New FDA recall guidance released
The FDA has released guidance to improve recall processes so the public are better equipped to protect themselves from recalled medicines.
2018 saw the FDA release draft guidance that sheds light on the body’s policy on warnings and notifications regarding recalled products.
As mentioned in Douglas Steam’s recent FDA blog who is the FDA’s Director, Office of Enforcement and Import Operations, Office of Regulatory Affairs: “When FDA identifies that a product it regulates violates the law, it protects the public by working with the manufacturer and distributors to facilitate the product’s recall (i.e., removal from the marketplace or product correction).”
With a view to enhance transparency and patient empowerment, the new FDA guidance provides insight into cases where a public warning should be issued about a recall.
Companies are given a timeline in which they would need to issue this warning. If the warning Is deemed as insufficient the regulatory authority may intervene and give its own announcement on the matter.
Recalls are in most cases voluntary – either initiated by the manufacturer or executed by the manufacturer after the FDA has communicated the issue. All recalls are monitored and reviewed by the FDA.
Want more? Pharma Logistics Compliance: 2018 Report
FDA risk classification
The FDA also signaled its switch to post recall listings before health risk classifications are identified. The classification process can sometimes take weeks or months to complete. The move to notify the public before recall classifications are available allows the public to access information at the earliest possible point. These instances will see recalls labeled as ‘not-yet-classified’.
These listings will be posted in the FDA’s enforcement report on a weekly basis.
Previously, recalls would only be listed in the report if they had been classified into a severity category. Recalls can be one of three classes with class one defined as “Reasonable probability that use/exposure will cause serious adverse health consequences or death.”
The FDA is to publish 98 draft guidance documents in 2018. Two are listed under pharmaceutical quality manufacturing standards, with one guidance focusing on Human Drug Compounding Outsourcing Facilities.
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