In November 2021, FDA announced a guidance regarding annual reporting of quantities of drugs manufactured or compounded. The deadline for the first reports, covering quantities produced in 2020, is Feb. 15. The comment period regarding this guidance document ended earlier this month.
The AAHP filed comments along with other organizations. Your association’s submission supported the comments filed by the Association for Accessible Medicines and by the Consumer Healthcare Products Association. Importantly, the AAHP’s comments focused on the large variety of homeopathic drug products and the relatively small quantities produced in comparison with the goals of collecting the information laid out in Section 31129(e) of the CARES Act.
On behalf of our membership, the AAHP requested revision of the guidance to only require submission of relevant and meaningful information. This suggestion was made to help FDA avoid future questions about the least burdensome approach to fulfilling the intention of data collection under the CARES Act. AAHP Members can read the entire submission here.
AAHP Briefs Industry on Compliance
In December, Leonard Krause, of AAHP Affiliate member FDA CONNECT, presented a succinct 30-minute webinar. After giving a brief history, he provided details on the information that companies must collect and report to FDA to comply with the new guidance as presently written. Leonard also explained how the information must be submitted, as well as suggested tips to make the reporting easier.
Two reports are due soon. The first report for 2020’s production numbers must be submitted by Feb. 15, 2022. The second report for 2021’s production numbers is due May 16, 2022. Thereafter, each year’s report must be submitted by Feb. 15 of the following year (i.e., 2022’s numbers are due Feb. 15, 2023).
If your company missed the webinar, you can receive a copy of the PowerPoint slides with all the information and a link to the recording from the AAHP office. Access to this information is at no cost to AAHP member firms. Non-members may receive the slides and access the recording for just $79; email the office for payment information.