21 CFR Part 601 - PART 601—LICENSING

  1. Subpart A—General Provisions (§§ 601.2 - 601.9)
  2. Subpart B [Reserved]
  3. Subpart C—Biologics Licensing (§§ 601.12 - 601.29)
  4. Subpart D—Diagnostic Radiopharmaceuticals (§§ 601.30 - 601.35)
  5. Subpart E—Accelerated Approval of Biological Products for Serious or Life-Threatening Illnesses (§§ 601.40 - 601.46)
  6. Subpart F—Confidentiality of Information (§§ 601.50 - 601.51)
  7. Subpart G—Postmarketing Studies (§ 601.70)
  8. Subpart H—Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible (§§ 601.90 - 601.95)
Authority:
15 U.S.C. 1451–1561; 21 U.S.C. 321, 351, 352, 353, 355, 356b, 360, 360c–360f, 360h–360j, 371, 374, 379e, 381; 42 U.S.C. 216, 241, 262, 263, 264; sec 122, Pub. L. 105–115, 111 Stat. 2322 (21 U.S.C. 355 note).
Source:
38 FR 32052, Nov. 20, 1973, unless otherwise noted.
Cross References:

For U.S. Customs Service regulations relating to viruses, serums, and toxins, see 19 CFR 12.21–12.23. For U.S. Postal Service regulations relating to the admissibility to the United States mails see parts 124 and 125 of the Domestic Mail Manual, that is incorporated by reference in 39 CFR part 111.