The COVID-19 pandemic has had a significant impact on health care systems and has resulted in an increased demand for PPE by health care professionals. By way of background, pharmacists and technicians who compound sterile human drugs use PPE to reduce the risk of microbes and other particles present on human skin, hair, and clothing contaminating a drug preparation, which could deem the drug “adulterated.” Under the Federal Food, Drug, and Cosmetic Act (FDCA), a compounded drug product is deemed adulterated if it has been prepared, packed, or held under insanitary conditions. See 21 U.S.C. § 351(a)(2)(A). Some insanitary conditions are related to the improper use of PPE during the compounding of sterile drugs, which include, for example:
- Engaging in aseptic processing wearing non-sterile gloves;
- Putting on gowning apparel in a way that may cause the gowning apparel to become contaminated; or
- Failing to disinfect or change gloves frequently enough given the nature of the operations to prevent contamination.
Due to the PPE supply chain impact brought on by COVID-19, FDA initially issued the Temporary PPE Guidance to communicate how it related to pharmacists’ and technicians’ use of PPE during human drug compounding at traditional compounding pharmacies. (Note: the Temporary PPE Guidance does not apply to federal facilities registered with FDA as outsourcing facilities.) FDA understood that compounders are currently experiencing difficulties obtaining PPE for sterile compounding, and in areas where PPE shortages are most severe, these shortages have the potential to impact the availability of compounded preparations for patients, especially those in critical need.
Therefore, as a temporary measure during the public health emergency, FDA does not intend to exercise enforcement action regarding compliance with the insanitary conditions provision when sterile drugs are compounded without standard PPE provided certain circumstances are present. A summary of these conditions is as follows:
- The compounder is unable to obtain a sufficient supply of PPE that it typically relies on to assure compliance with the insanitary conditions provisions discussed above;
- The drugs compounded meet the conditions set forth in Section 503A of the FDCA;
- The compounder employs certain risk mitigation strategies or employs terminal sterilization techniques where standard PPE is not used; and
- The compounder complies with certain recordkeeping requirements.
In the update to the Temporary PPE Guidance, and as part of FDA’s proposed strategies to reduce risk of microbial proliferation in a potentially contaminated product, FDA clarified that drugs can be compounded under this policy in a segregated compounding area that is not in a cleanroom when the following beyond-use dates are utilized:
- Up to 12 hours for products stored at room temperature; and
- Up to 24 hours for products stored refrigerated.
FDA’s issuance of the Temporary PPE Guidance and its recent update are among the many guidances and policies FDA has issued for compounders during the COVID-19 pandemic, which is further evidence that FDA is aware of the critical role compounders play in the drug supply chain and in providing needed medications to patients.
For compounders that are experiencing PPE shortages, we recommend consulting the Temporary PPE Guidance to determine a safe path forward for compounding while also remaining compliant with FDA’s guidance and expectations. Should you have any questions regarding how to comply with FDA’s Temporary PPE Guidance, or any of the issues raised in this alert, please do not hesitate to reach out to Rachael Pontikes, Emily Hussey, David Hartmann, or Kelly Kearney.
Our Reed Smith Coronavirus team includes multidisciplinary lawyers from Asia, EME and the United States who stand ready to advise you on the issues above or others you may face related to COVID-19.
For more information on the legal and business implications of COVID-19, visit the Reed Smith Coronavirus (COVID-19) Resource Center or contact us at COVID-19@reedsmith.com
Client Alert 2020-330
