FDA expands COVID-19 drug compounding policy to smaller pharmacies

Regulatory NewsRegulatory News | 21 April 2020 |  By 

After allowing registered outsourcing facilities to compound certain drugs used to treat patients on ventilators in response to soaring demand and shortages amid the coronavirus disease (COVID-19) pandemic, the US Food and Drug Administration (FDA) says it will now allow some smaller compounders to make those drugs as well.
In a new guidance, FDA says the policy applies to state-licensed pharmacies and federal facilities, which are regulated under Section 503A of the Federal Food, Drug, and Cosmetic Act, and unlike outsourcing facilities, do not have to adhere to current good manufacturing practice (cGMP) requirements and may only compound drugs based on prescriptions for individual patients. (RELATED: FDA allows compounding of needed hospital drugs for COVID-19, Regulatory Focus 16 April 2020).
“FDA recognizes that during the COVID-19 public health emergency, even with the recent temporary regulatory flexibility provided to outsourcing facilities, the supply of FDA-approved drugs and drugs compounded by outsourcing facilities may not be sufficient to meet urgent needs for drugs used to treat hospitalized patients,” FDA writes.
While emphasizing that compounded drugs produced by outsourcing facilities are subject to “more robust quality standards,” FDA says it does not intend to object to pharmacies compounding drugs that are essentially copies of commercially available drugs that are listed in Appendix A of the guidance and providing them to hospitals even when they do not have a patient-specific prescription.
Most of the drugs, which mirror those permitted under FDA’s policy for outsourcing facilities, are currently in shortage.
FDA dictates that drugs compounded under the policy are provided to hospitals treating patients with COVID-19 and says that hospitals should first attempt to obtain FDA-approved or outsourcing facility-made versions of the drugs.
Under the policy, FDA provides a set of default beyond use dates (BUD) based on the processing and storage conditions of the drugs for compounders to use. Compounders are instructed to use a shorter BUD if there is information indicating that the drug may not be physiochemically stable for the duration of the default BUD or if the pharmacy is lacking the personal protective equipment it typically uses to ensure that compounded drugs are not made in insanitary conditions.
FDA also says that pharmacies should notify state authorities before providing drugs compounded under the policy to hospitals to ensure that the relevant authorities do not object to them providing the drugs without a patient-specific prescription.
Additionally, FDA says that hospitals should “maintain records of both the entity supplying the hospitals with such products and the patients that receive such products” and to the extent allowable by law, provide records to compounders that identify which patients received the drugs.
“Such records may be important to allow follow-up if quality issues or adverse events are reported associated with drugs the pharmacy has provided,” FDA writes.


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