The agency clarified to the American Pharmacists Association that in accordance with the new rules, drugs on its drug shortages list are considered to be “not commercially available,” meaning compounding facilities don’t have to follow compounding limits for drugs that are “essentially a copy” of a drug already on the market.
This temporary rule means a compounding pharmacist could copy an otherwise commercially available drug as long as it’s for a specific patient.
The FDA also said it doesn’t intend to take action if a compounding facility fills orders for a compounded drug that is essentially a copy of an approved drug that has been discontinued and is no longer on the market.
Read the full news release here.
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