Compounding pharmacies express frustrations from incomplete FDA guidance

Some pharmacists are expressing frustration over the time it is taking for the FDA to finalize its guidance on various areas involving compounded drugs, according to a November 2016 report from the U.S. Government Accountability Office.

Nearly a quarter of stakeholder organizations said it is difficult for pharmacies to move forward without final guidance from the FDA about which drugs it considers difficult to compound. Adding drugs to a bulk drug list exempts them from stringent provisions of the Federal Food, Drug and Cosmetic Act and means that pharmacies can use those drugs as active ingredients in compounded medications. (more…)

In Pharmacy Practice News, Hasson describes impact of FDA scrutiny of compounding drugs

The FDA has provided a new look at its efforts to ensure the safety of compounded drugs over the past three years in a report released earlier this month. This progress report comes days after the beginning of a criminal trial involving a fatal fungus meningitis outbreak in 2012 that occurred due to drugs being compounded with contaminated and expired ingredients. The compounded drugs were blamed for more than 60 deaths and 750 cases of infection, affecting patients in 20 states, according to the FDA.

Since that event, the safety of compounded drugs has been in the spotlight. In 2013, Congress enacted the Drug Quality and Security Act, which stepped up oversight of compounding pharmacies. The FDA says it has devoted significant agency resources to implementing and enforcing the compounding-related regulations.

In an article published by Pharmacy Practice News, Keith Hasson, managing partner of Hasson Law Group, notes that the report “reads like a document trying to justify [the FDA’s] efforts in the compounding pharmacy space, and they make a pretty good case.” (more…)

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…)