Critical medications for COVID-19 patients are becoming increasingly scarce
Due to the COVID-19 pandemic, hospitals across the United States are currently experiencing difficulty accessing some FDA-approved drug products for the treatment of patients infected with the novel coronavirus. Not only are ventilators in great demand and in short supply, but many hospitals are facing looming shortages of medications that are critical to safely and effectively maintaining hospitalized patients on ventilators. While some of these critical FDA-approved drug products appear on FDA’s Drug Shortage List, many do not.
A growing number of hospitals are concerned that certain drug products not included on FDA’s Drug Shortage List will become unavailable. These concerns are exacerbated by regional disparities in COVID-19 infection rates and other fast-evolving, difficult-to-predict circumstances.
Therefore, FDA has turned to traditional compounding pharmacies and outsourcing facilities to fill this critical gap in medication for seriously ill patients.
Compounding facilities will fill the critical gap in care
Under normal circumstances, traditional compounding pharmacies and outsourcing facilities are permitted to compound medications only when prepared pursuant to certain regulatory conditions as set forth in Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act.
In light of the ongoing public health emergency related to COVID-19, however, FDA has signaled that it will permit traditional compounding pharmacies and outsourcing facilities to get these vital medications to the patients that need them as soon as possible. Specifically, if certain specific conditions set out in the Temporary Guidances are met, FDA will allow (1) a traditional compounding pharmacy to compound a drug that is essentially a copy of a commercially available drug or to provide a drug to a hospital without obtaining a patient-specific prescription, and (2) an outsourcing facility to (i) compound a drug product that is essentially a copy of an FDA-approved drug, (ii) use a bulk drug substance to prepare a drug product that is not on FDA’s approved 503B Bulks List, or (iii) not meet current good manufacturing practice (cGMP) requirements for product stability testing and the establishment of an expiration date.
In order to comply with the Temporary Guidances, outsourcing facilities must ensure that:
- the compounded preparation appears on a list in Appendix A of the Temporary Guidances and contains only one of the active ingredients enumerated on that list – there are currently 13, all of which are intended or expected to be sterile;
- the compounded preparation is provided directly to a hospital only after that hospital informs the outsourcing facility that it (i) is treating patients with COVID-19, and (ii) has made reasonable attempts to locate an FDA-approved drug product containing the same active ingredient for the same route of administration, but has been unable to do so;
- the bulk drug substances used by the outsourcing facility to compound the preparation (i) are in conformance with applicable United States Pharmacopeia and National Formulary monograph standards, (ii) are sourced from facilities registered with FDA, and (iii) are accompanied by a valid certificate of analysis; and
- the outsourcing facility’s cGMP practices regarding stability testing and expiration dates meet the conditions of enforcement discretion described in Appendices B and C of the Temporary Guidances.
While traditional compounding pharmacies are similarly limited to compounding only the drugs listed in Appendix A, they can act as a fallback for a hospital only after the hospital has confirmed that it has been unable to locate the drug product first from an outsourcing facility. Additionally, compounding pharmacies must ensure that:
- the prescription order is marked with a notation that the drug is being provided to a patient infected with COVID-19;
- they request that the hospital provides documentation exhibiting the identity of the patient to whom the drug is administered within one month of sending the drug to the hospital; and
- before providing the drug to the hospital, they receive approval from their home-state boards of pharmacy to dispense prescriptions that are not, as of yet, patient-specific.
We strongly encourage compounding pharmacies and outsourcing facilities that are interested in providing this critical service to closely review the requirements and exceptions set forth in the Temporary Guidances and their Appendices to ensure compliance with FDA’s expectations during this unprecedented time.
What’s next for compounding facilities?
FDA intends for the Temporary Guidances to remain in effect only for the duration of the public health emergency related to COVID-19. Moreover, as the effects of the pandemic continue to evolve, FDA is looking to compounding facilities (both pharmacies and outsourcing facilities alike) to play a critical role in the drug supply and, as such, FDA has indicated that it may amend the list of drug products compounders are entitled to compound under the Temporary Guidances, as necessary.
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 2020-249
