For alignment with language in the preamble of the CY 2025 PFS proposed rule (89 FR 61977) and the clarification made to 428.302(b)(1) as described above, we have clarified in this final rule at 428.303(b)(1) that CMS will apply a likely to be in shortage rebate reduction to the applicable period in which the request was submitted or the following applicable period, depending on the timing of the submission of the request
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Patients self-injecting vitamin B12 without telling their GP, finds study A large proportion of patients with a vitamin B12 deficiency self-inject medication sourced online, citing difficulty with accessing treatment from GPs
Patients should not use the medication and should contact their healthcare provider or pharmacist if they observe any of the following: For clear solution products (Ozempic, Wegovy, Trulicity, Victoza, Saxenda, Mounjaro, Zepbound, Byetta): Discoloration : The solution appears yellow (beyond slight yellowish tint allowed in some products), brown, or any color other than clear and colorless to slightly yellow (per product-specific labeling) Cloudiness or turbidity : The medication appears hazy, milky, or cloudy rather than clear Visible particles : Any floating particles, crystals, flakes, or sediment are present in the solution For Bydureon BCise (exenatide extended-release): For all products: Frosting or ice crystals : Evidence that the medication has been frozen, even if subsequently thawed Damaged pen or cartridge : Cracks, leaks, or other physical damage to the delivery device Additional circumstances requiring medication disposal include: Exceeded in-use time limits : For multi-dose pens, the medication has been in use longer than the manufacturer's specified period after first use Past expiration date : The printed expiration date has passed Unknown storage history : Uncertainty about whether the medication was properly stored or exposed to temperature extremes Suspected freezing : The medication may have been exposed to freezing temperatures during storage or transport Patients experiencing unexpected hyperglycemia or reduced therapeutic effect should consider the possibility of degraded medication, particularly if storage conditions may have been compromised
