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) The pharmacist-in-charge shall be assisted by additional pharmacists and pharmacy technicians commensurate with the scope of services provided.
      4. (D) If the pharmacist-in-charge is employed on a part-time or consulting basis, a written agreement shall exist between the facility and the pharmacist, and a copy of the written agreement shall be made available to the board upon request.

   2. (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) developing a system for the compounding, sterility assurance, quality assurance and quality control of sterile pharmaceuticals compounded within the institutional pharmacy;
      4. (D) developing a system to assure that all pharmacy personnel responsible for compounding and/or supervising the compounding of sterile pharmaceuticals within the pharmacy receive appropriate education and training and competency evaluation;
      5. (E) providing written guidelines and approval of the procedure to assure that all pharmaceutical requirements are met when any part of preparing, sterilizing, and labeling of sterile pharmaceuticals is not performed under direct pharmacy supervision;
      6. (F) developing a system for bulk compounding or batch preparation of drugs;
      7. (G) establishing specifications for procurement and storage of all pharmaceutical materials including pharmaceuticals, components used in the compounding of pharmaceuticals, and drug delivery devices;
      8. (H) participating in the development of a formulary for the facility, subject to approval of the appropriate committee of the facility;
      9. (I) developing a system to assure that drugs to be administered to inpatients are distributed pursuant to an original or direct copy of the practitioner's medication order;
      10. (J) developing a system for the filling and labeling of all containers from which drugs are to be distributed or dispensed;
      11. (K) assuring that the pharmacy maintains and makes available a sufficient inventory of antidotes and other emergency drugs as well as current antidote information, telephone numbers of regional poison control center and other emergency assistance organizations, and such other materials and information as may be deemed necessary by the appropriate committee of the facility;
      12. (L) maintaining records of all transactions of the institutional pharmacy as may be required by applicable law, state and federal, and as may be necessary to maintain accurate control over and accountability for all pharmaceutical materials including pharmaceuticals, components used in the compounding of pharmaceuticals, and drug delivery devices;
      13. (M) participating in those aspects of the facility's patient care evaluation program which relate to pharmaceutical utilization and effectiveness;
      14. (N) participating in teaching and/or research programs in the facility;
      15. (O) implementing the policies and decisions of the appropriate committee(s) relating to pharmaceutical services of the facility;
      16. (P) providing effective and efficient messenger or delivery service to connect the institutional pharmacy with appropriate areas of the facility on a regular basis throughout the normal workday of the facility;
      17. (Q) developing a system for the labeling, storage, and distribution of investigational new drugs, including maintenance of information in the pharmacy and nursing station where such drugs are being administered, concerning the dosage form, route of administration, strength, actions, uses, side effects, adverse effects, interactions and symptoms of toxicity of investigational new drugs;
      18. (R) assuring that records in a data processing system are maintained such that the data processing system is in compliance with Class C (Institutional) pharmacy requirements;
      19. (S) assuring that a reasonable effort is made to obtain, record, and maintain patient medication records;
      20. (T) assuring the legal operation of the pharmacy, including meeting all inspection and other requirements of all state and federal laws or rules governing the practice of pharmacy; and

      21. (U) 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.

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.

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

      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 in subsection (f) of this section; and
         2. (ii) are supervised by a pharmacist who has completed the training specified in subsection (f) of this section 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) 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) Special education, training, and evaluation requirements for pharmacy personnel compounding or responsible for the direct supervision of pharmacy personnel compounding sterile pharmaceuticals.

   1. (1) General.

      1. (A) All pharmacy personnel preparing sterile pharmaceuticals shall receive didactic and experiential training and competency evaluation through demonstration, testing (written or practical) as outlined by the pharmacist-in-charge and described in the policy and procedure or training manual. Such training shall include instruction and experience in the following areas:

         1. (i) aseptic technique;
         2. (ii) critical area contamination factors;
         3. (iii) environmental monitoring;
         4. (iv) facilities;
         5. (v) equipment and supplies;
         6. (vi) sterile pharmaceutical calculations and terminology;
         7. (vii) sterile pharmaceutical compounding documentation;
         8. (viii) quality assurance procedures;
         9. (ix) aseptic preparation procedures, including proper gowning and gloving technique;
         10. (x) the handling of cytotoxic and hazardous drugs; and
         11. (xi) general conduct in the controlled area.
      2. (B) The aseptic technique of each person compounding or responsible for the direct supervision of personnel compounding sterile pharmaceuticals shall be observed and evaluated as satisfactory through written or practical tests and process validation and such evaluation documented.

      3. (C) Although process validation may be incorporated into the experiential portion of a training program, process validation must be conducted at each pharmacy where an individual compounds sterile pharmaceuticals. No product intended for patient use shall be compounded by an individual until the on-site process validation test indicates that the individual can competently perform aseptic procedures, except that a pharmacist may compound sterile pharmaceuticals and supervise pharmacy technicians compounding sterile pharmaceuticals without process validation provided the pharmacist:

         1. (i) has completed a recognized course in an accredited college of pharmacy or a course sponsored by an American Council on Pharmaceutical Education approved provider which provides 20 hours of instruction and experience in the areas listed in this paragraph; and
         2. (ii) completes the on-site process validation within seven days of commencing work at the pharmacy.
      4. (D) Process validation procedures for assessing the preparation of specific types of sterile pharmaceuticals shall be representative of all types of manipulations, products, and batch sizes that personnel preparing that type of pharmaceutical are likely to encounter.

      5. (E) The pharmacist-in-charge shall assure continuing competency of pharmacy personnel through in-service education, training, and process validation to supplement initial training. Personnel competency shall be evaluated:

         1. (i) during orientation and training prior to the regular performance of those tasks;
         2. (ii) whenever the quality assurance program yields an unacceptable result;
         3. (iii) whenever unacceptable techniques are observed; and
         4. (iv) at least on an annual basis.

   2. (2) Pharmacists.

      1. (A) All pharmacists who compound sterile pharmaceuticals or supervise pharmacy technicians compounding sterile pharmaceuticals shall:

         1. (i) complete through a single course, a minimum 20 hours of instruction and experience in the areas listed in paragraph (1) of this subsection. Such training may be evidenced by either:

            1. (I) completion of a structured on-the-job didactic and experiential training program at this pharmacy which provides 20 hours of instruction and experience in the areas listed in paragraph (1) of this subsection. Such training may not be transferred to another pharmacy unless the pharmacies are under common ownership and control and use a common training program; or
            2. (II) completion of a recognized course in an accredited college of pharmacy or a course sponsored by an American Council on Pharmaceutical Education approved provider which provides 20 hours of instruction and experience in the areas listed in paragraph (1) of this subsection; and

         2. (ii) possess knowledge about:

            1. (I) aseptic processing;
            2. (II) quality control and quality assurance as related to environmental, component, and end-product testing;
            3. (III) chemical, pharmaceutical, and clinical properties of drugs;
            4. (IV) container, equipment, and closure system selection; and
            5. (V) sterilization techniques.
      2. (B) The required experiential portion of the training programs specified in this paragraph must be supervised by an individual who has already completed training as specified in paragraph (2) or (3) of this subsection.

   3. (3) Pharmacy technicians. In addition to the qualifications and training outlined in subsection (e) of this section, all pharmacy technicians who compound sterile pharmaceuticals shall:

      1. (A) have a high school or equivalent education;

      2. (B) either:

         1. (i) complete through a single course, a minimum of 40 hours of instruction and experience in the areas listed in paragraph (1) of this subsection. Such training may be obtained through the:

            1. (I) completion of a structured on-the-job didactic and experiential training program at this pharmacy which provides 40 hours of instruction and experience in the areas listed in paragraph (1) of this subsection. Such training may not be transferred to another pharmacy unless the pharmacies are under common ownership and control and use a common training program; or
            2. (II) completion of a course sponsored by an ACPE approved provider which provides 40 hours of instruction and experience in the areas listed in paragraph (1) of this subsection; or

         2. (ii) complete a training program which is accredited by the American Society of Health-System Pharmacists (formerly the American Society of Hospital Pharmacists). Individuals enrolled in training programs accredited by the American Society of Health-System Pharmacists may compound sterile pharmaceuticals in a licensed pharmacy provided:

            1. (I) the compounding occurs only during times the individual is assigned to a pharmacy as a part of the experiential component of the American Society of Health-System Pharmacists training program;
            2. (II) the individual is under the direct supervision of and responsible to a pharmacist who has completed training as specified in paragraph (2) of this subsection; and
            3. (III) the supervising pharmacist conducts in-process and final checks; and
      3. (C) on January 1, 2001, discontinue preparation of sterile pharmaceuticals if the technician has not taken and passed the National Pharmacy Technician Certification Exam or other examination approved during an open meeting by the Board. Such pharmacy technicians may continue to compound sterile pharmaceuticals during the interim between the effective date of these rules and January 1, 2001, if they maintain documentation of completion of the training specified in subparagraph (B) of this paragraph.
      4. (D) acquire the required experiential portion of the training programs specified in this paragraph under the supervision of an individual who has already completed training as specified in this paragraph or paragraph (2) of this subsection.

   4. (4) Documentation of Training. A written record of initial and in-service training and the results of written or practical testing and process validation of pharmacy personnel shall be maintained and contain the following information:

      1. (A) name of the person receiving the training or completing the testing or process validation;
      2. (B) date(s) of the training, testing, or process validation;
      3. (C) general description of the topics covered in the training or testing or of the process validated;
      4. (D) name of the person supervising the training, testing, or process validation; and
      5. (E) signature (first initial and last name or full signature) of the person receiving the training or completing the testing or process validation and the pharmacist-in-charge or other pharmacist employed by the pharmacy and designated by the pharmacist-in-charge as responsible for training, testing, or process validation of personnel.

7. (g) Identification of pharmacy personnel. All pharmacy personnel shall wear an identification tag or badge which bears the person's name and identifies him or her by title or function 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, 24 TexReg 7265;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.