Press Release from Senators on New Legislation

Draft legislation preserves the states’ primary role in traditional pharmacy regulation and clarifies FDA authority over those making sterile products without prescriptions and shipping across state borders

Apr 26 2013

Washington, D.C., April 26 – Chairman of the Senate Health, Education, Labor and Pensions Committee U.S. Senator Tom Harkin (D-Iowa) and Ranking Member Lamar Alexander (R-Tenn.), with Senators Al Franken (D-Minn.) and Pat Roberts (R-Kan.) and other members of the HELP Committee, today released draft legislation that would improve the safety of compounded human and animal drugs by making clear the compounding oversight responsibilities of state and federal authorities.

The draft legislation makes a clear distinction between traditional compounding—which will continue to be regulated primarily by state pharmacy boards—and compounding manufacturers that make sterile products without, or in advance of, a prescription and sell those products across state lines. The compounding manufacturers would be regulated by the Food and Drug Administration.

Harkin said:  “This legislation is a significant step forward in protecting the public from unsafe compounded products.  By clarifying FDA authority over high-risk compounding practices, this bill will enhance protections for patients taking compounded drugs and help prevent crises like last year’s tragic meningitis outbreak.

Alexander said: “Last year’s meningitis outbreak was a nightmare for Tennesseans, and this legislation will help ensure that it never happens again. Our goal with this bill is to put an end to FDA inaction and make it clear who is on the flagpole—who is in charge and accountable for oversight of these pharmacies and manufacturers.”

Franken said: "When drugs are prescribed to make a patient healthier – and in many cases, save a life –  that patient should know their prescription is exactly what the doctor ordered. We've seen far too many deaths in this country because some pharmacies have acted more like drug manufacturers – without following rigorous safety rules. This legislation will keep Minnesotans safe by ensuring that drug manufacturers have appropriate oversight, and that responsible pharmacies don't see any unnecessary restrictions."

Roberts said: “This legislation was very carefully crafted as an attempt to address concerns from stakeholders and patients. It represents a thorough and bipartisan effort to clear up any question about who is accountable for ensuring compounded drugs are safe for the patients who receive them. We owe it to victims and the American people to get this right.”

This draft legislation clarifies a national, uniform set of rules for compounding manufacturers while preserving the states’ primary role in traditional pharmacy regulation.

In addition to distinguishing between pharmacies and manufacturers, and clarifying proper oversight of each, the legislation sets forth requirements on compounding manufacturers. They must register with the FDA and tell the agency what products they have made, make products under a pharmacist’s oversight and in compliance with good manufacturing practices, and investigate and report adverse events. 

The draft legislation allows FDA to identify categories of drugs that currently cannot be safely compounded, preserves and enhances current protections regarding the ingredients from which drugs are compounded, and preserves the line between compounding manufacturers and traditional manufacturers by placing prohibitions on wholesale distribution of compounded products.

The draft bill also would encourage communication among states and increase communication between states and the FDA. If FDA receives a complaint from a state regulatory agency about a traditional pharmacy in another state, the FDA must relay that information to the relevant state pharmacy board within 15 days.

Senators Harkin, Alexander, Franken and Roberts and other members of the HELP Committee are requesting that stakeholders provide feedback on the policy merits, potential unintended consequences, and opportunities to improve the legislative language. 

Senators push expanded oversight of compound pharmacies

A bipartisan group of senators want to give federal regulators greater oversight of compound pharmacies following bacterial contaminations nationwide that have killed at least 50 people and sickened hundreds more.

Sens. Tom Harkin (D-Iowa), Lamar Alexander (R-Tenn.), Al Franken (D-Minn.) and Pat Roberts (R-Kan.) released a draft bill on Friday to make the blurry regulatory lines surrounding the pharmacies more clear.

“By clarifying FDA authority over high-risk compounding practices, this bill will enhance protections for patients taking compounded drugs and help prevent crises like last year’s tragic meningitis outbreak,” Harkin wrote in support of the proposal.

Read more: http://thehill.com/blogs/regwatch/legislation/296513-senators-push-expanded-oversight-of-compound-pharmacies#ixzz2RbrFDZAB 
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Senate bill targets large compounding pharmacies

Friday, April 26, 2013

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By:

Associated Press

WASHINGTON — Large specialty pharmacies like the one that triggered a deadly meningitis outbreak last year would be subject to federal safety inspections and manufacturing standards under a new Senate proposal introduced Friday.

The draft bill is the first Senate effort to address the recent outbreak tied to contaminated compounded drugs that sickened more than 700 Americans and killed more than 50 others.

The wave of deadly fungal infections was identified in September and linked to a large Massachusetts compounding pharmacy, which regulators said was operating more like a manufacturer.

continue reading here

Draft bill gives FDA authority over some pharmacies

By Toni Clarke

WASHINGTON (Reuters) - The Food and Drug Administration would gain greater authority overpharmacies that compound sterile drugs and ship them across state lines under proposed legislation announced on Friday.

The proposal from a bipartisan group of U.S. senators comes in the wake of a meningitis outbreak last fall that killed 53 people and sickened more than 700. The outbreak was linked to a tainted steroid distributed by the New England Compounding Center.

The proposal would draw a distinction between traditional compounding pharmacies, which make drugs based on specific prescriptions for individual patients, and those such as NECC, which make products without prescriptions for physicians to keep for future use.

"By clarifying FDA authority over high-risk compounding practices, this bill will enhance protections for patients taking compounded drugs and help prevent crises like last year's tragic meningitis outbreak," Iowa Democrat Tom Harkin, chairman of the Senate health committee that developed the draft legislation, said in a statement.

The bill would create a new class of drugmaker that would be regulated by the FDA but would be exempt from the full raft of regulations that apply to traditional pharmaceutical companies.

For example, these "compounding manufacturers" would not be required to submit their products to the FDA for approval before selling them. Nor would they be required to negotiate the labeling of their drugs with the FDA; they would only be required to indicate that the products are compounded and list certain other specified information.

continue reading here

THE BUZZ Roberts pushes bill to regulate drug compounding April 26

BY DAVE HELLING

Sen. Pat Roberts, Republican of Kansas, and several colleagues have released the draft of a bill designed to increase supervision of firms that mix pharmaceuticals, a process known as compounding.  continue reading here

continueccon
Read morce here: http://www.kansascity.com/2013/04/26/4203776/roberts-pushes-bill-to-regulate.html#storylink=cpy

Proposal gives FDA control over compounding pharmacies

By Toni Clarke, Reuters

The U.S. Food and Drug Administration would gain greater authority over pharmacies that compound sterile drugs and ship them across state lines under proposed legislation announced on Friday.

The proposal from a bipartisan group of U.S. senators comes in the wake of a meningitis outbreak last fall that killed 53 people and sickened more than 700. The outbreak was linked to a tainted steroid distributed by the New England Compounding Center.

The proposal would draw a distinction between traditional compounding pharmacies, which make drugs based on specific prescriptions for individual patients, and those such as NECC, which make products without prescriptions for physicians to keep for future use.

"By clarifying FDA authority over high-risk compounding practices, this bill will enhance protections for patients taking compounded drugs and help prevent crises like last year's tragic meningitis outbreak," Iowa Democrat Tom Harkin, chairman of the Senate health committee that developed the draft legislation, said in a statement.

The bill would create a new class of drugmaker that would be regulated by the FDA but would be exempt from the full raft of regulations that apply to traditional pharmaceutical companies.

For example, these "compounding manufacturers" would not be required to submit their products to the FDA for approval before selling them. Nor would they be required to negotiate the labeling of their drugs with the FDA; they would only be required to indicate that the products are compounded and list certain other specified information.

These companies would no longer be licensed as pharmacies. They would be required to register with the FDA, and report to the agency any problems reported by patients or physicians. They would also be required to pay an annual fee to defray the cost of FDA inspections.

Compounding manufacturers would not be allowed to compound biologic products made from live organisms or other complex drugs. And they would be prohibited from compounding FDA-approved drugs unless they are in short supply.

Traditional compounding pharmacies would continue to be licensed and regulated by state boards of pharmacy.

A spokeswoman for the FDA, Erica Jefferson, said the agency was reviewing the draft "and looks forward to continuing to work closely with the committee to address existing limitations in the law."

It is unclear how many of the nation's roughly 2,800 compounding pharmacies would fall into the new category, but initial estimates put the number at fewer than 500. They would be defined not by their sales volume, but by whether they make products that are at high risk for contamination and sell them across state lines.

Ever since the meningitis outbreak, the FDA has been pilloried by Republicans in Congress, who say the agency should have been more aggressive in its oversight of NECC.

The FDA concedes as much but has argued that a complex legal landscape has hampered its ability to regulate the industry since compounding pharmacies have historically been regulated by the states and have not been required to register with the FDA.

The proposed legislation encourages greater communication among states and between states and the FDA.

Missouri Board of Pharmacy List of Disciplinary Action

view here

Missouri Board of Pharmacy Job Opening for Inspector

CAREER OPPORTUNITY
An Equal Opportunity Employer
TITLE: Pharmaceutical Consultant (Inspector/Investigator) LOCATION: Professional Registration – Missouri Board of Pharmacy –
Territory includes St. Louis area
(Territory will be designed so that successful applicant may use residence as office.) TRAVEL: Up to 80% travel with occasional overnight travel required
STARTING SALARY: $78,012 (Pay Range A 38)
Salary increase available if appointment is a promotion
SCREENING DATE: April 22, 2013
APPLICATION PROCESS:
Screening to begin April 22, 2013. Please send cover letter, resume, transcripts and three professional references to:
Division of Professional Registration
Missouri Board of Pharmacy
ATTN: Pharmaceutical Consultant PO Box 625
Jefferson City, MO 65102 tammy.siebert@pr.mo.gov
Fax: (573) 526-3464 EOE : F/M/V/D
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:
Inspect all pharmacies and/or locations where drugs are dispensed and all drug distributor facilities to assure compliance with state and federal laws and regulations. Complete reporting form for each inspection or re- inspection.
Conduct Quality Assurance Inspections and Audits.
Conduct investigations based on complaints received by the Board, including but not limited to, gathering evidence, conducting drug audits, interviewing licensee, complainant and/or witnesses, preparing written report for Board review, testifying in hearings held before the Administrative Hearing Commission, the Board of Pharmacy or courts of competent jurisdiction.
Monitor progress of disciplined licensees by various means.
Educate pharmacists on new rules/laws.
Respond to written and verbal inquiries regarding pharmacy law and appropriate pharmacy practice. Implement board decisions and clearly reflect Board position to licensees.
Attend board meetings as needed, as well as other state/national meetings as directed.
Employee is expected to exercise high independence and initiative in the performance of assigned duties. Obtain samples of compounded drugs for testing within the random sampling program.
Central activities common to this class concern the interpretation of rules, regulations and procedures pertaining to the dispensing of drugs and related pharmaceutical standards of service as well as the analysis of pharmacological and therapeutic standards and values.
Perform other related work as assigned.
JOB KNOWLEDGE, SKILLS, AND ABILITIES:
Knowledge of state requirements for licensure of pharmacists, pharmacies and drug distributors and other board related laws and regulations.
Extensive knowledge of the professional principles and practices of pharmacy.
Considerable knowledge of federal and state laws regulating the practice of pharmacy.
Ability to answer technical questions concerning pharmacy practice. Ability to communicate effectively, both verbal and written.
Ability to compose written reports.
Ability to prioritize job responsibilities and work independently.
View all job openings with the Division of Professional Registration at www.pr.mo.gov EOE:F/M/V/D

The Ashp Discussion Guide For Compounding Sterile Preparations PDF And Ebook Files - DocsFiles

The Ashp Discussion Guide For Compounding Sterile Preparations PDF And Ebook Files - DocsFiles

FDA Blog Court Rules in Novel False Claims Act Case Where One Pharmaceutical Company Sues Another By Delia A. Stubbs –

The U.S. District Court for the Central District of California issued a ruling last week in an unusual, if not unprecedented, case arising from alleged federal False Claims Act (“FCA”) violations where one drug manufacture has sued its competitor.  InAmphastar Pharm., Inc. v. Aventis Pharma SA, No. 09-0023 (C.D. Cal.), Amphastar, on behalf of the United States, alleged in its amended qui tam complaint that Aventis had “fraudulently inflated the price of enoxaparin” thus overcharging the federal and various state governments in violation of the FCA.  Interestingly, Amphastar’s claims are predicated on allegations that Aventis fraudulently sold Lovenox®, that was “in essence, non-patented enoxaparin,” thereby charging inflated prices.  Slip Op. at *7, n. 9.  In an earlier decision, the U.S. Court of Appeals for the Federal Circuit affirmed the district court’s ruling that Aventis engaged in “inequitable conduct” and thus held its patents regarding Lovenox® unenforceable.  Id. at *2, n. 4.

Continue to read here

Question of the Day: 4/25/2013 The Source of the Bulk Powders Used in Compounding Can Be A Problem If the Powders Are Not Tested And Determined To Be What The Sellers Claim the Powders Are.

Compounders may cut expenses by buying cheaper powders, not having them tested, etc. then use them to compound.  This can be a public health risk in that the compounded product may not be the potency it is suppose to be.  How can the FDA and state boards of pharmacy address this problem when they barely have enough resources to do what they are doing now to inspect compounders?

Drug compounding supplier Arseus buys U.S.-based Freedom Pharma

BRUSSELS | Thu Apr 25, 2013 6:46am BST

(Reuters) - Belgium-based Arseus (RCUS.BR), the world's biggest supplier of ingredients to pharmacists so they can mix up their own versions of drugs, bought U.S.-based FreedomPharmaceuticals for an undisclosed sum, it said on Thursday.

The acquisition strengthens its global position in the market for drug compounding, where pharmacists assemble medicines themselves specifically tailored to the needs of their customers.

Arseus said in a statement that it paid 5.5 times EBITDA for FreedomPharmaceuticals, which expects to achieve turnover of about $25 million in 2013.

Source found here

Arizona Veterinary Medical Association Newsletter (January 2012) Addresses Compounding

to read click here

New Online Ads Highlight the Need for Veterinarians to Carry Controlled Substances

New Online Ads Highlight the Need for Veterinarians to Carry Controlled Substances

New Infographic Shows Need for Veterinarians to Use Controlled Substances in Various Settings

New Infographic Shows Need for Veterinarians to Use Controlled Substances in Various Settings

A Message About Compounding: To Veterinarians, From Veterinarians

A Message About Compounding: To Veterinarians, From Veterinarians

FDA device will screen for fake medicines overseas By MATTHEW PERRONE, AP Health Writer Updated 11:24 am, Wednesday, April 24, 2013

WASHINGTON (AP) — U.S. health officials are making a high-tech screening device available in Africa to help spot counterfeit malaria pills in hopes that the technology may eventually be used to combat the fake drug trade worldwide.

The Food and Drug Administration announced Wednesday that U.S. partners in Ghana will begin using a federally developed handheld device to screen for fake or diluted versions of two common malaria pills.

More than a third of malaria-fighting pills used in Africa and Asia are either fake or bad quality, according to a study released last year. Rampant drug counterfeiting has undermined efforts to fight the mosquito-borne disease, which causes fever, chills and flu-like illness. Malaria kills more than 660,000 people each year, more than 90 percent of them in Africa.

If the FDA's counterfeit detection device, or CD-3, proves effective in Ghana, the agency hopes to mass produce it on an international scale, which could ultimately reduce counterfeiting around the world.

Counterfeit medicines have long been a problem in developing regions like Africa and Asia, but more fake drugs have been making their way to U.S. pharmacies and hospitals as drug supply chains increasingly stretch across continents. Over 80 percent of the active ingredients used in U.S. pharmaceuticals are now manufactured overseas, according to one congressional estimate.

"We live in a world where the marketplace is increasingly global, where the supply chain of drugs is increasingly vulnerable and we are seeing many more problems with substandard and counterfeit drugs around the world," said FDA Commissioner Margaret Hamburg, in an interview with The Associated Press. "Unfortunately developing economies are the most burdened by this problem, but we've had serious threats to health in this country as well."

Read more: http://www.sfgate.com/news/medical/article/FDA-device-will-screen-for-fake-medicines-overseas-4460265.php#ixzz2RRlmBkyK

NABP --FDA Reports Unsanitary Conditions at Compounding Facilities, Calls for More Regulatory Authority

April 24, 2013 1:40 pm Topics: Compounding

FDA Commissioner Margaret A. Hamburg, MD, reported in a recent FDA blog article that agency inspectors encountered “objectionable conditions” at 30 of the 31 sterile compounding pharmacies they recently examined. Some of the conditions they witnessed included black particles floating in vials of supposedly sterile medicine, rust and mold in clean rooms, and technicians handling “sterile” products with bare hands. FDA conducted the inspections, most of which involved coordination with the relevant state board of pharmacy, in the wake of the fungal meningitis outbreak caused by contaminated injectable drugs compounded by NECC. In the blog article, Hamburg cited the resistance that FDA inspectors met – including some pharmacies blocking access to facility records – as grounds for granting the agency more authority to regulate sterile and nonsterile compounding firms. Additional information about the inspections is available on the FDA Web site.

Source from here

Number of Compounding Issues Discussed During April 2013 Washington State Board of Pharmacy Meeting

To view the agenda at that meeting click here

State of Washington Board of Pharmacy Compounding Standards

• Hot Topic: Pharmacist/Pharmacy Compounding Standards

During the past few months, we have been following the New England Compounding Center meningitis outbreak and subsequent public health issues related to pharmacy compounding. To date, 34 people have died and 490 injured nationwide. NECC surrendered its license in several states, including its home state of Massachusetts.
We strongly encourage Washington State pharmacies and pharmacists that engage in the practice of compounding to review Chapter 246-878 WAC. The rule defines compounding as the act of combining two or more ingredients in the preparation of a prescription. The rules go on to establish the conditions by which a pharmacist can compound drug products. More pharmacist/pharmacy compounding standards information.

Pharmacy Compounding Standards

Standards for Pharmacist/Pharmacies Compounding Drug Products

• Pharmacists may compound drugs in very limited quantities prior to receiving a valid prescription for an individual based on past routine prescribing patterns.
• The patient and prescriber must authorize the use of a compounded product if substituted for a commercially available product. The prescriber’s authorization is in addition to signing the substitution permitted side of the written prescription, or advising the substitution when a verbal prescription is issued. The prescriber must document the authorization on the prescription or in the patient’s medication record.
• Drugs/substances used for compounding must meet official compendia requirements.
• The compounding of inordinate amounts of drugs, relative to the practice site, in anticipation of receiving prescriptions without any historical basis is considered manufacturing.
• Pharmacists/Pharmacies shall not offer compounded drug products to other state-licensed persons or commercial entities for subsequent resale, except in the course of professional practice for a practitioner to administer to an individual patient.
• Compounding pharmacies/pharmacists may advertise or otherwise promote the fact that they provide prescription compounding services; however, they shall not solicit business (e.g., promote, advertise, or use salespersons) to compound specific drug products.
• Records and Reports related to Compounding Procedures or other records required by Chapter 246-878 WAC must be retained for at least two years. This is consistent with all prescription records (WAC 246-869-100).
• All records must be readily available at the pharmacy/establishment for authorized inspection during the retention period. As part of the inspection, the records are subject to photocopying or other means of reproduction.
• Compounding records may be kept either in its original format or as true copies, such as photocopies, microfilm, microfiche, or other accurate reproductions of the original records.

Source found here

MA Sterile Compounding Report Due April 26, 2013

Find form at http://www.mass.gov/eohhs/docs/dph/quality/boards/pharmacy/247cmr-amendments-sterile-compunding-reporting-form.pdf

source of information found here

Maryland Board of Pharmacy March Meeting Minutes Including Legislation on Compounding

F. Legislation & Regulations	A. Jeffers, Legislation & Regulations Manager	LEGISLATION: 1.There was discussion for Board approval of amendments to HB 986 State Board of Pharmacy – Sterile Compounding – Permits: 12-4A-01(B)(1)(I) – strike “pharmacist” from this definition since a prescription is based on a practitioner and patient relationship. 12-4A-01(B)(2) – strike “small quantities” since there is no national definition for this term. 12-4A-02(F) – reword to be “A PERSON THAT PREPARES AND DISTRIBUTES STERILE DRUG PRODUCTS INTO OR WITHIN THE STATE WITHOUT A PRESCRIPTION ORDER SHALL HOLD:” This revision was made for clarification purposes and to avoid confusion. 12-4A-02(G)(2)(I) – strike “PRODUCT” and replace with “FACILITY”. The Board believes it would be cumbersome to issue waivers for one product at a time. A facility may be producing more than one continue reading minutes here	Motion by M. Gavgani to amend HB 986 as stated in these minutes. Motion was seconded by D. Chason.	Motion was approved.

LA Regulation Revision Committee Agenda for May 9, 2013

NOTE: This agenda is tentative until 24 hours in advance of the meeting, at which time the most recent revision becomes official.
Revised 04-14-2013

1. Call to Order
   
2. Quorum Call
   
3. Call for Additional Agenda Items
   
4. Opportunity for Public Comment
   
5. Consideration of Minutes from Previous Meeting – April 9, 2013
   
6. Old Business
   
   1. Hospital pharmacy dispensing/distribution processes and recordkeeping rules
      [Regulatory Proposal 2013-A ~ Pharmacy Recordkeeping (Draft #5)]
      
   2. Act 142 of 2010 Legislature, re Chapter 29 – Prescription Monitoring Program (definition of ‘negligible amounts’)
      
   3. Signatures on electronic prescriptions
      
   4. Standards for pharmacies hosting immunization activities
      
   5. Expansion of pharmacy permits to include:
      (1) Call centers with cognitive services
      (2) Pharmacists exercising cognitive services outside a pharmacy
      
   6. Act 276 of 2012 Legislature – preferential licensing procedures for military trained applicants and their spouses [Regulatory Proposal 2013-G (Draft #1)]
      
   7. Collaborative drug therapy management (CDTM) update
      [Regulatory Proposal 2013-H (Draft #1)]
      
   8. Pharmacist verification of medications in automated dispensing systems [La. R.S. 37:1212]
      
   9. Foreign pharmacy interns
      
   10. Disposition of dispensed prescription medications from central fill pharmacy
       
   11. Review of penal pharmacy rule [Regulatory Proposal 2013-J (Draft #1)]
       
7. Adjourn
   

NOTE: Pursuant to the Open Meetings Law at La. R.S. 42:16, the committee may, upon 2/3 affirmative vote of those members present and voting, enter into executive session for the limited purpose of (1) discussion of the character, professional competence, or physical or mental health of a licensee, (2) investigative proceedings regarding allegations of misconduct, (3) strategy sessions or negotiations with respect to litigation, (4) discussions regarding personnel matters, or other purposes itemized at La. R.S. 42:17. 

Sequester to reduce FDA food inspections, official says --Will It Also Reduce Inspections of and Enforcement Against Compounding Pharmacies?

To read article about cutting food inspections
click here

Lack of Authority, Resources Invites Contamination at Compounding Pharmacies

Lack of Authority, Resources Invites Contamination at Compounding Pharmacies

Do Compounding Marketing Representatives Make This Much Money On Average?

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In USD as of Apr 24, 2013		55k	110k	165k
Compounding marketing representative	$152,000

Average Compounding marketing representative salaries for job postings nationwide are 126% higher than average salaries for all job postings nationwide.

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In USD as of Apr 24, 2013		55k	110k	165k
Marketing Sales Representative	$30,000
Territory Sales Representative	$46,000
Pharmacy Technician	$31,000

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