CHAPTER 190. DISCIPLINARY GUIDELINES
SUBCHAPTER B. VIOLATION GUIDELINES
The Texas Medical Board (Board) proposes an amendment to Chapter 190, relating to Disciplinary Guidelines, §190.8, Violation Guidelines.
The amendment to §190.8 adds an exception to the requirement in paragraph (1)(L) that a physician may only prescribe drugs to a person with whom a proper professional relationship has been established, for the prescription of drugs for a partner of a patient who may have a sexually transmitted disease.
Elsewhere in this issue of the Texas Register, the Texas Medical Board contemporaneously adopts the amendment on an emergency basis.
Robert D. Simpson, General Counsel for the Board, has determined that for the first five-year period the section is in effect there will be no fiscal implications to state or local government as a result of enforcing the section as proposed.
Mr. Simpson has also determined that for each year of the first five years the section as proposed is in effect the public benefit anticipated as a result of enforcing this proposal will be to authorize physicians to prescribe medication for a partner of a patient who may have a sexually transmitted disease. There will be no effect to individuals required to comply with the rule as proposed. There will be no effect on small or micro businesses.
Comments on the proposal may be submitted to Sally Durocher, P.O. Box 2018, Austin, Texas 78768-2018, or e-mail comments to: rules.development@tmb.state.tx.us. A public hearing will be held at a later date.
The amendment is proposed under the authority of the Texas Occupations Code Annotated, §153.001, which provides 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.
No other statutes, articles or codes are affected by this proposal.
§190.8.Violation Guidelines.
When substantiated by credible evidence, the following acts, practices, and conduct are considered to be violations of the Act. The following shall not be considered an exhaustive or exclusive listing.
(1) Practice Inconsistent with Public Health and Welfare. Failure to practice in an acceptable professional manner consistent with public health and welfare within the meaning of the Act includes, but is not limited to:
(A) - (K) (No change.)
(L) prescription of any dangerous drug or controlled substance without first establishing a proper professional relationship with the patient.
(i) - (ii) (No change.)
(iii) Notwithstanding the provisions of this subparagraph, establishing a professional relationship is not required for a physician to prescribe medications for sexually transmitted diseases for partners of the physician's established patient, if the physician determines that the patient may have been infected with a sexually transmitted disease.
(M) - (N) (No change.)
(2) - (6) (No change.)
This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.
Filed with the Office of the Secretary of State on March 13, 2009.
TRD-200901067
Mari Robinson, J.D.
Interim Executive Director
Texas Medical Board
Earliest possible date of adoption: April 26, 2009
For further information, please call: (512) 305-7016
CHAPTER 281. ADMINISTRATIVE PRACTICE AND PROCEDURES
SUBCHAPTER C. DISCIPLINARY GUIDELINES
The Texas State Board of Pharmacy proposes amendments to §281.65, concerning Schedule of Administrative Penalties. The amendments, if adopted, increase the administrative penalties for allowing individuals to work in a pharmacy without a pharmacy technician registration or with a delinquent pharmacy technician registration.
Gay Dodson, R.Ph., Executive Director/Secretary, has determined that, for the first five-year period the rule is in effect, there will be no fiscal implications for state or local government as a result of enforcing or administering the rule.
Ms. Dodson has determined that, for each year of the first five-year period the rule will be in effect, the public benefit anticipated as a result of enforcing the rule will be to deter future violations and to enhance protection of the public. There is no fiscal impact for individuals, small or large businesses or to other entities which are required to comply with this section.
Comments on the proposed amendments may be submitted to Allison Benz, R.Ph., M.S., Director of Professional Services, Texas State Board of Pharmacy, 333 Guadalupe Street, Suite 3-600, Austin, Texas 78701, FAX (512) 305-8082. Comments must be received by 5 p.m., May 1, 2009.
The amendments are proposed under §§551.002, 554.051, 565.051, and 568.035 of the Texas Pharmacy Act (Chapters 551 - 566 and 568 - 569, Texas 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 §565.051 as authorizing the agency to discipline a license holder or applicant for a license or renewal of a license. The Board interprets §568.035 as authorizing the agency to discipline an applicant or registrant.
The statutes affected by this rule: Texas Pharmacy Act, Chapters 551 - 566 and 568 - 569, Texas Occupations Code.
§281.65.Schedule of Administrative Penalties.
The board has determined that the assessment of an administrative penalty promotes the intent of §551.002 of the Act. In disciplinary matters, the board may assess an administrative penalty in addition to any other disciplinary action in the circumstances and amounts as follows:
(1) The following violations by a pharmacist may be appropriate for disposition with an administrative penalty with or without additional sanctions or restrictions:
(A) - (Q) (No change.)
(R) allowing an individual to perform the duties of
a pharmacy technician without a valid registration: $500 - $2,000
[$250 - $1,000];
(S) - (CC) (No change.)
(2) The following violations by a pharmacy may be appropriate for disposition with an administrative penalty with or without additional sanctions or restrictions:
(A) - (P) (No change.)
(Q) allowing an individual to perform the duties of
a pharmacy technician without a valid registration:
$500- 3,000 [$250 - $1500];
(R) - (BB) (No change.)
(3) - (6) (No change.)
This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.
Filed with the Office of the Secretary of State on March 16, 2009.
TRD-200901087
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Earliest possible date of adoption: April 26, 2009
For further information, please call: (512) 305-8028
The Texas State Board of Pharmacy proposes amendments to §283.4, concerning Internship Requirements, and §283.6, concerning Preceptor Requirements and Ratio of Preceptors to Pharmacist-Interns. The amendments, if adopted, clarify the requirements for a change of name or change of address for pharmacist interns, clarify the charge for a duplicate or amended certificate for pharmacist interns and preceptors, eliminate the requirement that a preceptor have one year of experience in the type of internship practice setting and only require the preceptor to have a year of experience as a licensed pharmacist, and eliminate the ratio of preceptors to pharmacist-interns in Texas college or school of pharmacy programs.
Gay Dodson, R.Ph., Executive Director/Secretary, has determined that, for the first five-year period the rule is in effect, there will be no fiscal implications for state or local government as a result of enforcing or administering the rule.
Ms. Dodson has determined that, for each year of the first five-year period the rule will be in effect, the public benefit anticipated as a result of enforcing the rule will be to clarify the notification requirements for interns with regard to a name change or address change and the charge for duplicate or amended certificates. There is no fiscal impact for individuals, small or large businesses or to other entities which are required to comply with this section.
Comments on the proposed amendments may be submitted to Allison Benz, R.Ph., M.S., Director of Professional Services, Texas State Board of Pharmacy, 333 Guadalupe Street, Suite 3-600, Austin, Texas 78701, FAX (512) 305-8082. Comments must be received by 5 p.m., May 1, 2009.
The amendments are proposed under §551.002 and §554.051 of the Texas Pharmacy Act (Chapters 551 - 566 and 568 - 569, Texas 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 statutes affected by this rule: Texas Pharmacy Act, Chapters 551 - 566 and 568 - 569, Texas Occupations Code.
§283.4.Internship Requirements.
(a) - (b) (No change.)
(c) College-/School-Based Internship Programs.
(1) Internship experience acquired by student-interns.
(A) (No change.)
(B) The terms of the student internship shall be as follows.
(i) The student internship shall be gained concurrent with college attendance, which may include:
(I) partial semester breaks such as spring breaks;
(II) between semester breaks; and
(III) whole semester breaks provided the student-intern attended the college/school in the immediate preceding semester and is scheduled with the college/school to attend in the immediate subsequent semester.
(ii) The student internship shall be obtained in pharmacies licensed by the board, federal government pharmacies, or in a board-approved program.
(iii) The student internship shall be in the presence of and under the supervision of a healthcare professional preceptor or a pharmacist preceptor.
(C) (No change.)
(2) - (3) (No change.)
(d) - (e) (No change.)
(f) Change of address and/or name. [Pharmacist-intern
Notification Requirement. A pharmacist-intern shall notify the board
in writing within 10 days of a change of address, giving the old and
new address.]
(1) Change of address. A pharmacist-intern shall notify the board electronically or in writing within 10 days of a change of address, giving the old and new address.
(2) Change of name. A pharmacist-intern shall notify the board in writing within 10 days of a change of name by:
(A) sending a copy of the official document reflecting the name change (e.g., marriage certificate, divorce decree, etc.);
(B) returning the current pharmacist-intern certificate which reflects the previous name; and
(C) paying a fee of $20.
(g) Duplicate or amended certificate. The fee for issuance of a duplicate or amended pharmacist-intern registration certificate shall be $20.
§283.6.Preceptor Requirements and Ratio of Preceptors to Pharmacist-Interns.
(a) Preceptor requirements.
(1) - (2) (No change.)
(3) To be recognized as a pharmacist preceptor, a pharmacist must:
(A) have at least:
(i) one year of experience as a licensed pharmacist
[in the type of internship practice setting]; or
(ii) six months of residency training if the pharmacy resident is in a program accredited by the American Society of Health-System Pharmacists;
(B) - (C) (No change.)
(b) Ratio of preceptors to pharmacist-interns.
(1) (No change.)
(2) The following is applicable to Texas college/school of pharmacy internship program only.
(A) Supervision. Supervision of a pharmacist-intern shall be:
(i) direct supervision when the student-intern or intern-trainee is engaged in functions associated with the preparation and delivery of prescription or medication drug orders; and
(ii) general supervision when the student-intern or intern-trainee is engaged in functions not associated with the preparation and delivery of prescription or medication drug orders.
(B) Exceptions to the 1:1 ratio. There is no ratio requirement for preceptors supervising intern-trainees and student-interns as a part of a Texas college/school of pharmacy program.
[(i) There is no ratio
requirement for preceptors supervising intern-trainees and student-interns
as a part of a Texas college/school of pharmacy when the intern-trainees
and student-interns are not engaging in dispensing activities, patient
counseling, or any activities requiring independent judgement.]
[(ii) A preceptor for a
Texas college/school of pharmacy internship program may supervise
one intern-trainee and one student-intern except as described in clause
(i) of this subparagraph.]
[(iii) Texas college/schools
of pharmacy may request a different preceptor to pharmacist-intern
ratio during the board's annual review and approval of their college/school
based, structured internship program. Any such ratio shall apply only
to the internship experience acquired as a part of the college/school
based, structured internship program.]
[(iv) In an emergency caused
by a natural or manmade disaster or any other exceptional situation
that causes an extraordinary demand for preceptors, the executive
director of the board, in his/her discretion, may allow a preceptor
in a Texas college/school of pharmacy internship program to supervise
up to two interns. The executive director shall notify the Texas colleges/schools
of pharmacy of the length of time a preceptor may supervise up to
two interns.]
(c) (No change.)
(d) The fee for issuance of a duplicate or amended preceptor certificate shall be $20.
This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.
Filed with the Office of the Secretary of State on March 16, 2009.
TRD-200901088
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Earliest possible date of adoption: April 26, 2009
For further information, please call: (512) 305-8028
SUBCHAPTER A. ALL CLASSES OF PHARMACIES
The Texas State Board of Pharmacy proposes amendments to §291.1, concerning Pharmacy License Application, and §291.3, concerning Required Notifications. The amendments, if adopted, clarify that pharmacies are required to notify patients when a pharmacy is changing locations, clarify that pharmacies are required to report the loss of controlled substances and dangerous drugs due to forged prescriptions, and delete the option of providing a notarized statement signed by the lessee and lessor certifying the existence of a lease as a part of the application for a pharmacy license.
Gay Dodson, R.Ph., Executive Director/Secretary, has determined that, for the first five-year period the rule is in effect, there will be no fiscal implications for state or local government as a result of enforcing or administering the rule.
Ms. Dodson has determined that, for each year of the first five-year period the rule will be in effect, the public benefit anticipated as a result of enforcing the rule will ensure that patients are notified when a pharmacy changes location, pharmacies properly notify the Board when prescriptions are forged by licensees or registrants, and an applicant for a pharmacy license has a proper lease. There is no fiscal impact for individuals, small or large businesses or to other entities which are required to comply with this section.
Comments on the proposed amendments may be submitted to Allison Benz, R.Ph., M.S., Director of Professional Services, Texas State Board of Pharmacy, 333 Guadalupe Street, Suite 3-600, Austin, Texas 78701, FAX (512) 305-8082. Comments must be received by 5 p.m., May 1, 2009.
The amendments are proposed under §551.002 and §554.051 of the Texas Pharmacy Act (Chapters 551 - 566 and 568 - 569, Texas 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 statutes affected by this rule: Texas Pharmacy Act, Chapters 551 - 566 and 568 - 569, Texas Occupations Code.
§291.1.Pharmacy License Application.
(a) To qualify for a pharmacy license, the applicant must submit an application including the following information:
(1) - (5) (No change.)
(6) copy of lease agreement [or alternatively,
a notarized statement signed by the lessee and lessor certifying the
existence of a lease agreement,] or if the location of the pharmacy
is owned by the applicant, a notarized statement certifying such location
ownership;
(7) - (15) (No change.)
(b) - (h) (No change.)
§291.3.Required Notifications.
(a) Change of Location and/or Name.
(1) (No change.)
(2) At least 14 days prior to the change of location of a pharmacy that dispenses prescription drug orders, the pharmacist-in-charge shall post a sign in a conspicuous place indicating that the pharmacy is changing locations. Such sign shall be in the front of the prescription department and at all public entrance doors to the pharmacy and shall indicate the date the pharmacy is changing locations.
(3) [(2)] Disasters, accidents,
and emergencies which require the pharmacy to change location shall
be immediately reported to the board. If a pharmacy changes location
suddenly due to disasters, accidents, or other emergency circumstances
and the pharmacist-in-charge cannot provide notification 14 days prior
to the change of location, the pharmacist-in-charge shall comply with
the provisions of paragraph (2) of this subsection as far in advance
of the change of location as allowed by the circumstances.
(b) (No change.)
(c) Change of Ownership.
(1) (No change.)
(2) The new application shall include the following information:
(A) the name and address of pharmacy;
(B) the type of ownership;
(C) the names, home addresses, dates of birth, phone numbers, and social security numbers of all owners; if a partnership or corporation, the name, title, home address, home phone number, date of birth, and social security number of all managing officers;
(D) the name and license number of the pharmacist-in-charge and of other pharmacists employed by the pharmacy;
(E) a copy of lease agreement [or alternatively,
a notarized statement signed by the lessee and lessor certifying the
existence of a lease agreement,] or if the location of the pharmacy
is owned by the applicant, a notarized statement certifying such location
ownership;
(F) a copy of the purchase contract or mutual agreement between the buyer and seller, or a notarized statement of intent to convey ownership signed by both the buyer and seller, stating the proposed date of ownership change;
(G) the signature of the pharmacist-in-charge;
(H) the notarized signature of the owner, or if the pharmacy is owned by a partnership or corporation, the notarized signature of an owner or managing officer;
(I) federal tax ID number;
(J) description of business services that will be offered;
(K) name and address of malpractice insurance carrier or statement that the business will be self-insured;
(L) the certificate of authority, if applicant is an out-of-state corporation;
(M) the articles of incorporation, if the applicant is a corporation;
(N) a current Texas Franchise Tax Certificate of Good Standing; and
(O) any other information requested on the application.
(3) - (5) (No change.)
(d) - (g) (No change.)
(h) Notification of Licensees or Registrants Obtaining Controlled Substances or Dangerous Drugs by Forged Prescriptions. If a licensee or registrant obtains controlled substances or dangerous drugs from a pharmacy by means of a forged prescription, the pharmacy shall report in writing to the board immediately on discovery of such forgery. A pharmacy shall be in compliance with this subsection by submitting to the board the following:
(1) name of licensee or registrant obtaining controlled substances or dangerous drugs by forged prescription;
(2) date(s) of forged prescription(s);
(3) name(s) and amount(s) of drug(s); and
(4) copies of forged prescriptions.
This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.
Filed with the Office of the Secretary of State on March 16, 2009.
TRD-200901089
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Earliest possible date of adoption: April 26, 2009
For further information, please call: (512) 305-8028
The Texas State Board of Pharmacy proposes amendments to §291.33, concerning Operational Standards, and §291.34, concerning Records. The amendments, if adopted, allow for the secure storage, management, and purchase/delivery of prescription medications during and after pharmacy hours from an automated storage and distribution device, and clarify that an original prescription may only be dispensed if the prescription is authorized by the prescriber.
Gay Dodson, R.Ph., Executive Director/Secretary, has determined that, for the first five-year period the rule is in effect, there will be no fiscal implications for state or local government as a result of enforcing or administering the rule.
Ms. Dodson has determined that, for each year of the first five-year period the rule will be in effect, the public benefit anticipated as a result of enforcing the rule will ensure the safe use of automated storage and distribution devices and prescriptions are dispensed as authorized. There is no fiscal impact for individuals, small or large businesses or to other entities which are required to comply with this section.
Comments on the proposed amendments may be submitted to Allison Benz, R.Ph., M.S., Director of Professional Services, Texas State Board of Pharmacy, 333 Guadalupe Street, Suite 3-600, Austin, Texas 78701, FAX (512) 305-8082. Comments must be received by 5 p.m., May 1, 2009.
The amendments are proposed under §551.002 and §554.051 of the Texas Pharmacy Act (Chapters 551 - 566 and 568 - 569, Texas 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 statutes affected by this rule: Texas Pharmacy Act, Chapters 551 - 566 and 568 - 569, Texas Occupations Code.
§291.33.Operational Standards.
(a) (No change.)
(b) Environment.
(1) (No change.)
(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) (No change.)
(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) A pharmacy may use an automated storage and distribution device as specified in subsection (i) of this section for pick-up of a previously verified prescription by a patient or patient's agent, provided the following conditions are met:
(I) 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.
(II) the pharmacy must maintain documentation of the absences of the pharmacist(s); and
(III) the prescription department is locked and secured to prohibit unauthorized entry.
(iv) [(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.
(v) [(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.
(vi) [(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) - (h) (No change.)
(i) Automated devices and systems.
(1) - (4) (No change.)
(5) Automated storage and distribution device. A pharmacy may use an automated storage and distribution device to deliver a previously verified prescription to a patient or patient's agent provided:
(A) the device is used to deliver refills of prescription drug orders and shall not be used to deliver new prescriptions as defined by §291.31(26) of the title (Relating to Definitions);
(B) the automated storage and distribution device may not be used to deliver a controlled substance;
(C) drugs stored in the automated storage and distribution device are stored at proper temperatures;
(D) the patient or patient's agent is given the option to use the system;
(E) the patient or patient's agent has access to a pharmacist for questions regarding the prescription either at the pharmacy where the automated storage and distribution device is located or by a telephone available at the pharmacy that connects directly to another pharmacy;
(F) the pharmacist-in-charge is responsible for the supervision of the operation of the system;
(G) the automated storage and distribution device has been tested by the pharmacy and found to dispense prescriptions accurately. The pharmacy shall make the results of such testing available to the board upon request;
(H) the automated storage and distribution device may be loaded with previously veritied prescriptions only by a pharmacist or by pharmacy technicians under the direction and direct supervision of a pharmacist;
(I) the pharmacy will make the automated storage and distribution device available for inspection by the board;
(J) the automated storage and distribution device is located within the pharmacy building whereby pharmacy staff has access to the device from within the prescription department and patients have access to the device from outside the prescription department. The device may not be located on an outside wall of the pharmacy and may not be accessible from a drive-thru;
(K) the automated storage and distribution device is secure from access and removal of prescription drug orders by unauthorized individuals;
(L) the automated storage and distribution device has adequate security system to prevent unauthorized access and to maintain patient confidentiality; and
(M) the automated storage and distribution device records a digital image of the individual accessing the device to pick-up a prescription and such record is maintained by the pharmacy for two years.
§291.34.Records.
(a) (No change.)
(b) Prescriptions.
(1) - (4) (No change.)
(5) Original prescription drug order records.
(A) Original prescriptions may be dispensed only in accordance with the prescriber's authorization as indicated on the original prescription drug order.
(B) [(A)] Original prescriptions
shall be maintained by the pharmacy in numerical order and remain
legible for a period of two years from the date of filling or the
date of the last refill dispensed.
(C) [(B)] If an original prescription
drug order is changed, such prescription order shall be invalid and
of no further force and effect; if additional drugs are to be dispensed,
a new prescription drug order with a new and separate number is required.
(D) [(C)] Original prescriptions
shall be maintained in three separate files as follows:
(i) prescriptions for controlled substances listed in Schedule II;
(ii) prescriptions for controlled substances listed in Schedules III - V; and
(iii) prescriptions for dangerous drugs and nonprescription drugs.
(E) [(D)] Original prescription
records other than prescriptions for Schedule II controlled substances
may be stored on microfilm, microfiche, or other system which is capable
of producing a direct image of the original prescription record, e.g.,
digitalized imaging system. If original prescription records are stored
in a direct imaging system, the following is applicable:
(i) the record of refills recorded on the original prescription must also be stored in this system;
(ii) the original prescription records must be maintained
in numerical order and separated in three files as specified in subparagraph
(D) [(C)] of this paragraph; and
(iii) the pharmacy must provide immediate access to equipment necessary to render the records easily readable.
(6) - (7) (No change.)
(c) - (j) (No change.)
This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.
Filed with the Office of the Secretary of State on March 16, 2009.
TRD-200901091
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Earliest possible date of adoption: April 26, 2009
For further information, please call: (512) 305-8028
The Texas State Board of Pharmacy proposes amendments to §291.129, concerning Satellite Pharmacy. The amendments, if adopted, delete the option of providing a notarized statement signed by the lessee and lessor certifying the existence of a lease as a part of the application for a pharmacy license and correct the citation with regard to Storage of Drugs.
Gay Dodson, R.Ph., Executive Director/Secretary, has determined that, for the first five-year period the rule is in effect, there will be no fiscal implications for state or local government as a result of enforcing or administering the rule.
Ms. Dodson has determined that, for each year of the first five-year period the rule will be in effect, the public benefit anticipated as a result of enforcing the rule will ensure that an applicant for a pharmacy license has a proper lease. There is no fiscal impact for individuals, small or large businesses or to other entities which are required to comply with this section.
Comments on the proposed amendments may be submitted to Allison Benz, R.Ph., M.S., Director of Professional Services, Texas State Board of Pharmacy, 333 Guadalupe Street, Suite 3-600, Austin, Texas 78701, FAX (512) 305-8082. Comments must be received by 5 p.m., May 1, 2009.
The amendments are proposed under §551.002 and §554.051 of the Texas Pharmacy Act (Chapters 551 - 566 and 568 - 569, Texas 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 statutes affected by this rule: Texas Pharmacy Act, Chapters 551 - 566 and 568 - 569, Texas Occupations Code.
§291.129.Satellite Pharmacy.
(a) - (d) (No change.)
(e) Operational requirements.
(1) Application for permission to provide satellite pharmacy services.
(A) A Class A or Class C pharmacy shall make application to the board to provide satellite pharmacy services. The application shall contain an affidavit with the notarized signatures of the pharmacist-in-charge and the person responsible for the on-site operation of the facility where the satellite pharmacy will be located and include the following:
(i) - (iii) (No change.)
(iv) copy of the lease agreement or if the location
of the satellite pharmacy is owned by the applicant, a notarized statement
certifying such location ownership [or alternatively, a
notarized statement signed by the lessee and lessor certifying the
existence of a lease].
(B) - (C) (No change.)
(2) (No change.)
(3) Environment.
(A) - (C) (No change.)
(D) The temperature of the satellite pharmacy shall
be maintained within a range compatible with the proper storage of
drugs in compliance with the provisions of §291.15 of this
title (relating to Storage of Drugs) [§291.33(f) of
this title including the requirements for temperature]. The
temperature of the refrigerator shall be maintained within a range
compatible with the proper storage of drugs requiring refrigeration.
(E) (No change.)
(4) - (7) (No change.)
(f) (No change.)
This agency hereby certifies that the proposal has been reviewed by legal counsel and found to be within the agency's legal authority to adopt.
Filed with the Office of the Secretary of State on March 16, 2009.
TRD-200901090
Gay Dodson, R.Ph.
Executive Director/Secretary
Texas State Board of Pharmacy
Earliest possible date of adoption: April 26, 2009
For further information, please call: (512) 305-8028