---
kind: "section"
citation: "31 C.F.R. § 515.547"
title: "31"
number: "515.547"
heading: "Certain transactions related to medical research and Cuban-origin pharmaceuticals; research samples."
url: "https://uscodex.org/cfr/31/515.547"
---

# §515.547. Certain transactions related to medical research and Cuban-origin pharmaceuticals; research samples.

- (a) Persons subject to U.S. jurisdiction are authorized to engage in all transactions incident to joint medical research projects with Cuban nationals.
- (b) Persons subject to U.S. jurisdiction are authorized to engage in all transactions incident to obtaining approval from the U.S. Food and Drug Administration (FDA) of Cuban-origin pharmaceuticals, including discovery and development, pre-clinical research, clinical research, regulatory review, regulatory approval and licensing, regulatory post-market activities, and the importation into the United States of Cuban-origin pharmaceuticals.
- (c) Persons subject to U.S. jurisdiction are authorized to engage in all transactions incident to the marketing, sale, or other distribution in the United States of FDA-approved Cuban-origin pharmaceuticals, including the importation into the United States of Cuban-origin pharmaceuticals.
- (d)
  - (1) **Opening and maintaining bank accounts at Cuban financial institutions to engage in authorized transactions.** The opening and maintenance of accounts, including the deposit of funds in such accounts by wire transfer, at a financial institution in Cuba, is authorized provided that such accounts are used only for transactions authorized pursuant to this section.
  - (2) **Closing bank accounts.** The closing of an account opened pursuant to the authorization in [paragraph (d)(1)](#d-1) of this section is authorized, provided that any transfer of funds may only be effected by wire transfer to an account maintained at a depository institution, as defined in [§ 515.333](/cfr/31/515.333.md), that is a person subject to U.S. jurisdiction.
- (e) **Specific licenses.**
  - (1) To the extent not authorized by [paragraph (b)](#b) of this section, specific licenses may be issued for the importation of Cuban-origin commodities for bona-fide research purposes in sample quantities only.
  - (2) Specific licenses may be issued for transactions related to medical research or pharmaceutical products not authorized by [paragraphs (a) through (c)](#a..c) of this section.

## Notes

### Amendments

[81 FR 71376, Oct. 17, 2016, as amended at 85 FR 60071, Sept. 24, 2020; 87 FR 35089, June 9, 2022]

### Authority

Authority: 22 U.S.C. 2370(a), 6001-6010, 7201-7211; 31 U.S.C. 321(b); 50 U.S.C. 4301-4341; Pub. L. 101-410, 104 Stat. 890 (28 U.S.C. 2461 note); 22 U.S.C. 6021-6091; Pub. L. 105-277, 112 Stat. 2681; Pub. L. 111-8, 123 Stat. 524; Pub. L. 111-117, 123 Stat. 3034; E.O. 9989, 13 FR 4891, 3 CFR, 1943-1948 Comp., p. 748; Proc. 3447, 27 FR 1085, 3 CFR, 1959-1963 Comp., p. 157; E.O. 12854, 58 FR 36587, 3 CFR, 1993 Comp., p. 614.

### Source

Source: 28 FR 6974, July 9, 1963, unless otherwise noted.

### Amendments

[81 FR 71376, Oct. 17, 2016, as amended at 85 FR 60071, Sept. 24, 2020; 87 FR 35089, June 9, 2022]