1. (a) Licensing requirements.

   1. (1) It is unlawful for a person to provide radioactive drug services unless such provision is performed by a person licensed to act as an authorized nuclear pharmacist, as defined by the board, or is a person acting under the direct supervision of an authorized nuclear pharmacist acting in accordance with the Act and its rules, and the regulations of the Texas Department of Health, Bureau of Radiation Control. Subsection (a) of this section does not apply to:

      1. (A) a licensed practitioner or his or her designated agent for administration to his or her patient, provided no person may receive, possess, use, transfer, own, acquire, or dispose of radiopharmaceuticals except as authorized in a specific or a general license as provided in Texas Regulations for Control of Radiation, Part 41, Texas Department of Health, or the Act;
      2. (B) institutions and/or facilities with nuclear medicine services operated by practitioners and who are licensed by the Texas Department of Health, Bureau of Radiation Control, to prescribe, administer, and dispense radioactive materials (drugs and/or devices).
   2. (2) An applicant for a Class B pharmacy shall provide evidence to the board of the possession of a Texas Department of Health Radiation Control Number.
   3. (3) A Class B pharmacy shall register annually with the board on a pharmacy license application provided by the board, following the procedures specified in §291.1 of this title (relating to Pharmacy License Application).
   4. (4) A Class B pharmacy which changes ownership shall notify the board within ten days of the change of ownership and apply for a new and separate license as specified in §291.4 of this title (relating to Change of Ownership).
   5. (5) A Class B pharmacy which changes location and/or name shall notify the board within ten days of the change and file for an amended license as specified in §291.2 of this title (relating to Change of Location and/or Name).
   6. (6) A Class B pharmacy owned by a partnership or corporation which changes managing officers shall notify the board in writing of the names of the new managing officers within ten days of the change, following the procedures in §291.3 of this title (relating to Change of Managing Officers).
   7. (7) A Class B pharmacy shall notify the board in writing within ten days of closing, following the procedures in §291.5 of this title (relating to Closed Pharmacies).
   8. (8) A separate license is required for each principal place of business and only one pharmacy license may be issued to a specific location.
   9. (9) A fee as specified in §291.6 of this title (relating to Pharmacy License Fees) will be charged for the issuance and renewal of a license and the issuance of an amended license.
   10. (10) A Class B pharmacy, licensed under the provisions of the Act, §560.051(a)(2), which also operates another type of pharmacy which would otherwise be required to be licensed under the Act, §560.051(a)(1), concerning community pharmacy (Class A), is not required to secure a license for such other type of pharmacy; provided, however, such licensee is required to comply with the provisions of §291.31 of this title (relating to Definitions); §291.32 of this title (relating to Personnel); §291.33 of this title (relating to Operational Standards); §291.34 of this title (relating to Records); §291.35 of this title (relating to Triplicate Prescription Requirements); and §291.36 of this title (relating to Class A Pharmacies Dispensing Compounded Sterile Parenteral and/or Enteral Products), contained in Community Pharmacy (Class A), to the extent such rules are applicable to the operation of the pharmacy.
   11. (11) A Class B pharmacy engaged in nonsterile compounding of drug products shall comply with the provisions of §§291.31 - 291.34 of this title (relating to Definitions, Personnel, Operational Standards, and Records for Class A (Community) Pharmacies) to the extent such rules are applicable to nonsterile compounding of drug products.

2. (b) Environment.

   1. (1) General requirements.

      1. (A) The pharmacy shall be enclosed and lockable.
      2. (B) The pharmacy shall have a designated controlled area for radiopharmaceuticals that is functionally separate from other areas of the facility. If non-sterile radiopharmaceuticals are dispensed, the controlled area for sterile radiopharmaceuticals shall be functionally separate from the controlled area for non-sterile radiopharmaceuticals.
      3. (C) The pharmacy shall have adequate space necessary for the storage, compounding, labeling, dispensing, and sterile preparation of drugs prepared in the pharmacy, and additional space, depending on the size and scope of pharmaceutical services.
      4. (D) The pharmacy shall be arranged in an orderly fashion and shall be kept clean. All required equipment shall be clean and in good operating condition.
      5. (E) A sink with hot and cold running water, exclusive of restroom facilities, designated primarily for use of admixtures, shall be available within the pharmacy area to all pharmacy personnel and shall be maintained in a sanitary condition at all times.
      6. (F) The pharmacy shall be properly lighted and ventilated.
      7. (G) The temperature of the pharmacy shall be maintained within a range compatible with the proper storage of drugs; the temperature of the refrigerator shall be maintained within a range compatible with the proper storage of drugs requiring refrigeration.
      8. (H) Animals, including birds and reptiles, shall not be kept within the pharmacy and in immediately adjacent areas under the control of the pharmacy. This provision does not apply to fish in aquariums, guide dogs accompanying disabled persons, or animals for sale to the general public in a separate area that is inspected by local health jurisdictions.

   2. (2) Special requirements for the compounding of sterile radiopharmaceuticals. When the pharmacy compounds sterile radiopharmaceuticals, the following is applicable.

      1. (A) Aseptic environment control device(s). The pharmacy shall prepare sterile radiopharmaceuticals in an appropriate aseptic environmental control device(s) or area, such as a laminar air flow hood, biological safety cabinet, or clean room which is capable of maintaining at least Class 100 conditions during normal activity unless the use of such device will expose pharmacy personnel to unacceptable levels of nuclear radiation. The aseptic environmental control device(s) shall:

         1. (i) be certified by an independent contractor according to Federal Standard 209E, et seq., for operational efficiency at least every year or when it is relocated; and
         2. (ii) have pre-filters inspected periodically and replaced as needed, in accordance with written policies and procedures, and the inspection and/or replacement date documented.
      2. (B) Controlled area. The pharmacy shall have a designated controlled area for the compounding of sterile radiopharmaceuticals that is functionally separate from areas for the preparation of non-sterile pharmaceuticals and is constructed to minimize the opportunities for particulate and microbial contamination.
      3. (C) Automated compounding device(s). If automated compounding device(s) are used, the pharmacy shall have a method to calibrate and verify the accuracy of automated compounding devices used in aseptic processing and document the calibration and verification on a routine basis.

   3. (3) Security requirements.

      1. (A) All areas occupied by a pharmacy shall be capable of being locked by key or combination, so as to prevent access by unauthorized personnel when a pharmacist is not on-site.
      2. (B) The pharmacy may authorize personnel to gain access to that area of the pharmacy containing dispensed sterile radiopharmaceuticals, in the absence of the pharmacist, for the purpose of retrieving dispensed prescriptions to deliver to patients. If the pharmacy allows such after-hours access, the area containing the dispensed sterile radiopharmaceuticals shall be an enclosed and lockable area separate from the area containing undispensed prescription drugs. A list of the authorized personnel having such access shall be in the pharmacy's policy and procedure manual.
      3. (C) 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.

3. (c) Prescription dispensing and delivery.

   1. (1) Generic Substitution. A pharmacist may substitute on a prescription drug order issued for a brand name product provided the substitution is authorized and performed in compliance with Chapter 309 of this title (relating to Generic Substitution).

   2. (2) Prescription containers (immediate inner containers).

      1. (A) A drug dispensed pursuant to a radioactive prescription drug order shall be dispensed in an appropriate immediate inner container as follows.

         1. (i) If a drug is susceptible to light, the drug shall be dispensed in a light-resistant container.
         2. (ii) If a drug is susceptible to moisture, the drug shall be dispensed in a tight container.
         3. (iii) The container should not interact physically or chemically with the drug product placed in it so as to alter the strength, quality, or purity of the drug beyond the official requirements.
      2. (B) Immediate inner prescription containers or closures shall not be re-used.

   3. (3) Delivery containers (outer containers).

      1. (A) Prescription containers may be placed in suitable containers for delivery which will transport the radiopharmaceutical safely in compliance with all applicable laws and regulations.
      2. (B) Delivery containers may be re-used provided they are maintained in a manner to prevent cross contamination.

   4. (4) Labeling.

      1. (A) The immediate inner container of a radiopharmaceutical shall be labeled with:

         1. (i) standard radiation symbol;
         2. (ii) the words "caution-radioactive material";
         3. (iii) the name of the radiopharmaceutical; and
         4. (iv) the unique identification number of the prescription.

      2. (B) The outer container of a radiopharmaceutical shall be labeled with:

         1. (i) the name, address, and phone number of the pharmacy;
         2. (ii) the date dispensed;
         3. (iii) the directions for use, if applicable;
         4. (iv) the unique identification number of the prescription;
         5. (v) the name of the patient if known, or the statement, "for physician use" if the patient is unknown;
         6. (vi) the standard radiation symbol;
         7. (vii) the words "caution-radioactive material";
         8. (viii) the name of the radiopharmaceutical;
         9. (ix) the amount of radioactive material contained in millicuries (mCi), microcuries (uCi), or bequerels (Bq) and the corresponding time that applies to this activity, if different from the requested calibration date and time;
         10. (x) the name or initials of the person preparing the product and the authorized nuclear pharmacist who checked and released the final product unless documents are maintained in the pharmacy identifying these individuals for each prescription dispensed;
         11. (xi) if a liquid, the volume in milliliters;
         12. (xii) the requested calibration date and time; and
         13. (xiii) the expiration date and/or time.
      3. (C) The amount of radioactivity shall be determined by radiometric methods for each individual preparation immediately at the time of dispensing and calculations shall be made to determine the amount of activity that will be present at the requested calibration date and time, due to radioactive decay in the intervening period, and this activity and time shall be placed on the label per requirements set out in paragraph (4) of this subsection.

4. (d) Pharmaceutical Care Services.

   1. (1) The following minimum level of pharmaceutical care services shall be provided whenever a therapeutic prescription drug order is dispensed and, when in the professional judgement of the pharmacist dispensing a diagnostic prescription drug order, the services are necessary to protect the patient's health while striving to produce positive patient outcomes. When it is determined that the following services are necessary, the dispensing pharmacist shall assure that efforts are made to gather the information necessary to properly perform the services.

      1. (A) Drug utilization review. A systematic ongoing process of drug utilization review shall be designed, followed, and documented to increase the probability of desired patient outcomes and decrease the probability of undesired outcomes from drug therapy with radiopharmaceuticals.

      2. (B) Drug regimen review.

         1. (i) For the purpose of promoting therapeutic appropriateness, an authorized nuclear pharmacist shall, prior to or at the time of dispensing, evaluate therapeutic prescription drug orders and patient medication history for:

            1. (I) known allergies;
            2. (II) rational therapy contraindications;
            3. (III) reasonable dose and route of administration;
            4. (IV) reasonable directions for use;
            5. (V) duplication of therapy;
            6. (VI) drug-drug interactions;
            7. (VII) drug-food interactions;
            8. (VIII) drug-disease interactions;
            9. (IX) adverse drug reactions;
            10. (X) proper utilization, including overutilization or underutilization; and
            11. (XI) clinical laboratory or clinical monitoring methods to monitor and evaluate drug effectiveness, side effects, toxicity, or adverse effects, and appropriateness to continued use of the drug in its current regimen.
         2. (ii) Upon identifying any clinically significant conditions, situations, or items listed in clause (i) of this subparagraph, the authorized nuclear pharmacist shall take appropriate steps to avoid or resolve the problem including consultation with the prescribing practitioner.
         3. (iii) The drug regimen review may be conducted by remotely accessing the pharmacy's electronic data base from outside the pharmacy by an individual Texas licensed pharmacist employee of the pharmacy, provided the pharmacy establishes controls to protect the privacy of the patient and the security of confidential records.

   2. (2) Other pharmaceutical care services which may be provided by authorized nuclear pharmacists include, but are not limited to, the following:

      1. (A) managing drug therapy as delegated by a practitioner as allowed under the provisions of the Medical Practice Act;
      2. (B) managing patient compliance programs;
      3. (C) providing preventative health care services; and
      4. (D) providing case management of patients who are being treated with high-risk or high-cost drugs, or who are considered "high risk" due to their age, medical condition, family history, or related concern.

5. (e) Equipment. The following minimum equipment is required in a nuclear pharmacy:

   1. (1) vertical laminar flow hood;
   2. (2) dose calibrator;
   3. (3) refrigerator;
   4. (4) Class A prescription balance, and accurate weights or balance of greater sensitivity if compounding occurs in the pharmacy which requires weighing;
   5. (5) scintillation analyzer;
   6. (6) microscope and hemocytometer;
   7. (7) adequate glassware, utensils, gloves, syringe shields and remote handling devices, and adequate equipment for product quality control;
   8. (8) adequate shielding material;
   9. (9) typewriter or comparable equipment;
   10. (10) radiation dosimeters for visitors and personnel and log entry book;
   11. (11) exhaust/fume hood with monitor, for storage and handling of all volatile radioactive drugs if applicable, to be determined by the Texas Radiation Control Bureau;
   12. (12) calculator; and
   13. (13) adequate radiation monitor(s).

6. (f) Library. A nuclear pharmacy shall maintain a reference library which shall include the following in hard copy or electronic format:

   1. (1) United States Pharmacopoeia/National Formulary with supplements;
   2. (2) federal and state laws and regulations relating to Texas pharmacy;
   3. (3) Texas Regulations for Control of Radiation;
   4. (4) reference on the safe handling of radioactive materials;
   5. (5) a minimum of three texts dealing with nuclear medicine science;
   6. (6) reference on sterile product preparation; and
   7. (7) Code of Federal Regulations, Title 49, Parts 106-199, with recent amendments.

7. (g) Radiopharmaceuticals and/or radioactive materials.

   1. (1) General requirements.

      1. (A) Radiopharmaceuticals may only be dispensed pursuant to a radioactive prescription drug order.
      2. (B) An authorized nuclear pharmacist may distribute radiopharmaceuticals to authorized users for patient use. A nuclear pharmacy may also furnish radiopharmaceuticals for departmental or physicians' use if such authorized users maintain a Texas radioactive materials license, and the radiopharmaceutical is labeled "for physician use," provided such distribution is documented in the control system.
      3. (C) An authorized nuclear pharmacist may transfer to authorized users radioactive materials not intended for drug use in accordance with Part 41 of the Texas Regulations for Control of Radiation, Texas Department of Health.
      4. (D) The transportation of radioactive materials from the nuclear pharmacy must be in accordance with current state and federal transportation regulations.

   2. (2) Procurement and storage.

      1. (A) The pharmacist-in-charge shall have the responsibility for the procurement and storage of drugs, but may receive input from other appropriate staff relative to such responsibility.
      2. (B) Prescription drugs and devices shall be stored within the prescription department or a locked storage area.

      3. (C) All drugs shall be stored at the proper temperature, 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 and 8 degrees Centigrade (36 and 46 degrees Fahrenheit). A freezer is a cold place in which the temperature is maintained thermostatically between -20 and -10 degrees Centigrade (-4 and -14 degrees Fahrenheit).
         2. (ii) Cool--Any temperature between 8 and 15 degrees Centigrade (46 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 labeling.
         3. (iii) Room temperature--The temperature prevailing in a working area. Controlled room temperature is a temperature thermostatically between 15 and 30 degrees Centigrade (59 and 86 degrees Fahrenheit).
         4. (iv) Warm--Any temperature between 30 and 40 degrees Centigrade (86 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. (3) Out-of-date and other unusable drugs or devices.

      1. (A) Any drug or device bearing an expiration date shall not be dispensed beyond the expiration date of the drug or device.
      2. (B) Outdated and other unusable drugs or devices shall be removed from dispensing stock and shall be quarantined together until such drugs or devices are disposed of properly.

8. (h) Loading bulk drugs into automated compounding devices.

   1. (1) Automated compounding device may be loaded with bulk drugs only by an authorized nuclear pharmacist or by supportive personnel under the direction and direct supervision of an authorized pharmacist.
   2. (2) The label of an automated compounding device container shall indicate the brand name and strength of the drug; or if no brand name, then the generic name, strength, and name of the manufacturer or distributor.

   3. (3) Records of loading bulk drugs into an automated compounding device shall be maintained to show:

      1. (A) name of the drug, strength, and dosage form;
      2. (B) manufacturer or distributor;
      3. (C) manufacturer's lot number;
      4. (D) expiration date;
      5. (E) quantity added to the automated compounding device;
      6. (F) date of loading;
      7. (G) name, initials, or electronic signature of the person loading the automated compounding device; and
      8. (H) name, initials, or electronic signature of the responsible authorized nuclear pharmacist.
   4. (4) The automated compounding device shall not be used until an authorized nuclear pharmacist verifies that the system is properly loaded and affixes his or her signature or electronic signature to the record specified in paragraph (3) of this subsection.

9. (i) Sterile radiopharmaceuticals.

   1. (1) Expiration date.

      1. (A) The expiration date assigned shall be based on:

         1. (i) established manufacturer's guidelines;
         2. (ii) published literature; or
         3. (iii) in-house or contracted stability studies.
      2. (B) The method for establishing expiration dates shall be documented.

   2. (2) Radioactive Drug Quality control. There shall be a documented, ongoing quality control program that monitors and evaluates personnel performance, equipment and facilities. Procedures shall be in place to assure that the pharmacy is capable of consistently preparing radiopharmaceuticals which are sterile and stable. Quality control procedures shall include, but are not limited to, the following:

      1. (A) recall procedures;
      2. (B) storage and dating;
      3. (C) documentation of appropriate functioning of refrigerator, freezer, and other equipment;
      4. (D) documentation of aseptic environmental control device(s) certification at least every year and the regular replacement of pre-filters as necessary;
      5. (E) a process to evaluate and confirm the quality of the prepared radiopharmaceutical; and
      6. (F) documentation of facility maintenance such as cleaning and environmental testing.

Source Note:The provisions of this §291.54 adopted to be effective March 19, 1998, 23 TexReg 2815; amended to be effective June 1, 2002, 27 TexReg 1781; amended to be effective June 23, 2003, 28 TexReg 4638.