With little activity seen in 2013 in the enforcement arena for marketed unapproved drug products, FDA will publish two Federal Register (FR) notices on January 10, 2014 addressing enforcement action for a number of products.

FDA will move against certain unapproved marketed codeine sulfate, codeine phosphate and dihydrocodeine containing products marketed without approved ANDAs or NDA or in full compliance with an appropriate OTC monograph (codeine cough syrup for children 6 years of age and older).  The prepublication of the FR notice can be found here. FDA notes that enforcement dates will concur with the publication of the notice in the FR on January 10, 2014 for any drug products that are not listed in full compliance under Section 510 of the Federal Food, Drug and Cosmetic Act.  For those products that are compliant with the listing provisions of the Act, FDA will exercise enforcement discretion as follows: Firms may not manufacture product for more than 45 days from date of publication of the FR notice and may not distribute product for more than 90 days after the FR publication.  FDA explains that this window of enforcement discretion is designed to give firms a chance to deplete their inventory and give patients a chance for orderly transfer of their medication to an alternate approved product.

In a separate FR notice (here), FDA announced the resolution of a number of outstanding DESI hearing requests that will result in enforcement action against marketed drug products that are subject to those requests or for similar and related products that may be marketed.  The categories of products that are covered by this FR notice include:

  • Dicyclomine hydrochloride products not covered by an ANDA or NDA or are subject to an approved application and not marketed for one of the indications found effective under the applicable DESI review (irritable colon, spastic colon, and mucous colitis).
  • Certain products containing a xanthine derivative and either phenobarbital (prescription or under an OTC monograph) or hydroxyzine hydrochloride.
  • Chlorthalidone products containing 100mg (safety issues for this strength, but not for the lower 25mg and 50mg products)
  • Certain fixed combination antibiotics and sulfonamides (e.g., Urobiotic-a combination of oxytetracycline, sulfamethizole and phenazopyridine)


While many of the above products are no longer being marketed, FDA notes that “[S]hipment in interstate commerce of any of the products identified in these dockets, or any identical, related, or similar (IRS) product to the products in these dockets, that is not the subject of an approved new drug application (NDA) or abbreviated new drug application (ANDA) (other than an over-the-counter (OTC) product that complies with an applicable OTC monograph) is unlawful as of the effective date of this notice.”

With this start to 2014, the question becomes will this be a year of sustained, substantial enforcement actions and efforts relative to unapproved marketed drug products after a very slow year or will this action be the exception rather than the rule for 2014.