Santa Clara Drug "The Compounding Shop" Voluntarily Surrenders License to California Board of Pharmacy

Santa Clara Drug “The Compounding Shop”, PHY 39079, Administrative Case AC 3990
San Jose, CA
Through a disciplinary action of the board, the license is voluntarily surrendered. Decision effective 4/10/2013.
View the decision

Pew Foundation Summary of Pharmacy Sterile Compounding Summit

 Summary of the Pharmacy Sterile Compounding Summit (PDF)

Comments of The Pew Charitable Trusts To the Senate HELP Committee On a Draft Proposal to Improve Drug Distribution Security

Apr 26, 2013
Project: Drug Safety Project


Dear Chairman Harkin, Ranking Member Alexander, Senator Bennet, and Senator Burr,

Thank you for the opportunity to comment on this draft proposal to secure drug distribution in the United States. We commend your continued bipartisan efforts on this important issue.

Counterfeiting and drug diversion, while thankfully far less common in the U.S. than in other parts of the world, remain matters of serious concern. The United States lacks strong baseline standards for licensure of pharmaceutical wholesalers, and we lack a standard system for companies to keep track of our pharmaceuticals during distribution. There is currently no way to check whether an individual vial or bottle is authentic or counterfeit. Despite the strength of laws in states such as California, multiple state requirements on drug traceability are not ideal either for companies or for consumers. The United States lags behind other countries that have already put in place serialization and verification requirements.

Pharmaceutical manufacturers are already making investments in drug serialization technology. To justify the expense – and the preemption of strong state laws – it is essential that any federal law achieve the following within a reasonable time frame:

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Pew Foundation--Safety Problems Confirm Need for Better Oversight

Apr 15, 2013
Project: Drug Safety Project


The U.S. Food and Drug Administration late last week said it found widespread safety violations at more than two dozen specialized compounding pharmacies. The agency’s announcement comes after a nationwide outbreak of meningitis that killed more than 50 people and sickened hundreds who received contaminated injections made at a Massachusettspharmacy.


Related: Summary of the Pharmacy Sterile Compounding Summit (PDF)

Table: U.S. Illnesses and Deaths Associated With Compounded Medications

Video: Briefing on Pharmacy Sterile Compounding Summit Proceedings


These recent events emphasize the need to strengthen oversight of the industry. An analysis by The Pew Charitable Trusts released this year found that 20 compounding errors over the previous decade were associated with 75 deaths and 1,022 illnesses. The call for better oversight was underscored by participants in a recent stakeholder summit convened by Pew, the American Society of Health-System Pharmacists, and the American Hospital Association, which today released the proceedings and recommendations on pharmacy sterile compounding.


The Pharmacy Sterile Compounding Summit included representatives of pharmacy organizations, doctors, hospitals and healthcare systems, compounding pharmacies, the FDA, state pharmacy boards, and the U.S. Centers for Disease Control and Prevention. Participants discussed how to address risks related to compounding -- reviewing the scope of the practice, quality standards, and oversight gaps.


Informed by these discussions, Pew, the American Society of Health-System Pharmacists, and the American Hospital Association offer the following recommendations:
Federal oversight must be strengthened for activities that go beyond traditional state-regulated pharmacy compounding and represent a high public health risk. Risk factors to be considered include volume of production, breadth of distribution, and inherent risk of the product itself.
Federal and state authorities should have clear roles and responsibilities to ensure the safety of compounded sterile drugs without leaving oversight gaps or duplicating efforts.
Regulators should consider establishing new quality standards for large-scale sterile compounding.
State pharmacy inspectors should have standardized training and assessment tools for consistent and robust oversight.


The deaths attributed to contaminated compounded medicines highlight the risks associated with facilities that no longer function as traditional pharmacies, yet are not regulated as manufacturers. Compounding pharmacies may prepare large batches of drugs and ship them to hospitals, clinics, and doctor’s offices across the United States. Current gaps in oversight of these operations have led to a regulatory limbo for the FDA, which oversees drug manufacturers, and states, which have primary authority over pharmacies in their jurisdiction.
Date added:

Apr 15, 2013
Project:

Drug Safety Project

GMP and Compounding Pharmacies --Great Charts of the FDA Inspections

Scott Sutton, Ph.D.

It seems self-evident today, but worth remembering, that the pharmaceutical industry exists on a foundation of trust. Patients or even doctors have no way to actually determine the strength, purity and quality of the medicines prescribed and taken. Everyone trusts that the label is accurate and the medicines are pure. This was not always the case and efforts to safeguard our medicine supply led directly to USP, FDA and the GMPs.

Recently we have been reminded of the critical nature microbial Quality control plays in safe medications as contaminated medicine shipped nationally from a compounding pharmacy has sickened hundreds. The New England Compounding Center (NECC) of Framingham, MA was responsible for the manufacture of preservativefree methylprednisolone acetate. This was an aseptically produced parenteral, delivered intrathecally (directly to the spinal column, bypassing most of the body’s defense mechanisms).

It is difficult to envision a more hazardous situation and the results have been disastrous. Three lots of this product have exposed over 20,000 individuals to risk of fungal meningitis, and by latest count (April 15, 2013 - http://www.cdc.gov/hai/outbreaks/meningitis-map.html) have resulted in infections in 733 patients and 53 deaths associated with these intrinsically contaminated medicines.

In response to this situation, FDA has embarked on an aggressive inspection schedule that resulted in multiple 483 findings in the beginning of 2013 (summarized in Table 1). Review of these 483 observations shows several common findings among the compounding pharmacies that received 483 observations during this time:

• Lack of procedures to prevent microbial contamination
• Problems with the Environmental Monitoring program
• Problems with batch release
• Lack of validation of the sterilization method
• Inadequate control/cleaning/qualification of critical equipment used in manufacture
• Issues with personnel gowning
• Expiry dating of manufactured medicines not supported by a stability study
• Issues with laboratory procedures or control of contract lab
• Issues with investigations
• Control of incoming raw materials and components

To continue reading and to view awesome charts click here

Second Question of the Day: 5/3/2013 Why Does the Help Senate Committee Not Have Someone from the Veterinary Industry Testifying When Compounding is A Major Part of their World?

HELP Committee List of Witness for May 9th Hearing

Full Committee Hearing - Pharmaceutical Compounding: Proposed Legislative Solution

Date:

Thursday, May 09 2013, 10:00 AM

Place:

430 Dirksen Senate Office Building

Witnessesreturn to top

Panel I

• Dr. Janet Woodcock , Director, Center for Drug Evaluation and Research, Food and Drug Administration, U.S. Department of Health and Human Services, Silver Spring, MD

Panel II

• Carmen S. Catizone , Executive Director, National Association of Boards of Pharmacy, Mount Prospect, IL
• Allan Coukell , Director, Medical Programs, The Pew Charitable Trusts, Washington, DC
• David G. Miller , Executive Vice President and CEO, International Academy of Compounding Pharmacy, Missouri City, TX
• Dr. Kasey K. Thompson , Vice President, Office of Policy, Planning and Communications, American Society of Health-System Pharmacists, Bethesda, MD

Agenda Posted for Colorado State Board of Pharmacy Meeting Set for May 16--A Number of Complaints Filed Against Compounding Pharmacies

Colorado State Board of Pharmacy Meeting Date: 05/16/2013 Time: 08:30 AM Title: Colorado State Board of Pharmacy Meeting Location: 1560 Broadway Ste 110D, Denver, CO 80202 Regular Meeting.  Agenda submission deadline is 4/22/13. Attachment(s): File Agenda.pdf

Colorado Board of Pharmacy Rules Manual-- New Rules Effective in 2013

To view click here

Editorial by Dr. Loyd Allen: Editorial: Documentation vs Opinion on Compounding Regulatory Activities

To read Dr. Allen's editorial in the latest edition of Compounding This Week: Newsletter click here

Upcoming Webinar and Events listed by IACP

Upcoming IACP Events




MAY16

Webinar: Being a Successful Advocate - Working with Your State and Federal Representatives
Online Webinar

1:00pm - 2:00pm


MAY30

ASCA Webinar: New Developments Affecting Compounding Pharmacies and What They Mean for Your ASC
Online Webinar

1:00pm - 2:00pm


JUN01

IACP's 19th Annual Compounders on Capitol Hill 2013
Crystal Gateway Marriott(map)


JUN22
GPhA 138th

For more information or to register go to the IACP website found here

Pharmacy Reflections: Changes in Compounding Pharmacy Oversight

Pharmacy Reflections: Changes in Compounding Pharmacy Oversight: On April 26 th , the United States Senate produced early compounding legislation, primarily in response to the Meningitis Outbreak...

CAPS Provides Input on Draft Sterile Compounding Legislation

05/03/2013

Supporting consistent federal oversight of sterile compounding in the United States, Central Admixture Pharmacy Services, Inc. (CAPS®), a B. Braun company, submitted its comments today

Bethlehem, PA – May 3, 2013 – Supporting consistent federal oversight of sterile compounding in the United States, Central Admixture Pharmacy Services, Inc. (CAPS^®), a B. Braun company, submitted its comments today to the U.S. Senate Committee on Health, Education, Labor, and Pensions (HELP) regarding the committee’s draft legislation on sterile compounding.

“We strongly believe that consistency will be the key,” said Mike Koch, CAPS Vice President, Marketing and Support Services. “To help ensure both patient safety and confidence in the nation’s drug supply, it’s important to hold all compounded sterile preparations made in the U.S. to a consistent set of quality standards, while avoiding potentially dangerous loopholes.”

CAPS delivers compounded sterile preparations daily, both locally and nationwide, from 25 locations. Included in the comments submitted to the Committee was support for the newly proposed “Compounding Manufacturer” category. CAPS looks forward to further engaging in the dialogue on this important patient safety legislation.

Source found here

Setting record straight | therecord --in Canada

Setting record straight | therecord

IACP Compounders on the Hill Last Day to Register--

Compounders on Capitol Hill (CCH) online registration closes today, May 2, 2013 at Midnight! Please join us at CCH and plan to stay for “Hill Day,” on Tuesday, June 4th. This is your opportunity to weigh in with lawmakers, and make your voice heard in the debate. There is strength in numbers, and a large turnout will bolster our effort.

Register online at www.iacprx.org/cch. #CCH2013

HORSE HEALTH Choosing Joint Health Products May 2, 2013 Find out how to make the best choice between FDA-approved innovator drugs, FDA-approved generic drugs, medical devices or compounded products.

From AQHA Corporate PartnerAdequan

When a horse or companion animal becomes sick or lame, you turn to your veterinarian for a diagnosis and the best, proven treatment to make your animal better.

But, just because a product is available for purchase doesn’t make it a proven product or the right product to treat the problem. So, do you treat with an FDA-approved innovator drug, an FDA-approved generic drug, a medical device or a compounded product?

In considering this question, Dr. Jeffrey Berk, a veterinarian at Equine Medical Associates in Lexington, Kentucky, says horse owners need to consider two things very carefully.

“When considering an alternative treatment, veterinarians and horse owners need to understand they are not guaranteed the same level of safety or quality — i.e. potency and purity — as you would with an FDA-approved product,” says Dr. Berk, who is a member of the Professional Conduct & Ethics Committee of the American Association of Equine Practitioners.

FDA-Approved Products

Some experts estimate that it takes four to six years and millions of dollars to get anFDA-approved animal drug from the laboratory to the marketplace. Most of the money is spent on conducting studies that prove the drug’s effectiveness in a form acceptable to the Food and Drug Administration, the governing body over both human and animal drug approval. The FDA approval process is the most extensive law of its kind in any country. All regulations are focused on protecting the end user and providing a safe, effective product. In short, the FDA will not allow a company to market a drug as FDA-approved if it has not proven its effectiveness in multiple scientific studies.

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FDA has wish list on regulating compounders Congress might be listening as quality control issues at compounders cause health-related death and illness -

By Eric F. Greenberg, Contributing Editor/Legal Columnist

 Those big news stories last fall about the contaminated injectable steroids from New England Compounding Center in Massachusetts might have been the first news you heard about compounding pharmacies, but it’s not hardly the start of the story. The U.S. Food and Drug Administration and industry have been struggling for years over the proper regulatory treatment for these facilities, and Congress and the courts have both helped change the shape of things as well. FDA is now asking for even more changes to give it a better ability to regulate compounding pharmacies.

The Massachusetts compounder marketed products that killed more than 50 people and made hundreds more sick. The company pretty clearly had poor quality procedures, but many people blamed FDA for not cracking down on them. FDA, in turn, lamented that its legal powers are more limited over compounders than over conventional drug manufacturers, even when, as in this case, the compounders were behaving much the same way as a manufacturer.

- See more at: http://www.packworld.com/trends-and-issues/regulatory/fda-has-wish-list-regulating-compounders.

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Question of the Day: 5/3/2013 Who Are The Key People That Congress Should Allow to Testify At the Hearing On May 9 Regarding the Proposed Federal Legislation on Compounding?

I think without a doubt Dr. Loyd Allen and Dr. Gigi Davidson.  Who else do you think should be on the list?

The Proposed Federal Legislation Regarding Compounding Is Focused More on Fees than On Making Advances to Protect the Health and Safety of the Public From Bad Compounders

Sue Tuck Richmond
May 3, 2013


A lot of people, including me, believe reform in the human and animal compounding world is greatly needed.  There are different views on how this reform should be accomplished.  Some think the reform needs to occur at the state level; others believe it will take the federal government's strong involvement to achieve the reform needed.  Still others believe a combination of reform at both the state and the federal government is necessary.

I have previously posted Ten Reasons This Legislation Should Not Be Passed in Its Current Form. Having previously drafting legislation on behalf of my U.S Attorney for the Department of  Justice to consider and having researched and briefed issues addressing statutory interpretation and legislative intent,  I know that drafting legislation is no easy task.  It is a lot easier to be on this side picking apart the legislation.  I also know that you have to start somewhere when trying to draft and pass new legislation.  I commend the  members of the HELP Senate Committee for starting the process of reform in the compounding world.  But this draft legislation is just that--the start of the process of reform.  The process of reform must include focusing on the health and safety of the public from bad compounders. I have to agree with the  Public Citizen Advocacy Group;  This proposed legislation is  "a major step backward for US drug safety."

No where in the draft of the legislation is it stated that protecting the health and safety of the public is the purpose of the legislation.  In the documents released with the draft legislation, it states that the "proposal would help improve the safety of compounded human and animal drugs by making clear the oversight responsibilities of state and federal authorities."  See Bipartisan HELP Senators Unveil Major Effort to Clarify Oversight for Pharmaceutical Compounding; Ensure Consumer Safety, p.1, The Section by Section, Summary of the Bipartisan Senate Discussion Draft, states:

This discussion draft establishes a clear boundary between traditional compounders and compounding manufacturers, which make sterile products without or in advance of a prescription and sell those products across state lines. It clarifies a national, uniform set of rules for compounding manufacturers while preserving the states’ primary role in traditional pharmacy regulation. The draft creates a similar structure for oversight of compounded animal drugs, and clarifies the law on compounding from bulk chemicals for animals.

The mention of public health and safety is sparse in any of the released documents.  The sparseness wouldn't be as big an issue if the proposed legislation would ultimately accomplish protecting the health and safety of the public from bad compounders.  However, this does not appear to be true for several reasons. 

First, the language of the proposal is confusing and doesn't make sense.  Why create a new category of  "compounding manufacturers" that only muddies the waters? Why allow "compounding manufacturers" to mass-produce drugs and sell them across state lines without obtaining FDA approval intended to ensure safe drugs when manufacturers of drugs are currently required to get approval and meet federal labeling requirements?  Second, I envision that if this legislation is passed as is much time will be spent in court litigating which category a pharmacy fits into and which rules apply.  I also envision like the Public Citizen's group that some manufacturers may decide to skip the FDA's regulatory processes entirely and instead compound on a large-scale basis.  This certainly won't further the cause of drug safety.  I also envision some large-scale compounders may scale back and not be "large-scale" anymore to avoid having to pay the large fee for inspection.  All of this shifting could result in much needed drugs being in short supply or simply unavailable.  These once large-scale compounders won't be under the FDA's watch so again the legislation doesn't further drug safety.  

The fee issue is an another matter.  The FDA needs funding to conduct these inspections. We all know the state of the current federal budget.  I can't blame the FDA for trying to fund the legislation in the legislation.  But again, since this legislation appears to be more about "fees" than fixing the broken compounding regulatory process, it leaves one wondering is this more a "revenue producing piece of legislation" than a "fixing a broken process piece of legislation?"  

In sum, the process of reform has begun.  The needed reform cannot be achieved with the proposed federal legislation.  I have always advocated that the more input from more people, groups, associations, etc. the better the chance of a workable, piece of legislation that in fact makes advances to protect the health and safety of the public from bad compounders while allowing the good compounders to continue to operate. Please listen Congress to what experts across the country have to say about how to reform the compounding world. Please do not forget that just as there are bad compounders there are also very good, highly skilled compounders who play by the rules everyday producing essential drugs for animals and humans.  We need to keep these good compounders and not run them off as we are removing the bad compounders.  With everyone working together to come up with the best reform, the goal of better, safer compounds can be achieved.

Monthly Archives: May 2013 Congress Drafts Legislation that would Expand the FDA’s Role in Regulating Compounding Pharmacies posted by william p. conaboy jr. on may 02, 2013

Mr. Conaboy believes:

The Draft Legislation will likely undergo significant revisions before its adoption — if it is adopted at all.  What is clear, however, is that the FDA is moving toward regulating compounding practices that have traditionally been regulated by state agencies.  Federal intervention will likely come to fruition in the near future, and many compounders who are not currently subject to the FDCA’s GMPs and other requirements will be faced with the challenge of having to comply with new regulations and additional oversight.  Accordingly, it is important that compounding entities become familiar with and track the Draft Legislation as it progresses as it appears that increased federal oversight is imminent.

To read his entire blog post click here

Law 360 Says Compounding Bill May Hand FDA New Power Over Health Care

Compounding Bill May Hand FDA New Power Over Health Care

Share us on:TwitterFacebookLinkedInBy Rachel Slajda

Law360, New York (April 30, 2013, 8:07 PM ET) -- If enacted as is, new draft legislation to give the U.S. Food and Drug Administration explicit authority over compounding pharmacies could strip states of much of their authority over compounders, outlaw common compounding practices and give the FDA some power to regulate the practice of medicine, a power courts have long left to the states, experts say.

Leaders of the Senate Health, Education, Labor and Pensions Committee last week released a draft bill that would grant the FDA its request for more explicit authority to regulate...

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