HHS Advisory Opinion States That Pharmacies May Order and Administer COVID-19 Tests in All States
As the number of coronavirus disease 2019 (COVID-19) fatalities in the United States climbs beyond 100,000, the US Department of Health and Human Services’ (HHS) Office of the General Counsel (OGC) has issued an advisory opinion that says licensed pharmacists may order and administer COVID-19 tests regardless of state or local restrictions. The advisory opinion addresses guidance issued on April 8, 2020, which authorized licensed pharmacists to administer COVID-19 tests, including serology tests, that Food and Drug Administration (FDA) has authorized.
In providing background for the advisory opinion, OGC explains that it has been asked whether the Public Readiness and Emergency Preparedness (PREP) Act allows licensed pharmacists to order and administer COVID-19 tests even in states that prohibit licensed pharmacists from ordering and administering those tests.
“As explained above, any state or local law or legal requirement that prohibits or effectively prohibits licensed pharmacists from ordering and administering FDA-authorized COVID-19 tests are different from or in conflict with the declaration – and therefore, a legal requirement under the PREP Act,” the advisory opinion states. “So during the effective period of the PREP Act declaration, a state or locality cannot establish, enforce, or continue any such legal requirements under the PREP Act’s preemption provision.”
Over 6,900 Applications Received for NABP Passport, a Service Supporting Boards’ COVID-19 Response
As of May 29, 2020, NABP has received more than 6,900 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.
FDA Issues Letter and New Guidance to Providers Regarding N95 Mask Sterilization
FDA has released a new letter for health care providers regarding the correct decontamination cycle used with certain products to decontaminate compatible N95 or N95-equivalent respirators during the COVID-19 pandemic. The letter includes a reminder that only the combination of certain products listed in the Emergency Use Authorization (EUA) are authorized for the decontamination of compatible N95 respirators. The letter also provided several recommendations for reprocessing staff in health care facilities.
In addition to this action, FDA has issued two guidance documents (one new guidance and one revised) for industry to help address potential shortages of personal protective equipment. These guidance documents are:
- Recommendations for Sponsors Requesting EUAs for Decontamination and Bioburden Reduction Systems for Face Masks and Respirators During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
- Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised)
The guidance documents help to address these potential shortages by facilitating the safe reuse and conservation of surgical masks and respirators for medical purposes through the use of decontamination and bioburden reduction systems. In addition, the guidance documents provide recommendations of alternatives and updated options for when FDA-cleared or National Institute for Occupational Safety and Health-approved N95 respirators are not available.
USP to Provide Further Opportunities for Stakeholder Engagement on BUD Provisions in General Chapters <795> and <797>
US Pharmacopeial Convention (USP) is conducting additional stakeholder engagement activities to foster input concerning beyond-use date (BUD) provisions in USP General Chapters <795> and <797>. These new engagement opportunities are being offered in response to the USP Appeals Panel’s final decision granting appeals to these chapters and remanding them to the Compounding Expert Committee with recommendations for further engagement on the issues that were raised.
USP is working with an independent party to design and lead outreach as part of its Stakeholder Engagement Plan. The goals of the plan are to engage stakeholders representing a diverse range of perspectives and gather additional information in a constructive series of facilitated sessions. These initiatives will focus on issues pertaining to the BUD provisions of the general chapters, with particular attention paid to the framework for establishing BUDs for sterile and nonsterile compounded preparations and BUD extensions beyond the defaults provided in the remanded chapters.
USP will announce additional details, including dates of the stakeholder engagement sessions and information about virtual participation, once they become available.