CHAPTER 162. SUPERVISION OF MEDICAL SCHOOL STUDENTS
The Texas Medical Board (Board) adopts amendments to §162.1, concerning Supervision of Medical School Students, without changes to the proposed text as published in the January 9, 2009, issue of the Texas Register (34 TexReg 167) and will not be republished.
The amendments to §162.1 provide for the supervision of a medical student who is not enrolled at a Texas medical school as a full-time student or visiting student.
Elsewhere in this issue of the Texas Register, the Board contemporaneously adopts the rule review of Chapter 162.
The Board sought stakeholder input through Stakeholder Groups, which made comments on the suggested changes to the rules at a meeting held on October 29, 2008. The comments were incorporated into the proposed rules.
The Board received no public written comments and no one appeared to testify at the public hearing held on February 6, 2009.
The amendment is adopted under the authority of the Texas Occupations Code Annotated, §153.001 and §154.006, which provide authority for the Board to adopt rules and bylaws as necessary to govern its own proceedings, perform its duties, regulate the practice of medicine in this state, enforce this subtitle, and establish rules related to licensure.
This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on February 17, 2009.
TRD-200900646
Mari Robinson, J.D.
Interim Executive Director
Texas Medical Board
Effective date: March 9, 2009
Proposal publication date: January 9, 2009
For further information, please call: (512) 305-7016
The Texas Medical Board (Board) adopts the repeal of §171.7, concerning Inactive Status, without changes to the proposed text as published in the January 9, 2009, issue of the Texas Register (34 TexReg 168) and will not be republished.
The repeal of §171.7 deletes a provision that recognizes an inactive status of a physician in training permit. The provision is unnecessary under the current procedure to issue a physician in training permit for the length of postgraduate training. The board considers a postgraduate training permit to be terminated if the holder of the permit is not engaged in the program of postgraduate training.
The Board sought stakeholder input through Stakeholder Groups, which made comments on the suggested changes to the rules at a meeting held on October 29, 2008. The comments were incorporated into the proposed rules.
The Board received no public written comments and no one appeared to testify at the public hearing held on February 6, 2009.
The repeal is adopted under the authority of the Texas Occupations Code Annotated, §153.001 and §154.006, which provide authority for the Board to adopt rules and bylaws as necessary to govern its own proceedings, perform its duties, regulate the practice of medicine in this state, enforce this subtitle, and establish rules related to licensure.
This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on February 17, 2009.
TRD-200900647
Mari Robinson, J.D.
Interim Executive Director
Texas Medical Board
Effective date: March 9, 2009
Proposal publication date: January 9, 2009
For further information, please call: (512) 305-7016
SUBCHAPTER B. TEMPORARY LICENSES
The Texas Medical Board (Board) adopts amendments §172.4, concerning State Health Agency Temporary License, with non-substantive changes to the proposed text as published in the October 31, 2008, issue of the Texas Register (33 TexReg 8869). The text of the rule will be republished.
The amendment updates the reference to the board rule requiring the holder of a temporary license under this section to show that the person has taken an examination within the last ten years.
The Board sought stakeholder input through Stakeholder Groups, which made comments on the suggested changes to the rules at a meeting held on October 29, 2008. The comments were incorporated into the proposed rules.
The Board received no public written comments and no one appeared to testify at the public hearing held on February 6, 2009.
The amendment is adopted under the authority of the Texas Occupations Code Annotated, §153.001 and §154.006, which provide authority for the Board to adopt rules and bylaws as necessary to govern its own proceedings, perform its duties, regulate the practice of medicine in this state, enforce this subtitle, and establish rules related to licensure.
§172.4.State Health Agency Temporary License.
An applicant may elect to apply for a state health agency temporary license in lieu of licensure.
(1) The executive director of the board may issue such a temporary license to an applicant:
(A) who holds a valid license in another state or Canadian province on the basis of an examination, that is accepted by the board for licensure;
(B) who has passed the Texas medical jurisprudence examination;
(C) whose application has been filed, processed, and found to be in order. The application shall be complete in every detail with the exception of compliance with §163.1(a)(9)(K) of this title (relating to Definitions of Examinations accepted by the board for licensure); and
(D) who holds a salaried, administrative, or clinical position with an agency of the State of Texas.
(2) The state health agency temporary license shall be requested by the chief administrative officer of the employing state agency and shall be issued exclusively to that agency. The chief administrative officer shall state whether the temporary license is for a:
(A) clinical position. This temporary license will be valid for a one-year period from the date of issuance and will not be renewable. The temporary license is revocable at any time the board deems necessary. To practice beyond one year, the holder of the temporary license must fully comply with §163.7 of this title (relating to Ten Year Rule). During the period that the state health agency clinical temporary license is in effect, the physician will be supervised by a licensed staff physician who will regularly review the temporary license holder's skill and performance. This temporary license will be marked "clinical"; or
(B) administrative non-clinical position. This temporary license will be valid for a one-year period from the date of issuance; however, it is revocable at any time the board deems necessary. The temporary license shall automatically expire one year after the date of issuance but may be re-issued annually at the request of the chief administrative officer of the employing state agency and at the discretion of the board. The holder of a state health agency temporary license, not designated as clinical, shall not practice medicine as that term is defined in the Medical Practice Act, TEX. OCCUPATIONS CODE ANN. §151.002(a)(13). This temporary license will be marked "administrative."
This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on February 17, 2009.
TRD-200900648
Mari Robinson, J.D.
Interim Executive Director
Texas Medical Board
Effective date: March 9, 2009
Proposal publication date: October 31, 2008
For further information, please call: (512) 305-7016
The Texas Medical Board (Board) adopts amendments to §175.1, concerning Application Fees, and §175.3, concerning Penalties, without changes to the proposed text as published in the January 9, 2009, issue of the Texas Register (34 TexReg 169) and will not be republished.
The amendment to §175.1 corrects fees charged for application for surgical assistant licenses and penalty fees for surgical assistants and physician assistants.
The amendment to §175.3 corrects penalty fees in accordance with statutory requirements.
The Board sought stakeholder input through Stakeholder Groups, which made comments on the suggested changes to the rules at a meeting held on October 29, 2008. The comments were incorporated into the proposed rules.
The Board received no public written comments and no one appeared to testify at the public hearing held on February 6, 2009.
The amendments are adopted under the authority of the Texas Occupations Code Annotated, §153.001 and §154.006, which provide authority for the Board to adopt rules and bylaws as necessary to govern its own proceedings, perform its duties, regulate the practice of medicine in this state, enforce this subtitle, and establish rules related to licensure.
This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on February 17, 2009.
TRD-200900649
Mari Robinson, J.D.
Interim Executive Director
Texas Medical Board
Effective date: March 9, 2009
Proposal publication date: January 9, 2009
For further information, please call: (512) 305-7016
The Texas Medical Board (Board) adopts amendments to §185.2, concerning Definitions, without changes to the proposed text as published in the October 31, 2008, issue of the Texas Register (33 TexReg 8871) and will not be republished.
The amendment revises the definition of a supervising physician to define an "unrestricted medical license."
The Board sought stakeholder input through Stakeholder Groups, which made comments on the suggested changes to the rules at a meeting held on October 29, 2008. The comments were incorporated into the proposed rules.
The Board received no public written comments and no one appeared to testify at the public hearing held on February 6, 2009.
The amendment is adopted under the authority of the Texas Occupations Code Annotated, §153.001 and §154.006, which provide authority for the Board to adopt rules and bylaws as necessary to govern its own proceedings, perform its duties, regulate the practice of medicine in this state, enforce this subtitle, and establish rules related to licensure.
This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on February 17, 2009.
TRD-200900650
Mari Robinson, J.D.
Interim Executive Director
Texas Medical Board
Effective date: March 9, 2009
Proposal publication date: October 31, 2008
For further information, please call: (512) 305-7016
The Texas Medical Board (Board) adopts amendments to §189.1, concerning Purpose and Scope and §189.2, concerning Definitions, without changes to the proposed text as published in the January 9, 2009, issue of the Texas Register (34 TexReg 170) and will not be republished.
The amendments to §189.1 add as a citation to statutory authority authorizing the Board to promulgate rules relating to the development of a program to monitor compliance of license holders who are subject to disciplinary action.
The amendments to §189.2 update the names of the Texas Medical Board and the Texas Physician Assistant Board and add chart monitoring to the definition of a monitoring physician.
Elsewhere in this issue of the Texas Register , the Board contemporaneously adopts the rule review of Chapter 189.
The Board sought stakeholder input through Stakeholder Groups, which made comments on the suggested changes to the rules at a meeting held on October 29, 2008. The comments were incorporated into the proposed rules.
The Board received no public written comments and no one appeared to testify at the public hearing held on February 6, 2009.
The amendments are adopted under the authority of the Texas Occupations Code Annotated, §153.001 and §154.006, which provide authority for the Board to adopt rules and bylaws as necessary to govern its own proceedings, perform its duties, regulate the practice of medicine in this state, enforce this subtitle, and establish rules related to licensure.
This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on February 17, 2009.
TRD-200900651
Mari Robinson, J.D.
Interim Executive Director
Texas Medical Board
Effective date: March 9, 2009
Proposal publication date: January 9, 2009
For further information, please call: (512) 305-7016
The Texas Optometry Board adopts amendments to §273.8, concerning Renewal of License, without changes to the proposed text as published in the December 5, 2008, issue of the Texas Register (33 TexReg 9856).
The amendments concern reinstatement of expired licenses and removes a requirement to conform to the statute.
No comments were received regarding the proposed amendments.
The amendments are adopted under the Texas Optometry Act, Texas Occupations Code, §351.151 and §351.304. The Texas Optometry Board interprets §351.151 as authorizing the adoption of procedural and substantive rules for the regulation of the optometric profession, and §351.304 to require reexamination upon license expiration.
No other sections are affected by the amendments.
This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on February 17, 2009.
TRD-200900659
Chris Kloeris
Executive Director
Texas Optometry Board
Effective date: March 9, 2009
Proposal publication date: December 5, 2008
For further information, please call: (512) 305-8502
The Texas Optometry Board adopts amendments to §280.8, concerning Optometric Glaucoma Specialist: Required Education, Examination and Clinical Skills Evaluation, and §280.10, concerning Optometric Glaucoma Specialist: Administration and Prescribing of Oral Medications and Anti-Glaucoma Drugs, without changes to the proposed text as published in the December 5, 2008, issue of the Texas Register (33 TexReg 9856).
The amendments clarify the requirements for finding that the course work and examination required to apply for the optometric glaucoma specialist license are part of the current curriculum of certified schools or colleges of optometry. Under the amendments, applicants may have the required skills evaluation performed by an ophthalmologist or optometric glaucoma specialist. The amendments to §280.10 concerns drug orders for Controlled Substances. The amendments add the additional information required by Senate Bill 1879, 80th Legislature, Regular Session, clarifies when a Controlled Substances registration is required, and updates citations in the Optometry Act.
Comments
The agency received comments from the Texas Ophthalmological Association on §280.8. No comments were received on §280.10.
Since August 2000, the agency has licensed 2,000 optometric glaucoma specialists. A majority of the agency's active licensees hold the optometric glaucoma specialist license and are therefore authorized to treat glaucoma under the provisions of §351.358 and §351.3581 of the Texas Optometry Act. The agency has adopted rules, 22 TAC §§280.8 - 280.11, concerning the licensing and practice of optometric glaucoma specialists.
Section 351.358 and §351.3581 were added to the Texas Optometry Act by House Bill 1059, 76th Legislature, Regular Session, with an effective date of September 1, 1999. Section Three of the bill added a new section to the Texas Optometry Act, titled Optometric Health Care Advisory Committee (Committee). Section Three is codified as §351.165 of the Texas Optometry Act. This section set up a committee to make recommendations to the agency and the Texas Medical Board regarding requirements for education and clinical training of applicants for the optometric glaucoma specialist license. The legislature specifically restricted the authority of the Committee in subsection (g), which states: "Unless continued in existence by act of the legislature, the Optometric Health Care Advisory Committee is abolished, and this section expires September 1, 2005." The legislature did not choose to continue this section, which therefore expired on September 1, 2005.
Prior to the abolishment of the Committee on September 1, 2005, the Committee, pursuant to §351.165, made recommendations for the education and training requirements necessary to apply for the optometric glaucoma specialist license. These recommendations were approved by the agency and the Texas Medical Board. These recommendations included a thirty hour course with a detailed description of the topics to be covered. The agency subsequently approved courses presented by optometry schools and a medical school.
The amendments to §280.8 do not change the course requirements recommended by the Committee and approved by both agencies. The amendments do seek to avoid the delay and extra expense in the licensing of optometric glaucoma specialists where it can be shown and certified by the agency that the thirty hour course and examination was provided in the education that the applicant received in optometry school. The amendments still require that an applicant for the optometric glaucoma specialist license comply with §351.3581 by completing an instructional clinical review course and passing an approved examination.
Portions of the thirty hour course may not have been part of the curriculum of all optometrists licensed prior to the enactment of §351.358 and §351.3581. These applicants for an optometric glaucoma specialist license were therefore required to take a course after receiving an optometry license. The agency finds no valid purpose is served by having current graduates from programs that include the thirty hour course and examination to immediately retake the course.
The commenter states that a course taken in school cannot be a review course and that therefore the requirement in §351.3581 for applicants to, ". . . complete an instructional clinical review course; . . ." cannot be met. The amendments to the rule require an instructional clinic review component. If the dean cannot certify that the school course work meets this requirement, the amendments do not allow the agency to find that the thirty hour course has been completed by the graduate. Therefore the agency disagrees with this comment.
The commenter also states that §351.3581 requires that a future applicant must be a therapeutic optometrist before taking the required course. The agency disagrees with this comment and interprets §351.3581 to require a therapeutic optometrist license as a requirement for license as an optometric glaucoma specialist, not as a requirement to take and pass the required course.
The agency agrees with the comments from the Texas Ophthalmological Association that §351.165 of the Texas Optometry Act expired on September 1, 2005. The agency also notes that the Optometric Health Care Advisory Committee was abolished on that same date.
The commenter stated that the expiration of §351.165 is not the repeal of that section, and that the recommendations made by the Optometric Health Care Advisory Committee did not expire with the expiration of the statute. The commenter further stated that the proposed amendments of the rule is inconsistent with statutory law.
The agency disagrees with the commenter that it does not have the legal authority to amend this rule regarding the method the agency may use to determine the competency of applicants for the optometric glaucoma specialist license. Section 351.165 has expired. The agency disagrees with the commenter regarding the status of §351.165. The expiration acted to repeal the section. Thus the agency is required to comply only with the sections still effective, §351.358 and §351.3581, which require applicants to take an instructional clinical course and exam.
The agency has determined that licensees who are authorized to treat glaucoma under the Texas Optometry Act, are also competent to make an evaluation of the skills of an applicant for that license. These are the same skills regularly employed by the licensees now authorized to treat glaucoma. Section 351.358 and §351.3581 do not contain a requirement that applicants for the optometric glaucoma specialist have a list of skills evaluated. However, the rule amendments maintain that requirement, but permit an optometric glaucoma specialist as well as an ophthalmologist to evaluate the skills. The rule amendments require applicants to comply with all the requirements of §351.3581.
The agency agrees with the commenter that §351.3581 refers to the requirements of §351.165, however, §351.165 has expired and the Committee authorized by that section was abolished. The agency disagrees with the commenter regarding the authority to adopt the amendments and asserts that these amendments comply with the requirements of §351.151 and §351.3581, the effective and applicable statutes for the rule amendments.
Statutory Authority
The amendments are adopted under the Texas Optometry Act, Texas Occupations Code, §§351.151, 351.358, and 351.3581; and under §481.074 of the Texas Health and Safety Code. The Texas Optometry Board interprets §351.151 as authorizing the adoption of procedural and substantive rules for the regulation of the optometric profession. Section 351.358 and §351.3581 set the requirements for optometric glaucoma specialist license and allow optometric glaucoma specialist licenses to prescribe Controlled Substances. Section 481.074 of the Texas Health and Safety Code sets out the requirements for a prescription order for Controlled Substances.
No other sections are affected by the amendments.
This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on February 17, 2009.
TRD-200900658
Chris Kloeris
Executive Director
Texas Optometry Board
Effective date: March 9, 2009
Proposal publication date: December 5, 2008
For further information, please call: (512) 305-8502
SUBCHAPTER B. COMMUNITY PHARMACY (CLASS A)
The Texas State Board of Pharmacy adopts amendments to §291.33, concerning Operational Standards, with changes to the proposed text as published in the December 26, 2008, issue of the Texas Register (33 TexReg 10408). The amendments are adopted with changes based on comments received as described below.
The amendments clarify that specified information on the prescription labels and written information provided to consumers must be printed in a type-size no smaller than 10-point Times Roman; and clarify that the prescription label is not required to include the identification code or initials of the dispensing pharmacist if the information is stored in the pharmacy's data processing system.
Comments were received as follows:
Davita Rx commented in support of the proposed amendments. The Board agrees with this comment.
Medco Health Solutions, Inc. commented that the proposed amendments with regard to the prescription label and written prescription information should allow for a font-size comparable to ten-point Times Roman. Medco commented that only specific items on the label including the patient name, drug and strength, directions for use, and use by date should be required to be in the specified font-size. The Board agrees with these comments and the adopted rule reflects the changes.
The National Association of Chain Drug Stores (NACDS) commented that it would be impossible to include all of the required elements of a prescription label in ten-point Times Roman font. Pharmacies would have no other option but to provide duplicative, accompanying written information with every prescription dispensed. NACDS recommended that rules be amended to require the important information printed on the prescription labels be printed in ten-point Times Roman font thus making it easier for patients to check that they have received the proper drug and can read the drug directions for use. NACDS commented that only the prescription number, patient name, directions for use, and drug name and strength be required to be in a specific font size. NACDS opposed the amendments to supplement the label information with written information if the label did not conform to the specific font. NACDS commented that the amendments requiring the written information be printed in a font-size no smaller than ten-point Times Roman would require pharmacies to use more paper and increase printing costs. The Board agrees with the comments to only require certain information on the label conform to the font-size requirements. The Board disagrees with the comments regarding the font-size on written information and supplemental information. Requiring a specific font-size will improve the readability of prescription labels and written information.
The amendments are adopted under §§551.002, 554.051, 562.006 and 562.0061 of the Texas Pharmacy Act (Chapters 551 - 566 and 568 - 569, Occupations Code). The Board interprets §551.002 as authorizing the agency to protect the public through the effective control and regulation of the practice of pharmacy. The Board interprets §554.051(a) as authorizing the agency to adopt rules for the proper administration and enforcement of the Act. The Board interprets §562.006 and §562.0061 as authorizing the agency to adopt rules regarding the prescription label and written information provided to consumers.
The statutes affected by the amendments: Chapters 551 - 566 and 568 - 569, Occupations Code.
§291.33.Operational Standards.
(a) Licensing requirements.
(1) A Class A pharmacy shall register annually or biennially with the board on a pharmacy license application provided by the board, following the procedures specified in §291.1 of this title (relating to Pharmacy License Application).
(2) A Class A pharmacy which changes ownership shall notify the board within ten days of the change of ownership and apply for a new and separate license as specified in §291.3 of this title (relating to Required Notifications).
(3) A Class A pharmacy which changes location and/or name shall notify the board within ten days of the change and file for an amended license as specified in §291.3 of this title.
(4) A Class A pharmacy owned by a partnership or corporation which changes managing officers shall notify the board in writing of the names of the new managing officers within ten days of the change, following the procedures in §291.3 of this title.
(5) A Class A pharmacy shall notify the board in writing within ten days of closing, following the procedures in §291.5 of this title (relating to Closed Pharmacies).
(6) A separate license is required for each principal place of business and only one pharmacy license may be issued to a specific location.
(7) A fee as specified in §291.6 of this title (relating to Pharmacy License Fees) will be charged for the issuance and renewal of a license and the issuance of an amended license.
(8) A Class A pharmacy, licensed under the provisions of the Act, §560.051(a)(1), which also operates another type of pharmacy which would otherwise be required to be licensed under the Act, §560.051(a)(2) concerning Nuclear Pharmacy (Class B), is not required to secure a license for such other type of pharmacy; provided, however, such licensee is required to comply with the provisions of §291.51 of this title (relating to Purpose), §291.52 of this title (relating to Definitions), §291.53 of this title (relating to Personnel), §291.54 of this title (relating to Operational Standards), and §291.55 of this title (relating to Records), contained in Nuclear Pharmacy (Class B), to the extent such sections are applicable to the operation of the pharmacy.
(9) A Class A (community) pharmacy engaged in the compounding of non-sterile pharmaceuticals shall comply with the provisions of §291.131 of this title (relating to Pharmacies Compounding Non-Sterile Preparations).
(10) A Class A (community) pharmacy engaged in the compounding of sterile pharmaceuticals shall comply with the provisions of §291.133 of this title (relating to Pharmacies Compounding Sterile Preparations).
(11) A Class A (Community) pharmacy engaged in the provision of remote pharmacy services, including storage and dispensing of prescription drugs, shall comply with the provisions of §291.121 of this title (relating to Remote Pharmacy Services).
(12) Class A (Community) pharmacy engaged in centralized prescription dispensing and/or prescription drug or medication order processing shall comply with the provisions of §291.123 of this title (relating to Centralized Prescription Drug or Medication Order Processing) and/or §291.125 of this title (relating to Centralized Prescription Dispensing).
(b) Environment.
(1) General requirements.
(A) The pharmacy shall be arranged in an orderly fashion and kept clean. All required equipment shall be clean and in good operating condition.
(B) A Class A pharmacy shall have a sink with hot and cold running water within the pharmacy, exclusive of restroom facilities, available to all pharmacy personnel and maintained in a sanitary condition.
(C) A Class A pharmacy which serves the general public shall contain an area which is suitable for confidential patient counseling.
(i) Such counseling area shall:
(I) be easily accessible to both patient and pharmacists and not allow patient access to prescription drugs;
(II) be designed to maintain the confidentiality and privacy of the pharmacist/patient communication.
(ii) In determining whether the area is suitable for confidential patient counseling and designed to maintain the confidentiality and privacy of the pharmacist/patient communication, the board may consider factors such as the following:
(I) the proximity of the counseling area to the check-out or cash register area;
(II) the volume of pedestrian traffic in and around the counseling area;
(III) the presence of walls or other barriers between the counseling area and other areas of the pharmacy; and
(IV) any evidence of confidential information being overheard by persons other than the patient or patient's agent or the pharmacist or agents of the pharmacist.
(D) The pharmacy shall be properly lighted and ventilated.
(E) The temperature of the pharmacy shall be maintained within a range compatible with the proper storage of drugs; the temperature of the refrigerator shall be maintained within a range compatible with the proper storage of drugs requiring refrigeration.
(F) Animals, including birds and reptiles, shall not be kept within the pharmacy and in immediately adjacent areas under the control of the pharmacy. This provision does not apply to fish in aquariums, guide dogs accompanying disabled persons, or animals for sale to the general public in a separate area that is inspected by local health jurisdictions.
(2) Security.
(A) Each pharmacist while on duty shall be responsible for the security of the prescription department, including provisions for effective control against theft or diversion of prescription drugs, and records for such drugs.
(B) The prescription department shall be locked by key, combination or other mechanical or electronic means to prohibit unauthorized access when a pharmacist is not on-site except as provided in subparagraphs (C) and (D) of this paragraph and paragraph (3) of this subsection. The following is applicable:
(i) If the prescription department is closed at any time when the rest of the facility is open, the prescription department must be physically or electronically secured. The security may be accomplished by means such as floor to ceiling walls; walls, partitions, or barriers at least 9 feet 6 inches high; electronically monitored motion detectors; pull down sliders; or other systems or technologies that will secure the pharmacy from unauthorized entrance when the pharmacy is closed. Pharmacies licensed prior to June 1, 2009, shall be exempt from this provision unless the pharmacy changes location. Change of location shall include the relocation of the pharmacy within the licensed address. A pharmacy licensed prior to June 1, 2009 that files a change of ownership but does not change location shall be exempt from the provisions.
(ii) Effective, June 1, 2009, the pharmacy's key, combination, or other mechanical or electronic means of locking the pharmacy may not be duplicated without the authorization of the pharmacist-in-charge or owner.
(iii) Effective, June 1, 2009, at a minimum, the pharmacy must have a basic alarm system with off-site monitoring and perimeter and motion sensors. The pharmacy may have additional security by video surveillance camera systems.
(C) Prior to authorizing individuals to enter the prescription department, the pharmacist-in-charge or owner may designate persons who may enter the prescription department to perform functions, other than dispensing functions or prescription processing, documented by the pharmacist-in-charge including access to the prescription department by other pharmacists, pharmacy personnel and other individuals. The pharmacy must maintain written documentation of authorized individuals other than individuals employed by the pharmacy who accessed the prescription department when a pharmacist is not on-site.
(D) Only persons designated either by name or by title including such titles as "relief" or "floater" pharmacist, in writing by the pharmacist-in-charge may unlock the prescription department except in emergency situations. An additional key to or instructions on accessing the prescription department may be maintained in a secure location outside the prescription department for use during an emergency or as designated by the pharmacist-in-charge for entry by another pharmacist.
(E) Written policies and procedures for the pharmacy's security shall be developed and implemented by the pharmacist-in-charge and/or the owner of the pharmacy. Such polices and procedures may include quarterly audits of controlled substances commonly abused or diverted; perpetual inventories for the comparison of the receipt, dispensing, and distribution of controlled substances; monthly reports from the pharmacy's wholesaler(s) of controlled substances purchased by the pharmacy; opening and closing procedures; product storage and placement; and central management oversight.
(3) Temporary absence of pharmacist.
(A) On-site supervision by pharmacist.
(i) If a pharmacy is staffed by only one pharmacist, the pharmacist may leave the prescription department for short periods of time without closing the prescription department and removing pharmacy technicians, pharmacy technician trainees, and other pharmacy personnel from the prescription department provided the following conditions are met:
(I) at least one pharmacy technician remains in the prescription department;
(II) the pharmacist remains on-site at the licensed location of the pharmacy and is immediately available;
(III) the pharmacist reasonably believes that the security of the prescription department will be maintained in his or her absence. If in the professional judgment of the pharmacist, the pharmacist determines that the prescription department should close during his or her absence, then the pharmacist shall close the prescription department and remove the pharmacy technicians, pharmacy technician trainees, and other pharmacy personnel from the prescription department during his or her absence; and
(IV) a notice is posted which includes the following information:
(-a-) the pharmacist is on a break and the time the pharmacist will return; and
(-b-) pharmacy technicians may begin the processing of prescription drug orders or refills brought in during the pharmacist's absence, but the prescription or refill may not be delivered to the patient or the patient's agent until the pharmacist verifies the accuracy of the prescription.
(ii) During the time a pharmacist is absent from the prescription department, only pharmacy technicians who have completed the pharmacy's training program may perform the following duties, provided a pharmacist verifies the accuracy of all acts, tasks, and functions performed by the pharmacy technicians prior to delivery of the prescription to the patient or the patient's agent:
(I) initiating and receiving refill authorization requests;
(II) entering prescription data into a data processing system;
(III) taking a stock bottle from the shelf for a prescription;
(IV) preparing and packaging prescription drug orders (i.e., counting tablets/capsules, measuring liquids and placing them in the prescription container);
(V) affixing prescription labels and auxiliary labels to the prescription container; and
(VI) prepackaging and labeling prepackaged drugs.
(iii) Upon return to the prescription department, the pharmacist shall:
(I) conduct a drug regimen review as specified in subsection (c)(2) of this section; and
(II) verify the accuracy of all acts, tasks, and functions performed by the pharmacy technicians prior to delivery of the prescription to the patient or the patient's agent.
(iv) An agent of the pharmacist may deliver a previously verified prescription to the patient or his or her agent provided a record of the delivery is maintained containing the following information:
(I) date of the delivery;
(II) unique identification number of the prescription drug order;
(III) patient's name;
(IV) patient's phone number or the phone number of the person picking up the prescription; and
(V) signature of the person picking up the prescription.
(v) Any prescription delivered to a patient when a pharmacist is not in the prescription department must meet the requirements for a prescription delivered to a patient as described in subsection (c)(1)(F) of this section.
(vi) During the times a pharmacist is absent from the prescription department a pharmacist intern shall be considered a registered pharmacy technician and may perform only the duties of a registered pharmacy technician.
(vii) In pharmacies with two or more pharmacists on duty, the pharmacists shall stagger their breaks and meal periods so that the prescription department is not left without a pharmacist on duty.
(B) Pharmacist is off-site.
(i) The prescription department must be secured with procedures for entry during the time that a pharmacy is not under the continuous on-site supervision of a pharmacist and the pharmacy is not open for pharmacy services.
(ii) Pharmacy technicians and pharmacy technician trainees may not perform any duties of a pharmacy technician or pharmacy technician trainee during the time that the a pharmacist is off-site.
(iii) An agent of the pharmacist may deliver a previously verified prescription to a patient or patient's agent during short periods of time when a pharmacist is off-site, provided the following conditions are met:
(I) short periods of time may not exceed two consecutive hours in a 24 hour period;
(II) a notice is posted which includes the following information:
(-a-) the pharmacist is off-site and not present in the pharmacy;
(-b-) no new prescriptions may be prepared at the pharmacy but previously verified prescriptions may be delivered to the patient or the patient's agent; and
(-c-) the date/time when the pharmacist will return.
(III) the pharmacy must maintain documentation of the absences of the pharmacist(s); and
(IV) the prescription department is locked and secured to prohibit unauthorized entry.
(iv) During the time a pharmacist is absent from the prescription department and is off-site, a record of prescriptions delivered must be maintained and contain the following information:
(I) date and time of the delivery;
(II) unique identification number of the prescription drug order;
(III) patient's name;
(IV) patient's phone number or the phone number of the person picking up the prescription; and
(V) signature of the person picking up the prescription.
(v) Any prescription delivered to a patient when a pharmacist is not on-site at the pharmacy must meet the requirements for a prescription delivered to a patient as described in subsection (c)(1)(F) of this section.
(c) Prescription dispensing and delivery.
(1) Patient counseling and provision of drug information.
(A) To optimize drug therapy, a pharmacist shall communicate 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, such as the following:
(i) the name and description of the drug or device;
(ii) dosage form, dosage, route of administration, and duration of drug therapy;
(iii) special directions and precautions for preparation, administration, and use by the patient;
(iv) common severe side or adverse effects or interactions and therapeutic contraindications that may be encountered, including their avoidance, and the action required if they occur;
(v) techniques for self monitoring of drug therapy;
(vi) proper storage;
(vii) refill information; and
(viii) action to be taken in the event of a missed dose.
(B) Such communication:
(i) shall be provided with each new prescription drug order;
(ii) shall be provided for any prescription drug order dispensed by the pharmacy on the request of the patient or patient's agent;
(iii) shall be communicated orally in person unless the patient or patient's agent is not at the pharmacy or a specific communication barrier prohibits such oral communication;
(iv) effective, June 1, 2010, shall be documented by recording the initials or identification code of the pharmacist providing the counseling in the prescription dispensing record on either the original hard-copy prescription. in the pharmacy's data processing system or in an electronic logbook; and
(v) shall be reinforced with written information relevant to the prescription and provided to the patient or patient's agent. The following is applicable concerning this written information.
(I) Written information must be in plain language designed for the consumer and printed in an easily readable font size comparable to but no smaller than ten-point Times Roman.
(II) When a compounded product is dispensed, information shall be provided for the major active ingredient(s), if available.
(III) 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:
(-a-) the pharmacist informs the patient or the patient's agent that the product is a new drug entity and written information is not available;
(-b-) the pharmacist documents the fact that no written information was provided; and
(-c-) if the prescription is refilled after written information is available, such information is provided to the patient or patient's agent.
(C) Only a pharmacist may verbally provide drug information to a patient or patient's agent and answer questions concerning prescription drugs. Non-pharmacist personnel may not ask questions of a patient or patient's agent which are intended to screen and/or limit interaction with the pharmacist.
(D) Nothing in this subparagraph shall be construed as requiring a pharmacist to provide consultation when a patient or patient's agent refuses such consultation. The pharmacist shall document such refusal for consultation.
(E) In addition to the requirements of subparagraphs (A) - (D) of this paragraph, if a prescription drug order is delivered to the patient at the pharmacy, the following is applicable.
(i) So that a patient will have access to information concerning his or her prescription, a prescription may not be delivered to a patient unless a pharmacist is in the pharmacy, except as provided in subsection (b)(3) of this section.
(ii) Any prescription delivered to a patient when a pharmacist is not in the pharmacy must meet the requirements described in subparagraph (F) of this paragraph.
(iii) A Class A pharmacy shall make available for use by the public a current or updated edition of the United States Pharmacopeia Dispensing Information, Volume II (Advice to the Patient), or another source of such information designed for the consumer.
(F) In addition to the requirements of subparagraphs (A) - (D) of this paragraph, if a prescription drug order is delivered to the patient or his or her agent at the patient's residence or other designated location, the following is applicable.
(i) The information specified in subparagraph (A) of this paragraph shall be delivered with the dispensed prescription in writing.
(ii) If prescriptions are routinely delivered outside the area covered by the pharmacy's local telephone service, the pharmacy shall provide a toll-free telephone line which is answered during normal business hours to enable communication between the patient and a pharmacist.
(iii) The pharmacist shall place on the prescription container or on a separate sheet delivered with the prescription container in both English and Spanish the local and if applicable, toll-free telephone number of the pharmacy and the statement: "Written information about this prescription has been provided for you. Please read this information before you take the medication. If you have questions concerning this prescription, a pharmacist is available during normal business hours to answer these questions at (insert the pharmacy's local and toll-free telephone numbers)."
(iv) The pharmacy shall maintain and use adequate storage or shipment containers and use shipping processes to ensure drug stability and potency. Such shipping processes shall include the use of appropriate packaging material and/or devices to ensure that the drug is maintained at an appropriate temperature range to maintain the integrity of the medication throughout the delivery process.
(v) The pharmacy shall use a delivery system which is designed to assure that the drugs are delivered to the appropriate patient.
(G) Except as specified in subparagraph (B) of this paragraph, in the best interest of the public health and to optimize drug therapy, upon delivery of a refill prescription, a pharmacist shall ensure that the patient or patient's agent is offered information about the refilled prescription. Either a pharmacist or other pharmacy personnel shall inform the patient or patient's agent that a pharmacist is available to discuss the patient's prescription and provide information.
(H) A pharmacy shall post a sign no smaller than 8.5 inches by 11 inches in clear public view at all locations in the pharmacy where a patient may pick up prescriptions. The sign shall contain the following statement in a font that is easily readable: "Do you have questions about your prescription? Ask the pharmacist." Such notification shall be in both English and Spanish.
(I) The provisions of this paragraph do not apply to patients in facilities where drugs are administered to patients by a person required to do so by the laws of the state (i.e., nursing homes).
(2) Pharmaceutical care services.
(A) Drug regimen review.
(i) For the purpose of promoting therapeutic appropriateness, a pharmacist shall, prior to or at the time of dispensing a prescription drug order, review the patient's medication record. Such review shall at a minimum identify clinically significant:
(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; and
(X) proper utilization, including overutilization or underutilization.
(ii) Upon identifying any clinically significant conditions, situations, or items listed in clause (i) of this subparagraph, the pharmacist shall take appropriate steps to avoid or resolve the problem including consultation with the prescribing practitioner. The pharmacist shall document such occurrences.
(iii) The drug regimen review may be conducted by remotely accessing the pharmacy's electronic data base from outside the pharmacy by an individual Texas licensed pharmacist employee of the pharmacy, provided the pharmacy establishes controls to protect the privacy of the patient and the security of confidential records.
(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 Practices;
(ii) administering immunizations and vaccinations under written protocol of a physician;
(iii) managing patient compliance programs;
(iv) providing preventative health care services; and
(v) 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.
(3) Generic Substitution.
(A) General requirements.
(i) In accordance with Chapter 562 of the Act, a pharmacist may dispense a generically equivalent drug product if:
(I) the generic product costs the patient less than the prescribed drug product;
(II) the patient does not refuse the substitution; and
(III) the practitioner does not certify on the prescription form that a specific prescribed brand is medically necessary as specified in a dispensing directive described in subparagraph (C) of this paragraph.
(ii) If the practitioner has prohibited substitution through a dispensing directive in compliance with subparagraph (C) of this paragraph, a pharmacist shall not substitute a generically equivalent drug product unless the pharmacist obtains verbal or written authorization from the practitioner and notes such authorization on the original prescription drug order.
(B) Prescription format for written prescription drug orders.
(i) A written prescription drug order issued in Texas may:
(I) be on a form containing a single signature line for the practitioner; and
(II) contain the following reminder statement on the face of the prescription: "A generically equivalent drug product may be dispensed unless the practitioner hand writes the words 'Brand Necessary' or 'Brand Medically Necessary' on the face of the prescription."
(ii) A pharmacist may dispense a prescription that is not issued on the form specified in clause (i) of this subparagraph, however, the pharmacist may dispense a generically equivalent drug product unless the practitioner has prohibited substitution through a dispensing directive in compliance with subparagraph (C)(i) of this paragraph.
(iii) The prescription format specified in clause (i) of this subparagraph does not apply to the following types of prescription drug orders:
(I) prescription drug orders issued by a practitioner in a state other than Texas;
(II) prescriptions for dangerous drugs issued by a practitioner in the United Mexican States or the Dominion of Canada; or
(III) prescription drug orders issued by practitioners practicing in a federal facility provided they are acting in the scope of their employment.
(iv) In the event of multiple prescription orders appearing on one prescription form, the practitioner shall clearly identify to which prescription(s) the dispensing directive(s) apply. If the practitioner does not clearly indicate to which prescription(s) the dispensing directive(s) apply, the pharmacist may substitute on all prescriptions on the form.
(C) Dispensing directive.
(i) Written prescriptions.
(I) A practitioner may prohibit the substitution of a generically equivalent drug product for a brand name drug product by writing across the face of the written prescription, in the practitioner's own handwriting, the phrase "brand necessary" or "brand medically necessary."
(II) The dispensing directive shall:
(-a-) be in a format that protects confidentiality as required by the Health Insurance Portability and Accountability Act of 1996 (29 U.S.C. Section 1181 et seq.) and its subsequent amendments; and
(-b-) comply with federal and state law, including rules, with regard to formatting and security requirements.
(III) The dispensing directive specified in this paragraph may not be preprinted, rubber stamped, or otherwise reproduced on the prescription form.
(IV) After, June 1, 2002, a practitioner may prohibit substitution on a written prescription only by following the dispensing directive specified in this paragraph. Two-line prescription forms, check boxes, or other notations on an original prescription drug order which indicate "substitution instructions" are not valid methods to prohibit substitution, and a pharmacist may substitute on these types of written prescriptions.
(V) A written prescription drug order issued prior to June 1, 2002, but presented for dispensing on or after June 1, 2002, shall follow the substitution instructions on the prescription.
(ii) Verbal Prescriptions.
(I) If a prescription drug order is transmitted to a pharmacist orally, the practitioner or practitioner's agent shall prohibit substitution by specifying "brand necessary" or "brand medically necessary." The pharmacists shall note any substitution instructions by the practitioner or practitioner's agent, on the file copy of the prescription drug order. Such file copy may follow the one-line format indicated in subparagraph (B)(i) of this paragraph, or any other format that clearly indicates the substitution instructions.
(II) If the practitioner's or practitioner's agent does not clearly indicate that the brand name is medically necessary, the pharmacist may substitute a generically equivalent drug product.
(III) To prohibit substitution on a verbal prescription reimbursed through the medical assistance program specified in 42 C.F.R., §447.331:
(-a-) the practitioner or the practitioner's agent shall verbally indicate that the brand is medically necessary; and
(-b-) the practitioner shall mail or fax a written prescription to the pharmacy which complies with the dispensing directive for written prescriptions specified in clause (i) of this subparagraph within 30 days.
(iii) Electronic prescription drug orders.
(I) To prohibit substitution, the practitioner or practitioner's agent shall note "brand necessary" or "brand medically necessary" on the electronic prescription drug order.
(II) If the practitioner or practitioner's agent does not clearly indicate on the electronic prescription drug order that the brand is medically necessary, the pharmacist may substitute a generically equivalent drug product.
(III) To prohibit substitution on an electronic prescription drug order reimbursed through the medical assistance program specified in 42 C.F.R., §447.331, the practitioner shall fax a copy of the original prescription drug order which complies with the requirements of a written prescription drug order specified in clause (i) of this subparagraph within 30 days.
(iv) Prescriptions issued by out-of-state, Mexican, Canadian, or federal facility practitioners.
(I) The dispensing directive specified in this subsection does not apply to the following types of prescription drug orders:
(-a-) prescription drug orders issued by a practitioner in a state other than Texas;
(-b-) prescriptions for dangerous drugs issued by a practitioner in the United Mexican States or the Dominion of Canada; or
(-c-) prescription drug orders issued by practitioners practicing in a federal facility provided they are acting in the scope of their employment.
(II) A pharmacist may not substitute on prescription drug orders identified in subclause (I) of this clause unless the practitioner has authorized substitution on the prescription drug order. If the practitioner has not authorized substitution on the written prescription drug order, a pharmacist shall not substitute a generically equivalent drug product unless:
(-a-) the pharmacist obtains verbal or written authorization from the practitioner (such authorization shall be noted on the original prescription drug order); or
(-b-) the pharmacist obtains written documentation regarding substitution requirements from the State Board of Pharmacy in the state, other than Texas, in which the prescription drug order was issued. The following is applicable concerning this documentation.
(-1-) The documentation shall state that a pharmacist may substitute on a prescription drug order issued in such other state unless the practitioner prohibits substitution on the original prescription drug order.
(-2-) The pharmacist shall note on the original prescription drug order the fact that documentation from such other state board of pharmacy is on file.
(-3-) Such documentation shall be updated yearly.
(D) Refills.
(i) Original substitution instructions. All refills, including prescriptions issued prior to June 1, 2001, shall follow the original substitution instructions or dispensing directive, unless otherwise indicated by the practitioner or practitioner's agent.
(ii) Narrow therapeutic index drugs.
(I) The board, in consultation with the Texas State Board of Medical Examiners, has determined that no drugs shall be included on a list of narrow therapeutic index drugs as defined in §562.013, Occupations Code.
(-a-) The board has specified in §309.7 of this title (relating to Dispensing Responsibilities) that for drugs listed in the publication, pharmacists shall use as a basis for determining generic equivalency, Approved Drug Products with Therapeutic Equivalence Evaluations and current supplements published by the Federal Food and Drug Administration, within the limitations stipulated in that publication. Pharmacists may only substitute products that are rated therapeutically equivalent in the Approved Drug Products with Therapeutic Equivalence Evaluations and current supplements.
(-b-) Practitioners may prohibit substitution through a dispensing directive in compliance with subparagraph (C) of this paragraph.
(II) The board shall reconsider the contents of the list if the Federal Food and Drug Administration determines a new equivalence classification which indicates that certain drug products are equivalent but special notification to the patient and practitioner is required when substituting these products.
(4) Substitution of dosage form.
(A) As specified in §562.002 of the Act, a pharmacist may dispense 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:
(i) the patient consents to the dosage form substitution;
(ii) the pharmacist notifies the practitioner of the dosage form substitution; and
(iii) 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;
(III) does not alter desired clinical outcomes;
(B) Substitution of dosage form may not include the substitution of a product that has been compounded by the pharmacist unless the pharmacist contacts the practitioner prior to dispensing and obtains permission to dispense the compounded product.
(5) Therapeutic Drug Interchange. A switch to a drug providing a similar therapeutic response to the one prescribed shall not be made without prior approval of the prescribing practitioner. This paragraph does not apply to generic substitution. For generic substitution, see the requirements of paragraph (3) of this subsection.
(A) The patient shall be notified of the therapeutic drug interchange prior to, or upon delivery, of the dispensed prescription to the patient. Such notification shall include:
(i) a description of the change;
(ii) the reason for the change;
(iii) whom to notify with questions concerning the change; and
(iv) instructions for return of the drug if not wanted by the patient.
(B) The pharmacy shall maintain documentation of patient notification of therapeutic drug interchange which shall include:
(i) the date of the notification;
(ii) the method of notification;
(iii) a description of the change; and
(iv) the reason for the change.
(6) Prescription containers.
(A) A drug dispensed pursuant to a prescription drug order shall be dispensed in a child-resistant container unless:
(i) the patient or the practitioner requests the prescription not be dispensed in a child-resistant container; or
(ii) the product is exempted from requirements of the Poison Prevention Packaging Act of 1970.
(B) A drug dispensed pursuant to a prescription drug order shall be dispensed in an appropriate container as specified on the manufacturer's container.
(C) Prescription containers or closures shall not be re-used. However, if a patient or patient's agent has difficulty reading or understanding a prescription label, a prescription container may be reused provided:
(i) the container is designed to provide audio-recorded information about the proper use of the prescription medication;
(ii) the container is reused for the same patient;
(iii) the container is cleaned; and
(iv) a new safety closure is used each time the prescription container is reused.
(7) Labeling.
(A) At the time of delivery of the drug, the dispensing container shall bear a label in plain language and printed in an easily readable font size, unless otherwise specified, with at least the following information:
(i) name, address and phone number of the pharmacy;
(ii) unique identification number of the prescription that is printed in an easily readable font size comparable to but no smaller than ten-point Times Roman;
(iii) date the prescription is dispensed;
(iv) initials or an identification code of the dispensing pharmacist;
(v) name of the prescribing practitioner;
(vi) name of the patient or if such drug was prescribed for an animal, the species of the animal and the name of the owner that is printed in an easily readable font size comparable to but no smaller than ten-point Times Roman;
(vii) instructions for use that is printed in an easily readable font size comparable to but no smaller than ten-point Times Roman;
(viii) quantity dispensed;
(ix) appropriate ancillary instructions such as storage instructions or cautionary statements such as warnings of potential harmful effects of combining the drug product with any product containing alcohol;
(x) if the prescription is for a Schedules 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";
(xi) if the pharmacist has selected a generically equivalent drug pursuant to the provisions of the Act, Chapters 562 and 563, the statement "Substituted for Brand Prescribed" or "Substituted for 'Brand Name'" where "Brand Name" is the actual name of the brand name product prescribed;
(xii) the name of the advanced practice nurse or physician assistant, if the prescription is carried out or signed by an advanced practice nurse or physician assistant in compliance with Subtitle B, Chapter 157, Occupations Code; and
(xiii) the name and strength of the actual drug product dispensed that is printed in an easily readable font size comparable to but no smaller than ten-point Times Roman, unless otherwise directed by the prescribing practitioner.
(I) The name shall be either:
(-a-) the brand name; or
(-b-) if no brand name, then the generic name and name of the manufacturer or distributor of such generic drug. (The name of the manufacturer or distributor may be reduced to an abbreviation or initials, provided the abbreviation or initials are sufficient to identify the manufacturer or distributor. For combination drug products or non-sterile compounded drug products having no brand name, the principal active ingredients shall be indicated on the label.)
(II) Except as provided in clause (xi) of this subparagraph, the brand name of the prescribed drug shall not appear on the prescription container label unless it is the drug product actually dispensed.
(B) If the prescription label required in subparagraph (A) of this paragraph is printed in a type size smaller than ten-point Times Roman, the pharmacy shall provide the patient written information containing the information specified in subparagraph (A) of this paragraph in an easily readable font size comparable to but no smaller than ten-point Times Roman.
(C) The label is not required to include the initials or identification code of the dispensing pharmacist specified in subparagraph (A) of this paragraph if the identity of the dispensing pharmacist is recorded in the pharmacy's data processing system. The record of the identity of the dispensing pharmacist shall not be altered in the pharmacy's data processing system.
(D) 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 institution (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:
(I) maintains medication administration records which include adequate directions for use for the drug(s) prescribed;
(II) maintains records of ordering, receipt, and administration of the drug(s); and
(III) provides for appropriate safeguards for the control and storage of the drug(s); and
(v) the dispensing container bears a label that adequately:
(I) identifies the:
(-a-) pharmacy by name and address;
(-b-) unique identification number of the prescription;
(-c-) name and strength of the drug dispensed;
(-d-) name of the patient;
(-e-) name of the prescribing practitioner and, if applicable, the name of the advanced practice nurse or physician assistant who signed the prescription drug order; and
(II) sets forth the directions for use and cautionary statements, if any, contained on the prescription drug order or required by law.
(d) Equipment and supplies. Class A pharmacies dispensing prescription drug orders shall have the following equipment and supplies:
(1) typewriter or comparable equipment;
(2) refrigerator;
(3) adequate supply of child-resistant, light-resistant, tight, and if applicable, glass containers;
(4) adequate supply of prescription, poison, and other applicable labels;
(5) appropriate equipment necessary for the proper preparation of prescription drug orders; and
(6) metric-apothecary weight and measure conversion charts.
(e) Library. A reference library shall be maintained which includes the following in hard-copy or electronic format:
(1) current copies of the following:
(A) Texas Pharmacy Act and rules;
(B) Texas Dangerous Drug Act and rules;
(C) Texas Controlled Substances Act and rules; and
(D) Federal Controlled Substances Act and rules (or official publication describing the requirements of the Federal Controlled Substances Act and rules);
(2) at least one current or updated reference from each of the following categories:
(A) patient information:
(i) United States Pharmacopeia Dispensing Information, Volume II (Advice to the Patient); or
(ii) a reference text or information leaflets which provide patient information;
(B) drug interactions: a reference text on drug interactions, such as Drug Interaction Facts. A separate reference is not required if other references maintained by the pharmacy contain drug interaction information including information needed to determine severity or significance of the interaction and appropriate recommendations or actions to be taken;
(C) a general information reference text, such as:
(i) Facts and Comparisons with current supplements;
(ii) United States Pharmacopeia Dispensing Information Volume I (Drug Information for the Healthcare Provider);
(iii) Clinical Pharmacology;
(iv) American Hospital Formulary Service with current supplements; or
(v) Remington's Pharmaceutical Sciences; and
(3) basic antidote information and the telephone number of the nearest Regional Poison Control Center.
(f) Drugs.
(1) Procurement and storage.
(A) The pharmacist-in-charge shall have the responsibility for the procurement and storage of drugs, but may receive input from other appropriate staff relative to such responsibility.
(B) Prescription drugs and devices and nonprescription Schedule V controlled substances shall be stored within the prescription department or a locked storage area.
(C) All drugs shall be stored at the proper temperature, as defined in the USP/NF and §291.15 of this title (relating to Storage of Drugs).
(2) Out-of-date drugs or devices.
(A) Any drug or device bearing an expiration date shall not be dispensed beyond the expiration date of the drug or device.
(B) Outdated drugs or devices shall be removed from dispensing stock and shall be quarantined together until such drugs or devices are disposed of properly.
(3) Nonprescription Schedule V controlled substances.
(A) Schedule V controlled substances containing codeine, dihydrocodeine, or any of the salts of codeine or dihydrocodeine may not be distributed without a prescription drug order from a practitioner.
(B) A pharmacist may distribute nonprescription Schedule V controlled substances which contain no more than 15 milligrams of opium per 29.5729 ml or per 28.35 Gm provided:
(i) such distribution is made only by a pharmacist; a nonpharmacist employee may not distribute a nonprescription Schedule V controlled substance even if under the supervision of a pharmacist; however, after the pharmacist has fulfilled professional and legal responsibilities, the actual cash, credit transaction, or delivery may be completed by a nonpharmacist:
(ii) not more than 240 ml (eight fluid ounces), or not more than 48 solid dosage units of any substance containing opium, may be distributed to the same purchaser in any given 48-hour period without a prescription drug order;
(iii) the purchaser is at least 18 years of age; and
(iv) the pharmacist requires every purchaser not known to the pharmacist to furnish suitable identification (including proof of age where appropriate).
(C) A record of such distribution shall be maintained by the pharmacy in a bound record book. The record shall contain the following information:
(i) true name of the purchaser;
(ii) current address of the purchaser;
(iii) name and quantity of controlled substance purchased;
(iv) date of each purchase; and
(v) signature or written initials of the distributing pharmacist.
(4) Class A Pharmacies may not sell, purchase, trade or possess prescription drug samples, unless the pharmacy meets all of the following conditions:
(A) the pharmacy is owned by a charitable organization described in the Internal Revenue Code of 1986, or by a city, state or county government;
(B) 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;
(C) the samples are for dispensing or provision at no charge to patients of such health care entity; and
(D) the samples are possessed in compliance with the federal Prescription Drug Marketing Act of 1986.
(g) Prepackaging of drugs.
(1) Drugs may be prepackaged in quantities suitable for internal distribution only by a pharmacist or by supportive personnel under the direction and direct supervision of a pharmacist.
(2) The label of a prepackaged unit shall indicate:
(A) brand name and strength of the drug; or if no brand name, then the generic name, strength, and name of the manufacturer or distributor;
(B) facility's lot number;
(C) expiration date; and
(D) quantity of the drug, if the quantity is greater than one.
(3) Records of prepackaging shall be maintained to show:
(A) name of the drug, strength, and dosage form;
(B) facility's lot number;
(C) manufacturer or distributor;
(D) manufacturer's lot number;
(E) expiration date;
(F) quantity per prepackaged unit;
(G) number of prepackaged units;
(H) date packaged;
(I) name, initials, or electronic signature of the prepacker; and
(J) signature, or electronic signature of the responsible pharmacist.
(4) Stock packages, repackaged units, and control records shall be quarantined together until checked/released by the pharmacist.
(h) Customized patient medication packages.
(1) Purpose. In lieu of dispensing two or more prescribed drug products in separate containers, a pharmacist may, with the consent of the patient, the patient's caregiver, or the prescriber, provide a customized patient medication package (patient med-pak).
(2) Definition. A patient med-pak is a package prepared by a pharmacist for a specific patient comprising a series of containers and containing two or more prescribed solid oral dosage forms. The patient med-pak is so designed or each container is so labeled as to indicate the day and time, or period of time, that the contents within each container are to be taken.
(3) Label.
(A) The patient med-pak shall bear a label stating:
(i) the name of the patient;
(ii) the unique identification number for the patient med-pak itself and a separate unique identification number for each of the prescription drug orders for each of the drug products contained therein;
(iii) the name, strength, physical description or identification, and total quantity of each drug product contained therein;
(iv) the directions for use and cautionary statements, if any, contained in the prescription drug order for each drug product contained therein;
(v) if applicable, a warning of the potential harmful effect of combining any form of alcoholic beverage with any drug product contained therein;
(vi) any storage instructions or cautionary statements required by the official compendia;
(vii) the name of the prescriber of each drug product;
(viii) the date of preparation of the patient med-pak and the beyond-use date assigned to the patient med-pak (which such beyond-use date shall not be later than 60 days from the date of preparation);
(ix) the name, address, and telephone number of the pharmacy;
(x) the initials or an identification code of the dispensing pharmacist; and
(xi) any other information, statements, or warnings required for any of the drug products contained therein.
(B) If the patient med-pak allows for the removal or separation of the intact containers therefrom, each individual container shall bear a label identifying each of the drug product contained therein.
(C) 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 institution (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:
(I) maintains medication administration records which include adequate directions for use for the drug(s) prescribed;
(II) maintains records of ordering, receipt, and administration of the drug(s); and
(III) provides for appropriate safeguards for the control and storage of the drug(s); and
(v) the dispensing container bears a label that adequately:
(I) identifies the:
(-a-) pharmacy by name and address;
(-b-) unique identification number of the prescription;
(-c-) name and strength of each drug product dispensed;
(-d-) name of the patient;
(-e-) name of the prescribing practitioner of each drug product and if applicable, the name of the advanced practice nurse or physician assistant who signed the prescription drug order; and
(II) for each drug product sets forth the directions for use and cautionary statements, if any, contained on the prescription drug order or required by law.
(4) Labeling. The patient med-pak shall be accompanied by a patient package insert, in the event that any drug contained therein is required to be dispensed with such insert as accompanying labeling. Alternatively, such required information may be incorporated into a single, overall educational insert provided by the pharmacist for the total patient med-pak.
(5) Packaging. In the absence of more stringent packaging requirements for any of the drug products contained therein, each container of the patient med-pak shall comply with official packaging standards. Each container shall be either not reclosable or so designed as to show evidence of having been opened.
(6) Guidelines. It is the responsibility of the dispensing pharmacist when preparing a patient med-pak, to take into account any applicable compendial requirements or guidelines and the physical and chemical compatibility of the dosage forms placed within each container, as well as any therapeutic incompatibilities that may attend the simultaneous administration of the drugs.
(7) Recordkeeping. In addition to any individual prescription filing requirements, a record of each patient med-pak shall be made and filed. Each record shall contain, as a minimum:
(A) the name and address of the patient;
(B) the unique identification number for the patient med-pak itself and a separate unique identification number for each of the prescription drug orders for each of the drug products contained therein;
(C) the name of the manufacturer or distributor and lot number for each drug product contained therein;
(D) information identifying or describing the design, characteristics, or specifications of the patient med-pak sufficient to allow subsequent preparation of an identical patient med-pak for the patient;
(E) the date of preparation of the patient med-pak and the beyond-use date that was assigned;
(F) any special labeling instructions; and
(G) the initials or an identification code of the dispensing pharmacist.
(i) Automated devices and systems.
(1) Automated compounding or counting devices. If a pharmacy uses automated compounding or counting devices:
(A) the pharmacy shall have a method to calibrate and verify the accuracy of the automated compounding or counting device and document the calibration and verification on a routine basis;
(B) the devices may be loaded with bulk or unlabeled drugs only by a pharmacist or by pharmacy technicians under the direction and direct supervision of a pharmacist;
(C) the label of an automated compounding or counting device 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;
(D) records of loading bulk or unlabeled drugs into an automated compounding or counting device shall be maintained to show:
(i) name of the drug, strength, and dosage form;
(ii) manufacturer or distributor;
(iii) manufacturer's lot number;
(iv) expiration date;
(v) date of loading;
(vi) name, initials, or electronic signature of the person loading the automated compounding or counting device; and
(vii) signature or electronic signature of the responsible pharmacist; and
(E) the automated compounding or counting device shall not be used until a pharmacist verifies that the system is properly loaded and affixes his or her signature to the record specified in subparagraph (D) of this paragraph.
(2) Automated pharmacy dispensing systems. This paragraph becomes effective September 1, 2000.
(A) Authority to use automated pharmacy dispensing systems. A pharmacy may use an automated pharmacy dispensing system to fill prescription drug orders provided that:
(i) the pharmacist-in-charge is responsible for the supervision of the operation of the system;
(ii) the automated pharmacy dispensing system has been tested by the pharmacy and found to dispense accurately. The pharmacy shall make the results of such testing available to the Board upon request; and
(iii) the pharmacy will make the automated pharmacy dispensing system available for inspection by the board for the purpose of validating the accuracy of the system.
(B) Quality assurance program. A pharmacy which uses an automated pharmacy dispensing system to fill prescription drug orders shall operate according to a written program for quality assurance of the automated pharmacy dispensing system which:
(i) requires continuous monitoring of the automated pharmacy dispensing system; and
(ii) establishes mechanisms and procedures to test the accuracy of the automated pharmacy dispensing system at least every six months and whenever any upgrade or change is made to the system and documents each such activity.
(C) Policies and procedures of operation.
(i) When an automated pharmacy dispensing system is used to fill prescription drug orders, it shall be operated according to written policies and procedures of operation. The policies and procedures of operation shall establish requirements for operation of the automated pharmacy dispensing system and shall describe policies and procedures that:
(I) include a description of the policies and procedures of operation;
(II) provide for a pharmacist's review, approval, and accountability for the transmission of each original or new prescription drug order to the automated pharmacy dispensing system before the transmission is made;
(III) provide for access to the automated pharmacy dispensing system for stocking and retrieval of medications which is limited to licensed healthcare professionals or pharmacy technicians acting under the supervision of a pharmacist;
(IV) require prior to use, that a pharmacist checks, verifies, and documents that the automated pharmacy dispensing system has been accurately filled each time the system is stocked;
(V) provide for an accountability record to be maintained which documents all transactions relative to stocking and removing medications from the automated pharmacy dispensing system;
(VI) require a prospective drug regimen review is conducted as specified in subsection (c)(2) of this section; and
(VII) establish and make provisions for documentation of a preventative maintenance program for the automated pharmacy dispensing system.
(ii) A pharmacy which uses an automated pharmacy dispensing system to fill prescription drug orders shall, at least annually, review its written policies and procedures, revise them if necessary, and document the review.
(D) Recovery Plan. A pharmacy which uses an automated pharmacy dispensing system to fill prescription drug orders shall maintain a written plan for recovery from a disaster or any other situation which interrupts the ability of the automated pharmacy dispensing system to provide services necessary for the operation of the pharmacy. The written plan for recovery shall include:
(i) planning and preparation for maintaining pharmacy services when an automated pharmacy dispensing system is experiencing downtime;
(ii) procedures for response when an automated pharmacy dispensing system is experiencing downtime;
(iii) procedures for the maintenance and testing of the written plan for recovery; and
(iv) procedures for notification of the Board, each patient of the pharmacy, and other appropriate agencies whenever an automated pharmacy dispensing system experiences downtime for more than two days of operation or a period of time which significantly limits the pharmacy's ability to provide pharmacy services.
(3) Final check of prescriptions dispensed using an automated pharmacy dispensing system. For the purpose of §291.32(b)(2) of this title (relating to Personnel), a pharmacist must perform the final check of all prescriptions prior to delivery to the patient to ensure that the prescription is dispensed accurately as prescribed.
(A) This final check shall be considered accomplished if:
(i) a check of the final product is conducted by a pharmacist after the automated system has completed the prescription and prior to delivery to the patient; or
(ii) the following checks are conducted by a pharmacist:
(I) if the automated pharmacy dispensing system contains bulk stock drugs, a pharmacist verifies that those drugs have been accurately stocked as specified in paragraph (2)(C)(i)(IV) of this subsection; and
(II) a pharmacist checks the accuracy of the data entry of each original or new prescription drug order entered into the automated pharmacy dispensing system.
(B) If the final check is accomplished as specified in subparagraph (A)(ii) of this paragraph, the following additional requirements must be met.
(i) The dispensing process must be fully automated from the time the pharmacist releases the prescription to the automated system until a completed, labeled prescription ready for delivery to the patient is produced.
(ii) The pharmacy has conducted initial testing and has a continuous quality assurance program which documents that the automated pharmacy dispensing system dispenses accurately as specified in paragraph (2)(A) and (B) of this subsection.
(iii) The automated pharmacy dispensing system documents and maintains:
(I) the name(s), initials, or identification code(s) of each pharmacist responsible for the checks outlined in subparagraph (A)(ii) of this paragraph; and
(II) the name(s), initials, or identification code(s) and specific activity(ies) of each pharmacist or pharmacy technician who performs any other portion of the dispensing process.
(iv) The pharmacy establishes mechanisms and procedures to test the accuracy of the automated pharmacy dispensing system at least every month rather than every six months as specified in paragraph (2)(B) of this subsection.
(4) Automated checking device.
(A) For the purpose of this subsection, an automated checking device is a fully automated device which confirms, after dispensing but prior to delivery to the patient, that the correct drug and strength has been labeled with the correct label for the correct patient.
(B) For the purpose of §291.32(b)(2) of this title, the final check of a dispensed prescription shall be considered accomplished using an automated checking device provided:
(i) a check of the final product is conducted by a pharmacist prior to delivery to the patient or the following checks are performed by a pharmacist:
(I) the prepackaged drug used to fill the order is checked by a pharmacist who verifies that the drug is labeled and packaged accurately; and
(II) a pharmacist checks the accuracy of each original or new prescription drug order.
(ii) the prescription is dispensed, labeled, and made ready for delivery to the patient in compliance with Class A (Community) Pharmacy rules; and
(iii) prior to delivery to the patient:
(I) the automated checking device confirms that the correct drug and strength has been labeled with the correct label for the correct patient; and
(II) a pharmacist performs all other duties required to ensure that the prescription has been dispensed safely and accurately as prescribed.
(C) If the final check is accomplished as specified in subparagraph (B) of this paragraph, the following additional requirements must be met.
(i) The pharmacy has conducted initial testing of the automated checking device and has a continuous quality assurance program which documents that the automated checking device accurately confirms that the correct drug and strength has been labeled with the correct label for the correct patient.
(ii) The pharmacy documents and maintains:
(I) the name(s), initials, or identification code(s) of each pharmacist responsible for the checks outlined in subparagraph (B)(i) of this paragraph; and
(II) the name(s) initials, or identification code(s) and specific activity(ies) of each pharmacist or pharmacy technician who perform any other portion of the dispensing process.
(iii) The pharmacy establishes mechanisms and procedures to test the accuracy of the automated checking device at least monthly.
This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on February 20, 2009.
TRD-200900720
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Effective date: March 12, 2009
Proposal publication date: December 26, 2008
For further information, please call: (512) 305-8028
CHAPTER 329. LICENSING PROCEDURE
The Texas Board of Physical Therapy Examiners adopts amendments to §329.6, concerning Licensure by Endorsement, without changes to the proposed text as published in the December 26, 2008, issue of the Texas Register (33 TexReg 10409). The amendments will assure that the board has reviewed all of the physical therapy licensure history of applicants to determine whether they are qualified to practice in Texas.
The amendments will require verification of licensure from all states in which an applicant holds or has held a physical therapy license.
Two comments from individuals were received regarding the changes currently proposed for this section. One person questioned whether the Board had any evidence that licensees who had entered the state by endorsement were a problem, and suggested that if there was no evidence that "bad actors" were being licensed, the change was not necessary and punitive to applicants. Both of the comments suggested that it would be an additional burden on those coming in by endorsement; one was most concerned with the additional cost, while the other one was more concerned that it would be too much of an administrative burden on the applicant, who would have to keep track of licenses previously held. The second comment also suggested that the board could require applicants to only verify licensure history for the past 10 years.
The Board believes that verification of all licenses has become more critical since an increasing number of PTs and PTAs are seeking concurrent licensure in multiple states. At this time there is no national source (accessible to a state board) for verifying all state disciplinary action against a licensee; therefore verification must be done individually with each state. The Board believes that, regardless of the number of states in which a professional may have worked, that professional may be expected to keep track of the states in which they have held a license. Also, although the cost to applicants holding multiple licenses will increase, the Board points out that requiring verification from all states for licensure by endorsement is a national standard, Texas being one of the few states which does not currently require it.
The amendments are adopted under the Physical Therapy Practice Act, Title 3, Subtitle H, Chapter 453, Texas Occupations Code, which provides the Texas Board of Physical Therapy Examiners with the authority to adopt rules consistent with this Act to carry out its duties in administering this Act.
This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on February 17, 2009.
TRD-200900660
John P. Maline
Executive Director
Texas Board of Physical Therapy Examiners
Effective date: March 9, 2009
Proposal publication date: December 26, 2008
For further information, please call: (512) 305-6900
The Texas Board of Physical Therapy Examiners adopts amendments to §341.6, concerning License Restoration, without changes to the proposed text as published in the December 26, 2008, issue of the Texas Register (33 TexReg 10410). The amendments will assure that the board has reviewed all of the physical therapy licensure history of applicants to determine whether they are qualified to practice in Texas, and will eliminate confusion about the expiration date of the restored license and the continuing education required to renew it.
The amendments will give people who restore their Texas licenses a full two year period of licensure before their licenses would expire. Currently, they are given no more than two years and no less than one year of licensure, based on their original license expiration date. The amendments also will require verification of licensure from all states in which an applicant holds or has held a license, and include editorial changes to language intended to clarify existing statements and requirements.
A comment was received from one individual regarding the changes currently proposed for this section. She suggested that requiring verification from all states would not only increase the cost of licensure by endorsement, but that it might put too large an administrative burden on those applicants, who would have to keep track of all licenses previously held. She also suggested that the board could require applicants to only verify licensure history for the past 10 years.
The Board believes that verification of all licenses has become more critical since an increasing number of PTs and PTAs are seeking concurrent licensure in multiple states. At this time there is no national source (accessible to a state board) for verifying all state disciplinary action against a licensee; therefore verification must be done individually with each state. The Board believes that, regardless of the number of states in which a professional may have worked, that professional may be expected to keep track of the states in which they have held a license. Also, the Board would point out that verification from all states for licensure by endorsement is a national standard, Texas being one of the few states which does not currently require it.
The amendments are adopted under the Physical Therapy Practice Act, Title 3, Subtitle H, Chapter 453, Texas Occupations Code, which provides the Texas Board of Physical Therapy Examiners with the authority to adopt rules consistent with this Act to carry out its duties in administering this Act.
This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on February 17, 2009.
TRD-200900661
John P. Maline
Executive Director
Texas Board of Physical Therapy Examiners
Effective date: March 9, 2009
Proposal publication date: December 26, 2008
For further information, please call: (512) 305-6900
SUBCHAPTER A. EXAMINATION
The Texas Board of Veterinary Medical Examiners adopts an amendment to §571.3, regarding the eligibility for examination and licensure, without changes to the proposed text as published in the November 7, 2008, issue of the Texas Register (33 TexReg 9042) and will not be republished.
The amendment corrects a misspelled word in subsection (d)(2)(C)(ii), changing "mush" to "must."
No comments were received regarding adoption of the amendment.
The amendment is adopted under the authority of the Veterinary Licensing Act, Occupations Code §801.151(a) which states that the Board may adopt rules necessary to administer the chapter as well as §801.151(b) which states that the Board may adopt rules of professional conduct appropriate to establish and maintain a high standard of integrity, skills, and practice in the veterinary medicine profession. Texas Occupations Code, Chapter 801, is affected by this amendment.
This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on February 18, 2009.
TRD-200900698
Loris Jones
Executive Assistant
Texas Board of Veterinary Medical Examiners
Effective date: March 10, 2009
Proposal publication date: November 7, 2008
For further information, please call: (512) 305-7563
SUBCHAPTER F. RECORDS KEEPING
The Texas Board of Veterinary Medical Examiners (Board) adopts amendments to §573.52, which discusses patient record keeping, without changes to the proposed text as published in the November 7, 2008, issue of the Texas Register (33 TexReg 9043) and will not be republished.
Section 573.52(a) sets forth requirements of patient record keeping by clarifying pre-existing requirements, and adding the following requirements to patients' records: client phone number, patient identification including name, species, breed, age, sex and description, diagnostic images or written summary of same if unable to save said image, applicable differential diagnosis or treatment, and notation of amendment, supplementation, change or correction in a patient record not made contemporaneously with the act or observation. The amendment also provides an exception to the requirement of taking the temperature of an individual animal when difficult to obtain.
The amendment to §573.52(b) requires veterinarians to maintain patient records for a minimum of five years, as opposed to three under the previous rule, and that said records be "readily available", as opposed to "maintained on the business premises" under the previous rule. It allows a veterinarian to destroy medical records relating to any civil, criminal or administrative proceeding if he or she knows the proceeding is finally resolved. The amendment allows a veterinarian, who is discontinuing his or her practice, to transfer ownership of records to another licensed veterinarian or group of veterinarians if the veterinarian provides notice consistent with §573.54, and the veterinarian assuming ownership of the records maintains them consistent with Chapter 573.
Section 573.52(c), requiring a veterinarian to provide patient records to a client within 15 days of request and collect associated fees, has been deleted in its entirety, and will be replaced by §573.52(d). The language of §573.52(c) was substantially incorporated into §573.53, adopted at the October 17, 2008 Board Meeting.
The amendments to §573.52 are intended to create a more comprehensive, uniform and convenient system of maintaining client records, and to alleviate the need for a veterinarian to review client records every three years to pull the rabies vaccination certificates.
Nine comments were received regarding the adoption of the amendments to §573.52. Three comments were in favor of the amendment, two were neither in favor or opposition, and four were opposed to the amendment to §573.52(b) increasing the time veterinarians are required to maintain patient records from 3 to 5 years, on grounds that it would impose unnecessary hardship upon veterinarians caused by increased storage requirements. The Board respectfully disagrees, as the amendment requires the records only be "readily available," which includes a computer database server, off-site facility, or any other location where the records are readily accessible to the veterinarian. Because rabies vaccination certificates are required by §573.51 to be kept for a minimum of 5 years, the Board feels that increasing the maintenance of all patient records from 3 to 5 years creates a more comprehensive, uniform and convenient system of record maintenance, and costs will be offset as licensees will no longer need to review client files at three years to remove rabies vaccination certificates.
The amendment is adopted under the authority of the Veterinary Licensing Act, Texas Occupations Code §801.151(a) which states that the Board may adopt rules necessary to administer the chapter as well as §801.151(b) which states that the Board may adopt rules of professional conduct appropriate to establish and maintain a high standard of integrity, skills, and practice in the veterinary medicine profession. Texas Occupations Code, Chapter 801, is affected by this amendment.
This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on February 18, 2009.
TRD-200900699
Loris Jones
Executive Assistant
Texas Board of Veterinary Medical Examiners
Effective date: March 10, 2009
Proposal publication date: November 7, 2008
For further information, please call: (512) 305-7563
The Texas Board of Veterinary Medical Examiners (Board) adopts new §573.54, regarding the transfer and disposal of patient records, without changes to the proposed text as published in the November 7, 2008, issue of the Texas Register (33 TexReg 9045) and will not be republished.
Section 573.54 addresses the notification requirements of a veterinarian who discontinues the provision of veterinary services without the continuation of his or her practice, whose license is voluntarily surrendered in lieu of disciplinary action, or whose license is revoked by the Board. This rule also provides the required method of notification to the veterinarian's clients following discontinuation of his or her practice, voluntarily surrender or Board revocation of license. This rule is intended to better facilitate the transfer of records to clients following the discontinuation of a veterinarian's practice for any of the above reasons.
Three comments were received regarding the adoption of this rule. One comment was in favor of the rule and two opposed the rule. The first was opposed to the requirement that written notice be given to clients seen in the last three years, on grounds that it places an "undue work load" on the veterinarian. The Board respectfully disagrees as the term "written notification" includes mail, e-mail, notation at the bottom of client's receipt and/or publication in a local newspaper. The same individual was opposed to the requirement that notice of discontinuation requires a veterinarian to post written notice in the veterinarian's office, on grounds that it will "harm the income of the veterinarian." The Board respectfully disagrees, as the veterinarian will have already made a decision to retire or move and said notice is simply part of the process of winding down the practice. The second comment states that the rule is ineffectual, as a client is not likely to see the posting in the veterinarian's clinic or the local newspaper. The Board respectfully disagrees, as the term "written notification" also includes mail, e-mail and/or notation at the bottom of client's receipt.
The new rule is adopted under the authority of the Veterinary Licensing Act, Texas Occupations Code §801.151(a) which states that the Board may adopt rules necessary to administer the chapter as well as §801.151(b) which states that the Board may adopt rules of professional conduct appropriate to establish and maintain a high standard of integrity, skills, and practice in the veterinary medicine profession. Texas Occupations Code, Chapter 801, is affected by this amendment.
This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on February 18, 2009.
TRD-200900700
Loris Jones
Executive Assistant
Texas Board of Veterinary Medical Examiners
Effective date: March 10, 2009
Proposal publication date: November 7, 2008
For further information, please call: (512) 305-7563
The Texas Board of Veterinary Medical Examiners (Board) adopts an amendment to §573.65, defining various terms used in the Veterinary Licensing Act or the Rules of the Board, without changes to the proposed text as published in the November 7, 2008, issue of the Texas Register (33 TexReg 9046) and will not be republished.
The amendment defines "invasive dentistry or invasive dental procedures" as "exposing of the dental pulp, or performing extractions" and is reflective of the current Board's interpretation of the term "invasive dental procedures" as used in §573.10(f), Supervision of Non-Licensed Employees.
Two comments were received regarding the adoption of the amendment. The first was in support of the amendment, and the second comment stated neither support nor objection.
The amendment is adopted under the authority of the Veterinary Licensing Act, Texas Occupations Code §801.151(a) which states that the Board may adopt rules necessary to administer the chapter as well as §801.151(b) which states that the Board may adopt rules of professional conduct appropriate to establish and maintain a high standard of integrity, skills, and practice in the veterinary medicine profession. Texas Occupations Code, Chapter 801, is affected by this amendment.
This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on February 18, 2009.
TRD-200900701
Loris Jones
Executive Assistant
Texas Board of Veterinary Medical Examiners
Effective date: March 10, 2009
Proposal publication date: November 7, 2008
For further information, please call: (512) 305-7563
The Texas Board of Veterinary Medical Examiners (Board) adopts an amendment to §575.5(e), regarding the amount of fees and reimbursement that are allowed for a subpoenaed witness or an expert witness called at the request of the Board, with a minor punctuation change to the proposed text as published in the November 7, 2008, issue of the Texas Register (33 TexReg 9046). The rule will be republished.
The amendment entitles a witness subpoenaed for deposition or hearing to $25 per diem, and reimbursement for travel expenses in the same manner as Board employees. It also entitles an expert witness called at the request of the Board to $200 per diem and reimbursement for travel expenses in the same manner as Board employees. This increases the amount previously allowed under §575.5(e), which was limited to "expenses incurred." The amendment reflects efforts by the Board to better compensate witnesses for inconveniences caused by compliance with a subpoena and, in the case of expert witnesses, to ensure that the Board makes every effort to secure the best testimony available to prosecute enforcement actions within the budget of a state agency.
Two comments were received regarding the adoption of the amendment. Both stated that the $25 per diem for witnesses was insufficient. One of the two comments stated that the $200 per diem for expert witnesses was also insufficient. The Board respectfully agrees, but is limited by budgetary concerns to the amendment.
The amendment is adopted under the authority of the Veterinary Licensing Act, Texas Occupations Code §801.151(a) which states that the Board may adopt rules necessary to administer the chapter. Texas Occupations Code, Chapter 801, is affected by this amendment.
§575.5.Subpoenas/Witness Expenses.
(a) In any proceeding involving an alleged violation of the Veterinary Licensing Act, Chapter 801, Occupations Code, including a contested case under the Administrative Procedure Act, Chapter 2001, Government Code, the Board may compel by subpoena:
(1) the attendance of witnesses for examination under oath; and
(2) the production for inspection or copying of books, accounts, records, papers, correspondence, documents, and other evidence relevant to the alleged violation.
(b) A party to a contested case hearing may request that the Board issue a subpoena or subpoena duces tecum, in accordance with Section 2001.089 of the APA, as may be hereafter amended. The requesting party must show good cause, relevancy, necessity of the testimony or documents, lack of undue inconvenience, imposition or harassment of the party required to produce the testimony or documents, and must deposit sums necessary to insure payment of expenses incident to the subpoenas. The written request shall be addressed to a sheriff or constable for service in accordance with Section 2001.089 of the APA.
(1) The party requesting the subpoena shall be responsible for the payment of any expense incurred in serving the subpoena, as well as reasonable and necessary expenses incurred by the witness who appears in response to the subpoena.
(2) The party requesting a subpoena duces tecum shall describe and recite with great clarity, particularity and specificity the books, records, and documents to be produced. The written request shall contain a description of the item sought, the name, address and title, if any, of the person or entity who has custody or control over the items, and the date and location at which the items are sought to be produced.
(3) If the subpoena is for the attendance of a witness, the written request shall contain the name, address, and title, if any, of the witness and the date and location at which the attendance of the witness is sought.
(c) A subpoena issued at the request of the Board's staff may be served personally by a Board employee, by certified mail, or by any other means authorized by law.
(d) The Board may delegate authority to issue subpoenas to the executive director.
(e) A witness, called at the request of the Board, who is not a party to the proceeding and who is subpoenaed to appear at a deposition or hearing or to produce books, papers, or other objects, shall be entitled to receive a fee of $25 per day and reimbursed for travel expenses in the same manner as Board employees. An expert witness called at the request of the Board shall be paid a fee of $200 per day and reimbursed for travel expenses in the same manner as Board employees.
(f) The pendancy of a SOAH proceeding does not preclude the board from issuing an investigative subpoena at any time.
This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on February 18, 2009.
TRD-200900702
Loris Jones
Executive Assistant
Texas Board of Veterinary Medical Examiners
Effective date: March 10, 2009
Proposal publication date: November 7, 2008
For further information, please call: (512) 305-7563