1. (a) Registration.

   1. (1) General requirements.

      1. (A) All clinic pharmacies shall register annually with the board on a form provided by the board, following the procedures specified in §291.1 of this title (relating to Pharmacy License Application).
      2. (B) All clinic pharmacies shall provide a copy of their policy and procedure manual, which includes the formulary, to the board with the initial license application.
      3. (C) The registration form shall be signed by the pharmacist-in-charge of the clinic pharmacy.
      4. (D) The owner or managing officer of the clinic shall sign the registration form and shall agree to comply with the rules adopted by the board governing clinic pharmacies.
      5. (E) The registration form shall be certified and state whether the clinic pharmacy is a sole ownership and give the name of the owner, or if a partnership, name all the managing partners, or if a corporation, name all the managing officers.

      6. (F) The following fees will be charged.

         1. (i) A fee as specified in §291.6 of this title (relating to Pharmacy License Fees) will be charged for the issuance of a new license and for each renewal.
         2. (ii) A pharmacy operated by the state or a local government that qualifies for a Class D license is not required to pay a fee to obtain a license.
      7. (G) When a clinic pharmacy changes ownership, a new and separate license application must be filed with the board and the old license returned to the board's office.
      8. (H) A Class D (clinic) pharmacy shall notify the board in writing of any change in name or location within 10 days.
      9. (I) A separate license is required for each principal place of business and only one pharmacy license may be issued to a specific location.
      10. (J) A clinic pharmacy shall notify the board in writing within 10 days of a change of the pharmacist-in-charge or staff pharmacist or consultant pharmacist.
      11. (K) A clinic pharmacy shall notify the board in writing within 10 days of permanent closing.

   2. (2) Registration requirements for facilities that operate at temporary clinic sites. A facility that operates a clinic at one or more temporary locations may be licensed as a Class D (clinic) pharmacy and provide dangerous drugs from these temporary locations provided:

      1. (A) the clinic pharmacy complies with the registration requirements in paragraph (1) of this subsection;
      2. (B) the clinic pharmacy has a permanent location where all dangerous drugs and records are stored;
      3. (C) no dangerous drugs are stored or left for later pickup by the patient at the temporary location(s), and all drugs are returned to the permanent location each day;
      4. (D) the permanent location is the address of record for the pharmacy;
      5. (E) the facility has no more than three temporary locations in operation simultaneously;
      6. (F) the clinic pharmacy notifies the board on the initial application of the locations of the temporary locations where drugs will be provided and the schedule for operation of such clinics; and
      7. (G) the clinic pharmacy notifies the board within 10 days of a change in address or closing of a temporary location or a change in schedule of operation of a clinic.

2. (b) Environment.

   1. (1) General requirements.

      1. (A) The clinic pharmacy shall have a designated area(s) for the storage of dangerous drugs and/or devices.
      2. (B) No person may operate a pharmacy which is unclean, unsanitary, or under any condition which endangers the health, safety, or welfare of the public.
      3. (C) The pharmacy shall comply with all federal, state, and local health laws and ordinances.
      4. (D) A sink with hot and cold running water shall be available to all pharmacy personnel and shall be maintained in a sanitary condition at all times.

   2. (2) Security.

      1. (A) Only authorized personnel may have access to storage areas for dangerous drugs and/or devices.
      2. (B) All storage areas for dangerous drugs and/or devices shall be locked by key or combination, so as to prevent access by unauthorized personnel.
      3. (C) The pharmacist-in-charge shall be responsible for the security of all storage areas for dangerous drugs and/or devices including provisions for adequate safeguards against theft or diversion of dangerous drugs and devices, and records for such drugs and devices.
      4. (D) The pharmacist-in-charge shall consult with clinic personnel with respect to security of the pharmacy, including provisions for adequate safeguards against theft or diversion of dangerous drugs and/or devices, and records for such drugs and/or devices.
      5. (E) Housekeeping and maintenance duties shall be carried out in the pharmacy, while the pharmacist-in-charge, consultant pharmacist, staff pharmacist, or supportive personnel is on the premises.

3. (c) Equipment. Each clinic pharmacy shall maintain the following equipment and supplies:

   1. (1) if the clinic pharmacy prepackages drugs for provision:

      1. (A) a typewriter or comparable equipment; and
      2. (B) an adequate supply of child-resistant, moisture-proof, and light-proof containers and prescription, poison, and other applicable identification labels used in dispensing and providing of drugs;
   2. (2) if the clinic pharmacy maintains dangerous drugs requiring refrigeration and/or freezing, a refrigerator and/or freezer;
   3. (3) if the clinic pharmacy compounds prescriptions, a properly maintained Class A prescription balance (with weights) or equivalent analytical balance. It is the responsibility of the pharmacist-in-charge to have such balance inspected at least every three years by the appropriate authority as prescribed by local, state, or federal law or regulations.

4. (d) Library. A reference library shall be maintained which includes the following:

   1. (1) current copies of the following laws:

      1. (A) Texas Pharmacy Act and rules; and
      2. (B) Texas Dangerous Drug Law;

   2. (2) current copies of at least two of the following references:

      1. (A) Facts and Comparisons with current supplements;
      2. (B) American Hospital Formulary Service with current supplements;
      3. (C) United States Pharmacopeia Dispensing Information (USPDI);
      4. (D) Physician's Desk Reference (PDR);
      5. (E) American Drug Index;
      6. (F) Phillip D. Hansten's Drug Interactions;
      7. (G) reference texts in any of the following subjects: toxicology, pharmacology, or drug interactions; or
      8. (H) reference texts pertinent to the major function(s) of the clinic.

5. (e) Drugs and devices.

   1. (1) Formulary.

      1. (A) Each Class D pharmacy shall have a formulary which lists all drugs and devices that are administered, dispensed, or provided by the Class D pharmacy.

      2. (B) The formulary shall be limited to the following types of drugs and/or devices, exclusive of injectable drugs for administration in the clinic and nonprescription drugs, except as provided in subparagraph (D) of this paragraph:

         1. (i) anti-infective drugs;
         2. (ii) musculoskeletal drugs;
         3. (iii) vitamins;
         4. (iv) obstetrical and gynecological drugs and devices;
         5. (v) topical drugs; and
         6. (vi) serums, toxoids, and vaccines.

      3. (C) The formulary shall not contain the following drugs or types of drugs:

         1. (i) Nalbuphine (Nubain);
         2. (ii) Butorphanol (Stadol);
         3. (iii) Propranol or other beta adrenergic receptor blocking agents;
         4. (iv) antipsychotics; and
         5. (v) Schedule I-V controlled substances.

      4. (D) Clinics with a patient population which consists of at least 80% indigent patients may petition the board to operate with a formulary which includes types of drugs and/or devices, other than those listed in subparagraph (B) of this paragraph based upon documented objectives of the clinic, under the following conditions.

         1. (i) Such petition shall contain an affidavit signed by the medical director, the pharmacist-in-charge, and the owner/chief executive officer of the clinic, and include the following documentation:

            1. (I) the objectives of the clinic;
            2. (II) the total number of patients served by the clinic during the previous fiscal year or calendar year;
            3. (III) the total number of indigent patients served by the clinic during the previous fiscal year or calendar year;
            4. (IV) the percentage of clinic patients who are indigent, based upon the patient population during the previous fiscal year or calendar year; and
            5. (V) the proposed formulary and the need for additional types of drugs based upon objectives of the clinic.

         2. (ii) Such petition shall be resubmitted annually in conjunction with the application for renewal of the pharmacy license.

            1. (I) Such renewal petition shall contain the documentation required in clause (i) of this subparagraph.
            2. (II) If at the time of renewal of the pharmacy license, the patient population for the previous fiscal year or calendar year is below 80% indigent patients, the clinic shall be required to submit an application for a Class A pharmacy license or shall limit the clinic formulary to those types of drugs and/or devices listed in subparagraphs (B) and (C) of this paragraph.

         3. (iii) The following additional requirements shall be satisfied.

            1. (I) Supportive personnel who are providing drugs shall be licensed nurses.
            2. (II) The pharmacist-in-charge, consultant pharmacist, or staff pharmacist shall make on-site visits to the clinic at least monthly.

         4. (iv) The board may consider the following items in approving or disapproving a petition for an expanded formulary:

            1. (I) the degree of compliance on past compliance inspections;
            2. (II) the size of the patient population of the clinic;
            3. (III) the number and types of drugs contained in the formulary; and
            4. (IV) the objectives of the clinic.

   2. (2) Storage.

      1. (A) Drugs and/or devices which bear the words "Caution, Federal Law Prohibits Dispensing without prescription" shall be stored in secured storage areas.

      2. (B) All drugs shall be stored at the proper temperatures, as defined by the following terms.

         1. (i) Cold--Any temperature not exceeding 8 degrees Centigrade (46 degrees Fahrenheit). A refrigerator is a cold place in which the temperature is maintained thermostatically between 2 degrees and 8 degrees Centigrade (36 degrees and 46 degrees Fahrenheit). A freezer is a cold place in which the temperature is maintained thermostatically between -20 degrees and -10 degrees Centigrade (-4 degrees and 14 degrees Fahrenheit).
         2. (ii) Cool--Any temperature between 8 degrees and 15 degrees Centigrade (46 degrees and 59 degrees Fahrenheit). An article for which storage in a cool place is directed may, alternatively, be stored in a refrigerator, unless otherwise specified in the individual monograph.
         3. (iii) Room temperature--The temperature prevailing in a working area. Controlled room temperature is a temperature maintained thermostatically between 15 degrees and 30 degrees Centigrade (59 degrees and 86 degrees Fahrenheit).
         4. (iv) Warm--Any temperature between 30 degrees and 40 degrees Centigrade (86 degrees and 104 degrees Fahrenheit).
         5. (v) Excessive heat--Temperature above 40 degrees Centigrade (104 degrees Fahrenheit).
         6. (vi) Protection from freezing--Where, in addition to the risk of breakage of the container, freezing subjects a product to loss of strength or potency, or to destructive alteration of the dosage form, the container label bears an appropriate instruction to protect the product from freezing.
      3. (C) Any drug and/or device bearing an expiration date may not be provided, dispensed, or administered beyond the expiration date of the drug and/or device.
      4. (D) Outdated drugs and/or devices shall be removed from stock and shall be quarantined together until such drugs and/or devices are disposed.
      5. (E) Controlled substances may not be stored at the clinic pharmacy.

   3. (3) Drug samples.

      1. (A) Drug samples supplied by manufacturers shall be properly stored, labeled, provided, or dispensed in the same manner as prescribed by these sections for dangerous drugs.
      2. (B) Samples of controlled substances may not be stored, provided, or dispensed.

   4. (4) Prepackaging and labeling for provision.

      1. (A) Drugs may be prepackaged and labeled for provision in the clinic pharmacy. Such prepackaging shall be performed by a pharmacist or supportive personnel under the direct supervision of a pharmacist and shall be for the internal use of the clinic.
      2. (B) Drugs must be prepackaged in suitable containers.

      3. (C) The label of the prepackaged unit shall bear:

         1. (i) the name and address of the clinic;
         2. (ii) directions for use;
         3. (iii) name and strength of the drug--if generic name, the name of the manufacturer or distributor of the drug;
         4. (iv) quantity;
         5. (v) lot number and expiration date; and
         6. (vi) appropriate ancillary label(s).
      4. (D) Records of prepackaging shall be maintained according to §291.94(b) of this title (relating to Records).

   5. (5) Labeling for provision of drugs and/or devices in an original manufacturer's container.

      1. (A) Drugs and/or devices in an original manufacturer's container shall be labeled prior to provision with the information set out in paragraph (4)(C) of this subsection.

      2. (B) Drugs and/or devices in an original manufacturer's container may be labeled by:

         1. (i) a pharmacist in a pharmacy licensed by the board; or
         2. (ii) supportive personnel in a Class D pharmacy, provided the drugs and/or devices and control records required by §291.94(c) of this title (relating to Records) are quarantined together until checked and released by a pharmacist.
      3. (C) Records of labeling for provision of drugs and/or devices in an original manufacturer's container shall be maintained according to §291.94(c) of this title (relating to Records).

   6. (6) Provision.

      1. (A) Drugs and/or devices may only be provided to patients of the clinic.
      2. (B) At the time of provision, the patient shall be provided verbal and/or written information on side effects, interactions, and precautions concerning the drug and/or device provided.
      3. (C) Drugs and/or devices may only be provided in accordance with the system of control and accountability for drugs and/or devices provided by the clinic; such system shall be developed and supervised by the pharmacist-in-charge.
      4. (D) Only drugs and/or devices listed in the clinic formulary may be provided.
      5. (E) Drugs and/or devices may only be provided in prepackaged quantities in suitable containers and/or original manufacturer's containers which are appropriately labeled as set out in paragraphs (4) and (5) of this subsection.

      6. (F) Such drugs and/or devices shall be labeled by a pharmacist licensed by the board; however, when drugs and/or devices are provided under the supervision of a physician according to standing delegation orders or standing medical orders, supportive personnel may at the time of provision print on the label the following information:

         1. (i) patient's name;
         2. (ii) date of provision; and
         3. (iii) practitioner's name.
      7. (G) Records of provision shall be maintained according to §291.94(d) of this title (relating to Records).
      8. (H) Controlled substances may not be provided or dispensed.
   7. (7) Dispensing. Dangerous drugs may only be dispensed by a pharmacist pursuant to a prescription order in accordance with §§291.31-291.36 of this title (relating to Community Class A Pharmacy).

6. (f) Pharmacy and therapeutics committee.

   1. (1) The pharmacy and therapeutics committee shall be composed of at least three persons and shall include the pharmacist-in-charge, the medical director of the clinic, and a person who is responsible for provision of drugs and/or devices.
   2. (2) The pharmacy and therapeutics committee shall develop the policy and procedure manual.
   3. (3) The pharmacy and therapeutics committee shall meet at least annually to review and update the policy and procedure manual.

7. (g) Policies and procedures.

   1. (1) Written policies and procedures shall be developed by the pharmacy and therapeutics committee and implemented by the pharmacist-in-charge.

   2. (2) The policy and procedure manual shall include, but not be limited to, the following:

      1. (A) a current list of the names and addresses of the pharmacist-in-charge, consultant-pharmacist, staff pharmacist(s), supportive personnel designated to provide drugs and/or devices, and the supportive personnel designated to supervise the day-to-day pharmacy related operations of the clinic in the absence of the pharmacist;
      2. (B) functions of the pharmacist-in-charge, consultant pharmacist, staff pharmacist(s), and supportive personnel;
      3. (C) objectives of the clinic;
      4. (D) formulary;
      5. (E) a copy of written agreement between the pharmacist-in-charge and the clinic;
      6. (F) date of last review/revision of policy and procedure manual; and

      7. (G) policies and procedures for:

         1. (i) security;
         2. (ii) equipment;
         3. (iii) sanitation;
         4. (iv) licensing;
         5. (v) reference materials;
         6. (vi) storage;
         7. (vii) packaging-repackaging;
         8. (viii) dispensing;
         9. (ix) provision;
         10. (x) supervision;
         11. (xi) labeling-relabeling;
         12. (xii) samples;
         13. (xiii) drug destruction and returns;
         14. (xiv) drug and/or device procuring;
         15. (xv) receiving of drugs and/or devices;
         16. (xvi) delivery of drugs and/or devices;
         17. (xvii) recordkeeping; and
         18. (xviii) inspection.

8. (h) Supervision.

   1. (1) The pharmacist-in-charge, consultant pharmacist, or staff pharmacist shall be in contact with the clinic on at least a monthly basis, either through written memos, documented telephonic conferences, or on-site visits.

   2. (2) The pharmacist-in-charge, consultant pharmacist, or staff pharmacist shall personally visit the clinic every three months to ensure that the clinic is following set policies and procedures, provided, however, that clinics who are operated by state or local governments and clinics who are funded by public money may petition the board for an alternative visitation schedule under the following conditions.

      1. (A) Such petition shall contain an affidavit signed by the medical director, the pharmacist-in-charge, and the owner/chief executive officer of the clinic, which states that the clinic has a current policy and procedure manual on file, has adequate security to prevent diversion of dangerous drugs, and is in compliance with all rules governing Class D pharmacies.

      2. (B) The board may consider the following items in determining an alternative schedule:

         1. (i) the degree of compliance on past compliance inspections;
         2. (ii) the size of the patient population of the clinic;
         3. (iii) the number and types of drugs contained in the formulary; and
         4. (iv) the objectives of the clinic.
      3. (C) Such petition shall be resubmitted annually in conjunction with the application for renewal of the pharmacy license.

Source Note:The provisions of this §291.93 adopted to be effective January 7, 1987, 11 TexReg 5128; amended to be effective July 29, 1987, 12 TexReg 2339; amended to be effective February 17, 1988, 13 TexReg 613; amended to be effective September 14, 1988, 13 TexReg 4575; amended to be effective September 27, 1991, 16 TexReg 5071; amended to be effective January 29, 1992, 17 TexReg 324.