(a) You must prepare a batch production record every time you manufacture a batch of a dietary supplement;

(b) Your batch production record must include complete information relating to the production and control of each batch;

(c) Your batch production record must accurately follow the appropriate master manufacturing record and you must perform each step in the production of the batch; and

(d) You must make and keep batch production records in accordance with subpart P of this part.


Tried the LawStack mobile app?

Join thousands and try LawStack mobile for FREE today.

  • Carry the law offline, wherever you go.
  • Download CFR, USC, rules, and state law to your mobile device.