Pharmacy News

President Signs Compounding Law

[January 1, 2014, AJHP News]

Kate Traynor

BETHESDA, MD 16 Dec 2013—A year after Congress began investigating deadly fungal infections linked to tainted medications prepared by a Massachusetts compounding pharmacy, a new law to improve the safety and quality of compounded sterile products is now on the books.

President Obama signed into law the Drug Quality and Security Act on November 27. The law was supported by ASHP, the American Pharmacists Association, the National Community Pharmacists Association, and the National Association of Chain Drug Stores.

Joseph Hill, ASHP's assistant director of government affairs and director of federal legislative affairs, said the law does two major things relating to pharmacy compounding: It eliminates language in the Federal Food, Drug, and Cosmetic Act that has resulted in conflicting court opinions on the federal regulation of pharmacy compounding, and it creates a new, voluntary process for entities to register with FDA as outsourcing facilities that prepare compounded sterile products.

Hill said the law is the product of compromise and thus lacks some elements ASHP had advocated for, such as explicit authority for FDA to inspect compounding operations.

But overall, he said, "we look at this as something that will improve the situation, especially with regards to the larger compounding facilities that prepare a lot of products, oftentimes without a patient prescription, and in some cases ship them across state lines."

Outsourcing facilities. The act defines outsourcing facilities as entities where sterile products are compounded by or under the supervision of a licensed pharmacist. Official outsourcing facilities must register with FDA and comply with requirements set forth in the act, such as the payment of user fees, reporting of data to FDA, and submitting to FDA inspections.

Outsourcing facilities do not need to obtain product-marketing approval from FDA. The facilities do not need to be licensed as pharmacies, and they may or may not process patient-specific prescriptions.

FDA is required to post on its website a list of the names and locations of registered outsourcing facilities. The list must indicate whether these entities compound products from bulk substances and if any bulk substances are used to produce sterile or nonsterile final products.

FDA Commissioner Margaret Hamburg acknowledged that nothing in the law prevents entities that don't register as outsourcing facilities from preparing and selling compounded sterile products to hospitals and physicians. But she said that marketplace dynamics may limit the appeal of products made by such businesses.

Hamburg said she hopes that outsourcing facilities "will be the standard of practice in terms of where providers will seek these kinds of products for their patients."

Hill said hospitals have been reevaluating their use of outsourcers since the 2012 outbreak of fungal infections, and the advent of outsourcing facilities may add a new layer of assurance to hospitals that purchase compounded sterile products.

He said that products sold by registered outsourcing facilities could potentially cost more than medications obtained from unregistered compounding pharmacies. But ASHP members have said that they typically use outsourcers when they need a medication that can't be compounded inhouse.

"Cost doesn't seem to be a driver," Hill said.

Office use. Hill noted that the act makes no mention of so-called office use of compounded drugs. The International Academy of Compounding Pharmacists, which did not support the final legislation, voiced concerns that physicians would no longer be able to administer compounded drugs to patients if the law were enacted.

Oklahoma Senator Tom Coburn, in remarks published in the November 14 Congressional Record, stated that office use of compounded medications would not be prohibited under the act.

"I want to make clear that this legislation does not change current State law or authority over the dispensing or distribution of medications by pharmacists, compounded or manufactured, for a prescriber's administration or to treatment of a patient within their practice," stated Coburn, who is a physician.

Coburn said office use and the entirety of pharmacy practice remain subject to state regulation, and FDA should not interpret the act as granting the agency to regulate such practices.

Hill said ASHP's interpretation of the act is likewise that "it leaves it to the state boards of pharmacy to determine how and whether they want to regulate" office use.

Communication. The law also requires improved information sharing between the Department of Health and Human Services (HHS) and state boards of pharmacy about issues related to compounding pharmacies and outsourcing facilities. In particular, HHS must notify all state boards of pharmacy when the department learns of a state's action against a compounder or determines that a pharmacy is not abiding by federal compounding requirements.

Inadequate information sharing between FDA and state pharmacy boards was cited in congressional investigations as a contributing factor in the 2012 outbreak.

Compounding-related provisions in the law go into effect immediately. Any FDA regulations that are needed to implement the provisions must undergo a formal rulemaking process, including the development and publication of a proposed rule, a 60-day public comment period, and a final rule to be published no more than 18 months after the proposed rule.

The bulk of the language in the law addresses supply-chain security, including electronic track-and-trace requirements for drug packages. ASHP has been generally supportive of federal efforts to improve the tracking and tracing of medications.


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