By Leonard Krause, FDA Connect, Inc.
If you haven't renewed your FDA Drug Establishment Registration and certified your existing drug products, it's not too late (or too early) to start.
According to FDA, "The annual drug registration renewal period is now open through Dec. 31, 2021. To keep drug registration status current in 2022, FDA must receive notification that a firm’s drug registration and listing information, 1) is certified as accurate and no changes have occurred since the previous update, 2) was updated, or 3) will be de-registered as firm will cease operations."
This means that you will need to submit a "No Change" notification to the FDA Structured Product Labeling (SPL) system if all of the information in your current Drug Establishment Registration is exactly the same as it was last year. If there has been any change, (i.e., a new contact person, a change in email or telephone number), you will need to submit a new version of the registration that includes the updated information. If by chance you changed the physical location of your manufacturing facility, you will need to submit a new Drug Establishment Registration. Prior to submission, make certain to acquire a new Data Universal Numbering System (DUNS) number that corresponds to the new address and submit a new Drug Establishment Registration to FDA with this updated information.
Certification of Drug Products
For those of you who submitted an SPL Drug listing to FDA for drug products listed during calendar year 2021, those products do not need to be certified. The listings are already valid for calendar year 2022. If the drug product was listed prior to 2021, and you have not submitted a modification to the SPL listing this calendar year, you will have to certify those drug products before December 31, 2021. This will keep them current in the FDA SPL system. If you do not certify a product, it will be purged from the system.
Firms that exclusively manufacture homeopathic medicines are exempt from paying the Over-the-Counter Monograph User Fee (OMUFA). Currently, for FY 2021, all allopathic manufacturers that produce medicines covered by an FDA monograph must pay $20,322 if they market under their own label or $13,548 if they are exclusively contract manufacturers. If your firm also manufactures allopathic drug products that are covered by a current FDA monograph, (i.e., skin protectants, sunscreens), your company is subject to the user fee for FY 2021 and beyond.
If your company produces homeopathic medicines exclusively, and you have not modified your Drug Establishment Registration to reflect this fact, make certain to submit a new Drug Establishment Registration. Make certain to indicate under your business qualifier that you "manufacture(s) human over-the-counter drug products not produced under an approved drug application or under a monograph." This indication will ensure that you will not be targeted for non-payment of user fees and will not be included in the OMUFA arrears list, among other sanctions.
Best of luck for the coming year, and I am looking forward to seeing AAHP members (pandemic willing) at the association's Annual Membership Meeting in Spring 2022!
Author: Leonard Krause, founder and president of FDA Connect, Inc., has 30 years’ experience working in the field of government compliance and market research. FDA Connect specializes in serving the homeopathic pharmaceutical industry. This Oregon-based consulting company offers electronic registration and product listing services to FDA on behalf of homeopathic and OTC drug manufacturers and marketers, as well as product label reviews and GNP due diligence audits of CMO's on behalf of Private Label Distributors. Contact Leonard by phoning 541-232-3030 or by emailing email@example.com.