What Pharmacists Should Know

Health and government officials are constantly learning new information about preventing, detecting, and treating the Coronavirus (COVID-19). Below are resources for pharmacists and other healthcare providers.

• Compounding and Compounding Hand Sanitizers
• Controlled Substances
• COVID-19 Test Administration
• Emergency Use Authorizations
• Medical Licensing Waivers
• Personal Protective Equipment
• Additional Resources

Compounding and Compounding Hand Sanitizers

• The most recent updates related to compounding from FDA can be found here. Information can also be found in the drug shortages section of the FDA website. Questions can be emailed to compounding@fda.hhs.gov.
• USP has released a Hand Sanitizer Tool Kit for compounders, drug manufacturers, and other facilities.

Controlled Substances

• Drug Enforcement Administration (DEA) has posted information on the registration of emergency temporary sites, telemedicine prescriptions for controlled substances, controlled substance prescription refills, DEA-222 form exceptions, and more.
• Effective January 31, 2020 and until the end of the Department of Health and Human Services’ (HHS) public health emergency declaration, DEA-registered practitioners are exempt from limitations imposed by the “five percent rule”.
• DEA has released guidance on the issuance of oral Schedule II prescriptions.
• FDA has issued guidance about a temporary policy on the distribution of drug samples.

COVID-19 Test Administration

• HHS released information about COVID-19 testing plans by state and jurisdiction and announced a national COVID-19 testing implementation forum. HHS also issued guidance under the PREP Act to expand access to safe and effective COVID-19 vaccines when they are made available.
• OASH’s Guidance for Licensed Pharmacists, COVID-19 Testing, and Immunity under the PREP Act was released on April 8. Additional documentation was compiled by APhA to help pharmacists understand this guidance.
• CDC has compiled resources and information for laboratories.
• The Centers for Medicare & Medicaid Services (CMS) has released a document detailing how pharmacies and other suppliers can apply for waivers that will let them temporarily enroll as independent clinical diagnostic laboratories, which are regulated by the agency.
• FDA issued testing information about ID NOW.
• FDA has provided important information on the use of antibody tests for COVID-19 including reporting adverse events. FDA has recommended that certain antibody tests for COVID-19 are no longer used by heath care providers and clinical laboratories.

Emergency use authorizations

•  FDA has revoked the emergency use authorization of chloroquine and hydroxychloroquine and has provided additional information for frequently asked questions.
• FDA has compiled information and a list of all current emergency use authorizations and guidance documents.

Medical Licensing Waivers

• A list of state medical licensure activity and emergency declarations can be found on the FSMB website.

Personal Protective Equipment

• FDA has compiled conservation strategies for personal protective equipment.
• ASHP is conducting biweekly surveys on the status of medical supplies during the COVID-19 pandemic.
• Hoarding or price gouging of PPE should be reported to the National Center for Disaster Fraud at 866/720-5721 or disaster@leo.gov.