Drug Quality and Dispensing – Part II

In my last post, we identified the FDA Orange Book as a good place to start when determining the safety and effectiveness of pharmaceuticals.  All FDA approved products go through significant evaluation; the Orange Book rates generics on their level of therapeutic equivalence to the original product.

Physicians considering pharmaceutical dispensing can also look at the source of the pharmaceuticals.  PCA Pharmaceuticals purchases medications directly from the manufacturer or from one of the large wholesalers.

A growing trend across the country is drug pedigree requirements.  The drug pedigree basically tracks the movement of the pharmaceutical from the manufacturer.  The goal of drug pedigrees is to reduce counterfeit products.  Not all states require pedigrees but reputable distributors can supply them when requested.  Pedigree laws are still evolving but provide another means for validating medications.  One note: states with pedigree laws do not apply requirements equally to all distributors.

Some clinics ask about imported pharmaceuticals.  There are two types of imported pharmaceuticals: legal and illegal.  Many reputable drug companies produce pharmaceuticals in foreign facilities.  These operations are required to be FDA licensed and their products must be approved by the FDA to be legally imported into the United States.  Illegal products come through alternate channels and are not cleared through the FDA process.  The drug name, manufacturer and strength must appear in the Orange Book to be verified.  Click on the Orange Book Query to check out any proprietary product.

Please note that these are broad-brush descriptions.  Exceptions exist and the clinic should investigate further when appropriate.

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