1. (a) General prohibition on return of prescription drugs. As specified in §431.021(w), Health and Safety Code, a pharmacist may not accept an unused prescription or drug, in whole or in part, for the purpose of resale or re-dispensing to any person, after the prescription or drug has been originally dispensed, or sold except as provided in subsection (b) of this section.

2. (b) Return of prescription drugs from health care facilities.

   1. (1) Purpose. The purpose of this subsection is to outline procedures for the return of unused drugs from a health care facility to a dispensing pharmacy as specified in the §562.1085 of the Occupations Code. Nothing in this section shall require a consultant pharmacist, health care facility or pharmacy to participate in the return of unused drugs.

   2. (2) Definitions. The following words and terms, when used in this section, shall have the following meanings, unless the context clearly indicates otherwise.

      1. (A) Consultant pharmacist--A pharmacist who practices in or serves as a consultant for a health care facility in this state.
      2. (B) Health care facility--A facility regulated under Chapter 242, Health and Safety Code.

   3. (3) Consultant pharmacist/health care facility responsibilities. A consultant pharmacist may return to a pharmacy certain unused drugs, other than a controlled substance as defined by Chapter 481, Health and Safety Code, purchased from the pharmacy.

      1. (A) The unused drugs must:

         1. (i) be approved by the federal Food and Drug Administration and be:

            1. (I) sealed in the manufacturer's original unopened tamper-evident packaging and either individually packaged or packaged in unit-dose packaging;
            2. (II) oral or parenteral medication in sealed single-dose containers approved by the federal Food and Drug Administration;
            3. (III) topical or inhalant drugs in sealed unit-of-use containers approved by the federal Food and Drug Administration; or
            4. (IV) parenteral medications in sealed multiple-dose containers approved by the federal Food and Drug Administration from which doses have not been withdrawn; and
         2. (ii) not be the subject of a mandatory recall by a state or federal agency or a voluntary recall by a drug seller or manufacturer.

      2. (B) A healthcare facility may not return any drug product that:

         1. (i) has been compounded;
         2. (ii) appears on inspection to be adulterated;
         3. (iii) requires refrigeration; or
         4. (iv) has less than 120 days until the expiration date or end of the shelf life.

      3. (C) The consultant pharmacist shall be responsible for assuring an inventory of the drugs to be returned to a pharmacy is completed. The following information shall be included on this inventory:

         1. (i) name and address of the facility or institution;
         2. (ii) name and pharmacist license number of the consultant pharmacist;
         3. (iii) date of return;
         4. (iv) date the prescription was dispensed;
         5. (v) unique identification number assigned to the prescription by the pharmacy;
         6. (vi) name of dispensing pharmacy;
         7. (vii) name, strength, and quantity of drug;
         8. (viii) signature of consultant pharmacist;

      4. (D) The health care facility shall send a copy of the inventory specified in subparagraph (C) of this paragraph to:

         1. (i) the pharmacy with the drugs returned; and
         2. (ii) the Health and Human Services Commission.

   4. (4) Dispensing/Receiving pharmacy responsibilities. If a pharmacy accepts the return of unused drugs from a health care facility, the following is applicable.

      1. (A) A pharmacist employed by the pharmacy shall examine the drugs to ensure the integrity of the drug product.

      2. (B) The pharmacy shall reimburse or credit the entity that paid for the drug including the state Medicaid program for an unused drug returned to the pharmacy. The pharmacy shall maintain a record of the credit or reimbursement containing the following information:

         1. (i) name and address of the facility or institution which returned the drugs;
         2. (ii) date and amount of the credit or reimbursement was issued;
         3. (iii) name of the person or entity to whom the credit or reimbursement was issued;
         4. (iv) date the prescription was dispensed;
         5. (v) unique identification number assigned to the prescription by the pharmacy;
         6. (vi) name, strength, and quantity of drug;
         7. (vii) signature of the pharmacist responsible for issuing the credit.
      3. (C) After the pharmacy has issued credit or reimbursement, the pharmacy may restock and redispense the unused drugs returned under this section.

   5. (5) Limitation on Liability.

      1. (A) A pharmacy that returns unused drugs and a manufacturer that accepts the unused drugs under §562.1085, Occupations Code, and the employees of the pharmacy or manufacturer are not liable for harm caused by the accepting, dispensing, or administering of drugs returned in strict compliance with §562.1085, Occupations Code, unless the harm is caused by:

         1. (i) wilful or wanton acts of negligence;
         2. (ii) conscious indifference or reckless disregard for the safety of others; or
         3. (iii) intentional conduct.
      2. (B) This section does not limit, or in any way affect or diminish, the liability of a drug seller or manufacturer under Chapter 82, Civil Practice and Remedies Code.
      3. (C) This section does not apply if harm results from the failure to fully and completely comply with the requirements of §562.1085, Occupations Code.
      4. (D) This section does not apply to a pharmacy or manufacturer that fails to comply with the insurance provisions of Chapter 84, Civil Practice and Remedies Code.

Source Note:The provisions of this §291.8 adopted to be effective December 23, 2003, 28 TexReg 11261.