1. (a) Definition of stock. "Stock" as used in these sections means dangerous drugs or controlled substances which are packaged in the original manufacturer's container.

2. (b) Disposal of stock dangerous drugs. A pharmacist, licensed by the board, is authorized to destroy stock dangerous drugs owned by a licensed pharmacy if such dangerous 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. However, the following procedures shall be followed in destroying any brand or dosage form of tripelennamine (e.g., PBZ), nalbuphine (e.g., Nubain), and carisoprodol (e.g., Soma):

   1. (1) the dangerous drugs are inventoried; and
   2. (2) the destruction is witnessed by another licensed pharmacist or a commissioned peace officer.

3. (c) Disposal of stock controlled substances. A pharmacist, licensed by the board, may dispose of stock controlled substances owned by a licensed pharmacy in accordance with procedures authorized by the Federal and Texas Controlled Substances Acts and sections adopted pursuant to such Acts. Disposal of controlled substances is deemed to be in accordance with the Federal and Texas Controlled Substances Acts and sections adopted pursuant to such Acts if any one of the following actions is taken:

   1. (1) transfer to a controlled substances registrant authorized to possess controlled substances is the preferred method of disposal (e.g., DEA registered disposal firm); if transferred, the stock controlled substances shall be documented by appropriate invoices, federal Drug Enforcement Administration (DEA) order forms, or other documents legally transferring the controlled substances; or

   2. (2) with prior DEA approval, destruction of the controlled substances according to following guidelines.

      1. (A) Community (Class A) pharmacies. This method of drug destruction may be used only one time in each calendar year.

         1. (i) The pharmacy shall inventory the controlled substances to be destroyed and itemize the inventory on DEA Form 41, making three copies.
         2. (ii) DEA approval shall be obtained by submitting a registered or certified letter to DEA at least 14 days prior to the anticipated destruction date indicating the day, time, and place of the anticipated destruction, and including a copy of DEA Form 41 which lists the controlled substances to be destroyed. No written or other response from DEA regarding the planned destruction will constitute DEA approval of the destruction.

         3. (iii) The controlled substances shall be destroyed beyond reclamation and disposed of in compliance with all applicable state and federal requirements on the approved date/time/place in the presence of one of the following witnesses:

            1. (I) a commissioned peace officer;
            2. (II) an agent of the Drug Enforcement Administration;
            3. (III) an agent of the Department of Public Safety; or
            4. (IV) an agent of the Texas Board of Pharmacy.
         4. (iv) After destruction of the drugs, DEA Form 41 shall be completed to indicate the method of destruction and be signed and dated by the registrant and witness.

         5. (v) The pharmacy shall distribute copies of the completed DEA Form 41 as follows:

            1. (I) maintain the original in the records of the pharmacy for at least two years; and
            2. (II) mail one copy to the appropriate DEA divisional office.

      2. (B) Institutional (Class C) pharmacies.

         1. (i) Written DEA approval giving authorization to destroy controlled substances must be obtained from the appropriate DEA divisional office. The hospital may destroy controlled substances at any time provided the written authorization is maintained in the files of the hospital pharmacy.
         2. (ii) The pharmacy shall inventory the controlled substances to be destroyed and itemize the inventory on DEA Form 41, making two copies.

         3. (iii) The controlled substances shall be destroyed beyond reclamation and disposed of in compliance with all applicable state and federal requirements in the presence of one of the following witnesses:

            1. (I) a commissioned peace officer;
            2. (II) a supervisory member of the hospital's security department;
            3. (III) an agent of the Drug Enforcement Administration;
            4. (IV) an agent of the Department of Public Safety; or
            5. (V) an agent of the Texas State Board of Pharmacy.
         4. (iv) After destruction of the drugs, DEA Form 41 shall be completed to indicate the method of destruction and be signed and dated by the registrant and witness.

         5. (v) The hospital pharmacy shall distribute copies of the completed DEA Form 41 as follows:

            1. (I) maintain the original in the records of the pharmacy for at least two years; and
            2. (II) mail one copy to the appropriate DEA divisional office.

Source Note:The provisions of this §303.2 adopted to be effective April 25, 1984, 9 TexReg 2019; amended to be effective February 17, 1988, 13 TexReg 614; 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.