Interesting Discussion At March 2013 Utah State Board of Pharmacy Meeting Regarding Compounding

Mr. Steinagel met with the Board and reviewed the Division’s response to recommendations made by the Compounding Task Force.

The task force recommends that the Division enforce  an inspection moratorium on compounding pharmacies. The Division is uncomfortable with this idea. The Division cannot cease issuing citations and disciplining compounding pharmacies.

The task force recommends that DOPL investigators and inspectors go through training on federal laws that regulate the pharmacy profession. The Division supports this idea and is willing to provide additional training for investigators. Five investigators will go through intensive NABP training in May that was scheduled before the task force met to discuss recommendations.
The task force encourages inspectors to educate licensees when they investigate them and follow-up on inspections. The Division supports this idea.
The task force recommends updating of the compounding self-inspection report. The Division agrees with this idea and will consult with Board members and others in the field as necessary as updates to the report are made. The Division will make updates to the report and submit a revised self- inspection report to the Board for review at the May meeting.
The task force recommends creation of self- inspection reports for Class B and C pharmacies. The Division is working on this.
The task force recommends that the Pharmacy Practice Act be revised. The Division is happy to provide input to Board members, legislators, and associations as they propose amendments to the Act. The Board will be discussing possible amendments to the Act during future Board meetings.
The task force recommends that standards regarding transferring compounds within the same institutional setting be clarified and that language in regard to manufacturing vs. traditional vs. non-traditional compounding be clarified. The Division is willing to work with the Board on these items.

The task force recommends that DOPL send a letter to compounding pharmacies. A letter was sent last year and the Division is willing to consider sending a second one this year.

The task force recommends that network-network- network become compliant with USP standards. This is something the Division agrees that the industry can work on.
Mr. Steinagel advised the Board that DOPL is interested in inviting NABP to come to Utah to make training available to representatives of pharmacies in Utah that engage in compounding. This training is three or four days and is very intensive. Mr. Steinagel advised the Board that it would require legislation to amend the laws upon which the inspection report is based.
The Board expressed concern regarding sending sterilized compounding out of state. Mr. Steinagel noted that currently pharmacies are self reporting to DOPL and encouraged the Board to consider the following options: (1) Creation of licensure for compounding pharmacy; (2) Require pharmacies to declare whether they do sterile compounding; (3) During renewal, have the pharmacy representative affirm whether they are engaging in sterile compounding. The Board will discuss this at a future meeting.

Quoted from Utah Board of Pharmacy March 3, 2013 minutes 

State Inspector Recommends to Vermont Board of Pharmecy that it Make USP 797 Standard for All Compounding Pharmacies to Follow

Compounding Pharmacy Rules – Inspector Vincent spoke to the Board about the issues he sees when inspecting. He feels our Rules do not adequately address sterile compounding and suggested the Board consider making USP 797 the standard for all compounding pharmacies to follow. Ms. Eaton suggested making a small committee, possibly two Board members with counsel and Mr. Klein, to discuss the adoption of USP 797 and refining the institutional pharmacy regulations.

Source found at http://vtprofessionals.org/opr1/pharmacists/minutes_agenda/Pharmacy_Minutes_2013_0327.

We're dedicated to patients' health: Another view by David Miller

David G. Miller6:29 p.m. EDT April 28, 2013

  Source quoted from USAToday

Let state boards enforce national standards

STORY HIGHLIGHTS

• NECC was essentially manufacturing drugs, not compounding.
• We're studying the bill released by several senators Friday.
• We're concerned that some provisions could reduce patient and physician access to customized medications.

When the tragic news of the deaths and sickness associated with products made at the New England Compounding Center came out last fall, the nation's attention appropriately focused on what went terribly wrong — and what steps to take to keep anything like it from ever happening again.

OUR VIEW: Time to fix 'broken' system

Pharmacists were more concerned than anyone because our profession is dedicated to one thing: the health of the patients we serve by compounding drugs upon request from authorized prescribers, such as doctors. NECC was essentially manufacturing drugs, not compounding.

The difficult matter that the public, the industry, policymakers and Congress are wrestling with is what regulations, laws or jurisdictions must be changed to make sure no NECCs happen again.

The International Academy of Compounding Pharmacists, representing 3,000 pharmacists nationwide, is studying the bill released by several senators Friday. We applaud the steps the Senate is taking to ensure that compounded medications are as safe as they can be.

But we believe aspects of the draft will need further discussion and refinement, and we intend to work with the committee on these. We plan to offer suggestions on improving standards to raise the quality of compounded medications.

Our group is also concerned that some provisions could reduce patient and physician access to customized medications, the very essential services that compounding pharmacists provide. We support nationwide standards enforced by each state's board of pharmacy, the entities that have traditionally regulated compounding pharmacies.

We also want to eliminate loopholes and don't believe that any group of pharmacies should be exempted from regulatory change, as this bill would do.

The states are responsible for licensing and oversight of medical providers, including compounding pharmacies, and the FDA is and should be responsible for pharmaceutical manufacturers. The terminology and some definitions in the proposed category of "compounding manufacturers" create confusion and blur authority of regulators. Our group will recommend improvements to make the proposed categories clearer.

Our members look forward to finding the right steps to ensure the safety of patients everywhere — steps that won't prevent compounding pharmacists from continuing to serve the public's vital health needs.

David G. Miller is CEO of the International Academy of Compounding Pharmacists.

Drug Traceability Drafts Reflect Progress, Supply Chain Stakeholders Say

(Daily News - 04-26-2013)
CHICAGO -- The majority of supply chain stakeholders believe all sectors of industry should be subject to federal standards under a drug traceability system, according to a survey by the Pew Charitable Trusts that emerges as members of Congress prepared to debate the development of a drug track and trace system, including potential exemptions and considerations for small pharmacies.
subscription required

Meningitis spreads to finger-pointing

Apr. 27, 2013 10:19 PM    Livingston County is all but the epicenter of the meningitis cases that have grown out of the scandal originating at a large-scale — and woefully unregulated — compounding pharmacy in Massachusetts.  continue reading here

The Chronicle of the Horse Has Interesting Discussion On-going Regarding Vets Liability or Compounded Medications

To read and follow this discussion click here

$15,000 Annual Fee for Compounding Manufacturers Could Net FDA $45 Million for Inspections

“No Compounding Allowed” Drugs Would Be Established Under Senate Draft Bill

By Cathy Dombrowski / Email the Author / Apr. 26, 2013 

Word Count: 1080 / Article # 14130426008 / Posted: April 26 2013 6:55 PM

---

Executive Summary

A $15,000 annual establishment fee for “compounding manufacturers” could net FDA $45 million for inspecting those compounding sites.

Subscription required here

Question of the Day: 4/27/13 Isn't IACP in fact correct that this bill will cause more confusion and blur the jurisdictional line?

IACP 'think[s] the term “compounding manufacturer” and several of the definitions of that new category create more confusion and further blur the jurisdictional authority of regulators."  Isn't IACP     in fact correct that this bill will cause more confusion and blur the jurisdictional line?  Won't this bill in fact cause more court litigation over these definitions, the jurisdiction and who in fact fits within these definitions and falls under the FDA's jurisdiction?

IACP's Statement Regarding Draft Federal Legislation

U.S. Senate HELP Committee Releases Draft Compounding Bill 

IACP just today received a copy of the draft bill and we are still reviewing it. We applaud the steps the Committee and the U.S. Senate are taking to ensure that compounded medications are as safe as they can be. IACP believes that the safety of patients must always be the first consideration of any pharmacy-oriented public policy. 

From our preliminary review of that draft, we see that there are some aspects of the draft that will need further discussion and refinement, and we intend to work with the Committee on these. The draft does not contain any provisions that speak directly to standards aimed at raising the quality of compounded medications.   Additionally, IACP is concerned that some provisions may reduce patient and physician access to customized medications, the very services that compounding pharmacists provide.

IACP reiterates its position that state boards of pharmacy are responsible for the licensing and oversight of compounding pharmacies and the FDA is responsible for overseeing and regulating pharmaceutical manufacturers. We think the term “compounding manufacturer” and several of the definitions of that new category create more confusion and further blur the jurisdictional authority of regulators. IACP will recommend improvements in the draft language to make the proposed categories more clear.

Most importantly, IACP is gravely concerned that compounding pharmacies located in hospitals and health systems have been exempted from many of the proposed changes. Such an exemption denies patients and their families the assurance, regardless of where they receive their medications, of the quality and safety that they deserve. 

We look forward to continuing to work with the House and Senate on refining this legislation.

U.S. Files 2nd Suit Accusing Novartis of Kickbacks to Doctors - Top Headlines on DecaPost.com

U.S. Files 2nd Suit Accusing Novartis of Kickbacks to Doctors - Top Headlines on DecaPost.com

Compounding pharmacies may be source of lethal injection drugs

Compounding pharmacies may be source of lethal injection drugs

PharMEDium Supports Draft Legislation, Efforts to Strengthen Oversight of the Compounding Industry

PharMEDium Supports Draft Legislation, Efforts to Strengthen Oversight of the Compounding Industry

Numerous Free Powerpoint Presentations on Compounding

can be found here

Powerpoint on Inspection of Pharmacy for Compliance to Florida Law done on April 8, 2013

can be viewed here

COMPOUNDING – Are you following the rules? Dr. Lynne White-Shim MS, DVM Assistant Director, Scientific Activities American Veterinary Medical Association Powerpoint

can be viewed here

Compounding Policy Update from AVMA

April 25, 2013 | AVMA@Work Editor |

We want to thank our members who shared their input on the proposed revisions to the AVMA’s Compounding and Compounding from Unapproved (Bulk) Substances policies. We received some great input.

Getting member feedback on these policies is critical, because we recognize there’s a balance to be struck between the necessity to use FDA-approved drugs with known safety and efficacy, while also meeting your compounding needs and those of your patients. We all recognize that compounding is a critical tool for specific patients with special needs that can’t always be met by FDA-approved drugs.

Word has it that the Senate is drafting federal legislation that could be introduced very soon. Therefore, our volunteer governance groups are going to be working as quickly as possible to solidify the AVMA’s compounding policies so that we can use them to advocate on your behalf on Capitol Hill, in defense of your compounding needs.

Stay tuned, because we will need your help communicating AVMA’s policies to members of Congress when legislation is ultimately introduced. In the meantime, we have helpful compounding resources on our website, including a new PDFyou can review to find out if you’re following the current rules.

Quoted from Source found here

Excellent Powerpoint presentation by Gigi Davidson on Compounding for Lab Animals

can be viewed here

Subcommittee on Oversight and Investigations Committee on Energy and Commerce Letter to Chairman Tim Murphy from Henry Waxman With Numerous Supporting Documents Attached and Linked

April 11, 2013

The Honorable Tim Murphy
Chairman
Subcommittee on Oversight and Investigations
Committee on Energy and Commerce
2125 Rayburn House Office Building
Washington, D.C. 20515

Dear Chairman Murphy:

            Next week, the Subcommittee will be holding our second hearing into the deadly meningitis outbreak caused by contaminated injectable drugs from the New England Compounding Center (NECC).  You have invited Margaret Hamburg, the Food and Drug Administration (FDA) Commissioner to testify at this hearing.  We think you should also invite the head of the International Academy of Compounding Pharmacists (IACP), the national organization representing compounding pharmacists.

            A key question for this hearing is why FDA has not acted more forcefully to protect the public from the risks of improperly compounded drugs.  At our November hearing, Commissioner Hamburg indicated that weak legislative authority, combined with a series of conflicting court decisions that caused uncertainty as to the validity of the authorizing statute itself, left the agency without adequate authority to act against drug compounders.[1]

IACP Briefing Provided to Congress on History and Status of Compounding for Animals

COMPOUNDING FOR ANIMALS
ISSUE BRIEFlNG
EXECUTIVE SUMMARY
Since its inception in 1930, FDA has allowed pharmacists to compound medications from bulk
active pharmaceutical in gredients (APIs) for non food an imal s, including companion, exotic, and
perfonnance animals.
However, in July 2003, FDA abruptly reversed this policy without any indication of the
reasoning or justification behind the substantial policy reversal. FDA's new prohibition on
compounding for non food animals will adversely affect the health and well-being of many pets
and will have broad repercussions on many small businesses.
IACP has repeatedly attempted to negotiate with FDA on these polici es. However, the Agency
remains unmoved. FDA sent infonnation to State Boards of Pharmacy in April 2004 announcing
the initiation of an inspection campaign against pharmacies that compound for animals.
Developments of this nature make this issue increasingly urgent for pharmacists and
veterinar ians who provide care for an imal patients.
NECESSITY OF VETERINARY COMPOUNDING
IACP strongly supports the rights of pharmacists to compound for non food animals from bulk
ingredients. Such compounding is part of the fundamental, historical practice ofphannacy and
necessary to preserve the health and well-being of many companion, exotic, and performance
animals. Ifphannacists are limited to using FDA-approved, commercially available drugs, many
animals will die, go untreated, or su ffer needlessly.

Oklahoma Veterinary Medical Board Veterinarian-Client-Patient-Relationship - VCPR FAQs

Veterinarian-Client-Patient-Relationship - VCPR

A certificate for display at your clinic regarding VCPR requirements is available - click here. VCPR FAQs

Q. What is a Veterinarian-Client-Patient Relationship (VCPR)?



A: While there are some differences in what is necessary to establish a valid VCPR for small animal medicine versus large animal medicine, the basic factors are the same: The veterinarian assumes responsibility for making medical judgments regarding the health of the animal based on a current thorough medical knowledge of the animal(s), such knowledge is gained by recently seeing or being personally acquainted with the keeping and care of the animal to the extent necessary to properly make appropriate medical decisions the veterinarian must keep readily accessible, written medical records of his/her knowledge and treatment of the animal with sufficient detail to clearly explain the initial exam and enable another veterinarian to take over treatment of the animal based on such records, the veterinarian must provide for some form of after care in case an emergency occurs after said care is provided; and the veterinarian's actions would conform to applicable federal law and regulations.



Q. What can happen when a valid VCPR doesn't exist?



A: Inappropriate prescription medications maybe given for undiagnosed or unrelated conditions;

Inappropriate dosages are given in unapproved locations;

Meat quality assurance guidelines are ignored;

A definitive diagnosis is never made; Evidence-based medicine is not practiced;

A food animal may go to slaughter with drug residue. ( A possible human safety issue caused by drug residue is the reason most, if not all new antibiotics are script drugs).



There are many variables or questions that must be considered or answered when establishing a valid VCPR, such as: Is your client a small animal owner; does the owner have a stocker/feeder cattle operation; or does the owner have a horse or horses for commercial reasons or for recreational use. If any one of the factors listed above is missing then a valid VCPR does not exist. If a veterinarian has any question about whether a valid VCPR exists, err on the side of caution and do not prescribe, dispense or administer drugs until a thorough medical exam is conducted. When dispensing medications for administration by an animal owner/client please be mindful of your client's ability to follow your instructions. The veterinarian must, can, or should weigh the relative risk of the medicine being properly administered to the patient as well as the risk of the medicine being diverted for improper use such as human consumption.

Any veterinarian prescribing, dispensing or administering medication to animals for which a valid VCPR does not exist is in violation of the Oklahoma Veterinary Practice Act.



Q. Why is a VCPR so important?



A: A valid VCPR involves a scientific/biological examination process, knowledge of pharmacology and experienced professional judgment exercised by a duly licensed veterinarian in deciding if, when and how medications are utilized for an animal. If you have a good working relationship with your veterinarian, he or she will be able to help, advise, and guide you in the use appropriate medications for your animal. By establishing this relationship, a veterinarian also gains a better understanding and working knowledge of your animal management practices. Therefore, your veterinarian can help you make medical judgments, assist you with withdrawal times in food animals, your recordkeeping system, and can provide “extra label” drug use when deemed necessary under special circumstances. (Some medications are dangerous and can compromise the patient's well-being). Seeking and following a qualified veterinarian's advice and supervision is highly recommended regarding drug use for animals, especially in any food animal.



Q. Does the veterinarian have the right to refuse to provide a prescription?



A: Prescribing, dispensing or administering prescription drugs to an animal is generally in the discretion of the treating veterinarian. However, the Board has consistently held that it is unprofessional conduct for a veterinarian to refuse to provide a prescription to a client if deemed medically necessary and the veterinarian would have dispensed the medication for use by the patient from their own clinic. In other words, if the medication is deemed necessary by the veterinarian for treatment of a patient, then said prescription may be either dispensed by the veterinarian or if the client requests a written prescription so that the prescription can be filled by an external pharmacy. This does not mean that the veterinarian is compelled to release a requested prescription to an animal owner when there are medical or safety reasons for not releasing it or they would not dispense the medication from their own practice. If the veterinarian dispenses narcotics/controlled substances they must report it to the State's Prescription Monitoring Program (PMP). The PMP reporting process provides continuity of information between practitioners, pharmacies, and state law enforcement to help prevent prescription drug diversion and misuse of drugs in the State. In accordance with the PMP process, controlled dangerous substances must be reported within 5 minutes of dispensing.

Also, an owner and veterinarian should keep in mind that it is considered unprofessional conduct by a veterinarian to prescribe, administer or dispense any veterinary prescription drug to or for an animal solely for training, show or racing purposes and not for a medically sound reason.

The Board's staff is available to address questions concerning a valid VCPR and can be reached at 405-524-9006.

Material quoted from here

Summary of Dr. Hamburg's Comments at FDLI Conference

Dr. Hamburg Opens Up FDLI Conference – Cites Budget Situation - Once again, FDA Commissioner Margaret A. Hamburg opened up the FDLI Conference here in Washington this week with an address that provided a comprehensive look at current agency activities and priorities.  She noted that the times are challenging, though the challenges traditionally faced by an agency with such a large mandate is “made all he more difficult as we seek to fulfill our mission with the added pressure of the ‘new austerity’.”  She said that FDA stands to lose approximately 209 million dollars this fiscal year – with $126 million in budget authority and $83 million of that in user fees because although the fees will continue to be collected, they will remain deposited with the U.S. Treasury.  She also provided overviews on the status of implementation of key legislation such as the Family Smoking Prevention and Tobacco Control Act of 2009, the Food Safety Modernization Act and FDASIA as well as discussing aspects of the compounding issue.

Quoted from here

Senate HELP Committee Seeks Input into Draft Compounding Legislation – In the wake of continuing high profile issues related to compounding, the Senate HELP Committee posted draft legislation this week, seeking input into the draft which is due to the Committee by May 3 at 6 PM (

 A link to the draft legislation was posted earlier but is included on  Eye on FDA tab that compiles resources related to the developing issues around compounding located on the blog.

Note of Importance: Hearing is set for sometime in May for New Draft Federal Legislation

After meningitis deaths, Alexander seeks clarity in FDA regulations By Michael Collins Posted April 26, 2013 at 6:41 p.m.

To read this article click here

New Compounding Legislation Borrows Heavily from FDA Framework, Will Include User Fees

New Compounding Legislation Borrows Heavily from FDA Framework, Will Include User Fees

Question of the Day: 4/26/2012 Will the draft federal legislation create more issues and gray areas than problems it will solve?

Tinton Falls pharmacist in tainted drugs case accused of negligence, misconduct

NEWARK - A Tinton Falls pharmacist could lose his license, and a facility he supervised could lose its permit to operate in New Jersey after shipping mold-contaminated intravenous fluids to a Connecticut hospital.
State Attorney General Jeffrey Chiesa has filed a complaint seeking the revocation of Tinton Falls compounding pharmacy Med Prep Consulting and the revocation of the license of pharmacist-in-charge Stephen Kalinoski over allegations of gross negligence and professional misconduct.

"Our investigation uncovered a disturbing pattern of alleged failures and violations with potentially grave ramifications for public health and safety,” Attorney General Chiesa said. “The State entrusts pharmacies and pharmacists with the ability to safely dispense medications that can be very harmful if contaminated or prepared incorrectly. Pharmacies and pharmacists who have demonstrably failed to live up to that trust, in violation of our laws and statutes, must be held accountable.”
Med Prep Consulting Inc. halted operation in mid-March after recalling its entire line of drugs when contaminated bags of magnesium sulfate it had compounded and dispensed to Yale-New Haven Hospital were found.
No injuries were reported but state and federal regulators, and the company, launched an investigation.

The State Division of Consumer Affairs found a number of violations committed under Kalinoski's supervision, including:

• Incorrectly labeled, packaged and compounded products, with "significant discrepancies" between product and labels in some cases.
• Products inadequately tested for sterility, which "allegedly created the risk that patients would receive non-sterile injectable drugs and be exposed to an unacceptable risk of infection."
• Alleged failure to require the sterilization of equipment and disinfecting of employees.
• Improper use and extension of 'use-by' dates, in some cases, allegedly printing dates more than two weeks later than permitted by state regulation.
• Allegedly failing to properly document its practices and procedures.
• Allegedly falsely representing its practices and and personnel to customers and investigators.

A compounding pharmacy prepares fluids and medications in bulk for hospitals in advance of their use on patients. The 20-year-old company compounds and dispenses more than 80 drugs in infusion bags, plastic syringes and glass vials. The supply is sent to hospital pharmacies throughout New Jersey, Pennsylvania, Connecticut and Delaware.
After giving Med Prep the opportunity to submit an answer to the Attorney General’s Complaint, the Board of Pharmacy will determine whether it will hold a hearing, or refer the State’s Complaint to the Office of Administrative Law for a hearing.


Source found  here

Copy of Draft Federal Legislation of FDA Authority Over Compounding

Draft Proposal on Pharmaceutical Compounding

Friday, April 26, 2013

This discussion draft reflects bipartisan efforts to develop consensus policy proposals regarding appropriate regulation of pharmaceutical compounding. Our goal is to solicit feedback on the policy merits, potential unintended consequences, and potential opportunities to improve the legislative language. The discussion draft is available below.  Please submit your written comments to compounding@help.senate.gov by 6 PM on May 3, 2013.

Please click here to see the discussion draft.

Please click here to see the section by section.

Please click here to see the one-pager.

More Press

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 
Follow us: @thehill on Twitter | TheHill on Facebook

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