Electronic Drug Registration and Listing Instructions

Drug establishment registration and drug listing information have, until now, been submitted using a paper-based format, i.e., Form FDA 2656 (Registration of Drug Establishment/Labeler Code Assignment), Form FDA 2657 (Drug Product Listing), and Form FDA 2658 (Registered Establishments’ Report of Private Label Distributors).

Beginning June 1, 2009, FDA no longer accepts paper submissions for drug establishment registration and listing unless a waiver is granted. Moving from a paper-based format to an electronic system will improve the timeliness and accuracy of the submissions.

To submit drug establishment registration and drug listing electronically:

* Go to: Electronic Submissions Gateway and obtain an gateway account.
* Go to: D & B website and request a DUNS number.
* Prepare the SPL. For more information you can go to the Structured Product Labeling Resources website.
* Send your SPL through the Gateway to the OC center.

Source: FDA

FDA warning letter or recall?

Some Facts

1. Of the 74 warning letters issued in 2007 32% contained citations with respect to improper or ineffective process validation.
2. Recalls resulting from improper or ineffective process validation has resulted in millions of dollars losses and significant drops in company share prices.
3. Ineffective process validation has resulted in the release of products that have caused severe harm or injury to end-users.
4. Process Validation problems have resulted in consent decrees and fines in the hundreds of millions of dollars.
5. Foreign manufacturers have been banned from importing their products into the United States when cited for process validation non-compliance.

FDA Recalls seem to be increasing which means that the FDA not only remains just as active, but may be taking stronger action now than ever before http://www.fda.gov/

References:

1. AAMI
2. www.complianceonline.com

Ranbaxy recalls drug from US market

Pharma major Ranbaxy Laboratories today said its US-based subsidiary, Ranbaxy Laboratories Inc Priceton NJ, was recalling capsules used in the treatment of acne (a type of skin disease) from the US market.

What it Recalled?

Ranbaxy Laboratories Inc Priceton NJ is conducting a voluntary recall of Sotret Isotretinoin capsules, USP 40 mg, which is limited to Lot No 1876849, currently available in the US market.

Source: Business Standard