Propofol is needed for intubation but supplies are limited
As with certain other drug products, FDA has received reports from hospitals that are having difficulty obtaining adequate supplies of FDA-approved propofol injectable emulsion, 10 mg per mL, used to support COVID-19 patients, particularly those who have been sedated and intubated. In fact, FDA-approved propofol products are so scarce that propofol is currently listed on FDA’s Drug Shortage List.
In order to fill this critical gap in care, traditional compounding pharmacies and outsourcing facilities with access to FDA-approved propofol products have signaled a desire to repackage or combine units of finished, FDA-approved propofol products to provide to hospitals treating patients infected with COVID-19. Giving larger supplies of propofol products to these hospitals will help to minimize exposure between patients and hospital staff and to conserve vital personal protective equipment.
In recognition of the important role that traditional compounding pharmacies and outsourcing facilities play in the U.S. health-care system’s response to the coronavirus pandemic, FDA has issued new guidance to allow traditional compounding pharmacies and outsourcing facilities to repackage and combine FDA-approved propofol products under certain conditions.
Compounding facilities will fill the critical gap in care
While existing FDA guidance addresses the repackaging of certain human drug products by traditional compounding pharmacies and outsourcing facilities (Repackaging Guidance), the Propofol Guidance is intended to address product changes that fall outside FDA’s Repackaging Guidance. For example, the Repackaging Guidance states that the drug products must be repackaged in a manner that does not conflict with its approved labeling, however, the critical shortage of propofol necessitates repackaging propofol drug products in a way that deviates from the Repackaging Guidance.
Pursuant to the Propofol Guidance, therefore, traditional compounding pharmacies and outsourcing facilities are permitted to repackage and combine FDA-approved propofol drug products under the following conditions:
- The repackaged or combined drug product is provided directly to a hospital only after the hospital informs the traditional compounding pharmacy or outsourcing facility that it (a) is treating patients with COVID-19, and (b) has been unable to obtain FDA-approved propofol products after making reasonable efforts;
- The repackaged or combined product is discarded immediately upon any change in appearance such as discoloration, visible separation of water and oil (for example, oil droplets), or the presence of particulate matter; and
- The product is repackaged or combined consistent with the Repackaging Guidance, except that:
a. FDA-approved propofol products may be repackaged or combined without doing so under nitrogen;
b. A beyond use date (BUD) of not more than 12 or 4 hours is applied, depending on whether the preservatives and antioxidants listed in the Description section of the FDA-approved products match; and
c. The container is suitable for storage of the drug product through its BUD, and the labeling includes specific storage instructions.
While FDA waives certain provisions of the Repackaging Guidance or extends others, it also highlights several requirements that remain in effect for both traditional compounding pharmacies and outsourcing facilities, such as, the drug product must be (i) prepared by or under the supervision of a licensed pharmacist, and (ii) distributed only in states in which the compounding facility meets all applicable state requirements. In addition, please note:
- Traditional compounding pharmacies must (a) still obtain a patient specific prescription prior to dispensing the repackaged or combined propofol drug product, and (b) repackage the products in accordance with USP Chapter <797>; and
- Outsourcing facilities must (a) adhere to current good manufacturing practices, subject to exceptions regarding BUDs and product containers, and (b) label the repackaged propofol drug products as set forth in an appendix.
We strongly encourage compounding pharmacies and outsourcing facilities that are interested in providing this critical service to closely review the requirements set forth in the Propofol Guidance and its appendices to ensure compliance with FDA’s expectations during this unprecedented time.
It is important to recognize that propofol is not one of the drug products listed in Appendix A to the Temporary Guidance documents summarized on reedsmith.com that FDA recently issued to permit the compounding of certain drug products by traditional compounding pharmacies and outsourcing facilities for patients hospitalized with COVID-19. As such, the Propofol Guidance pertains solely to the repackaging and combining of FDA-approved propofol drug products.
FDA intends for the Propofol Guidance to remain in effect only for the duration of the public health emergency related to COVID-19, or for such shorter time as FDA may announce by updating or withdrawing the guidance based on the evolving nature of the public health emergency. With the Propofol Guidance, FDA continues to look to compounding facilities to play a critical role in the drug supply.
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 COVIDemail@example.com.
Client Alert 2020-269