SILVER SPRING, Md.,
April 19, 2018
/PRNewswire-USNewswire/ -- U.S. District Judge Kristine G. Baker for the Eastern District of
Arkansas entered a consent decree
of permanent injunction today between the U.S. and Cantrell Drug
Company of Little Rock, Arkansas,
and the company's Chief Executive Officer and co-owner,
James L. McCarley, Jr.
The consent decree prohibits Cantrell and McCarley from
manufacturing, processing, packing, holding, or distributing drugs
until they comply with the Federal Food, Drug, and Cosmetic Act
(FD&C Act) and FDA regulations, in addition to other
requirements.
"As a public health agency, the FDA is committed to fully
implementing the Drug Quality and Security Act for compounded drugs
set forth by Congress that helps ensure compounded drugs are made
under appropriate production standards," said FDA Commissioner
Scott Gottlieb, M.D. "We'll continue
to take action against compounders who produce drugs under
substandard conditions and put the health of patients at risk."
The complaint filed with the consent decree alleges that
Cantrell manufactured and distributed purportedly sterile drug
products, such as injectable opioids and antibiotics, that were
adulterated under the FD&C Act because the drugs were made
under insanitary conditions and in violation of current good
manufacturing practice (CGMP) requirements. Drugs that are
prepared, packed or held under insanitary conditions whereby they
may have become contaminated with filth or rendered injurious to
health are adulterated under the FD&C Act.
The consent decree requires Cantrell to cease operations until
it completes corrective actions, including hiring a qualified
independent expert to inspect its facility to ensure the company is
complying with the FD&C Act and CGMP requirements. Under the
consent decree, Cantrell cannot resume operations until it receives
authorization from the FDA.
Cantrell is registered as an outsourcing facility under section
503B of the FD&C Act. The Drug
Quality and Security Act, signed into law on Nov. 27, 2013, added a new section --
503B – to the FD&C Act. Under
section 503B, a compounder can elect
to register as an outsourcing facility. Outsourcing facilities must
comply with CGMP requirements, are inspected by the FDA according
to a risk-based schedule and must meet certain other conditions,
such as reporting adverse events and providing the FDA with certain
information about the products they compound.
The complaint was filed by the U.S. Department of Justice on
behalf of the FDA.
For more information:
- Compounding: Inspections, Recalls and Other Actions
- FDA alerts health care professionals and patients not to use
compounded drugs from Cantrell Drug Company; agency seeks action to
stop production and distribution
- Cantrell Drug Company Issues Voluntary Nationwide Recall of All
Sterile Drug Products Due to Lack of Sterility Assurance
- Cantrell Drug Company, Little Rock,
AR, 483 Issued 03/22/2018
- Cantrell Drug Company, Little Rock,
AR. 483 Issued 06/29/2017
- Warning letter: Cantrell Drug Company 1/21/15
The FDA, an agency within the U.S. Department of Health and
Human Services, protects the public health by assuring the safety,
effectiveness, and security of human and veterinary drugs, vaccines
and other biological products for human use, and medical devices.
The agency also is responsible for the safety and security of our
nation's food supply, cosmetics, dietary supplements, products that
give off electronic radiation, and for regulating tobacco
products.
Media Inquiries: Lyndsay
Meyer, 240-402-5345, lyndsay.meyer@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
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SOURCE U.S. Food and Drug Administration