1. (a)

   1. (1) Every practitioner and LTCF shall keep a record of such controlled substances received, administered, dispensed, or professionally used otherwise than by prescription in order to maintain complete accountability.

   2. (2) The record shall in every case show the:

      1. (A) Date of receipt;
      2. (B) Name and address of the person or business from whom received; and
      3. (C) Kind and quantity of such controlled substances received.

2. (b)

   1. (1) The record shall show the:

      1. (A) Controlled substances:

3. (i) Sold;

   1. (ii) Administered;

      1. (iii) Dispensed; or

         1. (iv) Otherwise disposed of;
      2. (B) Date of selling, administering, or dispensing;
      3. (C) Name and address of the person to whom or for whose use the controlled substances were sold, administered, or dispensed or the owner and species of animal for which the controlled substances were sold, administered, or dispensed; and
      4. (D) Name, strength, and quantity of controlled substances.

   2. (2) Persons engaged in research on the use of controlled substances may withhold the name and other identifying characteristics of individuals who are the subjects of the research.

      1. (c)
   3. (1) Institutional practitioner and LTCF records shall be designed so that all clinical personnel are using the same records in caring for patients, and if diversion does occur, the chance of discovery is increased.

   4. (2) The basic records of receipt and disposition of controlled substances within the institution are the:

      1. (A) Patient medication records; and
      2. (B) Controlled substances procurement and disposition records.

   5. (3) Patient medication records shall consist of at least the:

      1. (A) Practitioners’ orders authorizing the dispensing and administration of medications;
      2. (B) Medication administration record indicating the date, time, and signature of licensed person administering controlled substances to the patient; and
      3. (C) Nurses’ notes indicating the date, time, and condition of the patient before and after the as-needed controlled substance was administered and signature of the licensed person administering the controlled substance.
   6. (4) In addition to patient medication records, a record of the procurement and disposition of a controlled substance shall be maintained.

   7. (5)

      1. (A) The disposition record shall reflect the:

         1. (i) Actual dosage administered to the patient;
         2. (ii) Patient’s name; and
         3. (iii) Date, time, and signature of the licensed person administering the controlled substance.
      2. (B) Any error of entry on the disposition and procurement record shall follow a policy for correction of errors and accurate accountability.
      3. (C) If the licensed person who procures the controlled substance is not the licensed person who administers the controlled substance, then both licensed persons shall sign the disposition record.

   8. (6)

      1. (A) When breakage or wastage of all or a partial dose of a controlled substance not in its original sealed package or not administered to a patient occurs, the amount administered and the amount wasted shall be:

         1. (i) Recorded by the licensed person who wasted the controlled substance; and
         2. (ii) Verified by the signature of another licensed person who observed the wastage and how it was wasted.
      2. (B) Controlled substances shall be wasted in such a manner that such substances are rendered unusable.

      3. (C) Licensed persons in this paragraph are those who are authorized by their current practice act to administer controlled substances, to include those licensed by the:

         1. (i) Arkansas State Medical Board;
         2. (ii) Arkansas State Board of Nursing;
         3. (iii) Arkansas State Board of Dental Examiners;
         4. (iv) Arkansas Board of Podiatric Medicine; and
         5. (v) State Board of Optometry.
      4. (D) Licensed pharmacists and paramedics shall also be allowed to witness wastage of controlled substances.

   9. (7)

      1. (A) Records to include electronic signatures in a closed system, i.e., hospital, generated by automatic medication distribution devices shall comply with this part unless specifically exempted by Pharmacy Services and Drug Control Section.

      2. (B) Policies and procedures shall be:

         1. (i) Developed to ensure security and accountability of controlled substances; and
         2. (ii) Approved administratively by Pharmacy Services and Drug Control Section prior to usage of such automatic medication distribution devices.
         3. (d) Each practitioner shall maintain inventory records in one (1) consolidated record system of all controlled substances under the licensed practitioner’s control and inventory shall be taken every two (2) years as required by the Drug Enforcement Administration.

4. (e)

   1. (1) Records of Schedules I and II substances shall be maintained separately from all other records.
   2. (2) Records of Schedules III, IV, and V substances shall be maintained either separately from all other records or in such form that the information required is readily retrievable from the ordinary business records for inspection and copying by authorized agents of Pharmacy Services and Drug Control Section.
   3. (3) Every record shall be maintained by the registrant for at least two (2) years.

5. (f)

   1. (1) Adequate accountability does not require the use of a specific system or form.
   2. (2) However, the system employed shall be designed so that all recordkeeping requirements are met.
6. (g) When an automated data processing system is used for the storage and retrieval of prescription orders for controlled substances, the system shall have the capability of generating a printout of all data that the user practitioner is responsible for maintaining under this part.

Codification Notes: “LTCF” means long-term care facility.