Just over three years ago, on November 27, 2013, Congress
amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by enacting the
Drug Quality and Security Act (DQSA). The first title of the DQSA, known as the
Compounding Quality Act, was passed in response to numerous serious adverse
events, including deaths, linked to poor quality compounded drugs. In particular,
in 2012, injectable drug products produced by a compounder and shipped across
the country caused a fungal meningitis outbreak that resulted in more than 60
deaths and 750 cases of infection, affecting patients in 20 states.
Compounded drugs can serve
an important medical need for patients. However, if a compounded drug does not
meet appropriate quality standards (e.g., if an injectable drug is
contaminated, or if a tablet contains too much active ingredient), it could
cause serious injury or death. Therefore, in implementing and enforcing the
compounding-related provisions of the FD&C Act, FDA seeks to strike a
balance between preserving access to lawfully-marketed compounded drugs for
patients who have a medical need for them while protecting patients from the
risks associated with compounded drugs that are not produced in accordance with
the applicable requirements of federal law.
FDA has devoted
significant agency resources to implementing and enforcing the
compounding-related provisions of the FD&C Act, including those added by
the DQSA, in the wake of the 2012 fungal meningitis outbreak and other serious
injuries and deaths.
Over the past three years,
FDA has:
• Significantly increased its inspections of facilities where
drugs are being compounded and taken appropriate regulatory actions in response
to violations of the law that put patients at risk;
• Issued numerous policy
documents, including draft and final guidance documents and proposed and final
regulations;
• Convened advisory committee meetings to obtain advice on
scientific, technical, and medical issues concerning drug compounding;
• Obtained input from stakeholders through a variety of
different mechanisms; and
• Worked closely with states to share information and coordinate
efforts.
The Regulatory
Framework and History of Drug Compounding Regulation
Most prescription
drugs are required to:
• undergo premarket approval to demonstrate safety and efficacy;
• be labeled with adequate directions for use so patients can
safely use drugs for their intended purposes; and
• be manufactured
according to current good manufacturing practice (CGMP) requirements, which are
intended to assure the identity, strength, quality, and purity of drugs by
requiring adequate control of manufacturing operations.
These requirements provide important protections to patients.
Under certain conditions, however, compounded drug products are not subject to
these requirements. Other protections, such as the prohibition on preparing
drugs under insanitary conditions, apply to all drug products, including
compounded drugs.
What is Drug
Compounding?
Drug compounding is often regarded as the process of combining,
mixing, or altering ingredients to create a sterile or non-sterile medication
tailored to the needs of a patient. Compounded drugs are not FDA-approved.
A drug may be compounded for a patient who cannot be treated
with an FDA-approved medication, such as a patient who has an allergy and needs
a medication to be made without a certain dye, or an elderly patient or a child
who cannot swallow a tablet or capsule and needs a medicine in a liquid dosage
form that is not otherwise available. Practitioners in hospitals, clinics, and
other health care facilities sometimes administer or dispense compounded drugs
to patients when an FDA-approved drug is not medically appropriate to treat
them.
In these situations, compounding can serve an important patient
need. However, some compounders engage in inappropriate compounding activities.
For example, FDA is aware that some compounders produce drugs for patients even
though an FDA-approved drug may have been medically appropriate for them. FDA
has also observed that some compounders have advertised compounded drugs as
safe and effective, sometimes for the treatment of serious diseases,
incorrectly suggesting the drugs had met the standard for FDA approval.
Risks of Compounded
Drugs
Because compounded drugs are not FDA-approved, FDA does not
verify their safety, effectiveness, or quality before they are marketed. FDA
also has observed that the labeling of compounded drugs often omits important
information such as directions to help ensure that the drugs are used safely
and warnings about possible side effects and drug interactions. In addition,
and of particular concern, poor compounding practices can result in serious
drug quality problems, such as contamination or medications that do not possess
the strength, quality, and purity they are supposed to have. This can lead to
serious patient injury and death.
In October 2012, the United States faced the most serious
outbreak associated with contaminated compounded drugs in recent history. A
pharmacy in Massachusetts shipped contaminated compounded drugs to patients and
health care providers throughout the country. The drugs, which were contaminated
with fungal growth, were injected into patients’ spines and joints. More than
750 people in 20 states developed fungal infections, and more than 60 people
died as a result. Approximately 14,000 patients received injections from the
lots of contaminated drug product.
Source: FDA
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