US · guidance
CMS Pub. 100-18, ch. 6, § 10.3
Commercially Available Combination Products
Only those combination products approved and regulated in their combination form by the FDA
as a drug, vaccine, insulin, or biological product, as described in paragraph (i), (ii), (iii), or (v)
of the Part D drug definition at §423.100 are eligible for Part D coverage. This requirement for
FDA approval applies to commercially available combination products meant for broad
distribution. Extemporaneously compounded prescription drug products (addressed separately
in this chapter in section 10.4 as well as in §423.120(d)) are not affected by this requirement.
Approved commercially available combination products include those with multiple active
ingredients combined in a single drug product and those products with multiple drugs that
remain separate but are co-packaged together and intended for dispensing as a single entity.
History
(Rev. 18, Issued: 01-15-16, Effective: 01-15-16; Implementation: 01-15-16)
Provenance
- Source
- cms.gov
- Retrieved
- 2026-09-17
- Edition
- iom-2026-09-17
- Content hash
390c517c81bb936ef5d35ec773d5742d356091e6974082d4064d3c1401ca63ef
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