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CPG Sec. 160.300 Requests for Records Under Section 703 August 1989

Issued by:
Guidance Issuing Office
Office of Regulatory Affairs


*Questions have existed among the field districts regarding the existence and extent of their authority to deal with demands for written requests under Section 703. A memorandum on 3/27/67 from the then Bureau of Regulatory Compliance to District Directors delegated to the districts full authority to issue letters upon demand under Section 703. This authority is still in effect.

Evidence obtained in response to a specific written request under Section 703 cannot be used in a criminal prosecution of the person from whom obtained. Your attention is invited to the definition of the term "person" contained in Section 201(e). This means that a contemplated defendant from whom evidence is so obtained will not be prosecuted with respect to any particular count in which evidence so obtained is directly or indirectly involved. This does not, however, mean that evidence obtained under this section cannot be used to support seizure action or a complaint for injunction.*


A *Section* 703 letter may be issued by the field or district office anytime a decision is made that the importance of the evidence to be obtained outweighs the disability of precluding prosecution of the person from whom the evidence is being obtained, on the particular facts about which the evidence is being sought. This assumes that the necessary evidence cannot be legally obtained from other sources.

*Material between asterisks is new or revised*

Issued: 12/3/73
Revised: 10/1/80, 8/31/89

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:

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

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

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