FDA Clarifies Compounding Rules, Offers Flexibility to Help Ease Drug Shortages During COVID-19 Pandemic
The Food and Drug Administration (FDA) noted it will use discretion in enforcing certain standards related to 503A and 503B compounding in an effort to ease drug shortages during the coronavirus disease 2019 (COVID-19) pandemic. During an April 30, 2020 American Pharmacists Association (APhA) webinar, the agency clarified it will “look to 503B compounders to grapple with drug shortages” and “turn to 503A compounders to fill in the gaps.”
In addition, the agency clarified that medications on the FDA drug shortage list are effectively considered “not commercially available,” which frees 503A and 503B compounding facilities from limits on compounding drugs that are “essentially a copy” of a product already available on the market. FDA also does not intend to take action if a 503A facility fills orders for a compounded drug that is essentially a copy of an approved drug that has been discontinued and is no longer marketed.
In April 2020, FDA issued a temporary guidance that granted flexibility for pharmacists to compound certain necessary medications under 503A for nonspecific patients hospitalized due to COVID-19. In addition, a temporary guidance was issued that granted enforcement flexibility for 503B outsourcing compounding facilities for drugs in shortage for patients hospitalized during the COVID-19 public health emergency. The guidance documents stipulate the conditions compounders must meet.
More information on these compounding rule clarifications is available on the APhA website.
Over 6,500 Applications Received for NABP Passport, a Service Supporting Boards’ COVID-19 Response
As of May 6, 2020, NABP has received more than 6,500 requests for an NABP Passport and has issued more than 49,300 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 (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.
PTCB Offers Online Proctored Exams to Expand Testing During COVID-19 Crisis
For the first time in the organization’s history, PTCB is now offering online proctored examinations to help expand testing services during the COVID-19 pandemic. Candidates seeking certification will have the option to take any PTCB exam from their own computer under the virtual supervision of a live proctor.
“During COVID-19, pharmacies across the nation depend on qualified pharmacy technicians as critically important members of the pharmacy team,” said PTCB Executive Director and CEO William Schimmel in a press release. “Offering secure online delivery of our exams dramatically widens the availability of testing for these essential team members and protects the safety of candidates who are ready to earn credentials and continue their career journeys.”
Online testing is available for all PTCB exams, including the Pharmacy Technician Certification Exam, the Certified Compounded Sterile Preparation Technician Exam, and the Assessment-Based Certificate Exams in Technician Product Verification and Medication History. The online exams have the same formats and completion times as the exams taken at a test center.
FDA, FTC Issue Warning Letters to Two Companies for Selling Fraudulent COVID-19 Products
As part of the agencies’ efforts to protect consumers, FDA and the Federal Trade Commission (FTC) have issued warning letters to two companies for selling fraudulent COVID-19 products. Both companies – Honey Colony LLC, and Dr Dhole’s Sushanti Homeopathic Clinic – sold products in the United States with misleading claims that the products are safe and/or effective for the prevention and treatment of 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 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/buy-safely.