FDA updates COVID-19 compounding guidance with reporting clarification

Regulatory NewsRegulatory News | 22 May 2020 |  By 

Two guidance documents related to compounding drugs during the coronavirus pandemic were updated by the US Food and Drug Administration (FDA) on Thursday. Among other updates, a requirement for weekly reporting will allow hospitals to identify which compounders are making what quantities of drugs currently in shortage during the public health emergency of the COVID-19 pandemic.
The FDA updated two separate guidance documents regarding compounding of fifteen drugs that are currently in shortage; most of them are medicines that treat patients who require intubation and mechanical ventilation. The first applies to outsourcing facilities, while the second applies to smaller pharmacy compounders.
(RELATED: FDA allows compounding of needed hospital drugs for COVID-19, Regulatory Focus 16 April 2020; FDA expands COVID-19 drug compounding policy to smaller pharmacies, Regulatory Focus 21 April 2020; Epinephrine and morphine added to FDA’s COVID-19 compounding lists, Regulatory Focus 20 May 2020).
The guidance for temporary compounding of drugs by outsourcing facilities was updated to specify timely product reporting. Beginning 1 June 2020, drug products compounded under the guidance should be included in weekly reports by the outsourcing facility. These reports should mirror the content usually provided in the facility’s biannual reports to the FDA. The outsourcing facility must also provide a record of the cumulative number of individual units of drug produced during the reporting period of 1 December through 31 May, and the period from 1 June through November 30 of each year.
“Hospitals can use this information, which FDA will post on its website, to help determine which outsourcing facilities are compounding drugs used for hospitalized patients with COVID-19,” FDA said.
Additional language in the updated guidance for outsourcing facilities clarifies that if the facility fills orders of a drug that is essentially a copy of a product that has already been approved by FDA, the agency does not intend to take action against the facility, as long as the drug would be covered by the guidance within 90 days of the facility’s compounding, distributing or dispensing the drug.
Container-closure integrity testing should be initiated with the first batch of drug and needs to be completed before a batch is released. Only one study needs to be conducted per formulation and container-closure system. The container-closure integrity test should be conducted on samples aged to or beyond the desired beyond-use date (BUD) or expiration date. To minimize the amount of testing required, FDA permits consideration of a bracketed or matrixing approach to testing.
For compounding of the 15 drugs by pharmacy compounders, the guidance now includes directions for adverse event reporting. The pharmacy should report adverse events that are associated with the drugs covered by the compounding guidance “as soon as possible, but no later than 15 days after receipt of such information to FDA’s MedWatch Adverse Event Reporting program,” says the guidance.

The minimum data to be reported includes the compounder name and contact information, patient information if available, and product information. Details of product information to be reported are ingredients, product strengths, dosage form, lot number and BUD. The report should also include a description of the adverse event.


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