SECTION 291.54. Operational Standards

(a) Licensing requirements.

(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 State Health Services, Radiation Control Program. Subsection (a) of this section does not apply to:

(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 accordance with the requirements of the Texas Department of State Health Services, Radiation Control Program, Texas Administrative Code, Title 25, Part 1, Subchapter F, §289.252 relating to Licensing of Radioactive Material, or the Act;

(B) institutions and/or facilities with nuclear medicine services operated by practitioners and who are licensed by the Texas Department of State Health Services, Radiation Control Program, to prescribe, administer, and dispense radioactive materials (drugs and/or devices).

(2) An applicant for a Class B pharmacy shall provide evidence to the board of the possession of a Texas Department of State Health Services radioactive material license or proof of application for a radioactive material license.

(3) A Class B pharmacy shall register 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) 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 §291.3 of this title (relating to Required Notifications).

(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 §291.3 of this title.

(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.

(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 Closing a Pharmacy).

(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) 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) 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); and §291.35 of this title (relating to Official Prescription Requirements), to the extent such rules are applicable to the operation of the pharmacy.

(11) A Class B pharmacy engaged in the compounding of non-sterile preparations, including radioactive preparations, shall comply with the provisions of §291.131 of this title (relating to Pharmacies Compounding Non-Sterile Preparations).

(12) A Class B pharmacy engaged in the compounding of sterile preparations, including radioactive preparations, shall comply with the provisions of §291.133 of this title (relating to Pharmacies Compounding Sterile Preparations) using only radiopharmaceuticals from FDA-approved drug products.

(13) Effective June 1, 2016, a Class B pharmacy may not renew a pharmacy license unless the pharmacy has been inspected by the board within the last renewal period.

(b) Environment.

(1) General requirements.

(A) The pharmacy shall be arranged in an orderly fashion and kept clean. All required equipment shall be clean and in good operating condition.

(B) The pharmacy shall have a sink with hot and cold running water within the pharmacy, exclusive of restroom facilities, available to all pharmacy personnel and maintained in a sanitary condition.

(C) The pharmacy shall be properly lighted and ventilated.

(D) 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.

(E) If the pharmacy has flammable materials, the pharmacy shall have a designated area for the storage of flammable materials. Such area shall meet the requirements set by local and state fire laws.

(2) Security requirements.

(A) All areas occupied by a pharmacy shall be capable of being locked by key, combination or other mechanical or electronic means to prohibit unauthorized access, when a pharmacist is not on-site except as provided in subparagraph (B) of this paragraph.

(B) The pharmacy may authorize personnel to gain access to that area of the pharmacy containing dispensed radiopharmaceuticals, in the absence of the pharmacist, for the purpose of retrieving the radiopharmaceuticals to be delivered patients. If the pharmacy allows such after-hours access, the area containing the dispensed 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.

(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

(c) Prescription dispensing and delivery.

(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 Substitution of Drug Products).

(2) Prescription containers (immediate inner containers).

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

(i) If a drug is susceptible to light, the drug shall be dispensed in a light-resistant container.

(ii) If a drug is susceptible to moisture, the drug shall be dispensed in a tight container.

(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.

(B) Immediate inner prescription containers or closures shall not be re-used.

(3) Delivery containers (outer containers).

(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.

(B) Delivery containers may be re-used provided they are maintained in a manner to prevent cross contamination.

(4) Labeling.

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

(i) standard radiation symbol;

(ii) the words "caution-radioactive material" or "danger, radioactive material";

(iii) the name of the radiopharmaceutical or its abbreviation; and

(iv) the unique identification number of the prescription.

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

(i) the name, address, and phone number of the pharmacy;

(ii) the date dispensed;

(iii) the directions for use, if applicable;

(iv) the unique identification number of the prescription;

(v) the name of the patient if known, or the statement, "for physician use" if the patient is unknown;

(vi) the standard radiation symbol;

(vii) the words "caution-radioactive material" or "danger, radioactive material";

(viii) the name of the radiopharmaceutical or its abbreviation;

(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;

(x) the initials or identification codes of the person preparing the product and the authorized nuclear pharmacist who checked and released the final product unless recorded in the pharmacy's data processing system. The record of the identity of these individuals shall not be altered in the pharmacy's data processing system.

(xi) if a liquid, the volume in milliliters;

(xii) the requested calibration date and time; and

(xiii) the expiration date and/or time.

(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.

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

(1) vertical laminar flow hood;

(2) dose calibrator;

(3) a calibrated system or device (i.e., thermometer) to monitor the temperature to ensure that proper storage requirements are met, if preparations are stored in the refrigerator;

(4) if applicable, a Class A prescription balance, or analytical balance and weights. Such balance shall be properly maintained and subject to periodic inspection by the board.

(5) scintillation analyzer;

(6) microscope and hemocytometer;

(7) equipment and utensils necessary for the proper compounding of prescription drug or medication orders. Such equipment and utensils used in the compounding process shall be:

(A) of appropriate design, appropriate capacity, and be operated within designed operational limits;

(B) of suitable composition so that surfaces that contact components, in-process material, or drug products shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product beyond acceptable standards;

(C) cleaned and sanitized immediately prior to each use; and

(D) routinely inspected, calibrated (if necessary), or checked to ensure proper performance;

(8) appropriate disposal containers for used needles, syringes, etc., and if applicable, cytotoxic waste from the preparation of chemotherapeutic agents, and/or biohazardous waste;

(9) all necessary supplies, including:

(A) disposable needles, syringes, and other aseptic mixing;

(B) disinfectant cleaning solutions;

(C) hand washing agents with bactericidal action;

(D) disposable, lint free towels or wipes;

(E) appropriate filters and filtration equipment;

(F) radioactive spill kits, if applicable; and

(G) masks, caps, coveralls or gowns with tight cuffs, shoe covers, and gloves, as applicable.

(10) adequate glassware, utensils, gloves, syringe shields and remote handling devices, and adequate equipment for product quality control;

(11) adequate shielding material;

(12) data processing system including a printer or comparable equipment;

(13) radiation dosimeters for visitors and personnel and log entry book;

(14) exhaust/fume hood with monitor, for storage and handling of all volatile radioactive drugs if applicable, to be determined by the Texas Department of State Health Services, Radiation Control Program; and

(15) adequate radiation monitor(s).

(e) Library. A nuclear pharmacy shall maintain a reference library which shall include the following in hard copy or electronic format current or updated copies of the following:

(1) Texas Pharmacy Act and rules;

(2) Texas Dangerous Drug Act and rules;

(3) Texas Controlled Substances Act and rules; and

(4) Federal Controlled Substances Act and rules (or official publication describing the requirements of the Federal Controlled Substances Act and rules); and

(5) a minimum of one text dealing with nuclear medicine science.

(f) Radiopharmaceuticals and/or radioactive materials.

(1) General requirements.

(A) Radiopharmaceuticals may only be dispensed pursuant to a radioactive prescription drug order.

(B) An authorized nuclear pharmacist may distribute radiopharmaceuticals to authorized users for patient use. A nuclear pharmacy may furnish radiopharmaceuticals for departmental or physicians' use if such authorized users maintain a Texas radioactive materials license.

(C) An authorized nuclear pharmacist may transfer to authorized users radioactive materials not intended for drug use in accordance with the requirements of the Texas Department of State Health Services, Radiation Control Program, Texas Administrative Code, Title 25, Part 1, Subchapter F, §289.252 relating to Licensing of Radioactive Material.

(D) The transportation of radioactive materials from the nuclear pharmacy must be in accordance with current state and federal transportation regulations.

(2) Procurement and storage.

(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.

(B) Prescription drugs and devices shall be stored within the prescription department or a locked storage area.

(C) All drugs shall be stored at the proper temperature, as defined in the USP/NF and §291.15 of this title (relating to Storage of Drugs).

(D) The pharmacy's generator(s) shall be stored and eluted in an ISO Class 7 or ISO Class 8 environment as specified in §291.133 of this title.

(3) Out-of-date and other unusable drugs or devices.

(A) Any drug or device bearing an expiration date shall not be dispensed beyond the expiration date of the drug or device.

(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.

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; amended to be effective June 6, 2004, 29 TexReg 5362; amended to be effective September 14, 2010, 35 TexReg 8357; amended to be effective September 14, 2015, 40 TexReg 6110