DEA Issues Temporary Exception to “Five Percent Rule” For Distributing CS to Other Dispensers
In response to the coronavirus disease 2019 (COVID-19) pandemic, Drug Enforcement Administration (DEA) has issued a temporary exception to 21 CFR 1307.11, also known as the “five percent rule,” to allow registered dispensers to distribute greater quantities of controlled substances (CS) to other practitioners. The five percent rule normally limits the number of dosage units of all CS distributed by a pharmacy or other dispenser to no more than 5% of all CS dispensed by the pharmacy during the calendar year. The general exception will allow DEA-registered practitioners that fully comply with all other requirements to now distribute CS beyond that limit. All distributions made by practitioners from January 1, 2020, until the public health emergency ends, or at an earlier date if specified by DEA, will be excluded from consideration in applying the five percent rule.
Questions and requests for additional information about the exception may be directed to the DEA Diversion Control Division, Policy Section at 571/362-3260.
US Passes Peak of New COVID-19 Cases, President Trump Says
Although COVID-19 continues to spread in hot spots across the country, data over the last few days appears to show that the United States has passed the national peak of new infections, President Donald J. Trump said at a White House briefing this week. Governor Andrew Cuomo of New York expressed similar sentiments on Monday, when he declared that “the worst is over . . . if we continue to be smart going forward.”
Other developments over the last few days include:
- Food and Drug Administration (FDA) is taking additional steps to ensure an adequate supply of antimalarial drugs that are being investigated as possible treatments for COVID-19.
- Centers for Medicare & Medicaid Services has postponed its 2019 benefit year HHS Risk Adjustment Data Validation process due to the pandemic.
- FDA has posted a new “At-a-Glance Summary” to highlight the agency’s major activities during the pandemic.
Daily updates on the spread of the virus, including a state-by-state breakdown of known infections and fatalities, are available from the Centers for Disease Control and Prevention. International information is available from the World Health Organization.
NABP continues to collect information about how boards of pharmacy are responding to COVID-19 in the Coronavirus Updates section of the NABP website. Pharmacists are also encouraged to check their state board(s) of pharmacy websites for jurisdiction-specific information. Additional resources for pharmacists and other health care providers are available from the American Pharmacists Association’s Pharmacists’ Guide to Coronavirus.
Nearly 5,000 Applications Received for NABP Passport, a Service Supporting Boards’ COVID-19 Response
As of April 16, 2020, NABP has received 4,780 requests for an NABP Passport and has processed more than 2,000 applications. 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.
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 (PTCB) 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 Temporary Guidance Policy on PPE for Sterile Compounding
In an effort to assist compounders with questions related to the impact of supply interruptions of personal protective equipment (PPE) during the COVID-19 pandemic, FDA has released a temporary policy guidance document for state-licensed pharmacies and federal facilities that are not registered as outsourcing facilities. The guidance document, Temporary Policy Regarding Non-Standard PPE Practices for Sterile Compounding by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency, Guidance for Industry, includes recommendations for preserving PPE supply and mitigation strategies to reduce the risk of product contamination without standard PPE. According to FDA, the policy is intended to only remain in effect for the duration of the COVID-19 pandemic.
This guidance is being implemented without prior public comments. Public comments may be submitted to FDA at any time for consideration by mail or through the online portal using instructions in the document. Questions about the guidance may be sent to compounding@fda.hhs.gov.
PTCB to Provide Online Proctored Test Deliveries
PTCB will soon launch an online proctored exam delivery of the Pharmacy Technician Certification Exam (PTCE) for candidates earning their Certified Pharmacy Technician (CPhT) credential, according to the PTCB website. This option will allow technicians to take the exam online from a remote computer under the virtual supervision of a live proctor. Online exam delivery uses security features, including face-matching technology and ID verification. PTCB also has plans to deliver online delivery for all credentialed exams.
DEA Releases 2020 Drugs of Abuse Resource Guide
DEA has released the 2020 edition of Drugs of Abuse, a DEA Resource Guide, which provides information on the most commonly abused and misused drugs in the US. Specifically, the document provides science-based information about the harms and consequences of drug use – including misuse of prescription drugs – and describes the possible consequences, overdose potential, origin, and legal status of these drugs. The 2020 digital edition updates the 2017 Drugs of Abuse publication with the most current information on new and emerging trends in drug misuse and abuse, including fentanyl, marijuana and marijuana concentrates, vaping, and stimulant drugs. The document also includes a list of additional drug education and prevention resources.