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…)
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…)
The FDA is stepping up its inspections of drug compounders, including those in Georgia. From May 2012 through April 2016, 265 traditional compounding pharmacies operating under Section 503A of the federal Food, Drug and Cosmetic Act were inspected across the nation, according to a November 2016 report from the U.S. Government Accountability Office. (more…)
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…)