GAO report shows how states are inspecting compounding pharmacies

Most states, including Georgia, inspect compounding pharmacies and take action when something is amiss, according to a November 2016 report from the U.S. Government Accountability Office.

Compounding pharmacies are inspected by states to obtain a license, in response to a complaint or as part of a reoccurring safety check. Forty-two states reported inspecting all licensed pharmacies operating in their state, and six states said that they had inspected some resident pharmacies. (more…)

What compounding pharmacies need to know about USP 795 guidelines on nonsterile drug preparations

Nonsterile drug compounding, which refers to formulating medications that patients drink, swallow or apply to the skin, is the most common kind of drug compounding done in community and hospital pharmacies. Despite the nonsterile designation, preventing contamination is still a key part of compliance with legal and professional standards, such as those described in the U.S. Pharmacopeia and enforced by the FDA and state pharmacy boards.

USP 795 is a chapter of guidelines to help ensure safe and quality compounding of nonsterile pharmaceutical preparations for humans and animals. The document serves as a reference that defines the responsibilities of the compounder and establishes preparation protocol, storage conditions, special counseling considerations, and other important criteria beyond standard pharmacy practice.

The guidelines define terminology essential to nonsterile compounding. USP 795 also outlines good habits and practices in compounding nonsterile pharmaceutical preparations to ensure patient safety while preserving preparation purity, potency and efficacy. This also includes defining specifications for compounding facility design, storage and handling requirements and packaging. (more…)

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.

(more…)