FDA clarifies relaxed compounding rules for pharmacies

A number of revisions to pharmacy compounding rules in response to the COVID-19 pandemic have been clarified by FDA.

A number of revisions to pharmacy compounding rules in response to the COVID-19 pandemic have been clarified by FDA. During a recent APhA webinar, the agency said that according to the new rules, drugs on its shortages list are deemed "not commercially available," which indicates that compounding facilities are not required 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 if it is for a specific patient. FDA added that it does not intend to take action if a compounding facility fills orders for a compounded drug that is essentially a copy of an approved drug that was discontinued and is no longer on the market.