Showing posts with label Office of Unapproved Drugs and Labeling Compliance. Show all posts
Showing posts with label Office of Unapproved Drugs and Labeling Compliance. Show all posts

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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Tuesday, June 26, 2012

What are unapproved drugs and why are they on the market?

From FDA website:

What are unapproved drugs and why are they on the market?

The original Federal Food and Drugs Act of 1906 brought drug regulation under federal law. That Act prohibited the sale of adulterated or misbranded drugs, but did not require that drugs be approved by FDA. In 1938, Congress required that new drugs be approved for safety.  In 1962, Congress amended the 1938 law to require manufacturers to show that their drug products were effective, as well as safe. As a result, all drugs approved between 1938 and 1962 had to be reviewed again for effectiveness.  To be consistent with current regulations and to ensure that all drugs have been shown to be safe and effective, all new drugs are required to have an approved application for continued marketing.
Many healthcare providers are unaware of the unapproved status of drugs and have continued to unknowingly prescribe them because the drugs’ labels do not disclose that they lack FDA approval.   In addition, since many unapproved drugs are marketed without brand names and have been available for many years, it is often assumed that these unapproved drugs are generic drugs.  This is not correct. Generic drugs have been evaluated and approved by FDA to demonstrate bioequivalence to a brand name reference drug.  Healthcare professionals and consumers can be assured that FDA-approved generic drug products have met the same quality, strength, purity and stability as brand name drugs. Additionally, the generic manufacturing, packaging, and testing sites must meet the same quality standards as those of brand name drugs. Unapproved drug products have not been evaluated and approved by FDA. Unapproved drugs are not generic medications, and neither their safety nor their efficacy can be assured.
Basics Question toggle Show all related FDA Basics Questions

The FDA website also contain the following:

All the above can be found here.

Monday, April 30, 2012

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.