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.


These insanitary conditions are FDA’s red flags for compounding pharmacies

sterileInsanitary conditions in compounding pharmacies can lead to tragedy. The 2012 outbreak of fungal meningitis, which killed more than 60 people and was caused by contaminated steroids, illustrates the seriousness of the problem. The FDA released guidance in August that represents the agency’s current thinking on insanitary conditions, which can be defined as “so dirty or ridden with germs as to be a danger to health.”

So what conditions are potential pitfalls for compounding pharmacies? (more…)

Fraud cases underscore new challenges for compounding pharmacies

skin-care-1491363Note: This article was published Nov. 3, 2016, in Specialty Pharmacy Times.

Fraud is a leading concern of federal investigators and the compounding pharmacies they oversee. Compounded drugs are covered by Medicare’s Part D program, and they accounted for a 56 percent increase in costs over the last year, according to a June report on Medicare spending.

Topical creams or gels that reduce pain are the fastest growing category of compounded drugs, and the average cost has risen to $331 per prescription, up from $40 in 2006.

In a number of recent cases, the government alleges that groups of marketers, pharmacists and doctors are working together to overbill Medicare beneficiaries. The drain on Medicare and workers’ compensation plans is forcing plan administrators to reevaluate payment options. (more…)

Georgia limits office use compounding to outsourcing facilities

6120124167_917a86f78b_bAn amendment to the Georgia Pharmacy Practice Act that went into effect July 1, 2016, authorizes the Board of Pharmacy to create rules for the permitting of outsourcing facilities and third-party logistics providers in Georgia. This change allows the state to recognize and create its own rules for outsourcing facilities under Section 503B of the Federal Food, Drug and Cosmetic Act. Those rules, once published, may be more restrictive than the minimum federal standards enforced by the FDA.

The new law makes it explicitly clear that an independent compounding pharmacy may only compound human drug products for “office use” at a licensed outsourcing facility. There is a carve out for hospital-based pharmacies and pharmacies owned or operated by hospitals, as well as for medical doctors who compound drugs for administering or dispensing to their own patients. (more…)

5 rules for a compounding pharmacy facing an FDA inspection

survey-1594962_960_720The FDA has put greater scrutiny on compounding pharmacies since August 2016, with inspectors making preliminary assessments on compliance for patient-specific prescriptions and other rules under Section 503A of the federal Food, Drug and Cosmetic Act.

The change allows investigators to cite deviations from the current good manufacturing practices when it appears the pharmacy does not qualify for exemptions. So a compounding pharmacy, operating under the belief that it is exempt from certain requirements, can now suddenly find itself criticized for failing to adhere to those requirements. (more…)

Should my compounding pharmacy become a registered outsourcing facility?

cure-1006812_1920In the nearly three years since the Drug Quality and Security Act of 2013 (DQSA) created a new level of fees, inspections and exemptions for registered outsourcing facilities, compounding pharmacy owners have been faced with the question of whether they should embrace the Food and Drug Administration’s registration and inspection procedures.

Their answer has been a resounding “no,” choosing instead to face the legal uncertainties and increased scrutiny under existing rules. Nationwide, only 63 outsourcing facilities have registered, and none of those are located in Georgia. (more…)