Compliance

One of the hottest topics over the last few years has been that of drug shortages and what to do about them. The FDA video explains that the Food and Drug Administration Safety and Innovation Act (FDASIA) made important changes to the way industry must report drug shortages.

The FDA is proposing to update its list of drug products (previously found in its regulations at 21 CFR 216.24) that have been removed from the market for safety or efficacy and cannot be legally compounded. It has also revised one product relative to its dosage form that allows compounding under the pharmacy compounding exemption. Since FDA has approved an ophthalmic form of bromfenac, it has removed the restriction to now permit the compounding in certain situations for this drug product but only for ophthalmic use, whereas this drug was previously excluded for any use by the Rule.

The Health and Human Services published its semiannual regulatory agenda and guess what popped up on review? The proposed date of finalization of the Rule on label changes that can be made by an ANDA holder relative to newly acquired safety information is listed as December 2014.

FDA issued a Draft Guidance, entitled Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification which describes the proper means of notification of FDA by trading partners of the potential suspect products. The requirements under the Drug Supply Chain Security Act (DSCSA) will kick in on January 1, 2015 and also requires firms to identify other immediate trading partners of their suspicion. The Guidance defines trading partners as manufacturers, repackagers, wholesalers or dispensers and requires the notice to be given to FDA within 24 hours of identifying a suspect product.

On May 13, 2014, the FDA took the third in an unusual series of evaluations to extend the expiration date of certain lots of the drug DuoDote Autoinjectors (atropine and pralidoxine chloride), a drug indicated for the initial treatment of poisoning by organophosphorous nerve agents and insecticides. The manufacturer of the drug product notified FDA of problems relative to under-dosing or failure to activate associated with a small number of its autoinjectors. The FDA responded with a letter (here) indicating that the Agency would exercise enforcement discretion and would, based on information provided by the firm, extend the expiration date for one year beyond the current established expiration date. FDA also noted that the firm would not need to revise the expiration date on the actual packaging.