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US FDA Clarifies Compounding Policies On Interstate Distribution, Drug Shortages

 
• By Joanne S. Eglovitch

The US FDA clarifies that drugs in shortage are not considered “essentially a copy” of an approved drug and can be compounded by traditional pharmacies and outsourcing facilities. This clarification is one of several recently announced by the agency.

Hospital building sign closeup, with sky reflecting in the glass. 3d rendering
FDA Will Not Yet Enforce Hospital Distance Limits For Compounding Pharmacies • Source: Shutterstock

The US Food and Drug Administration has announced several clarifications on its policies on drug compounding, these include not imposing limits on the amount of compounded drugs pharmacies can distribute over state lines. However, that will change once the FDA and state agencies agree on a final memorandum of understanding (MOU) on interstate compounding.

Another clarification is that drugs in shortage are not considered “essentially a copy” of an approved drug and can be compounded by traditional pharmacies and outsourcing facilities.

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