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GUIDANCE DOCUMENT

Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products March 2011

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2009-D-0568
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

OMB Control No. 0910-0675
Expiration Date:  04/30/2023

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled “Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products.” The guidance encourages manufacturers of medically necessary drug products (MNPs) and components to develop production plans in the event of an emergency that results in high absenteeism at one or more production facilities. The purpose of the guidance is to provide to industry considerations for developing plans for these types of emergencies, as well as to discuss the Center for Drug Evaluation and Research's (CDER's) intended approach to assist in avoiding drug product shortages that may have a negative impact on the national public health during such emergencies.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2009-D-0568.

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