PURPOSE: This rule establishes requirements for non-electronic (manual) prescription record keeping.

1. (1) Pharmacies that maintain a non-electronic prescription record system shall maintain the following information in its system for each original and refilled prescription:

   1. (A) The date the prescription was prescribed and the date of initial dispensing, if different;
   2. (B) A unique, sequential prescription label number;
   3. (C) If applicable, a unique readily retrievable identifier;
   4. (D) The name of the patient(s), or if an animal, species and owner’s name;
   5. (E) The prescriber’s name, if an oral prescription, signature if a written or faxed prescription. Electronic signatures shall comply with all applicable provisions of 20 CSR 2220-2.085;
   6. (F) Name, strength and dosage of drug, device or poison dispensed and the directions for use;
   7. (G) The number of refills authorized;
   8. (H) The quantity dispensed in weight, volume, or number of units;
   9. (I) The date of refill, if any;
   10. (J) The identity of the pharmacist responsible for reviewing the accuracy of data on each original prescription;
   11. (K) The identity of the pharmacist responsible for verifying the final product prior to dispensing on each original and refill prescription, if different;
   12. (L) Whether generic substitution has been authorized by the prescriber;
   13. (M) Any change or alteration made to the prescription dispensed based on contact with the prescriber to show a clear audit trail. This shall include, but is not limited to, a change in quantity, directions, number of refills, or authority to substitute a drug;
   14. (N) The address of the prescriber and the patient when the prescription is for a controlled substance;
   15. (O) The prescriber’s Drug Enforcement Administration (DEA) number when the prescription is for a controlled substance; and
   16. (P) If additional refills are authorized and added to the prescription, a notation indicating the method and source of the authorization must be a part of the manual record or hard copy, in such case the expiration date of the original prescription shall remain the same; and
   17. (Q) Any prescription, when it is for a controlled substance, must comply with all requirements of federal and state controlled substance laws.
2. (2) The information specified in section (1) shall be required and recorded on all prescriptions prior to dispensing by a pharmacist/pharmacy.
3. (3) Prescription hard copies must be maintained and filed sequentially by the prescription label number or a unique readily retrievable identifier. Except as otherwise provided by 20 CSR 2220-2.010(1)(J), prescription hard copies shall be retrievable at the time of inspection.

AUTHORITY: sections 338.095, 338.100, 338.140, and 338.240, RSMo Supp. 2012, and section 338.280, RSMo 2000.* Original rule filed Jan. 10, 2013, effective Aug. 30, 2013. *Original authority: 338.095, RSMo 1993, amended 2007; 338.100, RSMo 1939, amended 1971, 1990, 1997, 1999, 2010; 338.140, RSMo 1939, amended 1981, 1989, 1997, 2011; and 338.240, RSMo 1951, amended 2011.