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COMPLIANCE POLICY GUIDE (CPG)

CPG Sec. 460.450 Status of Mail-Order Filling of Prescriptions May 1987

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

BACKGROUND:

The question has been raised as to whether or not filling of prescriptions through the mail is legal under Section 503(b) of the FD&C Act. Some organizations have offered mail-order prescription filling services to the general public and other organizations have filled such prescriptions only for their members. All of these organizations have generally made their appeal on the basis of cut-rate prices.

POLICY:

We have <> considered the status of the mail-order filling of prescriptions under the Act. We have concluded that these transactions are legal under Section 503(b) as long as the prescriptions are written by licensed physicians, the precise drug called for is dispensed, and the drug is labeled in accordance with this section.

<> Indicates material has been deleted

Issued: 7/26/76
Revised: 10/1/80, 5/22/87

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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