June 18, 2015
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FDA panel recommends including brilliant blue on list of bulk substances for use in compounding

By a vote of 10 in favor, two against and no abstentions, with two members not voting, the FDA Center for Drug Evaluation and Research Pharmacy Compounding Advisory Committee recommended yesterday that brilliant blue G be included on a list of bulk drug substances that may be used for compounding.

Section 503A of the Food, Drug and Cosmetic Act (FDCA) “provides that a drug product can be compounded using bulk drug substances that do not have an applicable [U. S. Pharmacopoeia] or [National Formulary] monograph and are not components of FDA-approved drugs to be compounded, if the bulk drug substances appear on a list developed by FDA and issued through regulation.”

Wiley Chambers, MD, Supervisory Medical Officer (Clinical Reviewer), Division of Transplant and Ophthalmology Products, OAP, OND, CDER, delivered the presentation of brilliant blue G for the FDA’s consideration to be included on the list.

“We believe that brilliant blue G is well-characterized physically and chemically, and can be compounded into a sterile dosage form for intravitreal use,” Chambers said. “Brilliant blue G has been used for staining for visualization of ophthalmic procedures since approximately 2006. Clinical trials have shown that, under certain circumstances, it’s more effective as a stain for visualization during ophthalmic procedures than the approved alternative.”

Pharmacy Compounding Advisory Committee member Michael A. Carome, MD, FASHP, who voted against recommending inclusion, voiced concern about the sterility of compounded brilliant blue G and suggested that the agent be compounded by outsourcing facilities, which are subject to current good manufacturing practice requirements under the Compounding Quality Act.

Member Elizabeth Jungman, JD, who voted for recommending inclusion, also suggested that the product may be more appropriate for outsourcing facilities.

Chambers added that potential immunogenic and carcinogenic risks are mitigated because the dye is washed out of the eye immediately after administration, and tissue that is stained is removed as part of the surgical procedure.

The committee also voted 10 yes and 2 no, with no abstentions and two members not voting, to recommend inclusion of the anti-allergic drug tranilast on the list.

Congress passed the Drug Quality and Security Act, which includes the Compounding Quality Act, in 2013 in the wake of infectious outbreaks traced to steroids and repackaged intravitreal Avastin produced at compounding pharmacies. – by Matt Hasson

Reference:

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM377052.pdf