drug; or if no brand name, then the generic name, strength, and name of the manufacturer or distributor. (iii) Records of loading bulk or unlabeled drugs into an automated compounding or drug dispensing system shall be maintained to show: (I)-(IV) (No change.) (V) quantity added to the automated drug compounding or dispensing system; (VI) (No change.) (VII) name, initials, or electronic signature of the person loading the automated compounding or drug dispensing system; and (VIII) name, initials, or electronic signature of the responsible pharmacist. (iv) The automated compounding or drug dispensing system shall not be used until a pharmacist verifies that the system is properly loaded and affixes his or her signature (first initial and last name or full signature) or electronic signature to the record specified in clause (iii) of this subparagraph. (4) Sterile pharmaceuticals compounded in the pharmacy. (A) Batch preparation. (i) Master work sheet. A master work sheet shall be developed and approved by a pharmacist for each batch of sterile pharmaceuticals to be prepared. Once approved, a duplicate of the master work sheet shall be used as the preparation work sheet from which each batch is prepared and on which all documentation for that batch occurs. The master work sheet shall contain at a minimum: (I) the formula; (II) the components; (III) the compounding directions; (IV) a sample label; (V) evaluation and testing requirements; (VI) sterilization method(s), if applicable; (VII) storage requirements; and (VIII) specific equipment used during aseptic preparation (e.g., specific automated compounding device). (ii) Preparation work sheet. The preparation work sheet for each batch of sterile pharmaceuticals shall document the following; (I) identity of all solutions and ingredients and their corresponding amounts, concentrations, or volumes; (II) manufacturer lot number for each component; (III) component manufacturer or suitable identifying number; (IV) container specifications (e.g., syringe, pump cassette); (V) unique lot or control number assigned to batch; (VI) expiration date of batch-prepared products; (VII) date of preparation; (VIII) name, initials, or electronic signature of the person(s) involved in the preparation; (IX) name, initials, or electronic signature of the responsible pharmacist; (X) end-product evaluation and testing specifications, if applicable; and (XI) comparison of actual yield to anticipated yield, when appropriate. (B) Labeling. The label of each sterile pharmaceutical shall bear at a minimum: (i) for patient-specific products, the patient's name and location or identification number; (ii) for batch prepared products, the unique lot or control number assigned to the batch; (iii) all solution and ingredient names, amounts, strengths, and concentrations, when applicable; (iv) expiration date and time, when applicable; (v) directions for use, including infusion rate, when appropriate; (vi) name or initials of the person preparing the product and, if prepared by supportive personnel, the name or initials of the pharmacist who checked and released the final product. (This information is not required on the label if it is maintained in a permanent record of the pharmacy); (vii) appropriate ancillary instructions such as storage instructions or cautionary statements, including cytotoxic warning labels where appropriate; and (viii) device-specific instructions, when appropriate. (C) Expiration date. (i) The expiration date assigned shall be based on currently available drug stability information and sterility considerations or appropriate in house or contract service stability testing. (ii) Sources of drug stability information shall include the following: (I) references (e.g., Remington's Pharmaceutical Sciences, Handbook on Injectable Drugs); (II) manufacturer recommendations; and (III) reliable, published research. (iii) When interpreting published drug stability information, the pharmacist shall consider all aspects of the final sterile product being prepared (e.g., drug reservoir, drug concentration, storage conditions). (iv) Methods used for establishing expiration dates shall be documented. (D) Quality control. There shall be a documented, ongoing quality control program that monitors and evaluates personnel performance, equipment and facilities. Procedures shall be in place to assure that the pharmacy is capable of consistently preparing pharmaceuticals which are sterile and stable. Quality control procedures shall include, but are not limited to, the following: (i) recall procedures; (ii) storage and dating; and (iii) documentation of appropriate functioning of refrigerator, freezer and other equipment. (iv) documentation of aseptic environmental control device(s) certification at least every six months and the regular replacement of pre-filters as necessary; and (v) a process to evaluate and confirm the quality of the prepared pharmaceutical product. (E) Quality assurance. (i) There shall be a documented, ongoing quality assurance program for monitoring and evaluating personnel performance and patient outcomes to assure an efficient drug delivery process, patient safety, and positive clinical outcomes. (ii) There shall be documentation of quality assurance audits at regular, planned intervals including infection control, sterile technique, delivery systems/times, order transcription accuracy, drug administration systems, adverse drug reactions and drug therapy appropriateness, as applicable. (iii) A plan for corrective action of problems identified by quality assurance audits shall be developed which includes procedures for documentation of identified problems and action taken. (iv) A periodic evaluation of the effectiveness of the quality assurance activities shall be completed and documented. (5) Sterile pharmaceuticals prepared in a location other than the pharmacy. A distinctive supplementary label shall be affixed to the container of any admixture. The label shall bear at a minimum: (A) patient's name and location; (B) name and amount of drug(s) added; (C) name of the basic solution; (D) name or identifying code of person who prepared admixture; and (E) expiration date of solution. (6) Distribution. (A) Medication orders. (i)-(ii) (No change.) (iii) Supportive personnel may not receive verbal medication orders. (iv) Institutional pharmacies shall be exempt from the labeling provisions and patient notification requirements of subsections (e) and (g) of sec.40 of the Act, as respects drugs distributed pursuant to medication orders. (B) Procedures. (i) Written policies and procedures for a drug distribution system (best suited for the particular institutional pharmacy) shall be developed and implemented by the pharmacist-in-charge, with the advice of the committee performing the pharmacy and therapeutics function for the facility. (ii) The written policies and procedures for the drug distribution system shall include, but not be limited to, procedures regarding the following: (I) pharmaceutical care services; (II) handling, storage and disposal of cytotoxic drugs and waste; (III) disposal of unusable drugs and supplies; (IV) security; (V) equipment; (VI) sanitation; (VII) reference materials; (VIII) drug selection and procurement; (IX) drug storage; (X) controlled substances; (XI) investigational drugs, including the obtaining of protocols from the principal investigator; (XII) prepackaging and manufacturing; (XIII) stop orders; (XIV) reporting of medication errors, adverse drug reactions/events, and drug product defects; (XV) physician orders; (XVI) floor stocks; (XVII) drugs brought into the facility; (XVIII) furlough medications; (XIX) self-administration; (XX) emergency drug supply; (XXI) formulary; (XXII) monthly inspections of nursing stations and other areas where drugs are stored, distributed, administered or dispensed; (XXIII) control of drug samples; (XXIV) outdated and other unusable drugs; (XXV) routine distribution of inpatient medication; (XXVI) preparation and distribution of sterile pharmaceuticals; (XXVII) handling of medication orders when a pharmacist is not on duty; (XXVIII) use of automated compounding or drug dispensing systems; (XXIX) use of data processing and direct imaging systems; (XXX) drug administration to include infusion devices, drug delivery systems, and first dose monitoring; (XXXI) drug labeling; (XXXII) record keeping; (XXXIII) quality assurance/quality control; (XXXIV) duties and education and training of professional and nonprofessional staff; and (XXXV) emergency preparedness plan, to include continuity of patient therapy and public safety. (g) Pharmaceutical care services. (1) The pharmacist-in-charge shall assure that at least the following pharmaceutical care services are provided to patients of the facility. (A) Drug utilization review. A systematic ongoing process of drug utilization review shall be developed in conjunction with the medical staff to increase the probability of desired patient outcomes and decrease the probability of undesired outcomes from drug therapy. (B) Drug regimen review. (i) For the purpose of promoting therapeutic appropriateness, a pharmacist shall evaluate medication orders and patient medication records for: (I) known allergies; (II) rational therapy-contraindications; (III) reasonable dose and route of administration; (IV) reasonable directions for use; (V) duplication of therapy; (VI) drug-drug interactions; (VII) drug-food interactions; (VIII) drug-disease interactions; (IX) adverse drug reactions; (X) proper utilization, including overutilization or underutilization; and (XI) clinical laboratory or clinical monitoring methods to monitor and evaluate drug effectiveness, side effects, toxicity, or adverse effects, and appropriateness to continued use of the drug in its current regimen. (ii) The drug regimen review shall be conducted on a prospective basis when a pharmacist is on duty, except for an emergency order, and on a retrospective basis as specified in subsection (e)(1) of this section when a pharmacist is not on duty. (iii) Any questions regarding the order must be resolved with the prescriber and a written notation of these discussions made and maintained. (C) Education. The pharmacist-in-charge in cooperation with appropriate multi- disciplinary staff of the facility shall develop policies that assure that: (i) the patient and/or patient's caregiver receives information regarding drugs and their safe and appropriate use; and (ii) health care providers are provided with patient specific drug information. (D) Patient monitoring. The pharmacist-in-charge in cooperation with appropriate multi-disciplinary staff of the facility shall develop policies to ensure that the patient's response to drug therapy is monitored and conveyed to the appropriate health care provider. (2) Other pharmaceutical care services which may be provided by pharmacists in the facility include, but are not limited to, the following: (A) managing drug therapy as delegated by a practitioner as allowed under the provisions of the Medical Practice Act, sec.3.06(d); (B) managing patient compliance programs; (C) providing preventative health care services; and (D) providing case management of patients who are being treated with high-risk or high-cost drugs, or who are considered "high risk" due to their age, medical condition, family history, or related concern. (h)-(i) (No change.) sec.291.75. Records. (a) (No change.) (b) Outpatient records. (1) Outpatient records shall be maintained as provided in sec.291.34 of this title (relating to Records), sec.291.35 of this title (relating to Triplicate Prescription Records), and sec.291.36 of this title (relating to Class A Pharmacies Compounding Sterile Pharmaceuticals), contained in Community Pharmacy (Class A). (2)-(3) (No change.) (c) Inpatient records. (1) Original medication orders. (A) Each original medication order shall bear the following information: (i) patient name and room number or identification number; (ii)-(iv) (No change.) (v) signature or electronic signature of the practitioner or that of his or her authorized agent. (B) (No change.) (2) (No change.) (3) Controlled substances records. Controlled substances records shall be maintained as follows. (A)-(B) (No change.) (4) Schedule II controlled substances records. Records of controlled substances listed in Schedule II shall be maintained as follows. (A)-(B) (No change.) (C) Distribution records for controlled substances listed in Schedule II shall bear the following information: (i) (No change.) (ii) prescribing or attending practitioner; (iii)-(iv) (No change.) (v) signature (first initial and last name or full signature) or electronic signature of the individual administering the controlled substance; (vi)-(vii) (No change.) (5) Floor stock records. (A) Distribution records for Schedule II-V controlled substances floor stock shall include the following information: (i) (No change.) (ii) prescribing or attending practitioner; (iii)-(v) (No change.) (vi) signature (first initial and last name or full signature) or electronic signature of the individual administering drug; (vii)-(viii) (No change.) (B)-(C) (No change.) (6) General requirements for records maintained in a data processing system. (A) (No change.) (B) Non-compliance with data processing requirements. If a hospital pharmacy's data processing system is not in compliance with the Board's requirements, the pharmacy must maintain a manual recordkeeping system. (C) (No change.) (D) Change or discontinuance of a data processing system. (i) Records of distribution and return for all controlled substances, and butorphanol (e.g., Stadol ), nalbuphine (e.g., Nubain ), tripelennamine (e.g., PBZ ) and carisoprodol (e.g., Soma ). A pharmacy that changes or discontinues use of a data processing system must: (I)-(II) (No change.) (ii) -(iii) (No change.) (E) (No change.) (7) Data processing system maintenance of records for the distribution and return of all controlled substances, and butorphanol (e.g., Stadol ), nalbuphine (e.g., Nubain ), tripelennamine (e.g., PBZ ), and carisoprodol (e.g., Soma ) to the pharmacy. (A) Each time a controlled substance, and/or butorphanol (e. g., Stadol ), nalbuphine (e.g., Nubain ), tripelennamine (e.g., PBZ ), or carisoprodol (e.g., Soma ) is distributed from or returned to the pharmacy, a record of such distribution or return shall be entered into the data processing system. (B)-(D) (No change.) (8)-(9) (No change.) (d) Distribution of controlled substances to another registrant. A pharmacy may distribute controlled substances to a practitioner, another pharmacy or other registrant, without being registered to distribute, under the following conditions. (1)-(3) (No change.) (4) If the distribution is for a Schedule I or II controlled substance, the following is applicable: (A) The pharmacy, practitioner or other registrant who is receiving the controlled substances shall issue copy 1 and copy 2 of a DEA order form (DEA 222) to the distributing pharmacy. (B) The distributing pharmacy shall: (i) complete the area on the DEA order form (DEA 222) titled TO BE FILLED IN BY SUPPLIER; (ii) maintain copy 1 of the DEA order form (DEA 222) at the pharmacy for two years; and (iii) forward copy 2 of the DEA order form (DEA 222) to the divisional office of the Drug Enforcement Administration. (e) Other records. Other records to be maintained by a pharmacy: (1) a permanent log of the initials or identification codes which will identify pharmacy personnel by name (the initials or identification code shall be unique to ensure that each person can be identified, i.e., identical initials or identification codes cannot be used); (2) copy 3 of DEA order form (DEA 222) which has been properly dated, initialed, and filed, and all copies of each unaccepted or defective order form and any attached statements or other documents; (3) a hard-copy of the power of attorney to sign DEA 222 order forms (if applicable); (4) suppliers' invoices of dangerous drugs and controlled substances; pharmacists or other responsible individuals shall verify that the controlled drugs listed on the invoices were actually received by clearly recording their initials and the actual date of receipt of the controlled substances; (5) (No change.) (6) a hard-copy of inventories required by sec.291.17 of this title (relating to Inventory Requirements) except that a perpetual inventory of controlled substances listed in Schedule II may be kept in a data processing system if the data processing system is capable of producing a hard-copy of the perpetual inventory on-site; (7)-(10) (No change.) (f)-(g) (No change.) This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Issued in Austin, Texas, on February 23, 1995. TRD-9502336 Fred S. Brinkley, Jr., R.Ph., M.B.A. Executive Director/Secretary Texas State Board of Pharmacy Effective date: March 16, 1995 Proposal publication date: August 23, 1994 For further information, please call: (512) 832-0661 Part XXI. Texas State Board of Examiners of Psychologists Chapter 469. Specialty Certification 22 TAC sec.469.2 The Texas State Board of Examiners of Psychologists adopts an amendment to sec.469.2, concerning Criteria for Health Service Providers in Psychology, without changes to the proposed text as published in the December 16, 1994, issue of the Texas Register (19 TexReg 9952). This rule is being amended because one section of the rule refers to a rule which has been repealed. This amendment will make the rules and regulations of the Board easier to understand and follow for certificands, licensees and the general public. No comments were received regarding adoption of the amendment. The amendment is adopted under Texas Civil Statutes, Article 4512c, which provide the Texas State Board of Examiners of Psychologists with the authority to promulgate rules consistent with the Statute. This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Issued in Austin, Texas, on February 22, 1995. TRD-9502315 Rebecca E. Forkner Executive Director Texas State Board of Examiners of Psychologists Effective date: March 16, 1995 Proposal publication date: December 16, 1994 For further information, please call: (512) 836-2036 TITLE 25. HEALTH SERVICES Part I. Texas Department of Health Chapter 14. County Indigent Health Care Program Subchapter F. Advisory Committee 25 TAC sec.14.501 The Texas Department of Health (department) adopts new sec.14.501, concerning the Indigent Health Care Advisory Committee, with changes to the proposed text as published in the December 2, 1994, issue of the Texas Register (19 TexReg 9446). In accordance with Texas Civil Statutes, Article 6252-33, the department must evaluate each of its advisory committees to determine whether the committee should be continued, modified, consolidated with other committees, or abolished. The present advisory committee, the Indigent Health Care Advisory Committee, was established in 1989. Upon review by the department, rules have been prepared for adoption by the board. The new section provides rules for the Indigent Health Care Advisory Committee that are consistent with other department advisory committees. No comments were received regarding adoption of the new section during the comment period. The department made minor editorial changes in subsection (a) (2) for clarity. The new section is adopted under Texas Civil Statutes, Article 6252-33, which set standards for the evaluation of advisory committees by the agencies for which they function; Health and Safety Code, sec.11.016, which allos the board to establish advisory committees; and under Health and Safety Code, sec.12.001, which provides the board with authority to adopt rules for the performance of every duty imposed by law upon the board, the department, and commissioner of health. sec.14.501. Indigent Health Care Advisory Committee. (a) The committee. An advisory committee shall be appointed under and governed by this section. (1) The name of the committee shall be the Indigent Health Care Advisory Committee. (2) The committee is established under the Health and Safety Code, sec.11.016, which allows the Board of Health (board) to establish advisory committees. (b) Applicable law. The committee is subject to Texas Civil Statutes, Article 6252-33, relating to state agency advisory committees. (c) Purpose. The purpose of the committee is to provide advice to the board in the area of the Indigent Health Care Program. (d) Tasks. (1) The committee shall advise the board concerning rules relating to the Indigent Health Care Program. (2) The committee shall carry out any other tasks given to the committee by the board. (e) Review and duration. By July 1, 1999, the board will initiate and complete a review of the committee to determine whether the committee should be continued, consolidated with another committee, or abolished. If the committee is not continued or consolidated, the committee shall be abolished on that date. (f) Composition. The committee shall be composed of 11 members consisting of two consumer and nine other representatives appointed by the board. (g) Terms of office. The term of office of each member shall be six years. (1) Members shall be appointed for staggered terms so that the terms of a substantial equivalent number of members will expire on August 31st of each year. (2) If a vacancy occurs, a person shall be appointed to serve the unexpired portion of that term. (h) Officers. The committee shall elect a presiding officer and an assistant presiding officer at its first meeting after August 31st of each year. (1) Each officer shall serve until the next regular election of officers. (2) The presiding officer shall preside at all committee meetings at which he or she is in attendance, call meetings in accordance with this section, appoint subcommittees of the committee as necessary, and cause proper reports to be made to the board. The presiding officer may serve as an ex-officio member of any subcommittee of the committee. (3) The assistant presiding officer shall perform the duties of the presiding officer in case of the absence or disability of the presiding officer. In case the office of presiding officer becomes vacant, the assistant presiding officer will serve until a successor is elected to complete the unexpired portion of the term of the office of presiding officer. (4) A vacancy which occurs in the offices of presiding officer or assistant presiding officer may be filled at the next committee meeting. (5) A member shall serve no more than two consecutive terms as presiding officer and/or assistant presiding officer. (6) The committee may reference its officers by other terms, such as chairperson and vice-chairperson. (i) Meetings. The committee shall meet only as necessary to conduct committee business. (1) A meeting may be called by agreement of department staff and either the presiding officer or at least three members of the committee. (2) Meeting arrangements shall be made by department staff. Department staff shall contact committee members to determine availability for a meeting date and place. (3) Each meeting of the committee shall be announced and conducted in accordance with the Open Meetings Act, Texas Government Code, Chapter 551. (4) Each member of the committee shall be informed of a committee meeting at least five working days before the meeting. (5) A simple majority of the members of the committee shall constitute a quorum for the purpose of transacting official business. (6) The committee is authorized to transact official business only when in a legally constituted meeting with quorum present. (7) The agenda for each committee meeting shall include an item entitled public comment under which any person will be allowed to address the committee on matters relating to committee business. The presiding officer may establish procedures for public comment, including a time limit on each comment. (j) Attendance. Members shall attend committee meetings as scheduled. Members shall attend meetings of subcommittees to which the member is assigned. (1) A member shall notify the presiding officer or appropriate department staff if he or she is unable to attend a scheduled meeting. (2) It is grounds for removal from the committee if a member cannot discharge the member's duties for a substantial part of the term for which the member is appointed because of illness or disability, is absent from more than half of the committee and subcommittee meetings during a calendar year, or is absent from at least three consecutive committee meetings. (3) The validity of an action of the committee is not affected by the fact that it is taken when a ground for removal of a member exists. (4) The attendance records of the members shall be reported to the board. The report shall include attendance at committee and subcommittee meetings. (k) Staff. Staff support for the committee shall be provided by the department. (l) Procedures. Roberts Rules of Order, Newly Revised, shall be the basis of parliamentary decisions except where otherwise provided by law or rule. (1) Any action taken by the committee must be approved by a majority vote of the members present once quorum is established. (2) Each member shall have one vote. (3) A member may not authorize another individual to represent the member by proxy. (4) The committee shall make decisions in the discharge of its duties without discrimination based on any person's race, creed, gender, religion, national origin, age, physical condition, or economic status. (5) Minutes of each committee meeting shall be taken by department staff. (A) A draft of the minutes approved by the presiding officer shall be provided to the board and each member of the committee within 30 days of each meeting. (B) After approval by the committee, the minutes shall be signed by the presiding officer. (m) Subcommittees. The committee may establish subcommittees as necessary to assist the committee in carrying out its duties. (1) The presiding officer shall appoint members of the committee to serve on subcommittees and to act as subcommittee chairpersons. The presiding officer may also appoint nonmembers of the committee to serve on subcommittees. (2) Subcommittees shall meet when called by the subcommittee chairperson or when so directed by the committee. (3) A subcommittee chairperson shall make regular reports to the advisory committee at each committee meeting or in interim written reports as needed. The reports shall include an executive summary or minutes of each subcommittee meeting. (n) Statement by members. The board, the department, and the committee shall not be bound in anyway by any statement or action on the part of any committee member except when a statement or action is in pursuit of specific instructions from the board, department, or committee. (o) Reports to board. The committee shall file an annual written report with the board. (1) The report shall list the meeting dates of the committee and any subcommittees, the attendance records of its members, a brief description of actions taken by the committee, a description of how the committee has accomplished the tasks given to the committee by the board, the status of any rules which were recommended by the committee to the board, anticipated activities of the committee for the next year, and any amendments to this section requested by the committee. (2) The report shall identify the costs related to the committee's existence, including the cost of agency staff time spent in support of the committee's activities. (3) The report shall cover the meetings and activities in the immediate preceding 12 months and shall be filed with the board each January. It shall be signed by the presiding officer and appropriate department staff. (p) Reimbursement for expenses. In accordance with the requirements set forth in Texas Civil Statutes, Article 6252-33, a committee member may receive reimbursement for the member's expenses incurred for each day the member engages in official committee business. (1) No compensatory per diem shall be paid to committee members unless required by law. (2) A committee member who is an employee of a state agency, other than the department, may not receive reimbursement for expenses from the department. (3) A nonmember of the committee who is appointed to serve on a subcommittee may not receive reimbursement for expenses from the department. (4) Each member who is to be reimbursed for expenses shall submit to staff the member's receipts for expenses and any required official forms no later than 14 days after each committee meeting. (5) Requests for reimbursement of expenses shall be made on official state travel vouchers prepared by department staff. This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Issued in Austin, Texas, on February 22, 1995. TRD-9502323 Susan K. Steeg General Counsel Texas Department of Health Effective date: March 16, 1995 Proposal publication date: December 2, 1994 For further information, please call: (512) 458-7236 Chapter 39. Primary Health Care Services Program The Texas Department of Health (department) adopts the repeal of sec.sec.39. 41-39.50; and new sec.39.41, concerning the Community Oriented Primary Care Advisory Committee. Section 39.41 is adopted with changes to the proposed text as published in the December 2, 1994, issue of the Texas Register (19 TexReg 9448). The repeal of sec.sec.39.41-39.50 is adopted without changes and will not be republished. The new section covers applicable law, purpose, tasks, review and duration, composition, terms of office, officers, meetings, attendance, staff, parliamentary procedures, subcommittees, statements by members, reports to the board, and reimbursement of members' expenses. The new section is adopted for the following reasons. In compliance with Texas Civil Statutes, Article 6252-33, the department must evaluate each of its advisory committees and determine whether each should be continued, modified, consolidated with other committees, or abolished. The present advisory committee, the State Primary Care Program Advisory Committee, was established in 1985. Upon review by the department, the committee's name has been changed, and its structure has been revised to create a better balance between consumer and nonconsumer members. The following comments were received concerning the repeals and new section. Comment: A commenter stated that a representative of a rural health clinic should be included on the committee. Response: The committee's membership categories are designed to include persons with a range of experiences and points of view, and to allow needed flexibility in making appointments. The committee's nonconsumer members include a physician who practices in a rural area, who could also represent issues concerning rural health clinics. No changes were made in the rules as a result of this comment. Comment: A commenter suggested that instead of the term "hospital" representative, a broader term such as "health systems" representative be should be used. Response: The department understands that many health systems are evolving as part of the dynamic change occurring in health care delivery at all levels. However, the term "hospital" was used to show the importance of hospital recognition to support community responsiveness, and to incorporate inpatient referral and linkage to primary care and broad health care finance issues. The current term is broad enough to allow selection of the type of representative suggested, and is retained without change. Comment: A commenter suggested that it would be important to have representatives of both a primary care training program and a school of public health. Response: The department feels that enough flexibility exists among the nonconsumer membership as a group to address this comment. Many of the proposed members will represent more than one interest and will provide broad expertise. Therefore the current language is retained without change. Comment: A commenter recommended that the committee's purposes should include providing advice to the Board of Health as well as to the department. Response: The department agrees and has amended sec.39.41(c) accordingly. Comment: A commenter felt that a representative from the field of mental health be should be included on the advisory committee. Response: The committee's composition as proposed does not preclude such a representative. In addition, the department feels that consultation on specific mental health issues is available from existing state agency committees. No changes were made as a result of this recommendation. Comment: A commenter suggested that the definition of "consumer" member should be clarified, and that the reference to "business representative" should be broadened to include other community stakeholders. Response: The department classifies any nonprovider as a consumer, and thus feels it is unnecessary to add a more specific definition to the rules. The department agrees that the term "business representative" should be changed, and has amended subsection (f)(2)(A) and (B) accordingly. Comment: A commenter stated that the dental representative should be retained on the advisory committee. Response: The department disagrees, because a Dental Advisory Committee already is available for needed consultation. The commenters were all individuals who expressed concerns, questions, and recommendations both in opposition to and in favor of the rules. State Primary Care Program Advisory Committee 25 TAC sec.sec.39.41-39.50 The repeals are adopted under Texas Civil Statutes, Article 6252-33, which set standards for the evaluation of advisory committees by the agencies for which they function; Health and Safety Code, sec.11.016, which allows the board to establish advisory committees; and sec.12.001(b), which provides the board with authority to adopt rules for the performance of every duty imposed by law upon the board, the department, and the commissioner of health. This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Issued in Austin, Texas, on February 22, 1995. TRD-9502324 Susan K. Steeg General Counsel Texas Department of Health Effective date: March 16, 1995 Proposal publication date: December 2, 1994 For further information, please call: (512) 458-7236 25 TAC sec.39.41 The new section is adopted under Texas Civil Statutes, Article 6252-33, which set standards for the evaluation of advisory committees by the agencies for which they function; Health and Safety Code, sec.11.016, which allows the board to establish advisory committees; and sec.12.001(b), which provides the board with authority to adopt rules for the performance of every duty imposed by law upon the board, the department, and the commissioner of health. sec.39.41. Community Oriented Primary Care Advisory Committee. (a) The committee. An advisory committee shall be appointed under and governed by this section. (1) The name of the committee shall be the Community Oriented Primary Care Advisory Committee. (2) The committee is established under Health and Safety Code, sec.11.016, which allows the board to establish advisory committees. (b) Applicable law. The committee is subject to Texas Civil Statutes, Article 6252-33, relating to state agency advisory committees. (c) Purpose. The purpose of the committee is to provide advice to the board and the department in planning, coordinating, and administering the development of a community-based comprehensive system of primary care, encompassing a full spectrum of psychosocial, preventive, acute/urgent, case management, and dental services. (d) Tasks. (1) The committee shall advise the board concerning rules relating to implementation of state primary care program activities. (2) The committee shall: (A) evaluate existing services and unmet community needs in developing primary care networks including services and providers; (B) review the primary care plan(s); (C) evaluate ongoing program efforts; (D) define and prioritize both short-range and long-range goals and objectives for primary care activities; and (E) review criteria and standards for primary care program implementation. (3) The committee shall carry out any other tasks given to the committee by the board. (e) Review and duration. By July 1, 1999, the Board will initiate and complete a review of the committee to determine whether the committee should be continued, consolidated with another committee, or abolished. If the committee is not continued or consolidated, the committee shall be abolished on that date. (f) Composition. The membership of the committee shall reflect the populations to be served by the program, with equal consideration of regional, ethnic, and gender distribution, and shall emphasize primary care provider and community oriented representation. (1) The board shall appoint members of the committee. (2) The committee shall be composed of 12 members, which shall include: (A) three consumer members, including at least two of whom are past or current consumers of services, and one community member; and (B) nine other members as follows; (i) two primary care physicians, one practicing in a rural area and one practicing in an underserved area; (ii) one representative of a local health department; (iii) one representative of a federally funded community health center; (iv) one representative of a hospital; (v) one educator or faculty member who trains primary care providers or a representative of an institution of higher education or a school of public health; (vi) one member with expertise in health care finance; (vii) one practicing professional nurse; and (viii) one practicing physician assistant or nurse practitioner. (g) Terms of office. The term of office of each member shall be six years. (1) Members shall be appointed for staggered terms with the terms of four members expiring August 31 of each even-numbered year beginning in 1996. (2) If a vacancy occurs, a person shall be appointed to serve the unexpired portion of that term. (h) Officers. The committee shall elect a presiding officer and an assistant presiding officer at its first meeting after August 31 of each year. (1) Each officer shall serve one-year terms and shall be eligible for reelection for one additional term. (2) The presiding officer shall preside at all committee meetings at which he or she is in attendance, call meetings in accordance with this section, appoint subcommittees of the committee as necessary, and cause proper reports to be made to the board. The presiding officer may serve as an ex-officio member of any subcommittee of the committee. (3) The assistant presiding officer shall perform the duties of the presiding officer in case of the absence or disability of the presiding officer. In case the office of presiding officer becomes vacant, the assistant presiding officer will serve until a successor is elected to complete the unexpired portion of the term of the office of presiding officer. (4) A vacancy which occurs in the offices of presiding officer or assistant presiding officer may be filled at the next committee meeting. (5) A member shall serve no more than two consecutive terms as presiding officer and/or assistant presiding officer. (6) The committee may refer to its officers by other terms, such as chairperson and vice-chairperson. (i) Meetings. The committee shall meet only as necessary to conduct committee business. (1) A meeting may be called by agreement of Texas Department of Health (department) staff and either the presiding officer or at least three members of the committee. (2) Meeting arrangements shall be made by department staff. Department staff shall contact committee members to determine availability for a meeting date and place. (3) Each meeting of the committee shall be announced and conducted in accordance with the Open Meetings Act, Texas Government Code, Chapter 551. (4) Each member of the committee shall be informed of a committee meeting at least five working days before the meeting. (5) A simple majority of the members of the committee shall constitute a quorum for the purpose of transacting official business. (6) The committee is authorized to transact official business only when in a legally constituted meeting with a quorum present. (7) The agenda for each committee meeting shall include an opportunity for any person to address the committee on matters relating to committee business. The presiding officer may establish procedures for public comment, including a time limit on each comment. (j) Attendance. Members shall attend committee meetings as scheduled. Members shall attend meetings of subcommittees to which they are assigned. (1) A member shall notify the presiding officer or appropriate department staff if he or she is unable to attend a scheduled meeting. (2) It is grounds for removal from the committee if a member cannot: (A) discharge the member's duties for a substantial part of the term for which the member is appointed because of illness or disability; (B) is absent from more than half of the committee and subcommittee meetings during a calendar year; or (C) is absent from at least three consecutive committee meetings. (3) The validity of an action of the committee is not affected by the fact that it is taken when a ground for removal of a member exists. (4) The attendance records of the members shall be reported to the board. The report shall include attendance at committee and subcommittee meetings. (k) Staff. Staff support for the committee shall be provided by the department. (l) Procedures. Roberts Rules of Order, Newly Revised, shall be the basis of parliamentary decisions except where otherwise provided by law or rule. (1) Any action taken by the committee must be approved by a majority vote of the members present once a quorum is established. (2) Each member shall have one vote. (3) A member may not authorize another individual to represent the member by proxy. (4) The committee shall make decisions in the discharge of its duties without discrimination based on any person's race, creed, gender, religion, national origin, age, physical condition, or economic status. (5) Minutes of each committee meeting shall be taken by department staff. (A) A draft of the minutes approved by the presiding officer shall be provided to the board and each member of the committee within 30 days of each meeting. (B) After approval by the committee, the minutes shall be signed by the presiding officer. (m) Subcommittees. The committee may establish subcommittees as necessary to assist the committee in carrying out its duties. (1) The presiding officer shall appoint members of the committee to serve on subcommittees and to act as subcommittee chairpersons. The presiding officer may also appoint nonmembers of the committee to serve on subcommittees. (2) Subcommittees shall meet when called by the subcommittee chairperson or when so directed by the committee. (3) A subcommittee chairperson shall make regular reports to the advisory committee at each committee meeting or in interim written reports as needed. The reports shall include an executive summary or minutes of each subcommittee meeting. (n) Statements by members. The board, the department, and the committee shall not be bound in any way by any statement or action on the part of any committee member except when a statement or action is in pursuit of specific instructions from the board, department, or committee. (o) Reports to board. The committee shall file an annual written report with the board. (1) The report shall include: (A) a list of the meeting dates of the committee and any subcommittees; (B) the attendance records of its members; (C) a brief description of actions taken by the committee; (D) a description of how the committee has accomplished the tasks given to the committee by the board; (E) the status of any rules which were recommended by the committee to the board; (F) anticipated activities of the committee for the next year; and (G) any amendments to this section requested by the committee. (2) The report shall identify the costs related to the committee's existence, including the cost of agency staff time spent in support of the committee's activities. (3) The report shall cover the meetings and activities in the immediately preceding 12 months and shall be filed with the board each July. The report shall be signed by the presiding officer and appropriate department staff. (p) Reimbursement for expenses. In accordance with the requirements set forth in Texas Civil Statutes, Article 6252-33, a committee member may receive reimbursement for the member's expenses incurred for each day the member engages in official committee business. (1) Committee members may not be reimbursed for compensatory per diem by the department unless required by law. (2) A committee member who is an employee of a state agency, other than the department, may not be reimbursed for expenses from the department. (3) A nonmember of the committee who is appointed to serve on a subcommittee may not be reimbursed for expenses from the department. (4) Each member who is to be reimbursed for expenses shall submit to staff the member's receipts for expenses and any required official forms no later than 14 days after each committee meeting. (5) Requests for reimbursement of expenses shall be made on official state travel vouchers prepared by department staff. This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Issued in Austin, Texas, on February 22, 1995. TRD-9502325 Susan K. Steeg General Counsel Texas Department of Health Effective date: March 16, 1995 Proposal publication date: December 2, 1994 For further information, please call: (512) 458-7236 Chapter 181. Vital Statistics Miscellaneous Provisions 25 TAC sec.181.28 The Texas Department of Health (department) adopts new sec.181.28, relating to format, style, content and type of paper used for the issuance of certified copies of vital records issued by the department, local registrars and county clerks, with changes to the proposed text as published in the November 15, 1994, issue of the Texas Register (19 TexReg 8926). The new section establishes the criteria for minimum built in safety features of security paper to be used for the issuance of such records; the format, content and style of records to be issued; and the procedures for issuance. The new section will decrease the number of fraudulent entitlement claims and the use of altered documents. The following comments were received relating to the proposed section. Comment: One staff member pointed out the original wording throughout the proposed section excluded county clerks if they were not local registrars; thus the new rule would not apply to them. Response: The department agrees with this oversight and changed the wording to include those county clerks that issue vital records but are not local registrars. The term "custodian" was also added for this same reason. 181.28(a)(3) stated "all certified copies or abstracts of birth records shall include at a minimum:" appears incorrect because such information may not be available on the record. They suggested the wording be changed to "...should include:" Response: The department fully agrees and changed the wording to reflect the correction. Comment: A commenter expressed support for the new rule, but also suggested changing the order of safety features required as proposed in sec.181.28(c) in order to allow printing procedures to be separated from paper requirements. Response: The department agrees with the suggestions and has changed the order of safety requirements as suggested. Comment: Concerning sec.181.28(c) and (d) a number of commenters supported the concept but were opposed to the additional cost to the local registrars and county clerks for security paper. Response: The department feels the increased cost would be minimal if all registrars were utilizing the same paper and the added benefit of fraud protection and prevention would more than offset the increased cost of the paper. No change was made as a result of the comment but the department is negotiating with several suppliers to effect standardization and establishment of a minimal cost supply of paper. Editorial changes were made for clarification purposes. Commenters to the proposed section included the City of Lubbock, American Bank Note Company, Scott-Merriman, Inc., Fort Bend County, Cherokee County, Corpus Christi-Nueces County Department of Public Health, Howard County, Howard County and the City of Euless. The commenters generally supported the new section, but raised some issues and concerns. The new section is adopted under authority of the Health and Safety Code, sec.192.003, which provides the Board of Health (board) with authority to adopt necessary rules for collecting, recording, transcribing, compiling and preserving vital statistics; sec.194.004, which requires the state registrar to prepare and issue detailed instructions necessary for the uniform observance of Title 3, Vital Statistics and maintenance of a perfect system of registration; sec.191.051, which provides that certified copies shall be in a form approved by the department; and sec.12.001, which provides the board with the authority to adopt rules for the performance of every duty imposed by law on the board, the department, or the commissioner of the department. sec.181.28. Instructions and Requirements for Issuance of Certified Copies of Vital Records by the State Registrar, Local Registrar, or County Clerk. (a) Birth certificates. (1) The state registrar, local registrar, or county clerk shall issue only two types of records for births: (A) a full reproduction of the legal portion of the original record as filed in their office with any addendum(s); or (B) an abstract or certification of birth facts, taken from the original record except for probate records and delayed records which may not be abstracted. An abstract or certification of birth facts shall be issued in one of four styles: (i) a standard abstract or certification; (ii) a wallet-sized abstract or certification; (iii) a typewritten abstract in accordance with Title 3, Health and Safety Code, sec.192.005 and sec.192.011, or when the condition of the original record does not permit full reproduction; or (iv) an heirloom style abstract or certification. (2) Each certified copy of a record, or abstract of a record, shall be issued over the signature or facsimile thereof of the officer to whom the record is entrusted, shall bear the seal of their office, and shall bear a statement of certification: (A) either as a part of the custodian's files; or (B) as authorized to be issued from the state registrar's file. (3) All certified copies or abstracts of birth records shall include at a minimum the following information, if known: (A) state or local file number; (B) given name(s); (C) surname; (D) date of birth; (E) state, and city or county of birth; (F) sex; (G) father's name; (H) mother's maiden name; (I) date of filing; (J) date issued; (K) certification statement; (L) signature or facsimile signature of the custodian; and (M) the seal of their office. (b) Death certificates. (1) The state registrar, local registrar, or county clerk shall issue only two types of death certificates: (A) a full reproduction of the original record and any addenda as filed in their office; or (B) a certification or abstract of death facts, taken from the original record. (2) All certifications or abstracts of death records shall include as a minimum: (A) state or local file number; (B) given name(s); (C) surname: (D) date of death; (E) date of birth; (F) state, city or county of death; (G) sex; (H) date of filing; (I) date issued; (J) certification statement; (K) signature or facsimile signature of the custodian; and (L) the seal of their office. (c) Security features. No certified copy or abstract shall be issued unless the issuing office provides security features in the paper used for issuance. Each sheet or document shall be made on paper which contains as a minimum, the following features: (1) consecutive numbers; (2) background security features; (3) a copy void pantograph; (4) an engraved border; (5) microline printing or security thread; (6) sensitized security paper; (7) prismatic printing; (8) erasable fluorescent printing; (9) non-optical brighteners; and (10) complex colors. (d) Other permitted security features. Other security features such as, but not limited to the following, may also be incorporated in the paper used: (1) intaglio printing; (2) security laminate; (3) latent image; (4) security thread; or (5) watermark. (e) Record retention. A record of the date issued, document number, name and address and form of identification to whom issued shall be made and maintained for a period of three years from the date issued. The application form, with the document number inserted, used to apply for a record will fulfill this requirement. This agency hereby certifies that the rule as adopted has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority. Issued in Austin, Texas, on February 22, 1995. TRD-9502322 Susan K. Steeg General Counsel Texas Department of Health Effective date: March 16, 1995 Proposal publication date: November 15, 1994 For further information, please call: (512) 458-7236