Resources

A few primary sources to keep handy, each checked to load before being listed here.

• Cornell Legal Information Institute (LII): 21 CFR § 606.160 — https://www.law.cornell.edu/cfr/text/21/606.160. The full records section this module quotes from twice: paragraph (c), the donor-number requirement, and paragraph (e), the per-location and cumulative deferred-donor records this module develops in depth for the first time in this curriculum. Already used in reading-a-cfr-citation and retention-across-record-types for its other paragraphs — reused here for a third.

• Cornell Legal Information Institute (LII): 21 CFR § 610.41 — https://www.law.cornell.edu/cfr/text/21/610.41. This module names 610.41 only, as 606.160(e) itself cites it, without quoting its text (not independently saved in sources/ for this curriculum). Use this link if you want to read the actual deferral-and-requalification rule 606.160(e)’s recordkeeping duty sits on top of.

• Cornell Legal Information Institute (LII): 21 CFR § 610.40 — https://www.law.cornell.edu/cfr/text/21/610.40. Same treatment: named only, as the test requirement 606.160(e)(2) and (e)(3) cite for the reactive results that trigger a 610.41 deferral. Useful background reading on what “tested reactive” actually refers to, not required to complete this module.