The U.S. Food and Drug Administration (“FDA”) recently issued guidance regarding the use and preservation of personal protective equipment (“PPE”) by 503A sterile compounding pharmacies during the COVID-19 public health emergency. Known as traditional compounding pharmacies, 503A sterile compounding pharmacies generally compound patient-specific prescriptions and are not registered with FDA as Section 503B outsourcing facilities. The FDA’s new guidance, which will remain in effect only for the duration of the public health emergency, should be reviewed in conjunction with related guidance published by the United States Pharmacopeial Convention (“USP”) (covered by Hall Render here), as USP standards are applicable under most state laws.
Issues Faced by Compounding Pharmacies
Like many other health care entities, compounding pharmacies continue to report that they are experiencing supply shortages of face masks, gowns, gloves and other PPE. FDA notes that these supply challenges may be especially acute for hospital and health system pharmacies.
Pharmacy personnel use PPE when conducting sterile compounding activities in order to meet FDA standards related to compounded drug quality and, under most state laws, must comply with applicable USP sterile practice standards. FDA standards require that compounders guard against performing sterile operations under insanitary conditions. This functions to prohibit the improper use of PPE, including the use of potentially non-sterile PPE. Compounders experiencing PPE shortages are therefore facing the choice of potentially violating sterile practice standards or failing to produce the necessary compounded drug products.
The FDA recognizes that PPE shortages may become severe and recommends that pharmacy compounders conserve available PPE or use non-standard PPE that confers equivalent or better protection for the compounded drug product. Accordingly, the agency is directing 503A compounding pharmacies to rely on its other recently issued guidance documents addressing face mask/respirator and gown/glove/apparel shortages. If PPE shortages cannot be ameliorated by relying on this guidance, FDA recommends compounders:
- Limit the number of personnel permitted to engage in the simultaneous compounding of human drugs; and
- Reduce sterile compounding activities, considering the risks or need for the compounded products intended to be sterile.
If these actions are not sufficient to meet demonstrated patient need, FDA importantly notes in this guidance that it does not intend to take enforcement action against 503A compounders related to the PPE use discussed above provided the compounder:
- Is not able to obtain sufficient supply of appropriate PPE typically used in sterile compounding;
- Employs the mitigation strategies discussed in the guidance or employs terminal sterilization when standard PPE is not used as long as basic garbing expectations are followed; and
- Retains documentation detailing: i) when compounding without standard PPE; ii) any changes in the sterilization approach (e.g., from aseptic processing to terminal sterilization); and iii) mitigation strategies utilized in a standard operating procedure.
Regarding the referenced mitigation strategies, the guidance addresses a number of mitigation strategies related to: i) the reuse of PPE or the use of inferior/homemade PPE; ii) the reduction of risk of contamination in the compounding environment when compounding without standard PPE; and iii) the reduction of risk of microbial proliferation in a potentially contaminated product.
Practical Takeaways
- This guidance applies to PPE use during human drug compounding at state-licensed 503A pharmacies or federal facilities that are not registered with the FDA as outsourcing facilities. FDA-registered 503B outsourcing facilities remain subject to current good manufacturing practice (“cGMP”) requirements for finished pharmaceuticals.
- Compounders should conduct a risk evaluation and assessment before employing any risk mitigation strategy either discussed in the guidance or any alternative strategy.
- If compounding without appropriate, standard PPE or if employing any risk mitigation strategy, compounders should appropriately document the circumstances, evaluations and responses to all such instances.
- Compounders should apply this guidance in conjunction with other FDA guidance addressing the use of PPE and continue to periodically verify the status of any guidance issued by FDA during the public health emergency.
- Keep in mind this guidance is in addition to a federal blanket waiver of the condition of participation requirements for sterile compounding at hospitals and critical access hospitals which allows “used face masks to be removed and retained in the compounding area to be re-donned and reused during the same work shift in the compounding area only” to conserve face mask supplies.
If you have questions about these issues or would like to be updated on any further developments, please don’t hesitate to contact:
- Todd Nova at (414) 721-0464 or tnova@hallrender.com;
- Andrew Harrison at (414) 721-0467 or aharrison@hallrender.com;
- Lindsey Croasdale at (414) 721-0443 or lcroasdale@hallrender.com; or
- Your regular Hall Render attorney.
Hall Render’s attorneys and professionals continue to maintain the most up-to-date information and resources at our COVID-19 Resource page, through our 24/7 COVID‑19 Hotline at (317) 429-3900 or by contacting your regular Hall Render attorney.
Hall Render blog posts and articles are intended for informational purposes only. For ethical reasons, Hall Render attorneys cannot—outside of an attorney-client relationship—answer specific questions that would be legal advice.
