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21CFR211.34

§ 211.34 Consultants.

124 citations

Regulation Text

Consultants advising on the manufacture, processing, packing, or holding of drug products shall have sufficient education, training, and experience, or any combination thereof, to advise on the subject for which they are retained. Records shall be maintained stating the name, address, and qualifications of any consultants and the type of service they provide.

Authority

21 U.S.C. 321,351,352,355,360b,360ddd,360ddd-1,371,374;42 U.S.C. 216,262,263a,264.

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21CFR211.34 — § 211.34 Consultants. | CFR Explorer | BioRegHub