A med spa in Texas recently received a letter from the Food and Drug Administration following an inspection that highlights two of the currently-in-effect requirements of the Drug Supply Chain Security Act.
The requirements:
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Pharmacies and other dispensers must exclusively deal with authorized trading partners, and
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Must inspect packages received for a serialized product identifier.
DSCSA-regulated prescription products that do not have a product identifier (and are not covered by a waiver or exemption) or that have a product identifier that fails verification should be reported to FDA. Click here to read a blog written by a former FDA attorney and click here for a DSCSA compliance checklist for NCPA members.
NCPA