6 bulk drug substances listed for use by compounding pharmacies under FDA proposal

The U.S. Food and Drug Administration has proposed adding a list of bulk drug substances that can be used in compounding to Section 503A of the Federal Food, Drug and Cosmetic Act. The rule proposed on Dec. 15, 2016, includes six bulk drug substances: Coomassie Brilliant Blue G-250, cantharidin, diphenylcyclopropenone, N-acetyl-D-glucosamine, squaric acid dibutyl ester and thymol iodide. The FDA also identified four bulk drug substances that it decided not to include on the list: oxitriptan, piracetam, silver protein mild and tranilast.

Section 503A outlines the requirements for exempting a compounded drug product from the more stringent provisions of the FD&C Act. To comply with the section, a licensed pharmacist in a state-licensed pharmacy or federal facility or a licensed physician must compound drug products using bulk drug substances that:

  • Comply with the standards of an applicable U.S. Pharmacopeial Convention or National Formulary monograph, if a monograph exists, and also with the USP chapter on pharmacy compounding.
  • If such a monograph does not exist, the drug substance must be a component of drugs approved by the FDA secretary.
  • If such a monograph does not exist and the drug substance is not a component of a drug approved by the FDA secretary, then it must appear on the 503A bulks list.

Currently, there is no official 503A bulks list, and the FDA intends to fill the legislative gap with this proposed rule. (more…)

Compounded medicines at center of complex web of federal and state regulations

In Georgia, the compounding of medications is regulated by the eight-member Georgia Board of Pharmacy, and under its rules, pharmacists may prepare compound drugs only for a valid prescription order or as part of routine prescription filling. If they start to produce large amounts of drugs without prescriptions, they are considered manufacturers.

In a law enacted July 1, Georgia clarified that sterile compounding not intended for specific patients can only be conducted by an outsourcing facility. This brought state law in line with federal law. Georgia’s law states “nothing in this Code section shall be construed to prohibit or interfere with the ability of a practitioner to compound drugs for administering or dispensing to their own patients.”

The law allows out-of-state firms and third-party logistics providers (those who transport the drugs, for example) to operate in the state if they have the same ownership as a licensed Georgia pharmacy. Additionally, out of state third-party logistics providers can be licensed by their resident state or by the federal Food and Drug Administration. (more…)

FDA pharmacy committee approves 2 substances for compounded medications, rejects 3 others

medicine-1582472_1920Two bulk substances that can treat warts and skin discoloration have been approved for use in compounded medications in a meeting of the U.S. Food and Drug Administration’s Pharmacy Compounding Advisory Committee. Three other ingredients were kept off the list by the eight-member committee, following the FDA’s recommendation.

It also unanimously voted to classify transdermal delivery systems, such as patches, as demonstrably difficult to compound during the Nov. 3 meeting.