DRAFT GUIDANCE ISSUED ON ELECTRONIC DISTRIBUTION OF DRUG RECALLS
The FDA has released a draft guidance that encourages industry to electronically
distribute important product information, such as that included in recalls and
drug safety announcements, and it explains procedures for doing so based on
regulations governing the paper circulation of such information.
"Over the years, we have worked with manufacturers to promote the use of electronic methods of communication and encourage the use of innovative technologies to disseminate safety information, particularly those that provide a public health benefit," states the guidance, "Using Electronic Means to Distribute Certain Product Information."
The guidance advocates the use of email, text messaging, fax or other electronic methods to disseminate recall communications governed by 21 CFR Part 7.49 and mailing of other important drug information regulated by 21 CFR Part 200.5.
The draft also addresses unregulated safety communications the FDA recommends manufacturers and distributors voluntarily issue to the public.
The electronic vehicle must "effectively convey the necessary information to the intended recipient," the guidance says. For electronic communications, industry must modify the recall communication and content instructions in 21 CFR Part 7.49(a) and 21 CFR Part 7.49(c) as necessary, the guidance states. For example, the regulation requires a recalling firm to promptly notify each of its affected direct accounts and states that the format, content and extent of the communication should be proportionate to the hazard and the recall strategy. The communication should explain that the product is subject to recall, that further distribution or use should cease and that the direct account should notify customers who received the product. It should also instruct recipients on what to do with the recalled product, the guidance says.