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COMPLIANCE POLICY GUIDE (CPG)

CPG Sec. 460.400 Computerized Prescription Recordkeeping by Pharmacies October 1980

Final
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

BACKGROUND:

The National Association of Boards of Pharmacy (NABP) Task Force on Innovative Pharmacy Care has recommended the use of automated systems in pharmacies to keep readily retrievable and accurate records.

POLICY:

The Food and Drug Administration regards the use of a computerized prescription recordkeeping system as satisfying the statutory requirements for prescription drug recordkeeping as set forth under Section 503(b) of the Federal Food, Drug, and Cosmetic Act, provided the system includes the following NABP recommended controls:

  1. The pharmacist has control over all prescriptions, i.e. the pharmacist must be able to ascertain quantities, refills remaining, time of previous filling and other information pertinent to adequate control.
  2. The pharmacist responsible for the initial fill of a prescription and any subsequent refills can be readily determined.
  3. The data is readily retrievable. The system must be capable of producing a listing of transactions to meet FDA and DEA regulations.
  4. All prescription transactions occurring while the automated system is inoperable must be entered into the system as soon as possible, after the system is repaired.
  5. Data in computerized prescription storage systems can be and is recreated in case of need.
  6. The system must provide for the confidentiality of patient information.

Issued: 10/1/80

Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.

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