The Center For Drug Evaluation And Research (CDER) is responsible for warning letters used for pharmacy compounding issues.  See the July 2012 Regulatory Procedures manual found here.  The manual provides the following information guidance:

The Compliance Management System (CMS) is now being used for electronic submission of Warning Letter recommendations from district offices. All recommendations by the district offices must use CMS for submitting the proposed Warning Letter, the FDA 483 supporting alleged violations, the EIR, and any written response by the firm. For any questions, or if you need to submit a document as a hardcopy, the CDER contact is: Director, Division of Domestic Drug Quality, 301-796-3255, fax 301-847-8743. Also, see Exhibit 4-1, the agency’s “Procedures for Clearing FDA Warning Letters and Untitled Letters.” All agency components responsible for issuing Warning Letters and Untitled Letters must follow these procedures.

FDA Division of New Drugs and Labeling Compliance

The FDA Regulatory Procedures Manual Dated July 12 (found here) defines the responsibilities of the Division of New Drugs and Labeling Compliance.  Note that number 7 and 8 appear to be identical.

1-4-2 Division of New Drugs and Labeling Compliance
The division’s primary responsibility is to protect the public health by ensuring compliance with the new drug and misbranding requirements of the Federal Food, Drug and Cosmetic Act as it relates to over-the-counter (OTC) drugs, prescription (Rx) drugs, and drugs falling within the health fraud program area.
The division consists of five teams, the Over-The-Counter Drugs Team, the Internet and Health Fraud Team, the Pharmacy Compounding Team, the New Drugs and Labeling Team, and the Import-Export Team. The functional statements for the Division of New Drugs and Labeling Compliance are:
1. Protects the public health by assuring compliance with the new drug and misbranding requirements of the Federal Food, Drug, and Cosmetic Act as it relates to over-the-counter (OTC) drugs, prescription (Rx) drugs, and drugs falling within the health fraud program area;
2. Develops compliance strategies, programs and policy guides to ensure that all OTC and Rx drugs marketed in the United States are properly labeled and meet applicable new drug requirements and to remove from the market fraudulent drug products that pose direct or indirect public health risks;
3. Maintains the integrity of imported drug products by assuring their compliance with applicable legal requirements;
4. Provides guidance and consults on export policies and procedures;
5. Directs field inspections and investigations and recommends, directs and/or coordinates case development and compliance actions regarding OTC, Rx, and health fraud drug products;
6. Provides enforcement and litigation support and guidance for OTC, Rx, and health fraud drugs, including support for State Attorney General and Office of Criminal Investigation cases;
7. Develops legislative proposals, implementing regulations, policy, and guidance documents; enforcement strategies; and outreach activities relating to pharmacy compounding;
8. Develops legislative proposals, implementing regulations, policy and guidance documents, enforcement strategies, and outreach activities relating to pharmacy compounding;
9. Monitors the Internet in support of division enforcement initiatives, actions and outreach programs; and,
10. Prioritizes unapproved drugs identified for regulatory action using risk based assessment and develops compliance strategies to address the most significant legal violations.

Medical Products Promoted Through Social Media: FDA to Issue Guidance

This article is found here.

A customer loads Pfizer's Facebook page and leaves a comment on a wall post asking about an off-label use of one the company's products. How should the pharmaceutical company respond, if at all? That issue is one of the many topics to be addressed in guidance the Food and Drug Administration is required to issue within two years. Section 1121 of the Food and Drug Administration Safety and Innovation Act (S. 3187), signed into law by President Obama on July 9, tasks the agency with issuing guidance on its policy "regarding the promotion, using the Internet (including social media), of medical products that are regulated by such Administration."  The forthcoming guidance is essential for the current generation. The developing social media and internet media are different from broadcast and print. They reach a global audience, can exist indefinitely,and are an active dialogue between people.The most contentious issue will be how companies should respond to off-label questions posed on social media platforms. Almost everyone objected to the FDA's stance in a December 2011 draft guidance that companies respond privately to any question on social media that addressed off-label uses.

The FDA had noted that it may be true "that the original, unsolicited off-label question may have been available to a very broad audience." Nonetheless, "the firm should not make its detailed response with off-label information publicly available within the same forum." The issue is important because federal law only permits companies from promoting a drug or medical device for uses that have received FDA clearance. The FDA also has not been hesitant to issue warning letters to companies it believes have engaged in improper off-label communications through social media.

Draft guidance.

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.

GSK to close Indian API plant and turn to third-party contractors

GSK to close Indian API plant and turn to third-party contractors