FDA's PCAC Meeting Scheduled for May 8-9, 2017
Tuesday, April 18, 2017
Posted by: Dagmar Anderson
Last Friday, FDA pre-published their Federal Register notice for the upcoming Pharmacy Compounding Advisory Committee (PCAC) meeting on May 8-9, 2017. The notice of the meeting along with the agenda, meeting materials, public participation information/submissions and webcast information can be found by clicking here.
Items nominated for the bulk list for discussion at this meeting are: nicotinamide adenine dinucleotide, nicotinamide adenine dinucleotide disodium reduced, nettle (Urtica dioica) whole plant, ubiquinol, vanadyl sulfate, and artemisinin. FDA is recommending that all of these items NOT be put on the bulks ("positive") list.
A nominator already has petitioned the FDA to include ubiquinone to be considered for the meeting along with their nomination of ubiquinol. FDA has said they will not include the two together. Nominators already have started discussing the path to re-nominate ubiquinone with sufficient evidence.
Also, FDA will be discussing one item for addition to the Demonstrably Difficult list. FDA is recommending to add "modified release drug products that employ coated systems (MRC)". In short, MRCs are drugs that utilize diffusion or osmotic systems. In reviewing the information in the meeting materials, FDA is not including compounded matrix style systems in their review.
According to the FDA, "The categories "modified release drug products," "sustained or time-release dosage forms," and "enteric-coated preparations," as well as a number of specific modified release drug products, have been nominated for the list of drug products or categories of drug products that present demonstrable difficulties for compounding (the Difficult to Compound List) under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act). At this time, and for the purposes of this review, we evaluated a subset of modified release technologies that we refer to as Modified Release drug products that employ Coated systems (or "MRC"). For the purpose of this review, we define MRC to include oral solid drug products that consist of a drug-containing core enclosed within a polymeric coating, and these coated systems are designed to release active ingredient at specified rates, patterns, and/or onsets through the gastrointestinal (GI) tract to produce systemic, enteric, or local action. For the purposes of this review, the Agency does not consider MRC to include matrix systems as described below."
IACP also has received questions on if this discussion would include the utilization of pre-made acid resistant capsules. In our review of the information it would appear that FDA does not include these dosage forms in their review. FDA's information about the review and recommendation of MRCs can be found here.
IACP's Executive Vice President John Voliva, RPh will attend the PCAC meeting in person, and will send live updates throughout the day.