Pharmacy Compounding in the News Again – Difficult to Compound List – A Long Time Coming

Looks like FDA is nearing the end of the daunting task of developing and (soon hopefully) publishing a “Difficult to Compound List” that has been in the works for nearly 17 years. At a meeting on July 13 and 14, 2000, an advisory committee on compounding (specifically, the Pharmacy Compounding Advisory Committee [PCAC]) provided FDA advice about the Agency’s efforts to develop a list of drugs that present demonstrable difficulties for compounding under section 503A of the FD&C Act (version in effect in 2000).  According to the Drug Quality and Security Act (November 2013), the Secretary of HHS is required to develop a Difficult to Compound List applicable to traditional compounders and outsourcing facilities under sections 503A and 503B.

The Agency previously solicited nominations for this list via the Federal Register of December 4, 2013 (78 FR 72840) and received approximately 71 unique nominations. Now, almost three and a half years after FDA invited all interested persons to nominate drug products or categories of drug products for inclusion on the Difficult to Compound List, they are creating a public docket so that interested parties can nominate drug products or categories of drug products that were not in the previously nominated 71 for inclusion on the list.

The new public docket allows interested parties to resubmit previous nominations with additional supporting information, submit comments, or to submit new products or product families. These submissions may be made to the Docket at any time.

Nominators are asked to include the name of the drug product or category of drug products being nominated, as well as the reason the drug product or category of drug products should be included on the list, considering the risks and benefits to patients. The nominations may be submitted either electronically or by paper. If a nominator wishes to submit confidential information, they must do this via the paper route submission. To facilitate FDA reviews, new submissions must answer the following six questions on the impact of the difficulty in compounding and the safety or effectiveness of the compounded drug product. Does the drug or drug family have (1) a complex formula; (2) a complex delivery mechanism; (3) a complex dosage form; (4) complexities in achieving or assessing bioavailability; (5) a complex compounding process; and (6) complex physiochemical or analytical testing.

Instructions for submissions, supplemental information and background (legal framework) are found at Federal Register / Vol. 82, No. 144 / Friday, July 28, 2017 / Notices [Docket No. FDA–2017–N–2562], Drug Products That Present Demonstrable Difficulties for Compounding Under the Federal Food, Drug, and Cosmetic Act; Establishment of a Public Docket.

The 71 previous nominations (in response to the December 2013 FDA request) may be viewed at under docket number FDA-2013-N-1523.