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GUIDANCE DOCUMENT

Compliance with 21 CFR Part 1271.150(c)(1) – Manufacturing Arrangements Guidance for Industry September 2006

Final

Compliance with 21 CFR Part 1271.150(c)(1) – Manufacturing Arrangements

Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

We, FDA, are issuing this guidance to emphasize to you, establishments that manufacture human cells, tissues, and cellular and tissue-based products (HCT/Ps), your responsibility to comply with Title 21 Code of Federal Regulations 1271.150(c)(1) (21 CFR 1271.150(c)(1)), if you enter into a contract, agreement, or other arrangement with another establishment to perform for you any step in manufacture. (Ref. 1). If you engage another establishment to perform for you any step in manufacture, that establishment must comply with requirements applicable to that manufacturing step (21 CFR 1271.150(c)(1)(i) and (ii)). The intent of this guidance is to highlight your responsibilities in ensuring that establishments that engage in any step in manufacture for you are in compliance with the current good tissue practice (CGTP) requirements of the HCT/P regulations in 21 CFR Part 1271.


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

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

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.

Questions?

Contact Point
Office of Communication, Outreach and Development (OCOD)
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3128
Silver Spring, MD 20993-0002
ocod@fda.hhs.gov
(800) 835-4709
(240) 402-8010