A newspaper article in the Boston Globe
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A newspaper article in the Boston Globe:
Boston Globe Newspaper Article
A new law was passed in 2013 called the “Compound Quality Act” which essentially requires all
compound pharmacies to register with the Food and Drug administration as “outsourcing
facilities”. If they register, they can continue in business under new regulations for oversight. If
they do not register, they are essentially out of business, as the new law would require FDA
approval for every drug they issue.
The essentials of the new law follow: (from
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/
ucm339764.htm#outsourcing
)
New USA Law
1. What is “compounding”?
In general, compounding is a practice in which a licensed pharmacist, a licensed physician, or, in
the case of an outsourcing facility, a person under the supervision of a licensed pharmacist,
combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an
individual patient.
2. Is combining two or more drugs considered compounding?
Yes, compounding includes the combining of two or more drugs.
3. Why do some patients need compounded drugs?
Sometimes, the health needs of a patient cannot be met by an FDA-approved medication. For
example:
if a patient has an allergy and needs a medication to be made without a certain dye; or
if an elderly patient or a child can’t swallow a pill and needs a medicine in a liquid form that is
not otherwise available.
4. Are compounded drugs approved by the FDA?
Compounded drugs are not FDA-approved. This means that FDA does not verify the safety, or
effectiveness of compounded drugs. Consumers and health professionals rely on the drug
approval process to ensure that drugs are safe and effective and made in accordance with Federal
quality standards. Compounded drugs also lack an FDA finding of manufacturing quality before
such drugs are marketed.
Generally, state boards of pharmacy will continue to have primary responsibility for the day-to-
day oversight of state-licensed pharmacies that compound drugs in accordance with the
conditions of
section 503A of the FDCA
, although FDA retains some authority over their
operations. However, outsourcing facilities that register under section 503B are regulated by
FDA and must comply with CGMP requirements and will be inspected by FDA according to a
risk-based schedule.
5. What are the risks associated with compounded drugs?
There can be health risks associated with compounded drugs that do not meet federal quality
standards. Compounded drugs made using poor quality practices may be sub- or super-potent,
contaminated, or otherwise adulterated. Additional health risks include the possibility that
patients will use ineffective compounded drugs instead of FDA-approved drugs that have been
shown to be safe and effective.
6. Who regulates and inspects facilities that compound drugs?
Generally, state boards of pharmacy will continue to have primary responsibility for the day-to-
day oversight of state-licensed pharmacies that compound drugs in accordance with the
conditions of
section 503A of the FDCA
, although FDA retains some authority over their
operations. For example, the adulteration or misbranding of drugs compounded under section
503A, or false or misleading statements in the labeling or advertising of such drugs, may result in
violations of Federal law. Firms that register with FDA as “outsourcing facilities” under section
503B will be regulated by FDA and inspected by FDA according to a risk-based schedule.
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