FDA Compliance Boot Camp 2012

 

Monday,  Sept.  24 -  Friday,  Sept.  28,  2012 

Register Now

 

For more information click here.

Seventh Annual FDA Inspections Summit

September 19-21, 2012

Each year, the FDA makes adjustments to its inspection processes and policies. This year is no exception. Recent important changes include:

• If you think you can easily stop the FDA from taking pictures of your facility during an inspection, think again.  The FDA now advises its inspectors to not ask for permission but take their cameras into facilities and take pictures as they see fit.  If a firm complains, the new policy is for the inspector to contact the firm’s legal counsel and advise the district management immediately.

• A new user fee may be assessed if FDA conducts a reinspection to evaluate corrective actions that were classified Official Action Indicated (OAI) and determined to be material.  This fee may also be assessed for not complying with a recall order issued by FDA under section 423 or 412(f).

• FDA investigators are actively data mining your records during inspections.  As nearly all inspectors are using laptops and tablets during their inspections, many are asking for electronic copies of complaint or AER data and taking it back to their hotel rooms each evening to dissect the data and be prepared to ask additional questions the next morning.  Providing old or inaccurate data can quickly lead to problems.

These changes and many more are to be discussed at the Seventh Annual FDA Inspections Summit.  Year after year, the crème de la crème of the industry make it their business to attend this conference and tap into the cumulative knowledge of an accomplished group of top officials from CDER, CDRH, CBER, the Office of Regulatory Affairs (and more).

Register today to hear about breaking news directly from prominent FDA officials. That's why you can't afford NOT to attend the Seventh Annual FDA Inspections Summit on Sept. 19-21 in Bethesda, MD.

Featured Speakers:

• Steve Silverman, Director, Office of Compliance, CDRH, FDA
• Lori Lawless, SCSO, Medical Device Specialist, ORA, FDA, Baltimore District
• Mary Malarkey, Director, Office of Compliance Biologics Quality, CBER, FDA

Summit Faculty:

• Barbara Immel, President, Immel Resources (Summit Chairperson)
• Steve Niedelman, Lead Quality Systems and Compliance Consultant, FDA & Life Sciences Practice, King & Spalding, former Deputy Associate Commissioner, Regulatory Operations and Chief Operating Officer, ORA, FDA
• Ron Johnson, President, Becker & Associates Consulting, Inc., former Director of Compliance, CDRH, FDA
• Dr. Gilda D’Incerti, CEO, Pharma Quality Europe
• Deborah Geyman, Senior Manager Corporate Quality Audit, St. Jude Medical
• Dr. Stephen Goldman, Managing Member, Stephen A. Goldman Consulting Services, formerly FDA’s first Medical Director of MedWatch
• Steven Grossman, President, HPS Group, Deputy Executive Director, Alliance for a Stronger FDA, Publisher, FDA Matters: The Grossman FDA Report, former Deputy Assistant Secretary for Health, HHS
• Connie Hoy, Vice President, RA/QA, Cutera
• Julie Larsen, Director, Inspection Readiness Services, BioTeknica
• Dr. Jeanne Mattern, Director, QHS Regulatory Compliance Office, Cleveland Clinic
• Dan O'Leary, President, Ombu Enterprises
• Matt Quirk, Manager, Clinical QA, St. Jude Medical
• Kenneth White, Principal Scientist, Clinical Research and Bioscience Group, Social & Scientific Systems
• Christina Arnt, Post Market Surveillance Manager, St. Jude Medical
• Braulio Ortiz, Principal/Sr. Quality Consultant, BioTeknica
• David Elder, Vice President of Strategic Compliance Services, PAREXEL Consulting
• Elaine Messa, Executive Vice President of the Medical Device Practice, Becker & Associates Consulting, Inc.
• Michael Bloh, Independent Safety and Pharmacovigilance Consultant
• Frederick Branding, Principal Attorney, Olson Frank Weeda
• Scott Cunningham, Partner, Covington & Burling
• Darshan Kulkarni, Principal Attorney, The Kulkarni Law Firm
• Cathy Burgess, Partner, Alston & Bird

Register Today

Click here for more information

FDA Now Has A Presentation Library On-Line

The Center for Drug Evaluation and Research now has a presentation library on-line that can be viewed here.

FDA Looking to Overhaul Compliance Approach

Visit www.drugregulations.org for the latest in Pharmaceuticals.

An article published in Regulatory Focus gives FDA's latest thinking on the relationship between Compliance and Quality.

In a presentation to the Regulatory Affairs Professionals Society's (RAPS) San Francisco membership chapter on 27 July 2012, Roh, regional food and drug director for FDA's Pacific Region, said the US Food and Drug Administration (FDA) is heading towards a significant change in compliance policy in the coming years. This is a result of rapidly surging imports of pharmaceutical, medical device and biologics products. Under the new system, stand-alone compliance issues would become secondary in importance to quality systems put in place by companies.

The rate at which products were being imported from overseas manufacturing facilities was fast outstripping FDA's ability to effectively exercise oversight. Some of the largest US trading partners are projected to experience enormous growth trends in imports, Roh said in his presentation. China in particular is expected to experience a 426% growth in exports by 2020, while India (+465%) and Mexico (+159%) are projected to exhibit similar percentage increases, though on a smaller overall scale. This could have huge ramifications for the US, which already imports approximately 10% of all products regulated by FDA. The US is expected to see growth rates between 5% and 8% during most years, with estimations going as high as 15% during some years.

To read rest of this article, click here.

Reminder: Administrative Record is Due in K-V v. FDA on 8/29/2012

08/09/2012		MINUTE ORDER granting 20 Motion for Extension of Time to File Administrative Record. Defendants are ORDERED to submit the administrative record on or before August 29, 2012. Signed by Judge Amy Berman Jackson on 8/9/12. (DMK) (Entered: 08/09/2012)
08/09/2012		Set/Reset Deadline: The Administrative Record is now due by 8/29/2012. (jth) (Entered: 08/09/2012)

FDA's Global Initiative; FDA Across the Globe

Global Initiative

Global production of FDA-regulated products has quadrupled over the last decade and continues to grow.  Today, FDA-regulated products originate from more than 150 countries, 130,000 importers and 300,000 foreign facilities.

Almost 40 percent of the fruits and nuts and 85 percent of the seafood consumed in America comes from abroad.  Similarly, more than 80 percent of the active pharmaceutical ingredients used to make medicines are imported. The growth in imports has been rapid and promises to accelerate.

Globalization has fundamentally altered the economic and security landscape and demands a major change in the way FDA fulfills its mission.  Over the next decade, FDA will transform from a predominantly domestically-focused agency operating in a globalized economy to a modern public health regulatory agency fully prepared for a complex globalized regulatory environment.

The agency is already working to increase transparency and accountability in the supply chain, developing better enforcement and regulatory tools, encouraging greater responsibility by industry, and enhancing collaboration with international regulatory counterparts and other third parties.

As our world transforms and becomes increasingly globalized, it is vital that we come together as a global community – in new, unprecedented, and even unexpected ways – to build a public health safety net for consumers around the world.
 

• More information on Global Operations

FDA has established international offices and posted staff in strategic locations around the world. They work closely with their national and regional regulatory counterparts, and with other U.S. government agencies stationed abroad, to perform functions essential to FDA’s ability to protect U.S. consumers. Learn more about FDA’s international offices and posts.

This article found on FDA;s website here.

The Global Drugstore: FDA No Longer a Domestic Agency

These days, a trip to the supermarket or drugstore is like a trip around the world.

Many of the products you and your family buy, the medicines you use, and the foods you eat are from other countries. Did you know, for example, that 80 percent of our seafood and 80 percent of the active ingredients in medications consumed in the United States comes from abroad?

“Global Engagement”, a new, in-depth report from the Food and Drug Administration (FDA), tells how the agency works to ensure that the imported foods, medical products, and other goods it regulates meet the same high standards for safety and quality set for products manufactured domestically.

The report was compiled to provide a face and voice to FDA’s global work, which includes overseas inspections and collaborations with governments in other countries, says FDA’s Mary Lou Valdez, associate commissioner for international programs.

Rather than focusing on the efforts of one FDA office or center, the report describes for the first time—through data, charts, vignettes, quotes, and narratives—the global engagement efforts taking place across the agency. The report also explains some of the challenges that FDA faces in fulfilling its mission.

“It truly is a different world for all of us working to ensure product safety,” says Valdez. “We had to recognize the complexity of the world in which we’re regulating.”

back to top 

From Farm to Fork

Take food. FDA regulates most food products in the United States, from the lettuce you put in your family’s dinner salad, to the eggs and juice you serve for breakfast.  As of 2011, roughly one in six FDA-regulated food products consumed in the United States comes from abroad. And the percentage is much higher in foods like fruits (about 50 percent) and vegetables (about 20 percent).

So the agency—empowered by the Food Safety Modernization Act signed into law in 2011—is focusing its efforts on making sure that foods from other countries meet U.S. safety standards before they reach the United States, and your family’s dinner plates. Investigators with FDA’s Office of Regulatory Affairs travel the globe to inspect facilities that produce food bound for the United States. Additionally, FDA’s Office of International Programs has stationed investigators in multiple overseas posts to complement these inspection efforts. 

“Consumers around the world, not just in the United States, expect and demand safe food, no matter its source,” says Michael Taylor, FDA’s deputy commissioner for foods.

back to top 

The Global Drugstore

These strategies also apply to medical products, which include prescription and over-the-counter drugs, biologics (like vaccines and tissue), and devices that range from tongue depressors to complex diagnostic tools.

Forty percent of drugs—generic and prescription—consumed in the United States are now manufactured in other countries.

Globalization of the medical product industry presents regulatory challenges from product development to final use by the consumer:

• The clinical trials of all medical products required for FDA approval are increasingly conducted abroad, adding the complexity of the review process.
• Many U.S. consumers can purchase medicines via the Internet directly from foreign sources, increasing their potential exposure to unsafe or ineffective medical products.
• Many medical devices are sold in nearly identical forms around the world but are known by different trade names, making it difficult to warn medical professionals and consumers about potential dangers.

back to top 

Global Strategies

The report outlines a variety of strategies to increase its engagement in the international public health community. These include:

• Opening new FDA posts overseas in key areas such as China, India, the Middle East, Europe, and Latin America. These help FDA build strong relationships with officials overseas and see first-hand how foreign-based facilities are operating.
• Developing strong and consistent international regulatory standards to allow countries to share a common foundation of science-based goals for product safety and quality. FDA’s Office of International Programs works with FDA’s centers and offices to share information, strategies and tools with other countries.
• Sharing and analyzing information and data in a way that will help regulatory agencies around the world use finite resources strategically.
• Working with other countries to monitor, prepare for, and respond to public health challenges, such as pandemics (widespread epidemics of infectious disease), natural disasters or broad distribution of tainted FDA-regulated products.
• Developing innovative strategies and tools for risk-based monitoring and inspection of imported products. An example is the PREDICT Application, a data-mining and pattern-tracing tool that FDA uses to screen imported products and identify those that  pose the greatest risk to public health.
• Working with international partners to advance the science used to assess the safety and effectiveness of regulated products, which can lead to more cost-effective and timely product development. One example is the development of vaccine technology by FDA’s Center for Biologics Evaluation and Research that was used, through an international partnership, to protect millions in Africa against meningitis.

“FDA is no longer a domestic agency,” says Valdez. "We have gone global because consumers' products come from many corners around the globe.  We have made significant contributions towards assuring global product safety and quality.”

“And we will continue to make many more to promote the health and well being of the American people and our fellow citizens around the world," she says.

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

April 23, 2012

This article appears on the FDA website here.

Motion to Dismiss and Memorandum in Support filed by FDA in case filed by K-V

To view the motion to dismiss, click here.
To view the memorandum in support of the motion to dismiss, click here.
To view exhibit 1 to memorandum in support of the motion to dismiss, click here.
To view exhibit 2 to memorandum in support of the motion to dismiss, click here.
To view exhibit 3 to memorandum in support of the motion to dismiss, click here.
To view exhibit 4 to memorandum in support of the motion to dismiss, click here.
To view exhibit 5 to memorandum in support of the motion to dismiss, click here.
To view the proposed order to the motion to dismiss, click here.

FDA's shutting down of faulty drug manufacturing facilities 'over-aggressive and excessive,' says Congress

(NaturalNews) Several members of Congress are up in arms over the U.S. Food and Drug Administration (FDA)'s recent crackdown on faulty drug manufacturing facilities across the country. According to the Washington Examiner and several other news outlets, House Oversight and Government Reform Committee (HOGRC) Chairman Darrell Issa (R-Cal.) has issued a public statement in protest of the FDA's regulatory actions, dubbing them "over-aggressive and excessive," and responsible for causing widespread shortages of "life-saving" drugs.

Dozens of drugs have had to be recalled just within the past year due to contamination, production, labeling, and dosage problems, which is why the FDA sent out 1,720 warning letters to drug companies -- the agency only sent out 474 warning letters in 2009 -- notifying them that changes needed to be made. But now Congress has turned the issue into a partisan one, and is actually accusing the FDA of doing too much in trying to protect the public from unsafe drugs.

Rep. Issa flip-flops on FDA enforcement actions
As many NaturalNews readers will remember, McNeil Consumer Healthcare, a division of Johnson & Johnson (J&J), voluntarily shut down its Fort Washington, Penn., facility back in 2010 after a series of drug recalls that included several million containers of various children's medicines. (http://www.naturalnews.com/030504_Johnson_&_recalls.html) It turned out that the McNeil manufacturing plant producing these medicines was infested with bacteria and filth. (http://consumerist.com)

At that time, Rep. Issa and several others issued a joint statement expressing concern about the filthy conditions at the McNeil plant, and actually indicted the FDA for allegedly failing to conduct proper inspections and recall procedures that Rep. Issa and others implied would have kept the public safe from the tainted products. (http://www.ipqpubs.com) Now, however, more than two years after his previous statements, Rep. Issa is singing a different tune, claiming that the FDA is doing too much to protect the public.

According to Rep. Issa, drug companies are having to slow or even stop production of certain "life-saving" drugs in order to come into compliance with FDA standards. So putting the lives of millions of patients at risk from exposure to tainted drugs is apparently not that big of a priority anymore since the FDA's regulatory actions are now cutting into Big Pharma's profit margins -- or as Rep. Issa and his cohorts have put it, "failing to ensure the availability of quality products."

So when the FDA steps in to stop drug companies from dispensing contaminated drugs, the agency is needlessly obstructing the nation's supply chain of critical drugs, in Rep. Issa's opinion. But when the FDA pursues supplement manufacturers, threatens walnut and cherry growers, and shuts down family farms (http://www.naturalnews.com/033280_FDA_raids_timeline.html" target="_blank">http://www.naturalnews.com/033280_FDA_raids_timeline.html), it is apparently just business as usual in the corrupt world of regulatory politics.

Rep. Issa was nowhere to be found when the FDA needlessly destroyed the entire business of Pennsylvania Amish farmer Dan Allgyer, obstructing access to that area's supply chain of raw milk. (http://www.naturalnews.com/035000_Amish_farmers_raw_milk_feds.html) He was also nowhere to be found when the FDA participated in a SWAT-style raid on Rawesome Foods near Los Angeles, Cal., which interfered with that local area's supply chain of organic, natural, and untainted foods. (http://www.naturalnews.com/033220_Rawesome_Foods_armed_raids.html)

For once, the FDA is actually doing a decent job of pursuing the dirty players in the drug industry, and Rep. Issa and others in Congress are complaining that these actions are inappropriate. It just goes to show how deeply corrupted the American political system has become.

Sources for this article include:

http://campaign2012.washingtonexaminer.com

http://in.reuters.com

http://www.forbes.com

Learn more: http://www.naturalnews.com/036390_drug_factories_FDA_violations.html#ixzz1ztnNOXfE

This article can be found here.

FDA Conducting Training Regarding Compounding of Animal Drugs for its Inspectors and State Inspectors

DATE:  June 1, 2012
FROM:  John Shafer
              Director, Division of Human Resource Development (HFC-60)
SUBJECT:  COURSE ANNOUNCEMENT: AMDUCA/Compounding Animal Drugs (VM207)
AMDUCA/Compounding Animal Drugs (VM207)
Nashville, TN
                Begin:    Tuesday, August 21, 2012 at 8:00 AM
                End:       Thursday, August 23, 2012 at NOON  COURSE DESCRIPTION /

OBJECTIVES:                                
This course is intended to instruct field investigators on the laws, regulations and policies pertaining to compounding of animal drugs and the Animal Drug Use Clarification Act related to the extra-label drug use in animals. Compounding of animal drugs has increased exponentially in the last few years.  Certain compounding practices undermine the animal drug approval process, and present unknown and potentially hazardous risk to animal and human health.  Animal drug compounding is addressed in various laws, regulations, and policies.  In order to adequately assess violations of concern, investigators need to understand the laws, regulations and policy that distinguish animal from human drug compounding. Extralabel drug use practices may especially result in violative food animal tissue residues.  Investigators need to understand under what circumstances extra-label drug use can or cannot be utilized in veterinary medicine.

Objectives:  Upon completion of this course, participants will be able to:
1.  Describe the regulations and guidance documents that address the proper use of animal drugs, the compounding of drugs for use in animals, and the extra label use of drugs in animals.
2.  Recognize appropriate investigative and data gathering techniques for conducting investigations of compounding pharmacies, veterinarians and food animal producers.  3.  Correctly complete the documentation required for the development of a successful enforcement
action.
Target Audience:  FDA investigators, state inspectors, compliance officers, and supervisors who are
actively engaged in inspections of animal drug compounding pharmacies and veterinarians’ extra label drug use in food producing animals or review or take compliance action on these inspection reports.

To read the entire announcement to FDA employees click here

Agreement Between FDA and China

FDA - SFDA

Agreement between
the Department of Health and Human Services
of the United States of America
and the State Food and Drug Administration
of the People's Republic of China on
the Safety of Drugs and Medical Devices

The Department of Health and Human Services (“HHS”) of the United States of America ("United States") and the State Food and Drug Administration ("SFDA") of the People’s Republic of China ("China") (hereinafter referred to together as "the Parties"):

Understanding the mutual benefits of protecting the public health through improved cooperation between the Parties with regard to monitoring and regulating the safety of drugs and medical devices;

Desiring to work together to better ensure the safety and quality of Drugs, Excipients, and Medical Devices; and

Recognizing that such cooperation can improve the health of the citizens of both the United States and China and enhance confidence in the regulation of Drugs, Excipients, and Medical Devices in both countries;

Have agreed as follows:

Article I    Purpose

The purpose of this Agreement is to establish methods of cooperation between the Parties that will provide the Food and Drug Administration within HHS (“HHS/FDA”) with additional information about products exported from the customs territory of China to the United States, provide SFDA with increased sharing of information about products exported from the United States to China, and encourage further regulatory cooperation between the Parties regarding Drug and Medical Device regulation.

Article II    General Principles

1. The Parties shall engage in regulatory cooperation regarding the export of Drugs, Excipients, and Medical Devices from the customs territory of China to the United States and Drugs, Excipients, and Medical Devices produced in the United States and exported to the customs territory of China as set out in Article VI and as further defined in Work Plans to be agreed upon by the Parties.
2. The Parties shall engage in information-sharing to improve their mutual understanding of, and to gain greater confidence in, each Party’s regulatory system as set out in Article V and as further defined in Work Plans to be agreed upon by  the Parties.  As specified in Article V, each Party shall share relevant information with the other Party, including on relevant laws, regulations, areas of jurisdiction, and public health and safety.
3. The Parties shall engage in regulatory cooperation regarding improving the authenticity, quality, safety, and effectiveness of Drugs, Excipients, and Medical Devices as set out in Articles IV and VI and as further defined in Work Plans to be agreed upon by the Parties. 

The Parties shall commit to annual meetings between senior Agency leaders to discuss and evaluate progress under this Agreement, among other things.

For purposes of this Agreement the following definitions shall apply:

1. "API" or "Active Pharmaceutical Ingredient" means any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of a drug, becomes an active ingredient of the drug product.  Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body.  
2. "Counterfeit Drugs and Medical Devices" means a product that is deliberately and fraudulently mislabeled with respect to identity and/or source.  Counterfeiting can apply to branded and generic products and may include products with correct ingredients, with wrong ingredients, without active ingredients, with incorrect quantity of active ingredient, or with fake packaging.
3. "Designated Drugs and Designated Medical Devices" means a Drug (including APIs) and Excipients or Medical Device, respectively, designated for inclusion in each phase of implementation, based on criteria established in Article IV. A.
4. "Drug" means any material commonly used for human pharmaceutical use.  The term includes the following materials:
   1. Finished-dosage forms (including both over-the-counter ("OTC") and prescription drugs);
   2. Drug substance, or active pharmaceutical ingredients ("APIs");
   3. Biologic drugs (e.g., vaccines and monoclonal antibodies); and
   4. Products taken by mouth intended to supplement the diet that:
      1. bear or  contain one or more of the following dietary ingredients: a vitamin; a mineral; an herb or other botanical; an amino acid; a dietary substance for use in humans to supplement the diet by increasing the total dietary intake; ora concentrate, metabolite, constituent, extract or combination of any of the above; and
      2. meet any one of the following characteristics:
             - are not clearly labeled as dietary supplements; or
             - contain claims to diagnose, cure, mitigate, treat, or prevent disease; or
             - contain substances that are regulated by HHS/FDA as APIs.

To read the rest of the agreement, click here.

Another Article Suggest that the FDA May Start Inspecting More Compounding Pharmacies

Another article entitled Report: Compounding Regulatory Issues Come to Light After 'Urgent' Recall by Alexander Gaffney  suggest that the FDA may start inspecting more compounding pharmacies.  The article states:

Not all pharmacists have the same level of skills and equipment,” said Rear Admiral Steven Galson, deputy director of the Center for Drug Evaluation and Research at FDA and the US’s acting surgeon general. “In some cases, compounders may lack sufficient controls—equipment, training, testing, or facilities—to ensure product quality or to compound complex products such as sterile or modified release drugs.”

Because the majority compounds are made-to-order and exist in small quantities, many current good manufacturing practices such as lot and batch testing are impossible. “The quality of the drugs that these pharmacists compound is uncertain and these drugs pose potential risks to the patients who take them,” concluded Galson.

However, large-volume suppliers such as Franck’s are frequently making batches of products in amounts suitable for quality testing, creating tensions between FDA and the compounders, report The Star-Banner.

In response, FDA is starting to leverage its oversight authority towards companies “whose activities raise the kinds of concerns normally associated with a drug manufacturer and whose compounding practices result in significant violations of” The Federal Food, Drug and Cosmetic Act, said Galston in previous testimony before Congress.

To read the entitle article, click here.

Mistakes by Franck's Pharmacy put spotlight on FDA's limited oversight of compounding

Story appears at Ocala.com:

Mistakes by Franck's Pharmacy put spotlight on FDA's limited oversight of compounding

By Carlos E. Medina
Correspondent

Published: Saturday, June 2, 2012 at 7:16 p.m.

Last Modified: Saturday, June 2, 2012 at 7:16 p.m.

The recent recalls of sterile products made by Franck's Pharmacy in Ocala, as well as its position as a high-volume drug maker, are aspects of the compounding pharmacy business that has troubled federal regulators for years.

The Federal Drug Administration, which is tasked with ensuring the safety of drugs in the nation, has limited oversight over compounding pharmacies like Franck's because of a 74-year-old law that allows pharmacists to “compound,” or create unique variations of existing drugs for patients.

But that law, and the FDA's lack of authority over the practice of compounding, may draw new scrutiny in the wake of a well-publicized mistake at Franck's that killed two dozen prized polo ponies in 2009 and the production of contaminated solutions that reportedly damaged the vision of 33 eye surgery patients in recent months.

Compounding pharmacies make medications and other medical preparations from scratch. They cannot make straight copies of commercially available medications and can only make medications when they are ordered by a doctor.

These pharmacies fine tune drugs to a patient's need, whether that means creating a specific dosage not offered by a manufacturer or a liquid form of a drug only available in pill form.

Historically, compounding was the way most people got their prescription medicines. As recently as the 1960s pharmacists routinely ground and mixed compounds in their stores to make the medicines prescribed by local doctors.

The age of mass-produced drugs is a phenomenon of the last fifty years. The availability of those mass-produced drugs eventually led most pharmacies only to dispense ready-made medicines.

To read the rest of the story, click here.

FDA Announces Final Strategic Plan for the Foods and Veterinary Medicine Program

April 23, 2012
The U.S. Food and Drug Administration (FDA) announces the release of the final Strategic Plan for the Foods and Veterinary Medicine Program (FVM) for 2012-2016. The plan addresses the responsibilities of the Center for Food Safety and Applied Nutrition and the Center for Veterinary Medicine while including activities supported by the Office of Regulatory Affairs. The plan illustrates the breadth and complexity of the program’s work and identifies priority initiatives. It outlines seven strategic program goals, each encompassing its own key objectives, as well as nearly 100 specific initiatives aimed at achieving goals and objectives.
The draft Strategic Plan was published on September 30, 2011, with a thirty-day comment period. The FDA carefully reviewed and considered all submitted comments before issuing this final Strategic Plan.

Click here to view the final plan.

The Compounding and Pharmacy Practices Branch of the United States Food and Drug Administration (FDA)

At the FDA, the Office of Unapproved Drugs and Labeling Compliance, Division of Prescription Drugs, Compounding and Pharmacy Practices Branch is responsible for compliance and enforcement issues relating to compounding.  More specifically, according to the FDA website, the Compounding and Pharmacy Practices Branch responsibilities include: 

• Working cooperatively with states to oversee compounded drug products and protect consumers from harmful compounded drugs
• Directing field inspections and investigations and recommending, directing and/or coordinating case development and compliance actions relating to compounded drug products and other related pharmacy practices.
• Providing enforcement and litigation support and guidance for compounded drug products and other related pharmacy practices
• Reviewing and developing legislative proposals and implementing regulations, policy and guidance documents, enforcement strategies, and outreach activities related to pharmacy compounding and other pharmacy-related issues.
• Using risk based assessments to identify and prioritize compounded drugs for regulatory action and developing compliance strategies to address violations.

FDA Division of Compliance: Inspecting Businesses that May be Manufacturing Under Guise of Compounding

The Division of Compliance of the United States Food and Drug Administration (FDA) has issued assignments to conduct inspections of firms, including internet pharmacies, who may be engaged in the practice of manufacturing under the guise of pharmacy compounding.  The FDA web site contains the following statement regarding Veterinary Drug Compounding.

Inspections, Compliance, and Criminal Investigations

.9.2 - VETERINARY DRUG ACTIVITIES

CVM is responsible for inspections of therapeutic and production drugs, and Active Pharmaceutical Ingredients (APIs). Therapeutic drugs are used in the diagnosis, cure, mitigation, treatment or prevention of disease. Production drugs are used for economic enhancement of animal productivity. Examples include: growth promotion, feed efficiency and increased milk production.
Preapproval inspections are conducted pursuant to pending NADA or ANADA applications.

Post approval inspections of veterinary drugs are conducted to determine compliance with the Current Good Manufacturing Practices (CGMPs) for Finished Pharmaceuticals under 21 CFR Part 211³. These cGMPs apply to both human and veterinary drugs. Information on veterinary drugs approved can be found in the "Green Book" database accessed through CVM's website.

APIs are active pharmaceutical ingredients. Many of the APIs used to manufacture dosage form drugs are imported from foreign countries. The intended source for an API must be indicated in NADA/ANADA submissions for new animal drug approvals. Any change in a source for an API would require a supplement to the application.

Extra label drug use refers to the regulations in 21 CFR Part 530⁴ codified as a result of the Animal Medicinal Drug Use Clarification Act⁵ (AMDUCA) of 1994. These regulations set forth the requirements that veterinarians must meet to prescribe extra label uses of FDA approved animal and human drugs. The regulations describe what is a valid veterinary-client-patient relationship as well as what is considered illegal extra label use. 21 CFR Part 530 addresses issues regarding extra label use in non-food as well as food producing animals. 21 CFR 530.41⁶ contains a list of drugs that cannot be used in an extra label manner in food-producing animals. During an inspection or investigation if you encounter any situations on suspected illegal extra label use of any FDA approved animal or human drugs or those prohibited for extra label use in food animals, you should contact CVM's Division of Compliance (HFV-230) (240-276-9200).

21 CFR Part 530 also addresses compounding of products from approved animal or human drugs by a pharmacist or veterinarian. The regulations clearly state compounding is not permitted from bulk drugs. This would include APIs. CVM has an existing CPG on Compounding of Drugs for Use in Animals (CPG 608.400⁷). A copy can be found on CVM's website. The Division of Compliance (HFV-230) has issued assignments to conduct inspections of firms, including internet pharmacies, who may be engaged in the practice of manufacturing under the guise of pharmacy compounding. You should contact the Division of Compliance (HFV-230) at 240-276-9200 to report instances of compounding or to seek guidance on inspectional issues, or regulatory and enforcement policies.