22 Tex. Admin. Code § 291.73

Current through Reg. 49, No. 49; December 6, 2024

Section 291.73 - Personnel

(a) Requirements for pharmacist services.

(1) A Class C pharmacy in a facility with 101 beds or more shall be under the continuous on-site supervision of a pharmacist during the time it is open for pharmacy services; provided, however, that pharmacy technicians and pharmacy technician trainees may distribute prepackaged and prelabeled drugs from a drug storage area of the facility (e.g., a surgery suite), in the absence of physical supervision of a pharmacist, under the following conditions:

(A) the distribution is under the control of a pharmacist; and

(B) a pharmacist is on duty in the facility.

(2) A Class C pharmacy in a facility with 100 beds or less shall have the services of a pharmacist at least on a part-time or consulting basis according to the needs of the facility except that a pharmacist shall be on-site at least once every seven days.

(3) A pharmacist shall be accessible at all times to respond to other health professional's questions and needs. Such access may be through a telephone which is answered 24 hours a day, e.g., answering or paging service, a list of phone numbers where the pharmacist may be reached, or any other system which accomplishes this purpose.

(b) Pharmacist-in-charge.

(1) General.

(A) Each institutional pharmacy in a facility with 101 beds or more shall have one full-time pharmacist-in-charge, who may be pharmacist-in-charge for only one such pharmacy except as specified in subparagraph (C) of this paragraph.

(B) Each institutional pharmacy in a facility with 100 beds or less shall have one pharmacist-in-charge who is employed or under contract, at least on a consulting or part-time basis, but may be employed on a full-time basis, if desired, and who may be pharmacist-in-charge for no more than three facilities or 150 beds.

(C) A pharmacist-in-charge may be in charge of one facility with 101 beds or more and one facility with 100 beds or less, including a rural hospital, provided the total number of beds does not exceed 150 beds.

(D) The pharmacist-in-charge shall be assisted by additional pharmacists, pharmacy technicians and pharmacy technician trainees commensurate with the scope of services provided.

(E) If the pharmacist-in-charge is employed on a part-time or consulting basis, a written agreement shall exist between the facility and the pharmacist, and a copy of the written agreement shall be made available to the board upon request.

(F) The pharmacist-in-charge of a Class C pharmacy with 101 beds or more, may not serve as the pharmacist-in-charge of a Class A pharmacy or a Class B pharmacy.

(2) Responsibilities. The pharmacist-in-charge shall have the responsibility for, at a minimum, the following:

(A) providing the appropriate level of pharmaceutical care services to patients of the facility;

(B) ensuring that drugs and/or devices are prepared for distribution safely, and accurately as prescribed;

(C) supervising a system to assure maintenance of effective controls against the theft or diversion of prescription drugs, and records for such drugs;

(D) providing written guidelines and approval of the procedure to assure that all pharmaceutical requirements are met when any part of preparing, sterilizing, and labeling of sterile preparations is not performed under direct pharmacy supervision;

(E) participating in the development of a formulary for the facility, subject to approval of the appropriate committee of the facility;

(F) developing a system to assure that drugs to be administered to patients are distributed pursuant to an original or direct copy of the practitioner's medication order;

(G) developing a system for the filling and labeling of all containers from which drugs are to be distributed or dispensed;

(H) assuring that the pharmacy maintains and makes available a sufficient inventory of antidotes and other emergency drugs as well as current antidote information, telephone numbers of regional poison control center and other emergency assistance organizations, and such other materials and information as may be deemed necessary by the appropriate committee of the facility;

(I) maintaining records of all transactions of the institutional pharmacy as may be required by applicable law, state and federal, and as may be necessary to maintain accurate control over and accountability for all pharmaceutical materials including pharmaceuticals, components used in the compounding of preparations, and participate in policy decisions regarding prescription drug delivery devices;

(J) participating in those aspects of the facility's patient care evaluation program which relate to pharmaceutical utilization and effectiveness;

(K) participating in teaching and/or research programs in the facility;

(L) implementing the policies and decisions of the appropriate committee(s) relating to pharmaceutical services of the facility;

(M) providing effective and efficient messenger or delivery service to connect the institutional pharmacy with appropriate areas of the facility on a regular basis throughout the normal workday of the facility;

(N) developing a system for the labeling, storage, and distribution of investigational new drugs, including access to related drug information for healthcare personnel in the pharmacy and nursing station where such drugs are being administered, concerning the dosage form, route of administration, strength, actions, uses, side effects, adverse effects, interactions and symptoms of toxicity of investigational new drugs;

(O) assuring that records in a data processing system are maintained such that the data processing system is in compliance with Class C (Institutional) pharmacy requirements;

(P) assuring that a reasonable effort is made to obtain, record, and maintain patient medication records;

(Q) assuring the legal operation of the pharmacy, including meeting all inspection and other requirements of all state and federal laws or rules governing the practice of pharmacy; and

(R) if the pharmacy uses an automated medication supply system, shall be responsible for the following:

(i) reviewing and approving all policies and procedures for system operation, safety, security, accuracy and access, patient confidentiality, prevention of unauthorized access, and malfunction;

(ii) inspecting medications in the automated medication supply system, at least monthly, for expiration date, misbranding, physical integrity, security, and accountability; except that inspection of medications in the automated medication supply system may be performed quarterly if:

(I) the facility uses automated medication supply systems that monitors expiration dates of prescription drugs; and

(II) security of the system is checked at regularly defined intervals (e.g., daily or weekly);

(iii) assigning, discontinuing, or changing personnel access to the automated medication supply system;

(iv) ensuring that pharmacy technicians, pharmacy technician trainees, and licensed healthcare professionals performing any services in connection with an automated medication supply system have been properly trained on the use of the system and can demonstrate comprehensive knowledge of the written policies and procedures for operation of the system; and

(v) ensuring that the automated medication supply system is stocked accurately and an accountability record is maintained in accordance with the written policies and procedures of operation.

(c) Consultant pharmacist.

(1) The consultant pharmacist may be the pharmacist-in-charge.

(2) A written agreement shall exist between the facility and any consultant pharmacist, and a copy of the written agreement shall be made available to the board upon request.

(d) Pharmacists.

(1) General.

(A) The pharmacist-in-charge shall be assisted by a sufficient number of additional licensed pharmacists as may be required to operate the institutional pharmacy competently, safely, and adequately to meet the needs of the patients of the facility.

(B) All pharmacists shall assist the pharmacist-in-charge in meeting the responsibilities as outlined in subsection (b)(2) of this section and in ordering, administering, and accounting for pharmaceutical materials.

(C) All pharmacists shall be responsible for any delegated act performed by pharmacy technicians or pharmacy technician trainees under his or her supervision.

(D) All pharmacists while on duty, shall be responsible for complying with all state and federal laws or rules governing the practice of pharmacy.

(E) A distributing pharmacist shall be responsible for and ensure that the drug is prepared for distribution safely, and accurately as prescribed unless the pharmacy's data processing system can record the identity of each pharmacist involved in a specific portion of the preparation of medication orders for distribution, in which case each pharmacist involved in the preparation of medication orders shall be responsible for and ensure that the portion of the process the pharmacist is performing results in the safe and accurate distribution and delivery of the drug as ordered. The preparation and distribution process for medication orders shall include, but not be limited to, drug regimen review, and verification of accurate medication order data entry, preparation, and distribution, and performance of the final check of the prepared medication.

(2) Duties. Duties of the pharmacist-in-charge and all other pharmacists shall include, but need not be limited to the following:

(A) providing those acts or services necessary to provide pharmaceutical care;

(B) receiving, interpreting, and evaluating prescription drug orders, and reducing verbal medication orders to writing either manually or electronically;

(C) participating in drug and/or device selection as authorized by law, drug and/or device supplier selection, drug administration, drug regimen review, or drug or drug-related research;

(D) performing a specific act of drug therapy management for a patient delegated to a pharmacist by a written protocol from a physician licensed in this state in compliance with the Medical Practice Act Subtitle B, Chapter 157, Occupations Code;

(E) accepting the responsibility for:

(i) distributing prescription drugs and devices with drug components pursuant to medication orders;

(ii) compounding and labeling of prescription drugs and devices with drug components;

(iii) proper and safe storage of prescription drugs and devices with drug components; and

(iv) maintaining proper records for prescription drugs and devices with drug components.

(3) Special requirements for compounding. All pharmacists engaged in compounding non-sterile preparations shall meet the training requirements specified in § 291.131 of this title (relating to Pharmacies Compounding Non-sterile Preparations).

(e) Pharmacy technicians and pharmacy technician trainees.

(1) General.

(A) All pharmacy technicians and pharmacy technician trainees shall meet the training requirements specified in § 297.6 of this title (relating to Pharmacy Technician and Pharmacy Technician Trainee Training).

(B) A pharmacy technician performing the duties specified in paragraph (2)(C) of this subsection shall complete training regarding:

(i) procedures for one pharmacy technician to verify the accuracy of actions performed by another pharmacy technician including required documentation; and

(ii) the duties that may be performed by one pharmacy technician and checked by another pharmacy technician.

(C) In addition to the training requirements specified in subparagraph (A) of this paragraph, pharmacy technicians working in a rural hospital and performing the duties specified in paragraph (2)(D)(ii) of this subsection shall complete the following. Training on the:

(i) procedures for verification of the accuracy of actions performed by pharmacy technicians including required documentation;

(ii) duties which may and may not be performed by pharmacy technicians in the absence of a pharmacist; and

(iii) pharmacy technician's role in preventing dispensing and distribution errors.

(2) Duties. Duties may include, but need not be limited to, the following functions under the supervision of and responsible to a pharmacist:

(A) Facilities with 101 beds or more. The following functions must be performed under the physically present supervision of a pharmacist:

(i) pre-packing and labeling unit and multiple dose packages, provided a pharmacist supervises and conducts a final check and affixes his or her name, initials or electronic signature to the appropriate quality control records prior to distribution;

(ii) preparing, packaging, compounding, or labeling prescription drugs pursuant to medication orders, provided a pharmacist supervises and checks the preparation prior to distribution;

(iii) bulk compounding or batch preparation provided a pharmacist supervises and conducts in-process and final checks and affixes his or her name, initials, or electronic signature to the appropriate quality control records prior to distribution;

(iv) distributing routine orders for stock supplies to patient care areas;

(v) entering medication order and drug distribution information into a data processing system, provided judgmental decisions are not required and a pharmacist checks the accuracy of the information entered into the system prior to releasing the order;

(vi) loading unlabeled drugs into an automated compounding or counting device provided a pharmacist supervises, verifies that the system was properly loaded prior to use, and affixes his or her name, initials or electronic signature to the appropriate quality control records;

(vii) accessing automated medication supply systems after proper training on the use of the automated medication supply system and demonstration of comprehensive knowledge of the written policies and procedures for its operation; and

(viii) compounding non-sterile preparations pursuant to medication orders provided the pharmacy technicians or pharmacy technician trainees have completed the training specified in § 291.131 of this title.

(B) Facilities with 100 beds or less.

(i) Physically present supervision. The following functions must be performed under the physically present supervision of a pharmacist unless the pharmacy meets the requirements for a rural hospital and has been approved by the board to allow pharmacy technicians to perform the duties specified in §562.1011 of the Texas Pharmacy Act and subparagraph (D)(ii) of this paragraph:

(I) pre-packing and labeling unit and multiple dose packages, provided a pharmacist supervises and conducts a final check and affixes his or her name, initials or electronic signature to the appropriate quality control records prior to distribution;

(II) bulk compounding or batch preparation provided a pharmacist supervises and conducts in-process and final checks and affixes his or her name, initials, or electronic signature to the appropriate quality control records prior to distribution;

(III) loading unlabeled drugs into an automated compounding or counting device provided a pharmacist supervises, verifies that the system was properly loaded prior to use, and affixes his or her name, initials, or electronic signature to the appropriate quality control records; and

(IV) compounding medium-risk and high-risk sterile preparations pursuant to medication orders provided the pharmacy technicians or pharmacy technician trainees:

(-a-) have completed the training specified in § 291.133 of this title (relating to Pharmacies Compounding Sterile Preparations); and

(-b-) are supervised by a pharmacist who has completed the training specified in § 291.133 of this title and who conducts in-process and final checks, and affixes his or her name, initials, or electronic signature to the label or if batch prepared, to the appropriate quality control records. (The name, initials, or electronic signature are not required on the label if it is maintained in a permanent record of the pharmacy.)

(ii) Electronic supervision or physically present supervision. The following functions may be performed under the electronic supervision or physically present supervision of a pharmacist:

(I) preparing, packaging, or labeling prescription drugs pursuant to medication orders, provided a pharmacist checks the preparation prior to distribution;

(II) distributing routine orders for stock supplies to patient care areas;

(III) entering medication order and drug distribution information into a data processing system, provided judgmental decisions are not required and a pharmacist checks the accuracy of the information entered into the system prior to releasing the order;

(IV) accessing automated medication supply systems after proper training on the use of the automated medication supply system and demonstration of comprehensive knowledge of the written polices and procedures for its operation;

(V) compounding non-sterile preparations pursuant to medication orders provided the pharmacy technicians or pharmacy technician trainees have completed the training specified in § 291.131 of this title; and

(VI) compounding low-risk sterile preparations pursuant to medication orders provided the pharmacy technicians or pharmacy technician trainees:

(-a-) have completed the training specified in § 291.133 of this title; and

(-b-) are supervised by a pharmacist who has completed the training specified in § 291.133 of this title, and who conducts in-process and final checks, and affixes his or her name, initials, or electronic signature to the label or if batch prepared, to the appropriate quality control records. (The name, initials, or electronic signature are not required on the label if it is maintained in a permanent record of the pharmacy.)

(C) Facilities with an ongoing clinical pharmacy program. A Class C pharmacy with an ongoing clinical pharmacy program may allow a pharmacy technician to verify the accuracy of the duties specified in clause (ii) of this subparagraph when performed by another pharmacy technician, under the following conditions:

(i) The pharmacy technician:

(I) is a registered pharmacy technician and not a pharmacy technician trainee; and

(II) meets the training requirements specified in § 297.6 of this title and the training requirements specified in paragraph (1) of this subsection.

(ii) If the requirements of clause (i) of this subparagraph are met, a pharmacy technician may verify the accuracy of the following duties performed by another pharmacy technician:

(I) filling medication carts;

(II) distributing routine orders for stock supplies to patient care areas; and

(III) accessing and restocking automated medication supply systems after proper training on the use of the automated medication supply system and demonstration of comprehensive knowledge of the written policies and procedures for its operation; and

(iii) The patient's orders have previously been reviewed and approved by a pharmacist.

(iv) A pharmacist is on duty in the facility at all times that the pharmacy is open for pharmacy services.

(D) Rural Hospitals.

(i) A rural hospital may allow a pharmacy technician to perform the duties specified in clause (ii) of this subparagraph when a pharmacist is not on duty, if:

(I) the pharmacy technician:

(-a-) is a registered pharmacy technician and not a pharmacy technician trainee; and

(-b-) meets the training requirements specified in § 297.6 of this title and those specified in paragraph (1) of this subsection;

(II) a pharmacist is accessible at all times to respond to any questions and needs of the pharmacy technician or other hospital employees, by telephone, answering or paging service, e-mail, or any other system that makes a pharmacist immediately accessible;

(III) the pharmacy is appropriately staffed to meet the needs of the pharmacy; and

(IV) a nurse or practitioner at the rural hospital or a pharmacist through electronic supervision as specified in paragraph (2)(B)(ii) of this subsection, verifies the accuracy of the actions of the pharmacy technician.

(ii) If the requirements of clause (i) of this subparagraph are met, the pharmacy technician may, during the hours that the institutional pharmacy in the hospital is open, perform the following duties in the pharmacy without the direct supervision of a pharmacist:

(I) enter medication order and drug distribution information into a data processing system;

(II) prepare, package, or label a prescription drug according to a medication order if a licensed nurse or practitioner verifies the accuracy of the order before administration of the drug to the patient;

(III) fill a medication cart used in the rural hospital;

(IV) distribute routine orders for stock supplies to patient care areas; and

(V) access and restock automated medication supply cabinets.

(3) Procedures.

(A) Pharmacy technicians and pharmacy technician trainees shall handle medication orders in accordance with standard, written procedures and guidelines.

(B) Pharmacy technicians and pharmacy technician trainees shall handle prescription drug orders in the same manner as those working in a Class A pharmacy.

(f) Owner. The owner of a Class C pharmacy shall have responsibility for all administrative and operational functions of the pharmacy. The pharmacist-in-charge may advise the owner on administrative and operational concerns. The owner shall have responsibility for, at a minimum, the following, and if the owner is not a Texas licensed pharmacist, the owner shall consult with the pharmacist-in-charge or another Texas licensed pharmacist:

(1) establishing policies for procurement of prescription drugs and devices and other products dispensed from the Class C pharmacy;

(2) establishing and maintaining effective controls against the theft or diversion of prescription drugs;

(3) if the pharmacy uses an automated pharmacy dispensing system, reviewing and approving all policies and procedures for system operation, safety, security, accuracy and access, patient confidentiality, prevention of unauthorized access, and malfunction;

(4) providing the pharmacy with the necessary equipment and resources commensurate with its level and type of practice; and

(5) establishing policies and procedures regarding maintenance, storage, and retrieval of records in a data processing system such that the system is in compliance with state and federal requirements.

(g) Identification of pharmacy personnel. All pharmacy personnel shall be identified as follows.

(1) Pharmacy technicians. All pharmacy technicians shall wear an identification tag or badge that bears the person's name and identifies him or her as a pharmacy technician.

(2) Pharmacy technician trainees. All pharmacy technician trainees shall wear an identification tag or badge that bears the person's name and identifies him or her as a pharmacy technician trainee.

(3) Pharmacist interns. All pharmacist interns shall wear an identification tag or badge that bears the person's name and identifies him or her as a pharmacist intern.

(4) Pharmacists. All pharmacists shall wear an identification tag or badge that bears the person's name and identifies him or her as a pharmacist.

22 Tex. Admin. Code § 291.73

The provisions of this §291.73 adopted to be effective April 23, 1982, 7 TexReg 1469; amended to be effective September 14, 1988, 13 TexReg 4318; amended to be effective September 5, 1990, 15 TexReg 4810; amended to be effective September 27, 1991, 16 TexReg 5071; amended to be effective January 29, 1992, 17 TexReg 324; amended to be effective September 30, 1993, 18 TexReg 6460; amended to be effective March 16, 1995, 20 TexReg 1543; amended to be effective March 21, 1996, 21 TexReg 2242; amended to be effective October 11, 1996, 21 TexReg 9443; amended to be effective April 7, 1997, 22 TexReg 3106; amended to be effective September 16, 1999, 24 TexReg 7265; amended tobe effective June 4, 2000, 25 TexReg 4816; amended to be effective August 31, 2000, 25 TexReg 8406; amended to be effective December 27, 2000, 25 TexReg 12728; amended to be effective September 12, 2001, 26 TexReg 6923; amended to be effective September 8, 2002, 27 TexReg 8242; amended to be effective March 4, 2004, 29 TexReg 2000; amended to be effective June 6, 2004, 29 TexReg 5376; amended to be effective September 11, 2005, 30 TexReg 5366; amended to be effective September 18, 2007, 32 TexReg 6333; amended to be effective September 7, 2008, 33 TexReg 7241; amended to be effective September 20, 2009, 34 TexReg 6323; amended to be effective March 11, 2010, 35 TexReg 2005; amended to be effective May 30, 2010, 35 TexReg 4177; amended to be effective December 7, 2010, 35 TexReg 10693; Amended by Texas Register, Volume 40, Number 49, December 4, 2015, TexReg 8766, eff. 12/6/2015; Amended by Texas Register, Volume 47, Number 48, December 2, 2022, TexReg 8041, eff. 12/6/2022