1. (a) Requirements for pharmacist services.

   1. (1) A Class C pharmacy in a facility licensed for 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 may distribute prepackaged and prelabeled drugs from a satellite pharmacy in the absence of on-site supervision of a pharmacist, under the following conditions:

      1. (A) the distribution is under the control of a pharmacist; and
      2. (B) a pharmacist is on duty in the facility.
   2. (2) A Class C pharmacy in a facility licensed for 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.
   3. (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.

2. (b) Pharmacist-in-charge.

   1. (1) General.

      1. (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.
      2. (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.
      3. (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 provided the total number of beds does not exceed 150 beds.
      4. (D) The pharmacist-in-charge shall be assisted by additional pharmacists and pharmacy technicians commensurate with the scope of services provided.
      5. (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.

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

      1. (A) providing the appropriate level of pharmaceutical care services to patients of the facility;
      2. (B) ensuring that drugs and/or devices are prepared for distribution safely, and accurately as prescribed;
      3. (C) providing written guidelines and approval of the procedure to assure that all pharmaceutical requirements are met when any part of preparing, sterilizing, and labeling of sterile pharmaceuticals is not performed under direct pharmacy supervision;
      4. (D) participating in the development of a formulary for the facility, subject to approval of the appropriate committee of the facility;
      5. (E) developing a system to assure that drugs to be administered to inpatients are distributed pursuant to an original or direct copy of the practitioner's medication order;
      6. (F) developing a system for the filling and labeling of all containers from which drugs are to be distributed or dispensed;
      7. (G) 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;
      8. (H) maintaining records of all transactions of the institutional pharmacy as may be required by applicable law, state and federal, and as may be necessary to maintain accurate control over and accountability for all pharmaceutical materials including pharmaceuticals, components used in the compounding of pharmaceuticals, and drug delivery devices;
      9. (I) participating in those aspects of the facility's patient care evaluation program which relate to pharmaceutical utilization and effectiveness;
      10. (J) participating in teaching and/or research programs in the facility;
      11. (K) implementing the policies and decisions of the appropriate committee(s) relating to pharmaceutical services of the facility;
      12. (L) 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;
      13. (M) developing a system for the labeling, storage, and distribution of investigational new drugs, including maintenance of information in the pharmacy and nursing station where such drugs are being administered, concerning the dosage form, route of administration, strength, actions, uses, side effects, adverse effects, interactions and symptoms of toxicity of investigational new drugs;
      14. (N) 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;
      15. (O) assuring that a reasonable effort is made to obtain, record, and maintain patient medication records;
      16. (P) 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

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

          1. (i) reviewing and approving all policies and procedures for system operation, safety, security, accuracy and access, patient confidentiality, prevention of unauthorized access, and malfunction;
          2. (ii) inspecting medications in the automated medication supply system, at least monthly, for expiration date, misbranding, physical integrity, security, and accountability;
          3. (iii) assigning, discontinuing, or changing personnel access to the automated medication supply system;
          4. (iv) ensuring that pharmacy technicians 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
          5. (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.

3. (c) Consultant pharmacist.

   1. (1) The consultant pharmacist may be the pharmacist-in-charge.
   2. (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.

4. (d) Pharmacists.

   1. (1) General.

      1. (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.
      2. (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.
      3. (C) All pharmacists shall be responsible for any delegated act performed by pharmacy technicians under his or her supervision.
      4. (D) All pharmacists while on duty, shall be responsible for complying with all state and federal laws or rules governing the practice of pharmacy.
      5. (E) A distributing pharmacist shall ensure that the drug is prepared for distribution safely, and accurately as prescribed. In addition, if multiple pharmacists participate in the preparation of medication orders for distribution, each pharmacist shall ensure the safety and accuracy of the portion of the process the pharmacist is performing. 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. (2) Duties. Duties of the pharmacist-in-charge and all other pharmacists shall include, but need not be limited to the following:

      1. (A) providing those acts or services necessary to provide pharmaceutical care;
      2. (B) receiving, interpreting, and evaluating prescription drug orders, and reducing verbal medication orders to writing either manually or electronically;
      3. (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;
      4. (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;

      5. (E) accepting the responsibility for:

         1. (i) distributing drugs and devices pursuant to medication orders;
         2. (ii) compounding and labeling of drugs and devices;
         3. (iii) proper and safe storage of drugs and devices; and
         4. (iv) maintaining proper records for drugs and devices.

   3. (3) Special requirements for compounding .

      1. (A) Non-Sterile Pharmaceuticals . All pharmacists engaged in compounding non-sterile pharmaceuticals shall meet the training requirements specified in §291.25 of this title (relating to Pharmacies Compounding Non-sterile Pharmaceuticals).
      2. (B) Sterile Pharmaceuticals. All pharmacists engaged in compounding non-sterile pharmaceuticals shall meet the training requirements specified in §291.26 of this title (relating to Pharmacies Compounding Sterile Pharmaceuticals).

5. (e) Pharmacy technicians.

   1. (1) General.

      1. (A) On June 1, 2004, all persons employed as pharmacy technicians must be either registered pharmacy technicians or pharmacy technician trainees as follows.

         1. (i) All persons who have passed the required pharmacy technician certification examination must be registered with the board under the provisions of this section.
         2. (ii) All persons who have not taken and passed the required pharmacy certification examination shall be designated pharmacy technician trainees under the provisions of §297.5 of this title (relating to Pharmacy Technician Trainees).
      2. (B) Between January 1, 2004, and May 31, 2004, all persons employed as pharmacy technicians who are qualified for registration by the board shall register according to the schedule designated by the board. Between January 1, 2004 and May 31, 2004, persons who are awaiting their scheduled time for registration and persons who have applied for registration, but the registration has not been completed shall comply with the rules in effect prior to January 1, 2004, relating to requirements and duties for certified or exempt pharmacy technicians.
      3. (C) All pharmacy technicians shall meet the training requirements specified in §297.6 of this title (relating to Pharmacy Technician Training).

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

      1. (A) pre-packing and labeling unit and multiple dose packages, provided a pharmacist supervises and conducts in-process and final checks and affixes his or her signature (first initial and last name or full signature) or electronic signature to the appropriate quality control records;
      2. (B) preparing, packaging, compounding, or labeling prescription drugs pursuant to medication orders, provided a pharmacist supervises and checks the preparation;
      3. (C) bulk compounding or batch preparation provided a pharmacist supervises and conducts in-process and final checks and affixes his or her initials to the appropriate quality control records;
      4. (D) distributing routine orders for stock supplies to patient care areas;
      5. (E) 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 or in compliance with the absence of pharmacist requirements contained in §291.74(e) of this title (relating to Operational Standards);
      6. (F) loading bulk 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 signature (first initial and last name or full signature) or electronic signature to the appropriate quality control records; and
      7. (G) may be allowed access to 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.

      8. (H) compounding sterile pharmaceuticals pursuant to medication orders provided the pharmacy technicians:

         1. (i) have completed the training specified in §291.26 of this title (relating to pharmacies compounding sterile pharmaceuticals; and
         2. (ii) are supervised by a pharmacist who has completed the training specified in §291.26 of this title and who conducts in-process and final checks, and affixes his or her initials to the label or if batch prepared, to the appropriate quality control records. (The initials are not required on the label if it is maintained in a permanent record of the pharmacy)

   3. (3) Special requirements for compounding.

      1. (A) Non-Sterile Pharmaceuticals. All pharmacy technicians engaged in compounding non-sterile pharmaceuticals shall meet the training requirements specified in §291.25 of this title.

      2. (B) Sterile Pharmaceuticals. Pharmacy technicians may compound sterile pharmaceuticals pursuant to medication orders provided the pharmacy technicians:

         1. (i) have completed the training specified subsection §291.26 of this title; and
         2. (ii) are supervised by a pharmacist who has completed the training specified in §291.26 of this title and who conducts in-process and final checks, and affixes his or her initials to the label or if batch prepared, to the appropriate quality control records. (The initials are not required on the label if it is maintained in a permanent record of the pharmacy).

   4. (4) Procedures.

      1. (A) pharmacy technicians shall handle medication orders in accordance with standard, written procedures and guidelines.
      2. (B) pharmacy technicians shall handle prescription drug orders in the same manner as those working in a Class A pharmacy.

6. (f) Identification of pharmacy personnel. All pharmacy personnel shall wear an identification tag or badge which bears the person's name and identifies him or her by title or function as follows:

   1. (1) Pharmacy technicians. All pharmacy technicians shall wear an identification tag or badge which bears the person's name and identifies him or her as a pharmacy technician trainee a registered pharmacy technician, or a certified pharmacy technician, if the technician maintains current certification with the Pharmacy Technician Certification Board or any other entity providing an examination approved by the Board.
   2. (2) Pharmacist interns. All pharmacist interns shall wear an identification tag or badge which bears the person's name and identifies him or her as a pharmacist intern.
   3. (3) Pharmacists. All pharmacists shall wear an identification tag or badge which bears the person's name and identifies him or her as a pharmacist.

Source Note: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, 24TexReg7265;amendedtobe 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.