If a pharmacy experiences a fire or other disaster, the following requirements are applicable.

1. (1) Responsibilities of the pharmacist-in-charge.

   1. (A) The pharmacist-in-charge shall be responsible for reporting the date of the fire or other disaster which may affect the strength, purity, or labeling of drugs, medications, devices, or other materials used in the diagnosis or the treatment of the injury, illness, and disease; such notification shall be immediately reported to the board, but in no event shall exceed 10 days from the date of the disaster.

   2. (B) The pharmacist-in-charge or designated agent shall comply with the following procedures.

      1. (i) If controlled substances, dangerous drugs, or Drug Enforcement Administration (DEA) order forms are lost or destroyed in the disaster, the pharmacy shall:

         1. (I) notify the DEA, Department of Public Safety (DPS), and Texas State Board of Pharmacy (board) of the loss of the controlled substances or order forms. A pharmacy shall be in compliance with this section by submitting to each of these agencies a copy of the DEA's report of theft or loss of controlled substances, DEA Form-106, immediately on discovery of the loss; and
         2. (II) notify the Texas State Board of Pharmacy in writing of the loss of the dangerous drugs by submitting a list of the dangerous drugs lost.

      2. (ii) If the extent of the loss of controlled substances or dangerous drugs is not able to be determined, the pharmacy shall:

         1. (I) take a new, complete inventory of all remaining drugs specified in §291.17(c) of this title (relating to Inventory Requirements);
         2. (II) submit to DEA and DPS a statement attesting that the loss of controlled substances is indeterminable and that a new, complete inventory of all remaining controlled substances was conducted and state the date of such inventory; and
         3. (III) submit to the board a statement attesting that the loss of controlled substances and dangerous drugs is indeterminable and that a new, complete inventory of the drugs specified in §291.17(c) of this title (relating to Inventory Requirements) was conducted and state the date of such inventory.
   3. (C) If the pharmacy changes to a new, permanent location, the pharmacist-in-charge shall comply with §291.2 of this title (relating to Change of Location and/or Name).
   4. (D) If the pharmacy moves to a temporary location, the pharmacist shall comply with §291.2 of this title (relating to Change of Location and/or Name). If the pharmacy returns to the original location, the pharmacist-in-charge shall again comply with §291.2 of this title.
   5. (E) If the pharmacy discontinues business (ceases to operate as a pharmacy), the pharmacist-in-charge shall comply with §291.5 of this title (relating to Closed Pharmacies).
   6. (F) The pharmacist-in-charge shall maintain copies of all inventories, reports, or notifications required by this section for a period of two years.

2. (2) Drug stock.

   1. (A) Any drug which has been exposed to excessive heat, smoke, or other conditions which may have caused deterioration shall not be dispensed.
   2. (B) Any potentially adulterated or damaged drug shall only be sold, transferred, or otherwise distributed pursuant to the provisions of the Texas Food Drug and Cosmetics Act (Chapter 431, Health and Safety Code) administered by the Bureau of Food and Drug Safety of the Texas Department of Health.

Source Note:The provisions of this §291.12 adopted to be effective February 17, 1988, 13 TexReg 612; amended to be effective September 30, 1993, 18 TexReg 6459; amended to be effective March 12, 2003, 28 TexReg 2082.