FDA Proposes Requiring Unit-Dose Packaging For Orally Disintegrating OTC Monograph Drugs

Separate Proposal Would Make Change Easier To Swallow

Marking most strident use of authorities it received in 2020 as part of an overhaul of monograph system, FDA publishes proposal to shift orally disintegrating formats to individual-dose packaging and a related proposal to minimize firms’ regulatory burden for making delivery format changes potential

CDER Office of Nonprescription Drugs' proposed order for individual packaging requirements for would establish OTC monograph condition B001. (Source: FDA/Citeline)

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