Initiation of Voluntary Recalls: Draft Guidance for Industry and FDA Staff

By Mark Land, AAHP President

Product recalls are an important tool that manufacturers and the U.S. Food and Drug Administration (FDA) use to minimize exposure to potentially harmful or ineffective products.¹ Drug product recalls are voluntary — that is to say, FDA does not have legal authority to recall a drug product. They do, however, have many tools at their disposal to encourage recall and discourage use of drug products.

When it comes to recalls, consumers depend on manufacturers and FDA to work quickly to protect their health. Quick execution minimizes consumer exposure to a health risk and prevents consumers from being injured.² To facilitate recalls, FDA has published a draft guidance Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C.

The draft guidance provides recommendations on how a manufacturer should prepare itself for a potential recall. Specifically, the guidance discusses employee training for recalls, appropriate recordkeeping, and procedures. To execute an effective and timely recall, companies must be prepared in advance to take all necessary steps.⁴ Details can be the difference between timely and delayed recall implementation.

For example, delays in evaluation of a potentially violative product, combined with inadequacy within the Health Hazard Evaluation process, can delay initiation of a recall by a week or two. Add another two weeks due to poor distribution records or lack of access to recall coordinators at retail chains. These delays are unacceptable for all recalls, but when it comes to Class 1 or 2 recalls, they are intolerable — meaning that FDA will take charge of communications to consumers and retailers, potentially at great expense to the brand.

Recent history has shown that homeopathic firms cannot be complacent. Preparedness and performance requires expertise, procedures, practice, and refinement. If you have not developed or reviewed a recall procedure, consider contacting an expert firm to help you prepare.

References

1. Land, M. “Recall Preparedness” Network News, American Association of Homeopathic Pharmacists November 2017. Available at: https://www.theaahp.org/regulatory/recall-preparedness.
2. Statement from FDA Associate Commissioner for Regulatory Affairs, Melinda K. Plaisier, on agency’s new steps to strengthen the process of initiating voluntary recalls. Available at: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm636462.htm.
3. United States Food and Drug Administration Draft Guidance for Industry Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C Guidance for Industry and FDA Staff, April 2019. Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/initiation-voluntary-recalls-under-21-cfr-part-7-subpart-c-guidance-industry-and-fda-staff.
4. Gooley, R. “Prepare for Recalls: 5 Crucial Steps,” Network News, American Association of Homeopathic Pharmacists, November 2017. Available at: https://www.theaahp.org/?s=gooley.