US · guidance
CMS SOM App. H, Tag V118
CDC RR-05 as Adopted by Reference 42 CFR 494.30(a)(1)(i)
Intravenous medication vials labeled for single use, including erythropoietin, should not be
punctured more than once.
Interpretive Guidance § 494.30(a)(1)(i)
Page 13 of 420
According to the CDC, once a needle has entered a vial labeled for single use, the sterility of the
product can no longer be guaranteed. Residual medication from two or more vials should not be
pooled into a single vial.
Single-use vials/ampules must be used for only one patient, should not be entered more than
once, and if entered, may not be stored for future use.
Staff should only enter vials with a new sterile syringe and needle. If both vials are single-use
and are discarded after the single entry into each, the same syringe may be used. If either vial is
multi-use, a different syringe must be used for entry into each vial.
History
Rev.
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
d0d579274846d83082b5b2fd8875fde0fbca24146f9a191f281780eab223379d
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