COVID-19

As the response to COVID-19 consumes more and more healthcare, industry and regulatory resources, developments in the FDA and pharmacy space not relating to COVID-19 are limited. When other developments are available, the FDA and Pharmacy Weekly Digest will continue to provide weekly coverage of the FDA and pharmacy sector during the current public health emergency. 

Here is our latest alert for FDA and State Boards of Pharmacy reactions to the coronavirus, which will be updated periodically.

All FDA-Issued Guidance on COVID-19 Will Be Immediately in Effect – The FDA will still accept comments on the guidance. The FDA is also streamlining the publication of a notice of availabilities. Rather than individual notices, the FDA will periodically publish a consolidated notice of availabilities for COVID-19.

DEA Published Webpage on COVID-19 Including Telemedicine – In case you missed it, the DEA provided guidance on controlled substance prescription refills, electronic prescribing of controlled substances and telemedicine. Under the guidance, “DEA-registered practitioners may issue prescriptions for controlled substances to patients for whom they have not conducted an in-person medical evaluation, provided …” subject to three conditions.

Food/Dietary Supplements

FDA Established a Webpage for Food Safety and COVID-19 – The webpage provides links to industry guidance and provides information in a question-and-answer format. Currently, there is no evidence to support transmission of COVID-19 by food. Of note, the FDA responds to what an employer should do if a worker in a food production/processing facility/farm tests positive for COVID-19.

Drugs

FDA Transitioned Certain New Drug Applications (NDAs) to Biologic License Applications (BLAs) – On March 23, under the deemed-to-be-a-license biologic provision of the Biologics Price Competition and Innovation Act of 2009, signed into law exactly 10 years ago, the FDA transitioned certain NDAs to BLAs. The final list of NDAs transitioned to BLAs is still not available. The FDA stated that the final list would be posted on March 24. When the final list becomes available, it will be on the deemed-to-be-a-license webpage. Also, the NDAs were removed from the FDA’s Orange Book of Approved Drug Products with Therapeutic Equivalence Evaluations.

Medical Devices

FDA Sent a Letter to Medical Device Establishments Regarding COVID-19 – The letter describes how the steps being taken to address the public health emergency impact the day-to-day operations of the Center for Devices and Radiological Health (CDRH) and industry. The CDRH has converted all in-person meetings with industry to teleconferences. The FDA also extended the response due dates by 60 days for marketing applications on hold as of March 16, where the response due date is on or before April 30.

Tobacco

FDA Issued Final Guidance on Submission of Plans for Cigarette Packages and Advertisements – The guidance describes the regulatory requirements to submit a cigarette plan: who submits a cigarette plan, the scope of a cigarette plan and when to submit one, what should be submitted as part of a cigarette plan, where to submit a cigarette plan, and what approval of a cigarette plan means.

Small Entity Compliance Guide Provided for Required Warnings for Cigarette Packages and Advertisements – The FDA issued the small entity compliance guide, which is presented in a question-and-answer format, to help small businesses understand and comply with the FDA’s final rule, “Required Warnings for Cigarette Packages and Advertisements,” which establishes newly required cigarette health warnings for cigarette packages and advertisements. The guide describes the consequences for being found out of compliance as well as detailed descriptions of how to comply with the final rule.

Pharmacy

FDA Updated the Categories of Substances Nominated for the 503B Bulk Drug Substances List – The FDA added hydroxychloroquine sulfate to category 1. This is noteworthy because hydroxychloroquine sulfate is being tested as a treatment for COVID-19. The FDA does not intend to take action against an outsourcing facility for compounding drugs using bulk drug substances identified in category 1, provided that the conditions described in the guidance are met. Additionally, the FDA removed hyaluronidase from category 1 because hyaluronidase was converted to a Biologic License Application on March 23.

Colorado Submitted Comments on the U.S. Department of Health & Human Services (HHS) Draft Canadian Importation Rule – In 2019, Colorado enacted a law that directed the state to seek permission from HHS to establish a drug importation plan. In response to HHS’ notice of proposed rulemaking, Colorado submitted a comment and requested four modifications from HHS: Do not limit importation program sponsorship to the state agency or “entity that regulates wholesale drug distribution and/or the practice of pharmacy”; allow for conditional approval of importation programs that do not specify importers, foreign sellers, repackagers/relabelers or labs; allow an importation program to include multiple foreign sellers in Canada, both horizontally and vertically; and allow for relabeling to occur in Canada and prior to importation of a drug to provide financial benefits to the country and engender Canadian support.

DEA Issued a Proposed Rule on Growing Marihuana for Research– The proposed rule would amend the provisions of the regulations governing applications by persons seeking to become registered with the DEA to grow marihuana as bulk manufacturers and add provisions related to the purchase and sale of this marihuana by the DEA. Comments on the proposed rule are due May 22.