FDA allows compounding of needed hospital drugs for COVID-19

To help meet soaring demand for drugs used to treat intubated patients amid the coronavirus disease (COVID-19) pandemic, the US Food and Drug Administration (FDA) on Thursday said it will temporarily allow registered outsourcing facilities to compound 13 commonly used hospital drugs.

FDA typically tries to address shortages by working with companies within the traditional pharmaceutical supply chain, but “in light of […] the COVID-19 pandemic, and in order to respond to evolving regional conditions, additional flexibility is temporarily needed to ensure that treatment options are available when hospitals are unable to obtain FDA-approved drugs.”

Most of the drugs included in the policy are anesthetic or analgesic drugs used to support patients on ventilators. Two-thirds of the drugs are currently in shortage, with many of the shortages being reported in recent weeks. (Related: FDA reports shortage of sedation drug used for putting COVID-19 patients on ventilatorsRegulatory Focus 2 April 2020; FDA reports more shortages of drugs used to put COVID-19 patients on ventilatorsRegulatory Focus 13 April 2020).

Drugs eligible for compounding during the COVID-19 public health emergency
DrugCurrently in ShortageTherapeutic Category
Cisatracurium besylateYesAnesthesia
Dexmedetomidine hydrochlorideYesdiscontinuation reportedAnesthesia
EtomidateYesdiscontinuation reportedAnalgesia, anesthesia
Fentanyl citrateYesAnalgesia, pediatric
Hydromorphone hydrochlorideYesAnalgesia
Ketamine hydrochlorideYesAnesthesia
Midazolam hydrochlorideYesAnesthesia, neurology
Norepinephrine bitartrateNoCardiovascular
Rocuronium bromideNo (resolved)Anesthesia
Vancomycin hydrochlorideNoAntibiotic
Vecuronium bromideNoAnesthesia

In a guidance detailing the policy, FDA says it will allow outsourcing facilities to compound drugs that are essentially copies of approved drugs that are listed within the guidance. FDA also says it will not take action against outsourcing facilities for using bulk drug substances that are not included on the agency’s 503B Bulks List or for not meeting certain current good manufacturing practice (cGMP) requirements for stability testing and expiration date.

To qualify for the policy, FDA says the compounded drugs must be listed in Appendix A of the guidance, be provided directly to hospitals treating patients with COVID-19 who have been unable to obtain FDA-approved versions of the drugs and meet other bulk drug substance requirements for conformity to United States Pharmacopeia (USP) monograph standards and facility sourcing.

The guidance also outlines FDA’s expectations for stability testing and expiration dating for sterile and non-sterile drugs and explains the conditions under which the agency will exercise enforcement discretion for stability testing and expiration dating requirements.

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