FDA authorizes certain compounders to compound alcohol-based hand sanitizers to ensure consumer demands can be met
FDA recognizes that the potential public health threat posed by COVID-19 is high, both globally and to United States residents. Hand hygiene (that is, hand washing and hand sanitizing) is a critical part of the United States response to COVID-19. When soap and water are not available, the Centers for Disease Control and Prevention (CDC) recommends consumers use an alcohol-based hand sanitizer that contains at least 60 percent alcohol. Due to this formal recommendation for hand sanitizing, hand sanitizers containing at least 60–70 percent alcohol or isopropyl alcohol are both in high demand and nearing shortage.
This is why just last week, FDA announced the availability of a guidance for industry entitled “Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency” (the Guidance). The Guidance permits compounders to compound alcohol-based hand sanitizers, subject to certain restrictions, for consumer use and for use as health care personnel hand rubs for the duration of the public health emergency.
State boards of pharmacy are waiving key pharmacy regulations to allow for maximum patient treatment and pharmacist safety
In addition to the Guidance, many state boards of pharmacy are temporarily revising or waiving their regulations to allow for more remote pharmacy practice or different staffing ratios to meet patient need while maintaining the health and safety of their pharmacists. For example:
- California State Board of Pharmacy: In light of the California governor’s declaration of a statewide emergency, the president of the California State Board of Pharmacy authorized waivers of specific provisions of pharmacy law, such as the staffing ratio provision, remote processing provisions, and signature requirements, among others.
- Florida Board of Pharmacy: The Florida Board is allowing its pharmacists to refill and dispense certain medications early.
- Texas State Board of Pharmacy: The Texas Board has temporarily suspended certain rule requirements, such as inspection requirements for certain classes of pharmacies, inventory notarization requirements, and in-person patient counseling requirements.
Pharmacies struggling to meet the needs of patients have options
Finally, pharmacies working to meet an increased volume of patient needs may consider looking to engage in central fill arrangements or perform intracompany transfers between commonly owned facilities. Both central fill arrangements and intracompany transfers are subject to the nuances of each state in which the pharmacy is located and to which the pharmacy is shipping.
Reed Smith is continuing to monitor developments in the compounding space during this critical time and will report additional developments. In the meantime, should you have any questions regarding any of the issues raised in this alert, please reach out to Rachael Pontikes, Emily Hussey, and Kelly Kearney at any time.
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 many 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 2020-149
