California Governor Issues Executive Order Regarding Over-The-Counter Drug Regulations
In an effort to promote the availability of certain medical supplies related to the COVID-19 pandemic as well as to respond to a shortage of fingerprinting services, Governor Newsom of California issued Executive Order N-68-20 which permits entities manufacturing over-the-counter drugs (such as hand sanitizer) to operate in California with only a temporary registration rather than a license from the Department of Public Health. Temporary registrations must include self-certification of compliance with the FDA guidance issued for those firms not federally registered as over-the-counter drug manufacturers or medical device manufacturers.
This temporary registration is permitted until the earliest of any of the following occurs:
- The expiration of a six-month registration period after which further temporary registration may be obtained;
- The Department of Public Health suspends or rescinds said temporary registration procedure; or
- The FDA withdraws or terminates any applicable federal guidance.
Additionally, the Department of Public Health is to establish procedures which will allow entities affected by the pandemic a grace period of up to 60 days to submit renewal fees after an applicable expiration date. A request for such a deferral must be made on letterhead along with timely application for renewal.
In response to the lack of fingerprinting services often required for background checks during the licensure process, the Order grants flexibility to the California Department of Criminal Justice in its authority to conduct criminal background checks based on identifying information other than fingerprints.
If you need help navigating the California regulatory environment in the wake of COVID-19, LicenseLogix is ready to assist. Contact us today for additional support.