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