# 21 C.F.R. § 1271.15 (2026): Are there any exceptions from the requirements of this part?

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/CFR_T21_P1271_S1271_15

## Section

- **Citation:** 21 C.F.R. § 1271.15 (2026)
- **Heading:** Are there any exceptions from the requirements of this part?
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** August 14, 2026
- **Source:** Compiled text
- **Location:** Title 21 CFR: Food and Drugs / Chapter I: FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES / Part 1271: HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS / Subpart A: General Provisions / § 1271.15: § 1271.15   Are there any exceptions from the requirements of this part?

## Text

(a) You are not required to comply with the requirements of this part if you are an establishment that uses HCT/P's solely for nonclinical scientific or educational purposes.
(b) You are not required to comply with the requirements of this part if you are an establishment that removes HCT/P's from an individual and implants such HCT/P's into the same individual during the same surgical procedure.
(c) You are not required to comply with the requirements of this part if you are a carrier who accepts, receives, carries, or delivers HCT/P's in the usual course of business as a carrier.
(d) You are not required to comply with the requirements of this part if you are an establishment that does not recover, screen, test, process, label, package, or distribute, but only receives or stores HCT/P's solely for implantation, transplantation, infusion, or transfer within your facility.
(e) You are not required to comply with the requirements of this part if you are an establishment that only recovers reproductive cells or tissue and immediately transfers them into a sexually intimate partner of the cell or tissue donor.
(f) You are not required to register or list your HCT/P's independently, but you must comply with all other applicable requirements in this part, if you are an individual under contract, agreement, or other arrangement with a registered establishment and engaged solely in recovering cells or tissues and sending the recovered cells or tissues to the registered establishment.

## Nearby sections

- [21 C.F.R. § 1271.1 (2026) § 1271.1   What are the purpose and scope of this part?](https://www.frixlaw.com/law-library/statutes/CFR_T21_P1271_S1271_1.md)
- [21 C.F.R. § 1271.3 (2026) § 1271.3   How does FDA define important terms in this part?](https://www.frixlaw.com/law-library/statutes/CFR_T21_P1271_S1271_3.md)
- [21 C.F.R. § 1271.10 (2026) § 1271.10   Are my HCT/P's regulated solely under section 361 of the PHS Act and the regulations in this part, and if so what must I do?](https://www.frixlaw.com/law-library/statutes/CFR_T21_P1271_S1271_10.md)
- [21 C.F.R. § 1271.15 (2026) § 1271.15   Are there any exceptions from the requirements of this part?](https://www.frixlaw.com/law-library/statutes/CFR_T21_P1271_S1271_15.md)
- [21 C.F.R. § 1271.20 (2026) § 1271.20   If my HCT/P's do not meet the criteria in § 1271.10, and I do not qualify for any of the exceptions in § 1271.15, what regulations apply?](https://www.frixlaw.com/law-library/statutes/CFR_T21_P1271_S1271_20.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/CFR_T21_P1271_S1271_15. Check the current official text before relying on it. Not legal advice.