Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Tuesday, September 24, 2013

Now Let's See How Florida (Home to Famous Franck's Pharmacy Fiasco) Compared to How the FDA found Florida's Compounding Pharmacies Where Doing


Anazaohealth Corporation, Tampa, FL
  •  483 Issued 2/22/2013 (PDF - 857KB)
  • Axium Healthcare Pharmacy (dba Balanced Solutions Compounding), Lake Mary, FL
    Balanced Solutions Compounding Pharmacy, LLC., Lake Mary, FL
    • Firm News Release: Balanced Solutions Compounding Pharmacy, LLC. Announces a Voluntary Nationwide Recall of All Sterile Compounded Products Due to a Lack of Sterility Assurance (04/17/2013)

  • The Compounding Shop St. Petersburg, FL
    • 483 Issued 9/3/2013 (PDF - 97KB)
    • Firm Press Release: In Cooperation with FDA, The Compounding Shop, LLC Declares a Voluntary Recall of All Lots of Sterile Compounded Products Due to a Lack of Sterility Assurance Distributed Within its Local Market Area (05/06/2013)
    • Amended 483 Issued 3/25/2013 (PDF - 10MB)
    • 483 Issued 3/22/2013 (PDF - 1.3MB)
    • FDA Press Release: FDA alerts health care providers of lack of sterility assurance of drug products from The Compounding Shop (03/08/2013)
    • Lowlite Investments, Inc. (dba Olympia Pharmacy), Orlando, FL
      • 483 Issued 3/21/2013 (PDF - 717KB)
      • Olympia Pharmacy, Orlando, FL
        • Firm Press Release: Lowlite Investments, Inc. d/b/a Olympia Pharmacy Announces a Voluntary Multi-State Recall of All Sterile Compounded Products Compounded Between December 17, 2012, and March 27, 2013, Due to Concerns About Sterility Assurance (05/29/2013) 
        • Wells Pharmacy Network LLC, Ocala, FL

Wednesday, May 22, 2013

Ranbaxy, FDA, FDASIA and Indian Pharma Credibility

May 20th, 2013 | Author: Dirk Rodgers
Americans benefit from the safest drugs and the safest drug supply chain in the world.  That’s a good thing, because we also consume more drugs for more conditions than anyone else in the world.  And that is precisely why everyone in the United States should readFortune Online’s new article covering the backstory that lead to the shocking May 13, 2013guilty plea by Ranbaxy USA, the US subsidiary of the India-based generic drug maker, to seven U.S. federal criminal counts of selling substandard and adulterated drugs with intent to defraud.  Once you start reading the article, you won’t be able to stop, thanks to the skillful writing of Katherine Eban, author of “Dangerous Doses”.
The company admitted to falsifying drug test data for years and for hundreds of products sold worldwide.  I was stunned by how callous company employees—from the lowest levels to the CEOs themselves—could be over the quality of their drug products.  They seemed to believe that regulations requiring testing for drug quality were unnecessary and excessive and deserved to be ignored and the required test results faked.
“Executives approached the regulatory system as an obstacle to be gamed. They bragged about who had most artfully deceived regulators”, Eban writes.
This went on for years.  You really need to read the article to understand just how outrageously the company performed.
Fortunately not all of the Ranbaxy employees felt that way.  Eban documents how a small number of isolated employees heroically did the right thing and reported the abuses.  But it took nearly a decade for the U.S. FDA and the U.S. Justice Department to extract the guilty plea last week.  Citizens all over the world owe a huge debt to these brave individuals.  In this case, hero whistleblower Dinesh Thakur, a former Ranbaxy executive, will receive approximately $48.6 million from the U.S. federal share of the settlement amount, but clearly, he didn’t do it for the reward money.
IS THE PROBLEM ENDEMIC IN INDIA?
I don’t know if the problem is endemic in India, but just the fact that the question can be legitimately raised after such an admission by a major Indian company is unfortunate, but no longer surprising.  The allegations of serious problems at Ranbaxy have certainly been known to regulatory agencies in the United States and India for many years.  Because the rules governing the U.S. FDA were historically designed under the assumption that all drugs sold in the U.S. were made in the U.S., the government appears to have had unfortunate difficulty investigating and acting against Ranbaxy during this time.
International crimes like those believed to have been committed in the Heparin incident in 2008and the Ranbaxy case are what led to last year’s FDA Safety and Innovation Act (FDASIA).  That law, passed last July as part of the prescription drug fee act (PDUFA), goes a long way toward converting the FDA into a regulatory agency that finally has worldwide reach for drugs that are intended for sale here.  As I read the Fortune article I kept thinking about how the FDA would have been able to act more quickly and decisively had FDASIA been in effect.
Not familiar with FDASIA?  You should be.  It is one of the most important changes to the Food, Drug and Cosmetics Act in decades.  See “The Supply Chain Provisions Of The FDA Safety & Innovation Act”.
“FALSE ACCUSATIONS”
A recent event that came to my mind as I read Eban’s article was last November’s Global Forum on Pharmaceutical AntiCounterfeiting in Washington DC, held by Reconnaissance International.  DK Singh, Director General of Foreign Trade, Ministry of Commerce and Industry with the Indian government made some comments that stuck in my mind as just a little out of place for an event like that.  Director Singh expressed India’s commitment to safeguarding medicines.  As proof, he cited the 2011 government mandate for serialization and track & trace of all drugs exported from India.
That mandate to serialize all drugs exported from India had always struck me as more of a marketing ploy than a serious attempt to impede illegitimate drugs from entering international markets from Indian soil.  If it were a recognized problem, why wouldn’t drugs sold into the Indian domestic market by these same companies be targeted first, or even at the same time?
Mr. Singh gave us the reason.  He said that the serialization requirement was to bolster the “credibility of Indian pharma products” around the world.  He said that, in the future, serialization-based track & trace requirements would help to resolve the “false accusations” that India is a source of global substandard and falsified drugs.  He said that he wanted to attract more pharma companies to India by showing that the Indian government is “industry friendly”.
Thanks to the U.S. FDA, the U.S. Justice Department and Eban, we now know that even a large, legitimate global pharmaceutical manufacturer was knowingly and routinely shipping large quantities of substandard medicines all over the world—including substandard antimalarials to Africa (shocking quote from a Ranbaxy executive as reported by Eban:  “Who cares?  It’s just blacks dying.“).  If those drugs had serial numbers attached to them, should that make them more credible?  NO.  Especially not if you can’t even trust the manufacturer.
So I ask, does the example of Ranbaxy reveal a widespread problem in India?  We’ll see how credible the government of India is on the issue of substandard and adulterated medicines by how they react to the Ranbaxy guilty plea.  Will they react with outrage at Ranbaxy… or at the U.S. FDA?
If they care more about the safety of their own citizens, let alone people in the United States, Africa and elsewhere, than they do about resolving pre-judged “false” accusations, they will clean their own house and adopt strict monitoring, international cooperation and meaningful penalties for infractions of global companies who reside there.
The government, industry and yes, the people of India must reject this and all forms ofcorruption and reform their approach and attitudes toward product safety and quality in general, both internationally and domestically.  They must always place true “patient safety”—and not just lip service—above “industry friendly”.  Only then will the Indian pharmaceutical industry earn the type of credibility they seek in the global marketplace after this sad episode.
Finally, thank you Mr. Thakur, wherever you are.  You are an inspiration and an example for us all.
So, dear reader, what is your reaction to “Dirty Medicine”?  Leave a comment below.
Dirk.
quoted from RXtrace found here

Friday, February 15, 2013

FDA's Position on Extra-Label Use of FDA Approved Drugs in Aniimals


Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA)

The Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA) allows veterinarians to prescribe extralabel uses of certain approved animal drugs and approved human drugs for animals under certain conditions. Extralabel use refers to the use of an approved drug in a manner that is not in accordance with the approved label directions. The key constraints of AMDUCA are that any extralabel use must be by or on the order of a veterinarian within the context of a veterinarian-client-patient relationship, must not result in violative residues in food-producing animals, and the use must be in conformance with the implementing regulations published at 21 CFR Part 530. A list of drugs specifically prohibited from extra-label use appears in the Code of Federal Regulations.
Extra-Label Use of FDA Approved Drugs in Animals
"Extra-label use" is defined as:
"Actual use or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling. This includes, but is not limited to, use in species not listed in the labeling, use for indications (disease and other conditions) not listed in the labeling, use at dosage levels, frequencies, or routes of administration other than those stated in the labeling, and deviation from labeled withdrawal time based on these different uses."
Under the provisions of the Animal Medicinal Drug Use Clarification Act of 1994, the FDA recognizes the professional judgment of veterinarians, and allows the extra-label use of drugs by veterinarians under certain conditions (21 CFR 530). Any drug used in an extra-label manner is by definition a prescription drug since the involvement of a veterinarian is required. Extra-label use of drugs may only take place within the scope of a valid veterinarian-client-patient relationship (VCPR) [4]. In the absence of a valid VCPR, if an approved new animal drug is used for a use for which it is not labeled, such use has caused the drug to be deemed unsafe and therefore adulterated under the Act (21 U.S.C. 351(a)(5)).
An approved new animal drug or human drug intended to be used for an extra-label purpose in an animal is not unsafe under the Act (21 U.S.C. 360b) and is exempt from the labeling requirements the Act (21 U.S.C. 502(f)), if such use is by or on the lawful written or oral order of a licensed veterinarian within the context of a valid veterinarian-client-patient relationship and such use complies with the extra-label use regulation (21 CFR Part 530). Extra-label use is limited to circumstances when the health of an animal is threatened, or suffering or death may result from failure to treat. This means that extra-label use to enhance production is prohibited. Extra-label use of drugs may be considered by food animal veterinarians only when:
  1. There is no approved new animal drug that is labeled for such use and that contains the same active ingredient in the required dosage form and concentration, except where a veterinarian finds, within the context of a valid veterinarian client patient relationship, that the approved new animal drug is clinically ineffective for its intended use.
  2. Before prescribing or dispensing an approved new animal or human drug for an extra-label use in food animals, the veterinarian must:
  • Make a careful diagnosis and evaluation of the conditions for which the drug is to be used;
  • Establish a substantially extended withdrawal period prior to marketing of milk, meat, eggs, or other edible products supported by appropriate scientific information, if applicable;
  • Institute procedures to assure that the identity of the treated animal or animals is carefully maintained; and
  • Take appropriate measures to assure that assigned time frames for withdrawal are met and no illegal drug residues occur in any food producing animal subjected to extra-label treatment.
The following additional conditions must be met for a permitted extra-label use, in food producing animals, of an approved human drug, or of an animal drug approved only for use in animals not intended for human consumption:
  • Such use must be accomplished in accordance with an appropriate medical rationale; and
  • If scientific information on the human food safety aspect of the use of the drug in food producing animals is not available, the veterinarian must take appropriate measures to assure that the animal and its food products will not enter the human food supply.
    Extra-label use of an approved human drug in a food producing animal is not permitted if an animal drug approved for use in food producing animals can be used in an extra-label manner for the particular use.
The prescribed or dispensed extra-label drug (prescription legend or over-the-counter) must bear labeling information which is adequate to assure the safe and proper use of the product.
Labeling of drugs prescribed for extra-label use
At a minimum, the following label information is recommended:
  1. The name and address of the prescribing veterinarian.
  2. The established name of the drug (active ingredient), or if formulated from more than one ingredient, the established name of each ingredient.
  3. Any directions for use specified by the practitioner (including class/species or identification of the animals; dosage, frequency, and route of administration; and, duration of therapy).
  4. Any cautionary statements specified by the veterinarian.
  5. The veterinarian's specified withdrawal/discard time(s) for meat, milk, eggs, or any food which might be derived from the treated animals.
Because extra-label use of animal and human drugs in nonfood-producing animals (companion, sporting, exotic, etc) does not ordinarily pose a threat to the public health, extra-label use of animal and human drugs is permitted in nonfood-producing animals except where the public health is threatened.
Extra-label use of drugs in treating animals is allowable only by licensed veterinarians within the context of a valid veterinarian-client-patient relationship, and does not include drug use in treating animals by the layman (except under the supervision of a licensed veterinarian).
Lay persons cannot be expected to have sufficient knowledge and understanding concerning animal diseases, pharmacology, toxicology, drug interactions, and other scientific parameters to use drugs in any way other than as labeled.
Limitations to Extra-Label Use Provisions of AMDUCA
In addition to uses which do not comply with the provision set forth in Sec. 530.10, the following specific extra-label uses are not permitted and result in the drug being deemed unsafe within the meaning of section 512 of the Act:
  1. Extra-label use in an animal of an approved new animal drug or human drug by a lay person (except when under the supervision of a licensed veterinarian);
  2. Extra-label use of an approved new animal drug or human drug in or on an animal feed;
  3. Extra-label use resulting in any residue which may present a risk to the public health; and
  4. Extra-label use resulting in any residue above an established safe level, safe concentration, or tolerance.
Prohibitions Under AMDUCA
FDA may prohibit the extra-label use of an approved new animal or human drug or class of drugs in animals if FDA determines that:
  1. An acceptable analytical method needs to be established and such method has not been established or cannot be established; or
  2. The extra-label use of the drug or class of drugs presents a risk to the public health.
A prohibition may be a general ban on the extra-label use of the drug or class of drugs or may be limited to a specific species, indication, dosage form, route of administration, or combination of factors.
Compounding Under AMDUCA
The extra-label drug use regulation also provides for the legal compounding of animal drugs from approved animal drugs and approved human drugs. The compounding must be in compliance with the provisions of the regulation as presented above. The regulation provides additional requirements for extra-label compounding (21 CFR 530.13).
The extra-label drug use regulation does not allow for legal animal drug compounding from active pharmaceutical ingredients (bulk drugs).

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FDA's Statement on Compounding of Animal Drugs last updated 1/18/2012


Compounding of Animal Drugs

In general, compounding an animal drug from an active pharmaceutical ingredient (bulk drug) is not permitted by the Act unless covered by an approved new animal drug application. This is true even if the compounder is a veterinarian or a pharmacist. However, CVM acknowledges the medical need for compounding may exist within certain areas of veterinary practice. The contemporary practice of veterinary medicine requires products to treat hundreds of conditions and diseases in dozens of species. Consequently, veterinarians continue to require products to treat diseases or conditions in animals for which no FDA-approved product is available. Generally, FDA will defer to state authorities regarding the day-to-day regulation of compounding by veterinarians and pharmacists of animal drugs. In limited circumstances, the agency may not object to compounding from specific bulk drugs under specific conditions. However, FDA will consider enforcement action when the activities of veterinarians and pharmacists are clearly outside the bounds of traditional pharmacy practice and are instead more akin to those of a drug manufacturer. Additional information on the FDA policy regarding animal drug compounding can be found in Compliance Policy Guide, Section 608.400, “Compounding of Drugs for Use in Animals5."
Animal drugs may be legally compounded from FDA-approved animal drugs and FDA-approved human drugs if the compounding practices are in conformance with the provisions of the regulation on the Extra-label Use of FDA-approved drugs6.

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Sunday, February 10, 2013

Reorganization of Foods and Veterinary Medicine Program At FDA

FDA ANNOUNCES REORGANIZATION FOR THE FOODS AND VETERINARY MEDICINE PROGRAM (VIA FDA)

The U.S. Food and Drug Administration announced in the Federal Register a reorganization for the Foods and Veterinary Medicine (FVM) program that was implemented on October 1, 2012. Under the reorganization, the Office of Foods is now the Office of Foods and Veterinary Medicine, led by Michael Taylor, the Deputy Commissioner for Foods and Veterinary Medicine.
Under the reorganization, the Center for Food Safety and Applied Nutrition (CFSAN), led by Michael Landa, and the Center for Veterinary Medicine (CVM), led by Bernadette Dunham, continue to report to Deputy Commissioner Taylor and remain the major operating units with responsibility for leading operations and regulatory policy development in their respective areas.
To read more visit the FDA website.
 
Source found here


Monday, October 1, 2012

New FDA hand-held scanner sheds light on counterfeits Agency might sell its patented device to other regulators September 27, 2012 | By Eric Palmer Read more: New FDA hand-held scanner sheds light on counterfeits - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/new-fda-hand-held-scanner-sheds-light-counterfeits/2012-09-27?utm_source=rss&utm_medium=rss#ixzz284qKoVCa Subscribe: http://www.fiercepharmamanufacturing.com/signup?sourceform=Viral-Tynt-FiercePharma Manufacturing-FiercePharma Manufacturing


Agency might sell its patented device to other regulators


Read more: New FDA hand-held scanner sheds light on counterfeits - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/new-fda-hand-held-scanner-sheds-light-counterfeits/2012-09-27?utm_source=rss&utm_medium=rss#ixzz284qSCJAx
Subscribe: http://www.fiercepharmamanufacturing.com/signup?sourceform=Viral-Tynt-FiercePharma Manufacturing-FiercePharma Manufacturing

Another FDA lawsuit over Exclusivity


FDA Law blog is reporting  that there is another  Orphan Drug Battle in that Depomed has Sued the FDA Over GRALISE Orphan Drug Exclusivity.  The complaint and post can be read here.

Wednesday, September 26, 2012

FDA Urged to Speed Approval of Drugs


A White House advisory body on Tuesday unveiled a plan to double the number of new prescription drugs that go on the market each year by more quickly approving drugs to treat high-risk patients.
The President's Council of Advisors on Science and Technology urged the Food and Drug Administration to expand its use of faster drug approvals to a wider range of diseases. The council suggested the FDA could begin to approve drugs that may help only a narrow and high-risk patient population, such as people who are morbidly obese, under what the council called "special medical use" approvals.
The advisory report gave few details of what new laws or regulations might be required to limit a new drug's use to such populations. Historically, the FDA doesn't attempt to police how doctors use drugs, though companies' marketing is restricted to the conditions specified on the label.
To read the remainder of the article click here

Wednesday, September 19, 2012

FDA OUDLC Updated website


Office of Unapproved Drugs and Labeling Compliance (OUDLC)


OUDLC’s Mission


To promote and protect public health through science driven, comprehensive, strategies and actions that communicate potential risks about drug products and minimize exposure to unsafe, ineffective, or poor quality unapproved or misbranded drugs.

OUDLC’s Vision

Using scientific, risk based strategies, and comprehensive compliance, we are global leaders in the effort to eliminate exposure to unapproved or misbranded drugs.

Immediate Office


Office Director: Kathleen Anderson, Pharm.D. (acting)
Associate Director for Policy and Communication: Gail Bormel, J.D., R.Ph. (acting)
Associate Director for Program Management and Organizational Strategy: Akilah Green, RN, MS, RAC (acting)
Associate Director for Risk Science, Intelligence, and Prioritization: Meghan Murphy, Ph.D. (acting)
Senior Medical Advisor: Charles Lee, MD
Director, Division of Prescription Drugs: Judy McMeekin, Pharm.D. (acting)
Director, Division of Non-Prescription Drugs and Health Fraud: Elizabeth Miller, Pharm.D. (acting)

Divisions


Mailing Address

Food and Drug Administration
Center for Drug Evaluation and Research
Office of Compliance
Office of Unapproved Drugs and Labeling Compliance
10903 New Hampshire Ave.
Silver Spring, MD 20993
Ph: (301) 796-3110
Fax: (301) 847-8745
Email: OUDLCMail@fda.hhs.gov

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Thursday, September 13, 2012

FDA says muscle, joint pain creams can cause burns


Read more here: http://www.sacbee.com/2012/09/13/4817100/fda-says-muscle-joint-pain-creams.html#storylink=cpy

Wednesday, September 12, 2012

Successful Year So Far for FDA Prosecutions


From all the press releases since January 2012, it looks like the FDA and the United States Attorneys' Offices have had a very successful year prosecuting crimes under the FDA's jurisdiction.

Recent Press Releases


To view all FDA press releases click here.

Sunday, September 9, 2012

FDA's Position on Compounding of Animal Drugs

Although this has been posted on the blog before, it is always worth reposting for new readers:

 

Compounding of Animal Drugs

In general, compounding an animal drug from an active pharmaceutical ingredient (bulk drug) is not permitted by the Act unless covered by an approved new animal drug application. This is true even if the compounder is a veterinarian or a pharmacist. However, CVM acknowledges the medical need for compounding may exist within certain areas of veterinary practice. The contemporary practice of veterinary medicine requires products to treat hundreds of conditions and diseases in dozens of species. Consequently, veterinarians continue to require products to treat diseases or conditions in animals for which no FDA-approved product is available. Generally, FDA will defer to state authorities regarding the day-to-day regulation of compounding by veterinarians and pharmacists of animal drugs. In limited circumstances, the agency may not object to compounding from specific bulk drugs under specific conditions. However, FDA will consider enforcement action when the activities of veterinarians and pharmacists are clearly outside the bounds of traditional pharmacy practice and are instead more akin to those of a drug manufacturer. Additional information on the FDA policy regarding animal drug compounding can be found in Compliance Policy Guide, Section 608.400, “Compounding of Drugs for Use in Animals."
Animal drugs may be legally compounded from FDA-approved animal drugs and FDA-approved human drugs if the compounding practices are in conformance with the provisions of the regulation on the Extra-label Use of FDA-approved drugs.
 
Quoted from FDA website found here.

The FDA's Position on Dispensing Veterinary Prescription Drugs and Labeling and Script Requirements

Dispensing Veterinary Prescription Drugs

Since adequate directions for safe and effective lay use cannot be written for animal prescription drug products, such products can only be sold on the prescription or other order of a licensed veterinarian (Section 503(f)). Prior to being sold or dispensed, they must remain in the possession of a person or firm regularly and lawfully engaged in the manufacture, transportation, storage, or wholesale or retail distribution of animal prescription drug products. The drug products may be distributed only by persons or firms authorized by State and local laws.
Sale (dispensing, shipping, or otherwise making available for use in animals) of an animal prescription drug product to the layperson may be made only by or on the bona fide prescription or other order of a licensed veterinarian. Sale of a animal prescription drug product to a layperson, except on a prescription or on order of a licensed practitioner, causes the product to be misbranded and subjects the seller to civil and/or criminal provisions of the Act.
A licensed veterinarian may legally use or dispense an animal prescription drug product only within the course of his/her professional practice where a valid veterinarian-client-patient relationship exists. Veterinarians employed by drug manufacturers or distributors may not legally dispense prescription drug products to laypersons unless they meet the above criteria. Similarly, practicing veterinarians or their employees may not legally sell animal prescription drug products to walk-in customers unless the same criteria are met. Federal regulations require that drug manufacturers provide at least the following information on the label of the finished package form of animal prescription drug products:
What information needs to be on the package label of animal Rx drugs?
  • the statement, "Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian;"
  • recommended or usual dosage;
  • route of administration, if it is not for oral use;
  • quantity or proportion of each active ingredient as well as the information required by section 502(e) of the Act;
  • names of inactive ingredients if it is for other than oral use;
  • an identifying lot or control number from which it is possible to determine the complete manufacturing history of the drug.
What needs to be included in the veterinarian’s prescription and included on the label of the dispensed product?
  • name and address of the dispenser;
  • serial number and date of the order or its filling;
  •  name and address of the veterinarian who prescribed or ordered the drug product;
  • directions for use; and
  • any necessary warning and precautionary statements including withdrawal times.
Any additional requirements of State or local laws for dispensed animal drug products must also be followed.
To protect themselves and their clients, veterinarians should make efforts to ensure their instructions are followed, especially when they prescribe or recommend drugs for food-producing animals that require a withdrawal period.