miércoles, 24 de septiembre de 2014

CDER SBIA Update: Beware of Rogue Wholesale Drug Distributors

FDA/CDER's Small Business and Industry Assistance (CDER SBIA)

Beware of Rogue Wholesale Drug Distributors

There is a growing network of rogue wholesale drug distributors selling potentially unsafe drugs in the U.S. market.
This morning, FDA launched “Know Your Source,” an educational program advising health care professionals and practice administrators to only purchase prescription drugs from wholesale drug distributors licensed in your state to protect your patients from unsafe and ineffective drugs. 
Drugs from rogue wholesale drug distributors may be harmful and expose your patients to unknown risks or side effects. To protect patients, FDA offers tips, including:
  • Beware of offers too good to be true: Aggressive marketing tactics and deep discounts on prescription drugs may indicate that the products are stolen, counterfeit, substandard, or unapproved.
  • Ensure you receive FDA-approved prescription drugs: Drugs that are not FDA-approved may have unknown or harmful ingredients, or may not have been manufactured, transported, or stored under proper conditions.
  • Buy from only wholesale drug distributors licensed in your state: While licensure alone is not a guarantee, looking for valid licensure in your state will help prevent unsafe and ineffective drugs from reaching your patients.
For more information, please visit FDA’s Know Your Source home page. We welcome further distribution to your members and thank you for your ongoing support of FDA and its mission.

The Small Business and Industry Assistance program in the Center for Drug Evaluation and Research (CDER SBIA) provides guidance and information to regulated domestic and international small pharmaceutical business and industry through its website, email notifications, and workshops. This notification system provides current information from CDER/FDA via e-mail on a biweekly basis that is relevant to small pharmaceutical business, which includes Federal Register notices, guidances, workshop announcements, etc. This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, please contact us Monday through Friday 8:00AM - 4:30PM.
Please take our CDER Small Business survey: https://www.surveymonkey.com/s/CDERSBIA_Evaluation

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