Showing posts with label Compliance. Show all posts
Showing posts with label Compliance. Show all posts

Saturday, August 25, 2012

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.

Tuesday, April 17, 2012

FDA Foods and Veterinary Medicine Program Strategic Plan for 2012 – 2016 Draft Targets Illegal Compounding

A draft of the FDA Foods and Veterinary Medicine Program Strategic Plan for 2012 – 2016 indicates that a new enforcement strategy to address illegal compounding of new animal drugs may be a top priority of the FDA in the future.  Cases such as Franck's and ApothCure (although not a case involving animal drugs) suggest that illegal compounding of drugs has already become a key initiative of the FDA.  The draft reads:

The FVM Program is concerned about the number of unapproved animal drug products
that are being sold and marketed to animal owners and veterinarians. To reduce the risk of
harm from substandard and illegally marketed animal drugs, the program will identify new
regulatory frameworks and enforcement strategies to combat this growing area of
concern.
Key Initiatives
7.2.1: Develop risk‐based frameworks that assure quality and safety for products
that are currently being marketed without FDA approval
7.2.2:  Develop and implement an enforcement strategy that addresses the illegal
compounding of new animal drugs and removes unsafe, ineffective or copycat
animal drugs from the market

To read the entire FDA Foods and Veterinary Medicine Program Strategic Plan for 2012-2016 click  here.

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.