Ask your Representatives to Sign Rep. Stewart / Carter Letter to FDA regarding office-use

Ask your Representatives to Sign Rep. Stewart / Carter Letter to FDA regarding office-use

On December 29, 2016, the Food & Drug Administration (FDA) issued a final Guidance for Industry (GFI) which continues to completely prohibit office-use compounding under state pharmacy laws. This guidance is a misinterpretation of the 2013 Drug Quality and Security Act (DQSA) regarding office-use compounding. Additionally, the FDA has unfortunately chosen to ignore broad and diverse stakeholder input, multiple congressional letters from both chambers, and clear directives in the House Report accompanying the FY2016 FDA appropriations legislation. This Guidance is VERY detrimental for patients and doctors to access compounded medications.

Luckily, Congressmen Chris Stewart and Buddy Carter are leading an effort to gather Representative signatures on a letter to FDA regarding office-use compounding. The letter requests that the FDA immediately rescind this GFI and issue a proposed rule, with notice and stakeholder input as required by the Administrative Procedure Act, that is consistent with the DQSA and that allows for office-use compounding by state-licensed pharmacies where it is authorized by state pharmacy laws.

We, McGuff Compounding Pharmacy Services, ask for your help to take action with us by clicking the link below to request the assistance of your congressman and senators to sign onto the letter to the FDA. This letter is being submitted to the FDA on April 28th, 2017 so time is of the essence.

If you have any questions at all, please do not hesitate to ask! You may email us at pharmacyanswers@mcguff.com or call us at 877-444-1133.

Reference Material:

Letter your Congressman will sign onto for the FDA

Food & Drug Administration final Guidance for Industry – Compounded Medications

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