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
Tuesday, December 3, 2013
Reliant Pharmacy was issued a FDA 483 on October 30, 2013 but it has not been posted on FDA website
Yeung Business Solutions, LLC dba Reliant Pharmacy
Investigator / FULL
Oct 30, 2013
No 483.
can purchase here
Reminder Weatherford Compounding Pharmacy LLC that reporters have tied to the doping issue in horse racing has been previously issued a 483 on February 3, 2012 by the FDA
Weatherford Compounding Pharmacy LLC 483 Feb 03, 2012
483 Issued On Feb 03, 2012
FDA inspectors audited the Weatherford Compounding Pharmacy LLC facility in Weatherford, TX, United States and issued a 483 on Feb 03, 2012.483 Details
- Inspection end: Feb 03, 2012
- Location: Weatherford, United States
- FEI: 3008790859
Related 483s
Weatherford Compounding Pharmacy LLC FDA 483 Feb 03, 2012
Specialty Medicine Compounding Pharmacy, P.C., South Lyon, MI FDA 483
Specialty Medicine Compounding Pharmacy, P.C., South
Lyon, MI
- 483 Issued 11/5/201395 (PDF - 3.2MB)
Leiter's Cambrian Park Drugs, Inc. (dba Leiter's Pharmacy), San Jose, CA FDA 483
Leiter's Cambrian Park Drugs, Inc. (dba Leiter's Pharmacy), San Jose,
CA
- 483 Issued 11/5/201345 (PDF - 3.8MB)
College Pharmacy Incorporated, Colorado Springs, CO FDA 483
College Pharmacy Incorporated, Colorado Springs, CO
- 483 Issued 3/15/201322 (PDF - 1.3MB)
Horsing and Doping --FEI: Endurance Group Seek Feedback on Tougher Rules
Horsetalk.co.nz - Full Article
By Horsetalk.co.nz on Nov 26, 2013 in News
Out-of-competition testing, tougher penalties, the requirement for medication logbooks for horses, and holding trainers accountable alongside riders are among measures to clean up endurance that have gone out to member nations of the FEI for consideration.
The world governing body’s Endurance Strategic Planning Group has taken its next step toward reforms aimed at cleaning up welfare issues in the sport, sending its detailed proposed recommendations to national federations...
Read more here:
http://horsetalk.co.nz/2013/11/26/endurance-group-feedback-measures/#axzz2llZ40e6B
Just Another Example Of Why We Need Regulation
This is slightly more wonky than I usually get, but its worth noting and revisiting this for a second.
We’ve all forgotten about it by now, but last October there was a multi-state meningitis outbreak that killed several people. The outbreak happened because a steroid solution created by a medical compounding center had become infected and had then been distributed to patients in various states.
As this outbreak occurred, Fox News was running one of their campaigns attacking regulation. I wrote about it at the time for Media Matters.
continue to read here
We’ve all forgotten about it by now, but last October there was a multi-state meningitis outbreak that killed several people. The outbreak happened because a steroid solution created by a medical compounding center had become infected and had then been distributed to patients in various states.
As this outbreak occurred, Fox News was running one of their campaigns attacking regulation. I wrote about it at the time for Media Matters.
Fox News has regularly attacked efforts at regulation by the federal government: Fox described the Environmental Protection Agency as “job terrorists” who are “strangling America;” cherry-picked data to make false claims about the cost of regulation; falsely claimed that government regulations were responsible for high unemployment; and even attacked laws regulating child labor and workplace safety.Nobody likes arbitrary, stupid, government red tape. But at the same time we need rules and regulations and enforcement in order to keep society operating, especially one as big as ours.
continue to read here
FDA To Urge Providers To Work With Registered Compounders
site.law360.com
Law360, New York (December 02, 2013, 3:39 PM ET) -- U.S. public health regulators have expanded oversight of drug compounders choosing to register with the U.S. Food and Drug Administration, but the agency will help boost participation despite its ...Hamburg Issues Call To Providers To Change Purchasing Policies--Use outsourcing compounding facilities to greatest degree possible.
FDA Commissioner Margaret Hamburg urged health care providers "to the greatest degree possible" to buy from outsourcing compounding facilities that voluntarily step up to FDA oversight as the agency Monday (Dec. 2) laid out policies for registration, reporting and enforcement under the newly signed drug compounding law.
quoted from insidehealthpolicy.com
quoted from insidehealthpolicy.com
Monday, December 2, 2013
Congressman Griffith's comments on the DQSA
Congressman Griffith's Weekly E-Newsletter 12.2.13
Bipartisan Bill I Worked On Signed Into Law
Last week, President Obama signed into law the Drug Quality and Security Act. This win for common sense came after investigations into last fall’s fungal meningitis outbreak tied to tainted injections prepared by Massachusetts’ New England Compounding Center (NECC).
Traditional compounding pharmacies are overseen by State boards of pharmacy. They tend to be small mom-and-pop operations, and make custom medications based on a doctor’s order.
The NECC had long ago stopped operating as a traditional compounding pharmacy. Instead, the NECC was engaged in large-volume drug manufacturing without proper prescriptions.
The NECC claimed that they were exempt from oversight by the Food and Drug Administration (FDA), which typically regulates the manufacturers of medicines. Despite the NECC’s claim, I believe that the FDA clearly had the authority they needed to have regulated the NECC and prevented the fungal meningitis outbreak.
Despite having received complaints from multiple States about the NECC, the FDA did not step in to investigate NECC for illegal manufacturing or share this important information with other States. My colleague, Rep. Diana DeGette (D-CO), recently wrote that the Colorado State Board of Pharmacy in 2011 identified issues with the NECC, having determined that the drugs being distributed in Colorado lacked proper prescriptions. She continued, “Our state board issued a cease-and-desist order to the NECC, and notified the Massachusetts Board as well. But that was all it could do; ultimately, it was not enough to stop the NECC's actions and prevent the tragic outbreak that swept across the nation a year later.”
Because of this oversight failure, the NECC is reported as having shipped more than 17,600 doses of the tainted steroid injection. FDA investigators later uncovered bacteria and mold at the NECC.
But more than 750 people throughout the United States were stricken with fungal meningitis resulting from these injections. Nationwide, 64 people were tragically killed as a result. At least two of those killed were from our region, and others continue to suffer.
After hearings into the outbreak, Rep. Gene Green (D-TX), Rep. DeGette, and I began working together on a bill to further define a compounding pharmacy and clarify oversight of the compounding drug manufacturing system. In September, after months of negotiations, we introduced the Compounding Clarity Act (H.R. 3089), which would clarify FDA authority over compounding, particularly over large-scale entities like the NECC that act as drug manufacturers.
The Griffith-Green-DeGette bill served as the foundation for the compounding pharmacy inspection portion of the Drug Quality and Security Act, which the President signed into law. It is a bipartisan, bicameral first step to ensure the safety of compounded drugs and help save lives, eliminating perceived confusion as to the oversight of pharmacies like the NECC that have worked the system to skirt both FDA and State regulations.
I will continue working on areas that need additional clarification, and will oversee the FDA’s interpretation and implementation of this law.
Unfortunately, for some, the Drug Quality and Security Act is too little, too late. And as with many proposals, the bill is not perfect. But it does represent consensus and common sense. I believe it would prevent another NECC-type outbreak from occurring.
quoted from here
Monday, Dec 2 | Andie Pivarunas (202-225-3861) | 1 comments
Bipartisan Bill I Worked On Signed Into Law
Last week, President Obama signed into law the Drug Quality and Security Act. This win for common sense came after investigations into last fall’s fungal meningitis outbreak tied to tainted injections prepared by Massachusetts’ New England Compounding Center (NECC).
Traditional compounding pharmacies are overseen by State boards of pharmacy. They tend to be small mom-and-pop operations, and make custom medications based on a doctor’s order.
The NECC had long ago stopped operating as a traditional compounding pharmacy. Instead, the NECC was engaged in large-volume drug manufacturing without proper prescriptions.
The NECC claimed that they were exempt from oversight by the Food and Drug Administration (FDA), which typically regulates the manufacturers of medicines. Despite the NECC’s claim, I believe that the FDA clearly had the authority they needed to have regulated the NECC and prevented the fungal meningitis outbreak.
Despite having received complaints from multiple States about the NECC, the FDA did not step in to investigate NECC for illegal manufacturing or share this important information with other States. My colleague, Rep. Diana DeGette (D-CO), recently wrote that the Colorado State Board of Pharmacy in 2011 identified issues with the NECC, having determined that the drugs being distributed in Colorado lacked proper prescriptions. She continued, “Our state board issued a cease-and-desist order to the NECC, and notified the Massachusetts Board as well. But that was all it could do; ultimately, it was not enough to stop the NECC's actions and prevent the tragic outbreak that swept across the nation a year later.”
Because of this oversight failure, the NECC is reported as having shipped more than 17,600 doses of the tainted steroid injection. FDA investigators later uncovered bacteria and mold at the NECC.
But more than 750 people throughout the United States were stricken with fungal meningitis resulting from these injections. Nationwide, 64 people were tragically killed as a result. At least two of those killed were from our region, and others continue to suffer.
After hearings into the outbreak, Rep. Gene Green (D-TX), Rep. DeGette, and I began working together on a bill to further define a compounding pharmacy and clarify oversight of the compounding drug manufacturing system. In September, after months of negotiations, we introduced the Compounding Clarity Act (H.R. 3089), which would clarify FDA authority over compounding, particularly over large-scale entities like the NECC that act as drug manufacturers.
The Griffith-Green-DeGette bill served as the foundation for the compounding pharmacy inspection portion of the Drug Quality and Security Act, which the President signed into law. It is a bipartisan, bicameral first step to ensure the safety of compounded drugs and help save lives, eliminating perceived confusion as to the oversight of pharmacies like the NECC that have worked the system to skirt both FDA and State regulations.
I will continue working on areas that need additional clarification, and will oversee the FDA’s interpretation and implementation of this law.
Unfortunately, for some, the Drug Quality and Security Act is too little, too late. And as with many proposals, the bill is not perfect. But it does represent consensus and common sense. I believe it would prevent another NECC-type outbreak from occurring.
quoted from here
FDA Will be Creating a Pharmacy Compounding Advisory Committee. Who Should be On it from the compounding pharmacy and pharmacists world?
Sections 503A and 503B require the creation of and consultation with a
Pharmacy Compounding Advisory Committee before issuance of certain regulations
required by the law. FDA intends to publish in the Federal Register
notices soliciting nominations for Committee members
Another Huge Wake Up Call for Compounding Pharmacies and Pharmacists of Human Compounds--The FDA is going to continue proactive and for-cause inspections of compounding pharmacies!!!--Consumers Will Want to Read this One Also!!!
FDA intends to continue proactive and for-cause inspections of compounding
pharmacies, and FDA plans to take aggressive action, including enforcement
actions, as appropriate to protect the public health.
For the past year, since the fungal meningitis outbreak began, FDA has been
conducting inspections of compounding pharmacies for cause (in response to
serious adverse event reports and reports of quality problems) and proactively
to identify pharmacies with deficient sterile compounding practices. Using a
risk-based model, we identified 29 firms for priority inspections focused on
their sterile processing practices. FDA identified secondary firms associated
with two of these inspections, for a total of 31 firms. Between October 1, 2012
and October 31, 2013, FDA completed 42 for-cause inspections in addition to the
31 proactive inspections.
When we identified problems during any of these inspections, we issued a Form FDA-4831 listing our inspection observations. We have issued a Form FDA-483 at the majority of the inspections we have conducted since the fall of 2012. As these Form FDA-483s reflect, we observed serious quality problems, including contaminated products and sterile practices that create a risk of contamination. Numerous recalls2 of sterile products have been conducted, and numerous pharmacies chose to stop sterile compounding after we identified problems with their sterile compounding processes. New problems continue to be identified at compounding pharmacies across the country, and FDA intends to continue its inspection and enforcement efforts to address these problems, using currently available resources. For oversight of outsourcing facilities registered under section 503B, FDA will use fees assessed and collected from those facilities in accordance with the law to supplement other agency resources.
quoted here
Regulatory Policy Information--the FDA Put The Compounding Regulatory Information for Human Compounds on One Page
Guidance for Industry: Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act (PDF - 91KB)1 (Draft Guidance)
-
Guidance for Industry: Registration for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (PDF - 60KB)2 (Draft Guidance)
-
Guidance for Industry: Interim Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (PDF - 107KB)3 (Draft Guidance)
quoted from FDA page found here
-
Note: Case law or judical decisions are an important part of the legal process; however, note that when a new statute is enacted and/or the language of a statute changes-- case law addressing or applying that statute may no longer be
presidential or persuasive. Be very careful in this area!! The answers may not be as easy as they first appear to be. An attorney might have an opinion about the case laws applicable but it is ultimately up to the courts to decide such issues.
FDA Boldly And Directly Answers Does the Drug Quality and Security Act (DQSA) cover the compounding of animal drugs?
No, the DQSA does not cover animal compounding. For
questions about animal drug compounding, contact FDA’s Center for Veterinary
Medicine at CVM_ExecSec@cvm.fda.gov.
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Wakeup call for compounding pharmacies and pharmacists: Here are your choices!
If a compounder chooses not to register as an outsourcing facility and
qualify for the exemptions under section 503B, the compounder could qualify for
the exemptions under section 503A of the FDCA. Otherwise, it would be subject to
all of the requirements in the FDCA applicable to conventional manufacturers.
FDA anticipates that state boards of pharmacy will continue their oversight and
regulation of the practice of pharmacy, including traditional pharmacy
compounding. The Agency also intends to continue to cooperate with State
authorities to address pharmacy compounding activities that may be violative of
the FDCA.
FDA Starts Regulating Compounding Pharmacies
The U.S. Food and Drug Administration on Monday began the process of regulating compounding pharmacies, which create new drug combinations or alter drugs to suit individual patient needs.
Under the Drug Quality and Security Act, signed into law Nov. 27 by President Barack Obama, these pharmacies are being encouraged to register with the FDA. The agency will then classify them as outsourcing pharmacies, enabling them to sell bulk drugs to hospitals and other health-care facilities.
The law was prompted by the deaths last year of 64 people who received fungus-contaminated steroid medications that were given in injections to treat back and joint pain. An additional 750 people in 20 states were sickened by the contaminated drug. The medication was made by the now-shuttered New England Compounding Center, in Framingham, Mass., according to federal health officials.
continue to read here
Under the Drug Quality and Security Act, signed into law Nov. 27 by President Barack Obama, these pharmacies are being encouraged to register with the FDA. The agency will then classify them as outsourcing pharmacies, enabling them to sell bulk drugs to hospitals and other health-care facilities.
The law was prompted by the deaths last year of 64 people who received fungus-contaminated steroid medications that were given in injections to treat back and joint pain. An additional 750 people in 20 states were sickened by the contaminated drug. The medication was made by the now-shuttered New England Compounding Center, in Framingham, Mass., according to federal health officials.
continue to read here
FDALaw Blog: Surprise! FDA Quickly Issues Compounding Draft Guidances
By Douglas B. Farquhar –
Well, that certainly didn’t take long.
FDA has clearly been eager to initiate its new, clarified powers over compounding pharmacies. President Obama only signed the new act (the Drug Quality and Security Act) the day before Thanksgiving, and this morning we find that FDA has already issued three draft guidances on human drug compounding. One restates prohibitions contained in earlier guidances from FDA. Another tells pharmaceutical compounders how they can register as “outsourcing facilities,” the new “voluntary” category for certain compounding pharmacies that ship compounded drugs across state lines. The third tells outsourcing facilities how they should report the drugs they compound. Links to the new guidances are included below.
Many of the provisions of the new Act, which was summarized in an earlier blog post, depend on issuance of regulations by FDA, and many of those regulations require input from an advisory committee that was disbanded years ago and hasn’t been reborn yet. As a result, there had been some speculation that the impact of the new Act would be somewhat delayed.
continue to read here
Well, that certainly didn’t take long.
FDA has clearly been eager to initiate its new, clarified powers over compounding pharmacies. President Obama only signed the new act (the Drug Quality and Security Act) the day before Thanksgiving, and this morning we find that FDA has already issued three draft guidances on human drug compounding. One restates prohibitions contained in earlier guidances from FDA. Another tells pharmaceutical compounders how they can register as “outsourcing facilities,” the new “voluntary” category for certain compounding pharmacies that ship compounded drugs across state lines. The third tells outsourcing facilities how they should report the drugs they compound. Links to the new guidances are included below.
Many of the provisions of the new Act, which was summarized in an earlier blog post, depend on issuance of regulations by FDA, and many of those regulations require input from an advisory committee that was disbanded years ago and hasn’t been reborn yet. As a result, there had been some speculation that the impact of the new Act would be somewhat delayed.
continue to read here
FDA moves swiftly on new compounding law
Written by
Walter F. Roche Jr.
The Tennessean
Acting with unusual speed and in the wake of a major fungal meningitis outbreak, officials of the U.S. Food and Drug Administration have announced plans to implement a new law regulating drug compounders.
In a news conference just five days after the new statute was signed into law by President Obama, FDA Commissioner Margaret A. Hamburg conceded that the law does not give her agency all the powers it would have liked but called it “a step forward.”
She said the new law should be “a great relief” to both health-care providers and patients.
The law does give the agency increased regulatory power, including on-site inspections, over those drug compounders who voluntarily choose to register with the agency, Hamburg said. The implementation will include a campaign to get physicians, hospitals and other health-care providers to use only those firms that choose to register, she said.
The Drug Quality and Security Act was passed in response to the fungal meningitis outbreak that killed 64 patients, including 16 treated in Tennessee. A now-defunct Massachusetts drug compounder, which shipped thousands of fungus-tainted vials of methylprednisolone acetate across the country, has been blamed for the outbreak.
Hamburg said a series of non-binding guidance documents was issued detailing how the agency intends, at this point, to begin the registration process. Once companies register, they will be subject to FDA inspection and will be required to file reports twice a year detailing just what drugs they are compounding.
“We do appreciate having greater clarity. There are, of course, other authorities we would like to have seen,” Hamburg said, citing as an example the authority to inspect company records.
She noted that the measure also eliminates a section in the old law limiting advertising. That provision was declared unconstitutional in a court case, which in turn led to confusion over the FDA’s regulatory authority.
Jane Axelrad, associate FDA director, said the agency does not now know how many companies fit into the new category of drug outsourcers created by the law.
“It’s too early to estimate,” she said, adding that it could be from 700 to 1,000.
Hamburg said the agency will have to rely on state regulators to help spot companies that should be registered or that deserve closer scrutiny. The law does call for increased communication between state pharmacy boards and the FDA
continue to read here
Advance ACA IACP ACVP Educational Conference With A Section on What's Going on Legislatively & Judicially? A Pharmacy Law Update by Deborah Pearce
Advance ACA IACP ACVP Educational Conference discount registration ends tomorrow at midnight! Register today and save $50! More information here. http://conta.cc/1cNM80J
IACP Town Hall Meeting This week...should be interesting!
IACP Members! Save the Date for a Town Hall, Wednesday, December 4th, 3 pm EST, 2 pm CST, 1 pm MST, 12 pm PST. HR 3204:
FDA Enforcement Action for Human Drugs Compounded by traditional compounders (not outsourcing facilities) Who Violate Section 503A Will Include
Warning Letters
Seizure of products
Injunction
Criminal Prosecution
The federal criminal prosecution includes but it is not limited to:
1. Producing Adulterated Drugs
2. Producing Unapproved Drugs; and
3. Misbranded Drugs
Source Draft Guidance Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug and Cosmetic Act
Seizure of products
Injunction
Criminal Prosecution
The federal criminal prosecution includes but it is not limited to:
1. Producing Adulterated Drugs
2. Producing Unapproved Drugs; and
3. Misbranded Drugs
Source Draft Guidance Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug and Cosmetic Act
KUDOS to the FDA for Quickly Releasing Guidance on the Compounding portions of the Drug Quality and Security Act!
[T]he release of the guidance just days after the signing of the legislation marks an unusual—perhaps even unprecedented—speed for the agency, which can sometimes take years to release guidance. The agency has been clamoring for more authority with which to confront the compounders since an October 2011 outbreak of fungal meningitis from a Massachusetts-based compounding pharmacy, the New England Compounding Center (NECC), and the speed may reflect its desire to move forward as quickly as possible.
quoted from here
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List of Places Viewing the Blog-Updated--added Kuwait, Senegal, San Martin, and Ethiopia
Algeria
Argentina
Australia
Austria
Azerbaijan
Bahamas
Bangladen
Bangladen
Bangladesh
Barbados
Belgium
Benin
Bosina & Herzegovina
Brazil
Bulgaria
Cayman Islands
Canada
Chile
China
Columbia
Costa Rica
Cote d'lvoire
Croatia
Cyprus
Czech Republic
Denmark
Dominica
Dominica
American Pharmacists Association Statement on HR 3204, Drug Quality and Security Act
WASHINGTON, DC – The American Pharmacists Association (APhA) applauds the final passage of H.R. 3204 the Drug Quality and Security Act. President Obama officially signed the compounding and track-and-trace legislation into law this afternoon during a bill signing ceremony in the Oval Office.
“APhA is grateful to Congress, staffers and the President for their focus on this challenging issue,” stated APhA Executive Vice President and CEO Thomas E. Menighan, BSPharm, MBA, ScD (Hon), FAPhA. “APhA played the critical role of a voice for the individual pharmacist throughout the drafting of this legislation by maintaining active involvement and communication with the HELP committee. Throughout the process we supported protecting patients from harm by improperly manufactured drug products while ensuring patient access to needed and properly prepared compounded medications.”
The legislation distinguishes compounders engaged in traditional pharmacy practice (ie: office use or one product per one patient prescription) from those making large volumes of compounded drugs without individual prescriptions. Compounders who wish to practice outside the scope of traditional pharmacy practice can register with the Food and Drug Administration as “outsourcing facilities,” subject to FDA oversight in much the same way as traditional manufacturers. Those who choose to remain traditional pharmacies will continue to be primarily regulated by State Boards of Pharmacy as they are in current law.
The new law also offers providers and patients better information about compounded drugs, by directing FDA to make a list of FDA-regulated outsourcing facilities available on FDA’s website, requiring detailed labeling on compounded drugs, and prohibiting false and misleading advertising.
“We appreciate that the legislation provides a clear delineation between compounders engaged in traditional pharmacy practice from those making large volumes of compounded drugs without individual prescriptions,” APhA wrote in a letter of support. “Our members were concerned about being forced to register with the FDA and this legislation would allow traditional pharmacies to continue to be regulated by state boards of pharmacy while creating outsourcing facilities that would be subject to FDA oversight.”
The legislation also includes the creation of a track-and-trace pathway for the more than 4 billion prescriptions that are written in America every year, which helps to ensure the safety of the drug-supply chain. The bill creates a new uniform framework for tracking drugs from the manufacturer to the pharmacy, including strengthening licensure requirements for wholesale distributors and third-party logistics providers and establishing nationwide drug serial numbers.
quoted from here
“APhA is grateful to Congress, staffers and the President for their focus on this challenging issue,” stated APhA Executive Vice President and CEO Thomas E. Menighan, BSPharm, MBA, ScD (Hon), FAPhA. “APhA played the critical role of a voice for the individual pharmacist throughout the drafting of this legislation by maintaining active involvement and communication with the HELP committee. Throughout the process we supported protecting patients from harm by improperly manufactured drug products while ensuring patient access to needed and properly prepared compounded medications.”
The legislation distinguishes compounders engaged in traditional pharmacy practice (ie: office use or one product per one patient prescription) from those making large volumes of compounded drugs without individual prescriptions. Compounders who wish to practice outside the scope of traditional pharmacy practice can register with the Food and Drug Administration as “outsourcing facilities,” subject to FDA oversight in much the same way as traditional manufacturers. Those who choose to remain traditional pharmacies will continue to be primarily regulated by State Boards of Pharmacy as they are in current law.
The new law also offers providers and patients better information about compounded drugs, by directing FDA to make a list of FDA-regulated outsourcing facilities available on FDA’s website, requiring detailed labeling on compounded drugs, and prohibiting false and misleading advertising.
“We appreciate that the legislation provides a clear delineation between compounders engaged in traditional pharmacy practice from those making large volumes of compounded drugs without individual prescriptions,” APhA wrote in a letter of support. “Our members were concerned about being forced to register with the FDA and this legislation would allow traditional pharmacies to continue to be regulated by state boards of pharmacy while creating outsourcing facilities that would be subject to FDA oversight.”
The legislation also includes the creation of a track-and-trace pathway for the more than 4 billion prescriptions that are written in America every year, which helps to ensure the safety of the drug-supply chain. The bill creates a new uniform framework for tracking drugs from the manufacturer to the pharmacy, including strengthening licensure requirements for wholesale distributors and third-party logistics providers and establishing nationwide drug serial numbers.
quoted from here
Question of the Day December 2, 2013 How many compounding pharmacies are currently violating the DQSA misbranding provision ( advertising in a false or misleading manner)? Should these compounding pharmacies be given warning letters or immediately charged with misbranding of drugs?
Summary: H.R.3204 — 113th Congress (2013-2014)
There is one summary for this bill. Bill summaries are authored by CRS.
Shown Here:
Introduced in House (09/27/2013)
Drug Quality and Security Act - Compounding Quality Act - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) with respect to the regulation of compounding drugs. Exempts compounded drugs from new drug requirements, labeling requirements, and track and trace requirements if the drug is compounded by or under the direct supervision of a licensed pharmacist in a registered outsourcing facility and meets applicable requirements. Establishes annual registration requirement for any outsourcing facility. Requires a facility to report biannually to the Secretary of Health and Human Services on what drugs are compounded in the facility and to submit adverse event reports. Subjects such facilities to a risk-based inspection schedule.
Requires the Secretary to: (1) publish a list of drugs presenting demonstrable difficulties for compounding that are reasonably likely to lead to an adverse effect on the safety or effectiveness of the drug, taking into account the risk and benefits to patients; and (2) convene an advisory committee on compounding before creating the list.
Requires the Secretary to assess an annual establishment fee on each outsourcing facility and a reinspection fee, as necessary.
Prohibits the resale of a compounded drug labeled “not for resale,” or the intentional falsification of a prescription for a compounded drug. Deems a drug to be misbranded if the advertising or promotion of a compounded drug is false or misleading in any particular.
Requires the Secretary to receive submissions from state boards of pharmacy: (1) describing any disciplinary actions taken against compounding pharmacies or any recall of a compounded drug, and (2) expressing concerns that a compounding pharmacy may be violating the FFDCA.
Revises compounding pharmacy requirements to remove prohibitions on advertising and promotion by compounding pharmacies and remove requirement that prescriptions filled by a compounding pharmacy be unsolicited.
Requires the Comptroller General (GAO) to report on pharmacy compounding and the adequacy of state and federal efforts to assure the safety of compounded drugs.
Drug Supply Chain Security Act - Establishes requirements to facilitate the tracing of prescription drug products through the pharmaceutical supply distribution chain.
Requires the Secretary to establish standards for the exchange of transaction documentation, which shall include transaction information, transaction history, and transaction statements.
Requires the Secretary to establish processes to: (1) provide waivers of requirements, including for undue economic hardship or emergency medical reasons; (2) provide exceptions to requirements relating to product identifiers if a product is packaged without sufficient space to bear the information; and (3) determine other products or transactions that should be exempt from the requirements of this Act.
Establishes requirements for drug manufacturers, wholesalers, dispensers, and repackagers to ensure that all prior transaction information is provided at each transfer of ownership.
Requires a manufacturer, wholesale distributor, dispenser, and repackager, in the event of a recall or for the purpose of investigating a suspect product or an illegitimate product, to provide within a reasonable time the applicable transaction documentation upon request by the Secretary or other appropriate federal or state official.
Requires a manufacturer or repackager to affix or imprint a product identifier on each package and homogenous case intended to be introduced in a transaction into commerce except for products that are required to have a standardized numerical identifier.
Requires a manufacturer, wholesale distributor, dispenser, or repackager to ensure that each of its trading partners is authorized.
Requires a manufacturer, wholesale distributor, dispenser, and repackager to implement systems to: (1) investigate suspect products; and (2) handle illegitimate products, including through quarantine, disposal, and appropriate notice to the Secretary and, as necessary, trading partners.
Requires manufacturers, wholesale distributors, and repackagers to verify returned products before further distribution.
Implements additional requirements related to the tracing of products at the package level ten years after enactment of this Act.
Requires the Secretary to establish projects and hold public meetings to enhance the safety and security of the pharmaceutical distribution supply chain.
Requires the Secretary to establish standards for the licensing of wholesale distributors and third party logistics providers.
Preempts state and local requirements related to tracing drugs through the distribution system, and licensure of wholesale distributors and third party logistics providers.
Excellus Blue Cross and Blue Shield Claim Form that Must Accompany claim for compounded medications
Compound Prescription Drug Claim Form
(PDF) - This form must accompany the Prescription Drug Claim Form for all compound medications
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