WASHINGTON Jan 9 A small number of U.S.
compounding pharmacies have begun registering with the Food and
Drug Administration under new legislation designed to tighten
control of the custom medication makers following a deadly
outbreak of fungal meningitis linked to a pharmacy in
So far, 11 compounding pharmacies have taken up the option
under the Drug Quality and Security Act of registering with the
FDA, a move they hope will give them a marketing edge.
The law signed in November aims to clarify the FDA's
authority to regulate compounding pharmacies after federal
regulators were blamed for not acting soon enough to shut down
the pharmacy at the center of the meningitis outbreak.
Names of the registered facilities were posted on the FDA's
website on Thursday. They range from big players such as
Pharmedium Services LLC to smaller outfits such as Marlborough
Hospital in Massachusetts and Medi-Fare Drug and Home Health
Center in Blacksburg, South Carolina. Some of the firms have
already been inspected, and even received warning letters from
the FDA, while others have yet to be inspected.
According to the International Academy of Compounding
Pharmacists, which represents pharmacists who make custom
medications, there are about 3,000 pharmacies which compound
sterile products - those that are at the greatest risk for
Centers that choose to register with the FDA must pay a fee,
adhere to good manufacturing standards, subject themselves to
routine inspections by the agency and report adverse events
associated with their products. In return, they join a new class
of compounding firm known as outsourcing facilities. These are
allowed to sell products in bulk to hospitals and physician
practices in the absence of individual prescriptions.
Pharmedium was one of the first to sign up. Its chief
executive, David Jonas, said in a statement in December that
going forward, "there will be more consistent regulations and
consistent oversight, which should raise the level of confidence
among hospital leaders, providers and their patients."
Pharmacists have long mixed tailored medications for
patients based on individual prescriptions; but over the past
two decades the practice has mushroomed, with some pharmacies
selling thousands of doses of regularly used mixtures for
physicians to keep on hand for future use.
In 2012, the New England Compounding Center in Framingham,
Massachusetts, distributed a contaminated steroid often used to
treat back pain. The product has been associated with more than
750 cases of fungal meningitis, including 64 deaths. The scandal
prompted Congress to pass a law clarifying the FDA's regulatory
authority over drug compounding.
The rules governing outsourcing facilities under the new law
are not as strict as those governing pharmaceutical companies
such as Pfizer Inc, whose products must be reviewed and
approved by the FDA before they can be sold. But they are
stricter than those governing a compounding pharmacy that
chooses not to register.
Pharmacies that do not register with the FDA will be
regulated by state boards of pharmacy. They will be allowed to
compound a certain amount of product in advance of receiving a
prescription but will not be allowed to sell without a
prescription. The FDA can inspect them in response to a
complaint, but the agency would require a court order to access
The FDA's hope is that healthcare organizations will choose
to buy from an FDA-regulated facility, and that customers will
press their suppliers to register with the agency. FDA
Commissioner Margaret Hamburg sent out hundreds of letters to
hospitals on Wednesday encouraging them to purchase compound
medication only from FDA-registered suppliers.
"As a purchaser of compounded drugs, you can play an
important role in improving the quality of compounded drugs by
requiring compounding pharmacies that supply drugs to your
facility to register as outsourcing facilities," she wrote.
The FDA said it is too soon to tell how many will ultimately
"We're hopeful that market forces will drive more firms to
register with FDA as outsourcers," agency spokesman Steven
Immergut said, "but only time will tell."
Allan Coukell, who oversees medical programs at The Pew
Charitable Trusts, said he is encouraged by the number of firms
that have registered since the law was passed on Nov. 27th.
"Very few have gotten off to as fast a start as this one,"
(Reporting by Toni Clarke; editing by Andrew Hay)