§ 211.34 Consultants.

Law · 21 CFR 211.34 · eCFR as of 25 Sep 2026 · checked 30 Sep 2026 · Official source: ecfr.gov

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.

Cited in FDA warning letters

Also referred to, outside the numbered violations, in: Columbia Cosmetics Manufacturing Inc., CDL Services, Inc. dba Technichem, Purolea Cosmetics Lab, Active Cosmetics Manufacturing Inc., Woodbine Products Company Inc..