FDA Allows Pharmacies to Compound Drugs to Fill Hospitals’ Needs

Over the last few days, FDA has issued several guidance documents relating to compounding of certain aqueous injectable drugs by outsourcing facilities, State-licensed pharmacies and Federal facilities for duration of the COVID-19 public health emergency, or for a shorter time as FDA may announce.  In an effort to mitigate actual or anticipated drug shortages for 13 drugs products needed to support the care of hospitalized COVID-19 patients, mostly ventilator-related drugs, FDA will permit compounding of drugs on its shortage list by registered outsourcing facilities 503(B) as well as 503(A) State-licensed pharmacies or Federal facilities when hospitals are unable to obtain these drugs.[1] FDA had previously issued a guidance for outsourcing facilities.[2]  FDA will not take action when the drugs listed below (list to be periodically updated) are compounded by 503(A) pharmacies as copies of commercially-available drugs or not pursuant to a patient-specific prescription. Hospital are encouraged to first seek a supply of these shortage drugs through 503(B) facilities which are subject to more robust quality standards (e.g. cGMPs). In cases where the supply chain from these facilities is not available to meet urgent needs, hospitals may turn to 503(A) pharmacies and Federal facilities to fill the void. Under the Guidance, FDA has provided default Beyond Use Dates (BUD). FDA also requests that state authorities that regulate pharmacy compounding (or the state where the hospital is located if different from the state where the compounder is located) be notified to ensure the relevant authorities do not object to providing the drugs without a patient-specific prescription.

The current drug list includes:

Cisatracurium besylate

Midazolam hydrochloride

Dexmedetomidine hydrochloride

Norepinephrine bitartrate

Etomidate

Rocuronium bromide

Fentanyl citrate

Vancomycin hydrochloride

Furosemide

Vecuronium bromide

Hydromorphone hydrochloride

Lorazepam

Ketamine hydrochloride

 

The actions by the FDA allows state-licensed pharmacies to fill a critical need for drugs used to treat patients with COVID-19, particularly those that are ventilator dependent. This is a opportunity for pharmacies to expand their contribution to the pandemic battle. However, pharmacies that want to compound these medications pursuant to the FDA guidance need to be cognizant of the regulatory risks and must comply with FDA and state-specific regulations. Frier Levitt’s team of pharmacist-lawyers are available to assist pharmacies in implementing a COVID-19 specific compounding program.

[1] Guidance for Industry; Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Pharmacy Compounders not Licensed as Outsourcing Facilities During the COVID-19 Public Health Emergency (April 2020),  https://www.fda.gov/regulatory-information/search-fda-guidance-documents/temporary-policy-compounding-certain-drugs-hospitalized-patients-pharmacy-compounders-not-registered

[2] Guidance for industry; Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health Emergency (April 2020), https://www.fda.gov/media/137031/download.

Tagged with: , , , , , , , , , , , , ,
Share: