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GUIDANCE DOCUMENT

Prescription Drug Marketing Act — Donation of Prescription Drug Samples to Free Clinics March 2006

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2002-D-0092
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance provides information for free clinics that receive donated prescription drug samples from licensed practitioners or other charitable institutions. The guidance discusses
 concerns that have been expressed by certain individuals regarding regulatory requirements in 21CFR 203.39 for drug sample donations.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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

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

All written comments should be identified with this document's docket number: FDA-2002-D-0092.

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