(a) Drugs dispensed to patients in health care facilities or institutions.
  (1) Destruction by the consultant pharmacist. The consultant pharmacist, if in good standing with the Texas State Board of Pharmacy, is authorized to destroy dangerous drugs dispensed to patients in health care facilities or institutions. A consultant pharmacist may destroy controlled substances as allowed to do so by federal laws or rules of the Drug Enforcement Administration. Dangerous drugs may be destroyed provided the following conditions are met.
    (A) A written agreement exists between the facility and the consultant pharmacist.
    (B) The drugs are inventoried and such inventory is verified by the consultant pharmacist. The following information shall be included on this inventory:
      (i) name and address of the facility or institution;
      (ii) name and pharmacist license number of the consultant pharmacist;
      (iii) date of drug destruction;
      (iv) date the prescription was dispensed;
      (v) unique identification number assigned to the prescription by the pharmacy;
      (vi) name of dispensing pharmacy;
      (vii) name, strength, and quantity of drug;
      (viii) signature of consultant pharmacist destroying drugs;
      (ix) signature of the witness(es); and
      (x) method of destruction.
    (C) The signature of the consultant pharmacist and witness(es) to the destruction and the method of destruction specified in subparagraph (B) of this paragraph may be on a cover sheet attached to the inventory and not on each individual inventory sheet, provided the cover sheet contains a statement indicating the number of inventory pages that are attached and each of the attached pages are initialed by the consultant pharmacist and witness(es).
    (D) The drugs are destroyed in a manner to render the drugs unfit for human consumption and disposed of in compliance with all applicable state and federal requirements.
    (E) The actual destruction of the drugs is witnessed by one of the following:
      (i) a commissioned peace officer;
      (ii) an agent of the Texas State Board of Pharmacy;
      (iii) an agent of the Texas Health and Human Services Commission, authorized by the Texas State Board of Pharmacy to destroy drugs;
      (iv) an agent of the Texas Department of State Health Services, authorized by the Texas State Board of Pharmacy to destroy drugs; or
      (v) any two individuals working in the following capacities at the facility:
        (I) facility administrator;
        (II) director of nursing;
        (III) acting director of nursing; or
        (IV) licensed nurse.
    (F) If the actual destruction of the drugs is conducted at a location other than the facility or institution, the consultant pharmacist and witness(es) shall retrieve the drugs from the facility or institution, transport, and destroy the drugs at such other location.
  (2) Destruction by a waste disposal service. A consultant pharmacist may utilize a waste disposal service to destroy dangerous drugs dispensed to patients in health care facilities or institutions. A consultant pharmacist may destroy controlled substances, including any dangerous drugs comingled with the controlled substances in a shared container, as allowed to do so by federal laws or rules of the Drug Enforcement Administration. Dangerous drugs not comingled with controlled substances may be transferred to a waste disposal service for destruction provided the following conditions are met.
    (A) The waste disposal service is in compliance with applicable rules of the Texas Commission on Environmental Quality and United States Environmental Protection Agency relating to waste disposal.
    (B) The consultant pharmacist seals the container of drugs in the presence of the facility administrator and the director of nursing or one of the other witnesses listed in paragraph (1)(E) of this subsection as follows:
      (i) tamper resistant tape is placed on the container in such a manner that any attempt to reopen the container will result in the breaking of the tape; and
      (ii) the signature of the consultant pharmacist is placed over this tape seal.
    (C) The sealed container is maintained in a secure area at the facility or institution until transferred to the waste disposal service by the consultant pharmacist, facility administrator, director of nursing, or acting director of nursing.
    (D) A record of the transfer to the waste disposal service is maintained. Such record shall contain the following information:
      (i) date of the transfer;
      (ii) signature of the person who transferred the drugs to the waste disposal service;
      (iii) name and address of the waste disposal service; and
      (iv) signature of the employee of the waste disposal service who receives the container.
    (E) The waste disposal service shall provide the facility with proof of destruction of the sealed container. Such proof of destruction shall contain the date, location, and method of destruction of the container.
  (3) Record retention. All records required in this subsection shall be maintained by the consultant pharmacist at the health care facility or institution for two years from the date of destruction.
(b) Drugs returned to a pharmacy. A pharmacist in a pharmacy may accept and destroy dangerous drugs that have been previously dispensed to a patient and returned to a pharmacy by the patient or an agent of the patient. A pharmacist may accept controlled substances that have been previously dispensed to a patient as allowed by federal laws of the Drug Enforcement Administration. The following procedures shall be followed in destroying dangerous drugs.
  (1) The dangerous drugs shall be destroyed in a manner to render the drugs unfit for human consumption and disposed of in compliance with all applicable state and federal requirements.
  (2) Documentation shall be maintained that includes the following information:
    (A) name and address of the dispensing pharmacy;
    (B) unique identification number assigned to the prescription, if available;
    (C) name and strength of the dangerous drug; and
    (D) signature of the pharmacist.

Source Note: The provisions of this §303.1 adopted to be effective September 20, 1977, 2 TexReg 3396; amended to be effective August 2, 1983, 8 TexReg 2698; amended to be effective August 30, 1984, 9 TexReg 4451; amended to be effective September 14, 1988, 13 TexReg 4326; amended to be effective June 11, 1991, 16 TexReg 2953; amended to be effective May 6, 1993, 18 TexReg 2625; amended to be effective September 30, 1993, 18 TexReg 6463; amended to be effective March 25, 1999, 24 TexReg 2024; amended to be effective March 12, 2003, 28 TexReg 2083; amended to be effective March 4, 2004, 29 TexReg 2013; amended to be effective September 13, 2009, 34 TexReg 6117; amended to be effectiveSeptember 12, 2011, 36 TexReg 5850; amended to be effective March 15, 2015, 40 TexReg 1090; amended to be effective March 7, 2023, 48 TexReg 1296