# 42 C.F.R. § 8.21 (2026): Applicability

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/CFR_T42_P8_S8_21

## Section

- **Citation:** 42 C.F.R. § 8.21 (2026)
- **Heading:** Applicability
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** August 14, 2026
- **Source:** Compiled text
- **Location:** Title 42 CFR: Public Health / Chapter I: PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES / Part 8: MEDICATIONS FOR THE TREATMENT OF OPIOID USE DISORDER / Subpart D: Procedures for Informal Review of Suspension or Proposed Revocation of OTP Certification, and of Adverse Action Regarding Withdrawal of Approval of an Accreditation Body / § 8.21: § 8.21   Applicability.

## Text

The procedures in this subpart apply when:
(a) The Secretary has notified an OTP in writing that its certification under the regulations in subpart B of this part has been suspended or that the Secretary proposes to revoke the certification; and
(b) The OTP has, within 30 days of the date of the notification or within 3 days of the date of the notification when seeking an expedited review of a suspension, requested in writing to the reviewing official, an opportunity for an informal review of the suspension or proposed revocation.
(c) The Secretary has notified an Accreditation Body of an adverse action taken regarding withdrawal of approval of the Accreditation Body under the regulations in subpart A of this part; and
(d) The Accreditation Body has, within 30 days of the date of the notification, requested in writing an opportunity for a review of the adverse action.

## Nearby sections

- [42 C.F.R. § 8.21 (2026) § 8.21   Applicability.](https://www.frixlaw.com/law-library/statutes/CFR_T42_P8_S8_21.md)
- [42 C.F.R. § 8.22 (2026) § 8.22   Definitions.](https://www.frixlaw.com/law-library/statutes/CFR_T42_P8_S8_22.md)
- [42 C.F.R. § 8.23 (2026) § 8.23   Limitation on issues subject to review.](https://www.frixlaw.com/law-library/statutes/CFR_T42_P8_S8_23.md)
- [42 C.F.R. § 8.24 (2026) § 8.24   Specifying who represents the parties.](https://www.frixlaw.com/law-library/statutes/CFR_T42_P8_S8_24.md)
- [42 C.F.R. § 8.25 (2026) § 8.25   Informal review and the reviewing official's response.](https://www.frixlaw.com/law-library/statutes/CFR_T42_P8_S8_25.md)
- [42 C.F.R. § 8.26 (2026) § 8.26   Preparation of the review file and written arguments.](https://www.frixlaw.com/law-library/statutes/CFR_T42_P8_S8_26.md)
- [42 C.F.R. § 8.27 (2026) § 8.27   Opportunity for oral presentation.](https://www.frixlaw.com/law-library/statutes/CFR_T42_P8_S8_27.md)
- [42 C.F.R. § 8.28 (2026) § 8.28   Expedited procedures for review of immediate suspension.](https://www.frixlaw.com/law-library/statutes/CFR_T42_P8_S8_28.md)
- [42 C.F.R. § 8.29 (2026) § 8.29   Ex parte communications.](https://www.frixlaw.com/law-library/statutes/CFR_T42_P8_S8_29.md)
- [42 C.F.R. § 8.30 (2026) § 8.30   Transmission of written communications by reviewing official and calculation of deadlines.](https://www.frixlaw.com/law-library/statutes/CFR_T42_P8_S8_30.md)
- [42 C.F.R. § 8.31 (2026) § 8.31   Authority and responsibilities of the reviewing official.](https://www.frixlaw.com/law-library/statutes/CFR_T42_P8_S8_31.md)
- [42 C.F.R. § 8.32 (2026) § 8.32   Administrative record.](https://www.frixlaw.com/law-library/statutes/CFR_T42_P8_S8_32.md)
- [42 C.F.R. § 8.33 (2026) § 8.33   Written decision.](https://www.frixlaw.com/law-library/statutes/CFR_T42_P8_S8_33.md)
- [42 C.F.R. § 8.34 (2026) § 8.34   Court review of final administrative action; exhaustion of administrative remedies.](https://www.frixlaw.com/law-library/statutes/CFR_T42_P8_S8_34.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/CFR_T42_P8_S8_21. Check the current official text before relying on it. Not legal advice.