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Regulatory Requirements
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Food and Drug Administration Regulations on Samples

You can access the FDA Drug Sample regulations at http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr203_01.html

203.30 Sample distribution by mail or common carrier.


203.31 Sample distribution by means other than mail or common carrier (direct delivery by a representative or detailer).


203.32 Drug sample storage and handling requirements.


203.33 Drug sample forms.


203.34 Policies and procedures; administrative systems.


203.35 Standing requests.


203.36 Fulfillment houses, shipping and mailing services, comarketing agreements, and third-party recordkeeping.


203.37 Investigation and notification requirements.


203.38 Sample lot or control numbers; labeling of sample units.


203.39 Donation of drug samples to charitable institutions.



Conference Call Training on Use of Samples»

Special Provisions for Free Clinics»


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