1. (a) General requirements.

   1. (1) The pharmacist-in-charge shall be responsible for taking all required inventories, but may delegate the performance of the inventory to another person(s).
   2. (2) The inventory shall be maintained in a written, typewritten, or printed form. An inventory taken by use of an oral recording device must be promptly transcribed.
   3. (3) The inventory shall be kept in the pharmacy and shall be available for inspection for two years.
   4. (4) The inventory shall be filed separately from all other records.

   5. (5) The inventory shall be in a written, typewritten, or printed form and include all stocks of the following drugs on hand on the date of the inventory (including any which are out-of-date):

      1. (A) all controlled substances;
      2. (B) all dosage forms containing nalbuphine (e.g., Nubain); and
      3. (C) all dosage forms containing carisoprodol (e.g., Soma).
   6. (6) The inventory may be taken either as of the opening of business or as of the close of business on the inventory date.
   7. (7) The inventory record shall indicate whether the inventory is taken as of the opening of business or as of the close of business on the inventory date. If the pharmacy is open 24 hours a day, the opening of business shall be 12:01 a.m. and the close of business shall be 12 midnight. The inventory shall indicate that it is a record of drugs on-hand as of the opening or closing of the business day.
   8. (8) The person(s) taking the inventory and the pharmacist-in-charge shall indicate the time the inventory was taken (as specified in paragraph (7) of this subsection) and shall sign and date the inventory with the date the inventory was taken. The signature of the pharmacist-in-charge and the date of the inventory shall be notarized within 72 hours or three working days of the completed initial, annual, change of ownership, and closing inventory.
   9. (9) The person(s) taking the inventory shall make an exact count or measure of all substances listed in Schedule I or II.
   10. (10) The person(s) taking the inventory shall make an estimated count or measure of all substances listed in Schedule III, IV, or V and dangerous drugs, unless the container holds more than 1,000 tablets or capsules in which case, an exact count of the contents must be made.
   11. (11) The inventory of Schedule I and II controlled substances shall be listed separately from the inventory of Schedule III, IV, and V controlled substances which shall be listed separately from the inventory of dangerous drugs.
   12. (12) If the pharmacy maintains a perpetual inventory of any of the drugs required to be inventoried, the perpetual inventory shall be reconciled on the date of the inventory.

2. (b) Initial inventory.

   1. (1) A new Class A (community) pharmacy or Class C (institutional) pharmacy shall take an inventory on the opening day of business. Such inventory shall include all stocks (including any out-of-date drugs) of the following:

      1. (A) all controlled substances;
      2. (B) all dosage forms containing nalbuphine (e.g., Nubain); and
      3. (C) all dosage forms containing carisoprodol (e.g., Soma).
   2. (2) In the event the Class A or C pharmacy commences business with none of the drugs specified in paragraph (1) of this subsection on hand, the pharmacy shall record this fact as the initial inventory.
   3. (3) The initial inventory shall serve as the pharmacy's inventory until the next May 1, or until the pharmacy's regular general physical inventory date, at which time the Class A or C pharmacy shall take an annual inventory as specified in subsection (c) of this section. Such inventory may be taken within four days of the specified inventory date and shall include all stocks (including out-of-date drugs).

3. (c) Annual inventory.

   1. (1) A Class A or C pharmacy shall take an inventory on May 1 of each year, or on the pharmacy's regular general physical inventory date. Such inventory may be taken within four days of the specified inventory date and shall include all stocks (including out-of-date drugs) of the following:

      1. (A) all controlled substances;
      2. (B) all dosage forms containing nalbuphine (e.g., Nubain); and
      3. (C) all dosage forms containing carisoprodol (e.g., Soma).
   2. (2) A Class A or C pharmacy applying for renewal of a pharmacy license shall include as a part of the pharmacy license renewal application a statement attesting that an annual inventory has been conducted, the date of the inventory, and the name of the person taking the inventory.

4. (d) Change of ownership.

   1. (1) A Class A or C pharmacy that changes ownership shall take an inventory of all of the following drugs on hand (including any which are out-of-date) on the date of change of ownership:

      1. (A) all controlled substances;
      2. (B) all dosage forms containing nalbuphine (e.g., Nubain); and
      3. (C) all dosage forms containing carisoprodol (e.g., Soma).
   2. (2) Such inventory shall constitute, for the purpose of this section, the closing inventory for the seller and the initial inventory for the buyer.
   3. (3) Transfer of any controlled substances listed in Schedule I or II shall require the use of official DEA order forms (Form 222C).
5. (e) Closed pharmacies. The pharmacist-in-charge of a Class A or C pharmacy that ceases to operate as a pharmacy shall forward to the board, within 10 days of the cessation of operation, a statement attesting that an inventory of the drugs specified in subsection (c) of this section on hand has been conducted, the date of closing, and a statement attesting the manner by which the dangerous drugs and controlled substances possessed by such pharmacy were transferred or disposed.

6. (f) Requirements for Class C (Institutional) pharmacies.

   1. (1) Perpetual inventory.

      1. (A) A Class C pharmacy shall maintain a perpetual inventory of all Schedule II controlled substances.
      2. (B) The perpetual inventory shall be reconciled on the date of the annual inventory.

   2. (2) Annual inventory.

      1. (A) An inventory shall be conducted on May 1 of each year, or on the pharmacy's regular general physical inventory date. Such inventory may be taken within four days of the specified inventory date and shall be in a written, typewritten, or printed form and include all stocks (including out-of-date drugs) of the following:

         1. (i) all controlled substances;
         2. (ii) all dosage forms containing nalbuphine (e.g., Nubain); and
         3. (iii) all dosage forms containing carisoprodol (e.g., Soma).
      2. (B) The annual inventory of the institution shall include all of the drugs specified in subparagraph (A) of this paragraph on hand in the pharmacy.

      3. (C) The inventory of the institution shall be maintained in the pharmacy; if an inventory is conducted in other departments within the institution, the inventory of the pharmacy shall be listed separately, as follows:

         1. (i) the inventory of drugs on hand in the pharmacy shall be listed separately from the inventory of drugs on hand in the other areas of the institution; and
         2. (ii) the inventory of drugs on hand in all other departments shall be identified by department.

7. (g) Change of pharmacist-in-charge of a pharmacy.

   1. (1) On the date of change of the pharmacist-in-charge of a Class A (community) or Class C (institutional) pharmacy, an inventory of the following drugs shall be taken:

      1. (A) all Schedule II controlled substances;
      2. (B) all dosage forms containing pentazocine (e.g., Talwin);
      3. (C) all dosage forms containing phentermine (e.g., Ionamin, Fastin, Adipex-P, etc.);
      4. (D) all dosage forms containing diazepam (e.g., Valium);
      5. (E) all dosage forms containing phendimetrazine (e.g., Bontril, Plegine, Prelu-2, etc.);
      6. (F) all dosage forms containing codeine;
      7. (G) all dosage forms containing hydrocodone (e.g., Tussionex, Tussend, Vicodin, Hycomine, etc.);
      8. (H) all dosage forms containing alprazolam (e.g., Xanax);
      9. (I) all dosage forms containing triazolam (e.g., Halcion);
      10. (J) all dosage forms containing butorphanol (e.g., Stadol);
      11. (K) all dosage forms containing nalbuphine (e.g., Nubain); and
      12. (L) all dosage forms containing carisoprodol (e.g., Soma).
   2. (2) This inventory shall constitute, for the purpose of this section, the closing inventory of the departing pharmacist-in-charge and the beginning inventory of the incoming pharmacist-in-charge.
   3. (3) If the departing and the incoming pharmacists-in-charge are unable to conduct the inventory together, a closing inventory shall be conducted by the departing pharmacist-in-charge and a new and separate beginning inventory shall be conducted by the incoming pharmacist-in-charge.

   4. (4) The incoming pharmacist-in-charge shall be responsible for the following actions:

      1. (A) deleting the name of the departing pharmacist-in-charge on the pharmacy license;
      2. (B) entering the name of the incoming pharmacist-in-charge on the pharmacy license;

      3. (C) notifying the board within 10 days in writing on a form provided by the board, that a change of pharmacist-in-charge has occurred. The notification shall include the following:

         1. (i) the name and license number of the departing pharmacist-in-charge;
         2. (ii) the name and license number of the incoming pharmacist-in-charge;
         3. (iii) the date the incoming pharmacist-in-charge became the pharmacist-in-charge; and

         4. (iv) a statement signed by the incoming pharmacist-in-charge attesting that:

            1. (I) an inventory has been conducted by the departing and incoming pharmacists-in-charge; if the inventory was not taken by both pharmacists, the statement shall provide an explanation; and
            2. (II) the incoming pharmacist-in-charge has read and understands the laws and rules relating to this class of pharmacy.

Source Note:The provisions of this §291.17 adopted to be effective September 1, 1987, 12 TexReg 2568; amended to be effective September 30, 1993, 18 TexReg 6459; amended to be effective July 16, 1999, 24 TexReg 5196; amended to be effective June 4, 2000, 25 TexReg 4777; amended to be effective March 12, 2003, 28 TexReg 2082.