---
kind: "section"
citation: "21 C.F.R. § 111.95"
title: "21"
number: "111.95"
heading: "Under this subpart E, what records must you make and keep?"
url: "https://uscodex.org/cfr/21/111.95"
---

# §111.95. Under this subpart E, what records must you make and keep?

- (a) You must make and keep records required under this subpart E in accordance with subpart P of this part.
- (b) Under this subpart E, you must make and keep the following records:
  - (1) The specifications established;
  - (2) Documentation of your qualification of a supplier for the purpose of relying on the supplier's certificate of analysis;
  - (3) Documentation for why meeting in-process specifications, in combination with meeting component specifications, helps ensure that the dietary supplement meets the specifications for identity, purity, strength, and composition; and for limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement; and
  - (4) Documentation for why the results of appropriate tests or examinations for the product specifications selected under [§ 111.75(c)(1)](/cfr/21/111.75.md?p=c-1) ensure that the dietary supplement meets all product specifications;
  - (5) Documentation for why any component and in-process testing, examination, or monitoring, and any other information, will ensure that a product specification that is exempted under [§ 111.75(d)](/cfr/21/111.75.md?p=d) is met without verification through periodic testing of the finished batch, including documentation that the selected specifications tested or examined under [§ 111.75 (c)(1)](/cfr/21/111.75.md?p=c-1) are not able to verify that the production and process control system is producing a dietary supplement that meets the exempted product specification and there is no scientifically valid method for testing or examining such exempted product specification at the finished batch stage.
  - (6) Documentation of FDA's response to a petition submitted under [§ 111.75(a)(1)(ii)](/cfr/21/111.75.md?p=a-1-ii) providing for an exemption from the provisions of [§ 111.75(a)(1)(i)](/cfr/21/111.75.md?p=a-1-i).

## Notes

### Amendments

[72 FR 34942, June 25, 2007, as amended at 72 FR 34968, June 25, 2007]

### Authority

Authority: 21 U.S.C. 321, 342, 343, 371, 374, 381, 393; 42 U.S.C. 264.

### Source

Source: 72 FR 34942, June 25, 2007, unless otherwise noted.

### Amendments

[72 FR 34942, June 25, 2007, as amended at 72 FR 34968, June 25, 2007]