Are nominal price sales to non-profit family planning clinics that do not qualify as 340B covered entities exempt from a manufacturers' Best Price?

Yes, to the extent they meet the requirements defined in the final regulation at 42 CFR 447.508(a)(4) and (5). This section of the regulation provides that nominal price sales to entities would be excluded from best price when purchased by an entity that is:

Described in section 501(c)(3) of the Internal Revenue Code (IRC) of 1986 and exempt from tax under section 501(a) of that Act or is State-owned or Operated; and,
Providing the same services to the same type of population as a covered entity described in 340B(a)(4) of the Public Health Service Act, but does not receive Federal funding under a provision of law referred in such section.

To determine whether an entity is ""non-profit or charitable organization"" under 501(c)(3) of the Internal Revenue Code (IRC), the IRS has an on-line tool and manufacturers can access that tool at https://www.irs.gov/charities-non-profits/charitable-organizations/exemption-requirements-501c3-organizations. As specified in the final rule, using this readily available information, manufacturers may make certain reasonable assumptions, in the absence of specific guidance, in their determinations of whether an entity is a non-profit or charitable organization, provided those reasonable assumptions are consistent with the requirements and intent of section 1927 of the Act and federal regulations(81 FR 5226).

The second prong of the regulation provides that the entity must provide services similar to 340B entities listed at 340B(a)(4) but do not receive Federal funding under this section of the law. The entities listed at www.hrsa.gov/opa/eligibility-and-registration/index.html include Title X Family planning clinics and sexually transmitted disease clinics. Therefore, to the extent non-profit family planning clinics provide the same types of services as Title X Family Planning clinics and/or sexually transmitted disease clinics, the nominal price sales to these entities would be exempt.