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FDA Issues a New Draft Guidance Document of Importance to the Prescription Drug Industry

On March 23, 2010, the Affordable Care Act was signed into law. Section 6004 of the Affordable Care Act includes a requirement for drug companies to submit certain drug sample information to FDA no later than April 1 of every year, beginning on April 1, 2012.

The Affordable Care Act Section 6004 states that:

Manufacturers and authorized distributors must submit the following information concerning drug sample redistribution to FDA: (1) the identity and quantity of drug samples requested; (2) the identity and quantity of drug samples distributed; (3) the name, address, professional designation, and signature of any person who makes or signs for the request, and (4) any other category of information determined appropriate by [the FDA].

The Food and Drug Administration (FDA) plans to publish a Draft Guidance Document on April 3, 2012 concerning section 6004. FDA’s Guidance provides information regarding the FDA’s implementation of the drug sample transparency reporting provisions of section 6004 of the Patient Protection and Affordable Care Act.

FDA’s Guidance will announce that:

FDA does not intend to object until at least October 1, 2012, if manufacturers and authorized distributors of record (ADRs) do not submit information under those reporting provisions and that the Agency intends to provide notice before revising its exercise of discretion with respect to compliance.

Though FDA will post this Guidance, FDA does provide instructions for those who prudently want to comply by the Affordable Care Act’s deadline. Registrar Corp’s team of experts keeps up-to-date with changes to FDA regulations and can help you comply.

For more information about the Affordable Care Act or any FDA regulation, please contact Registrar Corp 24/7 at http://www.registrarcorp.com/livehelp or call us at +1-757-224-0177.





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