N.H. Admin. Code § Ph 702.04

Current through Register No. 50, December 12, 2024
Section Ph 702.04 - Automated Data Processing Systems

All pharmacies shall have an automated data processing system to be used for the storage of original, faxed or written prescriptions and the retrieval of refill information for all prescription orders including, but not limited to, controlled substances in schedules II, III, IV, and V, as defined in 21 CFR 1308.11-1308.15 subject to the following conditions:

(a) The system shall provide security against improper manipulation or alteration of stored records. Individual access codes shall be unique to each licensed location and shall not be available to any other location;
(b) A pharmacy shall make arrangements with the supplier of data processing services or materials to assure that the pharmacy continues to have access to the complete prescription and dispensing records if the relationship with such supplier terminates for any reason. A pharmacy shall assure continuity in the maintenance of records for the protection of public health;
(c) Any computerized system shall provide on-line retrieval, via electronic display or hard-copy printout, of all prescription records processed at that licensed location;
(d) The information required by (c) above shall include:
(1) The original prescription number;
(2) The date of issuance of the original prescription order by the practitioner;
(3) The full name and address of the patient;
(4) The name, address, and DEA registration number of the practitioner, when applicable;
(5) The name, strength, dosage form, quantity prescribed, and quantity dispensed if different from the quantity prescribed, and the total number of refills authorized by the prescribing practitioner, if any; and
(6) The date each fill is dispensed.
(e) Any computerized system shall also provide on-line retrieval, via electronic display or hard-copy printout, of the current refill history of all prescription orders including controlled substances in schedules III, IV, and V;
(f) This refill history shall include:
(1) The name of the drug;
(2) The date of refill;
(3) The quantity dispensed;
(4) The identification code, or name or initials of the dispensing pharmacist for each refill; and
(5) The total number of refills dispensed to date for that prescription order;
(g) Documentation of the fact that the refill information entered into the computer each time a pharmacist refills an original prescription order, including refill orders for a schedule III, IV, or V controlled substances is correct shall be provided by:
(1) A hard-copy printout of each day's controlled substance prescription order refill data which shall be verified, dated, and signed by each pharmacist who refilled such prescription orders; or
(2) In lieu of such a printout, the pharmacy shall maintain a bound log book, or separate file, in which each individual pharmacist involved in such dispensing shall sign a statement each day, attesting to the fact that the refill information entered into the computer that day has been reviewed by him and is correct as shown;
(h) The hard-copy printout or log book referenced in (g) above shall be kept at the pharmacy, in a separate file, for a period of 4 years from the dispensing date;
(i) The computerized system shall have the capability of producing a printout of all refill data and shall include:
(1) A refill-by-refill audit trail for any specified strength and dosage form of any controlled substance;
(2) Name of the prescribing practitioner;
(3) Name and address of the patient;
(4) Quantity dispensed on each refill;
(5) Date of the dispensing for each refill;
(6) Name or identification code of the dispensing pharmacist; and
(7) The number of the original prescription order;
(j) In any computerized system employed by a user pharmacy, the central recordkeeping location shall be capable of sending the printout to the pharmacy within 48 hours;
(k) Each pharmacy using an automated data processing system shall maintain on file a hard copy of all controlled substance prescriptions in schedules II, III, IV and V, excluding electronic, preserving all information contained on the original written or oral prescription. Any computer generated material shall be affixed to the rear of the prescription, leaving the face of the prescription intact; and
(l) Computer-produced prescription container labels shall comply with RSA 318:47-a, RSA 318:47-b and RSA 318-B:13, II.

N.H. Admin. Code § Ph 702.04

#1639, eff 11-1-80; ss by #2260, eff 1-5-83; ss by #2914, eff 11-27-84; ss by #4600, eff 8-1-89; ss by #6094-B, INTERIM, eff 9-21-95, EXPIRED, 1-19-96

New. #6181-B, eff 2-5-96, EXPIRED: 2-5-04

New. #8316, eff 3-26-05

Amended by Volume XXXV, Number 32 Filed August 13, 2015, Proposed by #10903, Effective 8/5/2015, Expires8/5/2025.
Amended by Volume XLII Number 28, Filed July 14, 2022, Proposed by #13398, Effective 6/16/2022, Expires 6/16/2032