Outsourcing Facilities Need More Regulatory Transparency From FDA To Compound Drugs In Shortage

02 Jul 2020

• By Joanne S. Eglovitch

Greater clarity on which drugs outsourcing facilities can compound from bulk ingredients and what good manufacturing practice requirements they will have to meet would go a long way toward enabling them to help prevent and resolve drug shortages, Pew report says. Another factor to consider: whether any loosening of restrictions during the pandemic will continue afterward.

Two pharmacists checking inventory at hospital pharmacy. Hospital staff stocktaking in drugstore. — Report Cites Reasons Why Outsourcing Facilities Not Compounding Drugs In Shortage • Source: Shutterstock

To incentivize more outsourcing facilities to compound drugs that are in shortage, the US Food and Drug Administration needs to provide greater regulatory transparency by finalizing its bulk drug compounding list and issuing final good manufacturing practice regulations for these facilities, according to a recent report from the Pew Charitable Trusts.

While the coronavirus pandemic has prompted the agency to loosen restrictions against compounding some shortage-prone drugs for emergency use, what...