FDA Updates Guidance Documents on Compounding For Hospitalized Patients During the COVID-19 Pandemic
Food and Drug Administration (FDA) has updated two guidance documents regarding temporary policies for compounding of hospitalized patients during the coronavirus disease 2019 (COVID-19) pandemic. The updated guidance documents include:
- Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health Emergency, which focuses on the compounding of drugs for hospitalized patients by registered outsourcing facilities.
- Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency Guidance for Industry, which focuses on compounding for hospitalized patients by state-licensed pharmacies and federal facilities, including hospital and health system pharmacies, that are not registered as outsourcing facilities.
Due to the nature of the public health emergency, both guidance document updates are being implemented without prior public comment, but public comments may still be submitted using the relevant online portals.
Over 6,800 Applications Received for NABP Passport, a Service Supporting Boards’ COVID-19 Response
As of May 22, 2020, NABP has received more than 6,800 requests for an NABP Passport and has issued nearly 50,000 passports. Launched in response to the COVID-19 crisis, this new service supports member state boards of pharmacy in processing requests for temporary and emergency licensure to pharmacists and pharmacy technicians. NABP Passport allows those seeking temporary or emergency nonresident licensure to submit state-specific requests for an NABP Passport through their NABP e-Profile. NABP then conducts the necessary license verification and disciplinary history review at no cost to the individual or the boards of pharmacy. To streamline the process for applicants, multiple states can be included in each request; therefore, the number of passports issued is higher than the number of requests.
Pharmacists must have at least one existing license to apply for the Passport, and pharmacy technicians must have a license/registration or hold a certification from the Pharmacy Technician Certification Board or Exam for the Certification of Pharmacy Technicians. Interns and pharmacy businesses can also apply for a Passport if allowed by the state in which they are seeking temporary or emergency licensure.
Approved NABP Passports are provided to the state boards of pharmacy for final approval in a secure system, NABP e-Profile Connect. States may opt to recognize the NABP Passport as a temporary license to practice in their state, or as a prerequisite to temporary, emergency licensure. Currently, 19 jurisdictions have indicated they will make use of this new service for pharmacists and technicians, and eight states have approved the service for interns. More information is available in the NABP Passport section of the NABP website.
List of Antibody Tests Being Removed From FDA’s ‘Notification List’
FDA has posted a list of antibody tests that are being removed from its “notification list” of tests that are being offered during the pandemic. Antibody tests on this new removal list include those voluntarily withdrawn from the notification list by the test’s commercial manufacturer and those for which there is not a pending Emergency Use Authorization (EUA) request or issued EUA.
On May 4, 2020, FDA announced revised guidance recommending that commercial manufacturers of antibody tests submit an EUA request within 10 business days from the date they notified FDA of their test validation or the date of publication of the revised policy, whichever was later. In keeping with FDA’s commitment to transparency, the agency is providing a list of antibody tests from commercial manufacturers that have been removed from the antibody test notification list. It is expected that this removal list will continue to be updated.
“Our action today is an important step the agency has taken to ensure that Americans have access to trustworthy tests,” said FDA Commissioner Stephen M. Hahn, MD, in a press release. “We have seen a high level of collaboration and engagement from developers who want to get this right, and we continue to be available to work extensively with industry to help them with developing accurate tests for the public.”
$225 Million Approved for COVID-19 Testing in Rural Communities, HHS Reports
The United States Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), has provided $225 million to rural health clinics for COVID-19 testing. These investments will support an estimated 4,500 clinics across the country to develop testing efforts and expand access to testing in rural communities.
“The funding may be used for a wide range [of] COVID-19 testing and related expenses including planning for implementation of a COVID-19 testing program, procuring supplies to provide testing, training providers and staff on COVID-19 testing procedures, and reporting data to HHS on COVID-19 testing activities,” said HRSA Administrator Tom Engels in a press release. “Funds may also be used for building or construction of temporary structures, leasing of properties, and retrofitting facilities as necessary to support COVID-19 response.”
According to HHS, rural health clinics are a special designation given to health care practices in underserved rural areas by the Centers for Medicare & Medicaid Services that help ensure access to care for rural residents. A state-by-state breakdown of this funding is available at the HRSA website.
FDA, FTC Issue Warning Letters to Two Amazon Associated Companies Selling Fake COVID-19 Treatments
As companies and other entities continue to falsely market products as treating or preventing COVID-19, FDA and the Federal Trade Commission (FTC) have issued warning letters to two companies participating in the Amazon Associates program. Life Unlearned, LLC, and SpiceTac were warned for making misleading claims that the products can mitigate, prevent, treat, diagnose, or cure COVID-19.
In the warning letters, FDA and FTC notified the companies that they have been added to a published list of websites that have received warning letters concerning the sale or distribution of COVID-19 related products in violation of the Federal Food, Drug, and Cosmetic Act. FDA has requested responses from the companies within 48 hours stating how they will correct the violations. Failure to correct the violations promptly may result in legal action, including product seizure and/or injunction.
FDA reminds consumers that there are currently no FDA-approved products to prevent or treat COVID-19. NABP encourages consumers to buy medicines or obtain information from NABP-verified websites to ensure they are using trustworthy, legitimate sources. They can check whether a website is verified or not recommended by searching for the web address in the safe sites search tool, located at www.safe.pharmacy.