Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Thursday, September 26, 2013
NOTE: Until the draft of the federal compounding legislation is released and reviewed it is very hard to predict any impact or issues it might have. For example, NYT indicate Under the new system, federal regulators would be able to track what the compounding pharmacies are making, receive reports about problems with any of the compounded drugs, and have the authority to conduct safety inspections.
Question of the Day September 26, 2013 Once you register (assuming it is now going to be optional) under the new federal compounding legislation (remembering there is an agreement; but it has not passed yet), can you "unregister" as an outsourcing facility later?Are there any penalties for doing that?
Reports Are that There will no Requirement that compounding pharmacies register under the new federal legislation. Not sure how that is going to work. I do know without funding to hire people the FDA will ultimately have no ability to enforce federal compounding legislation and thus ultimately nothing in all probability will change.
More Sway for F.D.A. Is Object of New Bill By SABRINA TAVERNISE Published: September 25, 2013
A bipartisan committee of lawmakers from the Senate and the House reached a compromise on Wednesday on legislation that would give the Food and Drug Administration greater control over compounding pharmacies. But analysts said it was still unclear whether the law would actually make drugs safer.
Lawmakers said the bill’s primary function was to help prevent another national health disaster like the meningitis outbreak last year that was traced to a large Massachusetts-based compounding pharmacy, a company that mixes specialty medicine. More than 60 people died and more than 700 were sickened after receiving injections of a contaminated steroid made by the pharmacy, the New England Compounding Company.
The F.D.A. has argued repeatedly that it has limited authority over compounders, which are now regulated by state boards of pharmacy, even though many ship drugs across state lines.
The bill’s authors argued that it would give the agency broader powers by placing some compounding pharmacies in a separate category that would require them to behave much like traditional drug manufacturers: to alert the authorities when something goes wrong with their products, to register with the F.D.A. and to allow agency officials into their facilities for inspection, much as traditional drug manufacturers do.
But the language of a statement issued late on Wednesday by the bill’s authors implied that companies would not be required to be part of the new category, leaving the option open to those compounding facilities “who wish” to join.
If being part of the new group is optional, that means there will be a reliance on the market to drive demand for products made under the stricter standards, said Allan Coukell, a drug policy expert at the Pew Charitable Trusts.
“It will be incumbent on the purchaser — the physician, clinic or hospital — to opt for drugs from F.D.A.-regulated facilities,” he said.
Under current law, compounders are not required to give the F.D.A. access to their books, or to allow them in to their production facilities for . About half of all the court orders the agency obtained over the past decade were for pharmacy compounders, although compounders were only a small part of the agency’s regulatory responsibilities.
A Senate staff member with knowledge of the legislation said the goal of the bill was to create an incentive for compounding pharmacies to register with the F.D.A., even though it is not a requirement for companies to do so.
continue to read here
Quoted from NABP--Michigan Lawmakers Consider Bill to Strengthen Compounding Regulations
A series of bills have been introduced to the Michigan Legislature that would include several provisions intended to strengthen the regulation of compounding in the state. The bills would require:
- an on-site “pharmacist-in-charge” at every compounding facility,
- detailed records for all sterile compounded products,
- criminal
background checks for new pharmacy owners, or those licensed before October 1, 2008, and - at least one biannual inspection for each facility.
As of September 6, 2013, Centers for Disease Control and Prevention (CDC) traced 264 cases and 19 deaths in the state of Michigan to the 2012 outbreak of fungal meningitis linked to contaminatedpain medications compounded at the New England Compounding Center in Massachusetts. These numbers led Michigan’s Attorney General, Bill Schuette, one of the bill’s backers, to call Michigan the “epicenter” of the outbreak. More information is available in a Detroit News article and in a Detroit Free Press article.
Senate, House Health Policy Leaders Announce Bipartisan, Bicameral Legislation to Address High-Risk Drug Compounding Practices and Secure the Pharmaceutical Supply Chain Wednesday, September 25, 2013
WASHINGTON, D.C. —Leaders from the Senate and House committees overseeing health policy today announced that they have reached an agreement on legislation to help ensure the safety of compounded drugs and our nation’s pharmaceutical supply chain. This legislation, the Drug Quality and Security Act, reflects a bipartisan, bicameral effort to improve drug safety and help prevent a future public health crisis like the 2012 meningitis outbreak tied to the New England Compounding Center.
“Plain and simple, this legislation will help ensure that providers and their patients have access to high-quality compounded drugs,” said Senate HELP Committee Chairman Tom Harkin (D-IA). “This legislation will improve the safety of compounded drugs by clarifying the oversight responsibilities of the FDA over large-volume compounders and by holding facilities to high quality standards. This bill also calls for an unprecedented tracing system that will track prescription drugs from manufacturing to distribution. I commend the bipartisan spirit that brought this compromise proposal together.”
“This bill will help prevent Tennessee families from living through another nightmare like last year’s tragic meningitis outbreak, which has killed 16 Tennesseans and sickened so many others. The FDA commissioner has warned us that an outbreak like this will happen again if we don’t clarify oversight, so I have worked hard with my colleagues in the House and Senate to make it clear at every compounding facility who’s on the flagpole—who’s in charge—of overseeing their compounding practices,” said Senate HELP Committee Ranking Member Lamar Alexander (R-TN).
“Today we are taking a notable step toward completing the important work of improving the security of our pharmaceutical supply chain and clarifying the regulation of drug compounding. This step will help us protect the health and safety of the American people,” said Energy and Commerce Committee Chairman Fred Upton (R-MI). “The leadership of Rep. Morgan Griffith, Rep. Bob Latta, Health Subcommittee Chairman Joe Pitts, and Oversight and Investigations Subcommittee Chairman Tim Murphy has been fundamental in achieving this bipartisan agreement. It has been nearly one year since the tragic, deadly fungal meningitis outbreak and I am pleased to be working with my colleagues in the Senate to send a bill to the president’s desk, bringing this investigative and legislative effort to a successful conclusion soon. In light of the missed opportunities to prevent the outbreak, with this bill we say, ‘never again.’”
“This legislation is a major stride toward the goal of ensuring the quality and safety of the medicines Americans rely upon every day," said Energy and Commerce Committee Ranking Member Henry A. Waxman (D-CA). "The bill will correct the constitutional defect in FDA’s drug compounding statute that has wreaked havoc on the Agency’s ability to effectively enforce the law for years. It will also give FDA the opportunity to have broad oversight of a new category of large compounding pharmacies. This is undoubtedly a step forward for public health. Further, we have developed a uniform system for tracking and tracing drugs to prevent counterfeits from entering the supply chain that maintains the strengths of the groundbreaking California system. I want to acknowledge the contributions of Reps. Frank Pallone, John Dingell, Diana DeGette, Gene Green, Jim Matheson, and former Rep., now Senator, Ed Markey to this bipartisan effort."
The bill clarifies current federal law regarding pharmacy compounding and resolves the patchwork of current federal regulation by applying a uniform standard nationwide.
Further, compounders who wish can register as outsourcing facilities, but those who choose to remain traditional pharmacies will continue to be regulated primarily by state boards of pharmacy, as they are in current law. Outsourcing facilities would be subject to oversight by the U.S. Food and Drug Administration (FDA) in much the same way as traditional manufacturers are monitored. FDA will know who these outsourcers are and what they are making, receive adverse event reports about compounded drugs, and have the authority and resources to conduct risk-based inspections.
The second title of the bill would replace today’s patchwork of state prescription-drug tracing laws by creating a new uniform framework for tracking drugs from the manufacturer to the pharmacy. There is currently no system for tracking the drugs that make up some four billion prescriptions per year in the United States, which means drugs that are stolen or counterfeit may not be discovered before reaching consumers.
A recently-released report from the nonpartisan Government Accountability Office (GAO) confirmed that legislation is needed to clarify the U.S. Food and Drug Administration’s (FDA) oversight of large-scale drug compounders. The nonpartisan office wrote that “this lack of consensus and differing FDA authority to oversee compounded drugs across the country has resulted in gaps in oversight of drug compounding,” posing a grave threat to public health.
Alexander Announces Agreement to Help Prevent Tennessee Families From “Living Through Another Nightmare Like Last Year’s Tragic Meningitis Outbreak” House action possible this week on legislation to clarify oversight of each compounding facility
Wednesday, September 25, 2013Liz Wolgemuth 202-224-8584
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"The FDA commissioner has warned us that, without fixing oversight, a similar outbreak will happen again, so I have worked hard with my colleagues in the House and Senate to make it clear at every compounding facility who’s on the flagpole—who’s in charge—of overseeing their compounding practices.” – Lamar Alexander
WASHINGTON, Sept. 25— Sen. Lamar Alexander (R-Tenn.), the senior Republican on the U.S. Senate health committee today announced that leaders from the Senate and House committees that oversee health policy have reached an agreement on legislation to help ensure the safety of compounded drugs and to track prescription drugs from the time they’re manufactured to the moment they are picked up at a drugstore. The House of Representatives may take action on the legislation this week, and Alexander said he hopes “the Senate acts promptly on the legislation, because the FDA commissioner has warned us that an outbreak like this will happen again if we don’t clarify oversight.”
Alexander said: “This bill will help prevent Tennessee families from living through another nightmare like last year’s tragic meningitis outbreak, which has killed 16 Tennesseans and sickened so many others. I have worked hard with my colleagues in the House and Senate to make it clear at every compounding facility who’s on the flagpole—who’s in charge—of overseeing their compounding practices.”
Today’s agreement was announced was by Alexander and Senate Health, Education, Labor and Pensions (HELP) Committee Chairman Tom Harkin (D-Iowa), House Energy and Commerce Chairman Fred Upton (R-Mich.) and Ranking Member Henry Waxman (D-Calif.). The bill clarifies current federal law regarding pharmacy compounding and resolves the patchwork of current federal regulation by applying a uniform standard nationwide.
Further, compounders who wish can register as outsourcing facilities, but those who choose to remain traditional pharmacies will continue to be regulated primarily by state boards of pharmacy, as they are in current law. Outsourcing facilities would be subject to oversight by the U.S. Food and Drug Administration (FDA) in much the same way as traditional manufacturers are monitored. FDA will know who these outsourcers are and what they are making, receive adverse event reports about compounded drugs, and have the authority and resources to conduct risk-based inspections.
The legislation will include the Drug Supply Chain Security Act, legislation passed unanimously by the Senate HELPCommittee, to replace today’s patchwork of state prescription-drug tracing laws by creating a new uniform framework for tracking drugs from the manufacturer to the pharmacy. There is currently no system for tracking the drugs that make up some 4 billion prescriptions per year in the United States, which means drugs that are stolen or counterfeit may not be discovered before reaching consumers.
Last November, when the Senate HELP Committee held its first hearing on the deadly meningitis outbreak, Alexander called for a new model of oversight of sterile compounding pharmacies.
A recently released report from the nonpartisan Government Accountability Office (GAO) confirmed that legislation is needed to clarify the FDA’s oversight of large-scale drug compounders. The report authors concluded that there are “gaps in oversight” and that “it is essential to have clear roles for FDA and states in regulation and oversight of drug compounding.”
Compromise bill announced on regulating drug compounders
Written by
Walter F. Roche Jr.
The Tennessean
A compromise bill that supporters say gives the U.S. Food and Drug Administration great regulatory control over drug compounders has been announced by congressional leaders from both the House and Senate, but it is unclear whether it has the support of the FDA itself.
The compromise was disclosed late Wednesday in press releases issued by U.S. Sen. Lamar Alexander, R-Tenn., and a bipartisan group of House leaders including U.S. Rep. Henry Waxman, a California Democrat.
The agreement comes a year after the beginning of a fungal meningitis outbreak that took the lives of 16 patients treated in Tennessee and 64 nationwide. The deadly outbreak has been blamed on a Massachusetts drug compounding company that shipped fungus-tainted spinal steroids to health-care providers in 20 states.
Industry officials said the compromise had been worked out over the weekend, but expressed concern that the FDA had last-minute objections.
Erica Jefferson, FDA spokeswoman, said she could not immediately comment on the matter. Actual copies of the legislation were not immediately available.
“This bill will prevent Tennessee families from living through another nightmare like last year’s tragic meningitis outbreak,” Alexander said in a prepared statement.
The congressional proposal has drawn criticism from advocacy groups like Washington, D.C.-based Public Citizen. Dr. Michael Carome, who heads the group, said both the House and Senate versions of the bill authorize a new category of drug manufacturers that will face less scrutiny than those now licensed by the FDA. He argues that the FDA already has the authority to regulate large drug compounders but has failed to do so.
Carome said Wednesday that he had yet to see the actual legislation and repeated his concerns.
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