Determination of the dating period of a product.

CFR · 2024-01-01 · US · Title 9

The following requirements do not apply to those biological products used for diagnostic purposes. (a) (b) (c) (d) (1) If the potency test specified in the filed Outline of Production of a licensed product is the one stated in the regulations, that potency test may be used in place of a stability-indicating assay for that fraction. (2) If the initial confirmation of dating study of a product in development on April 13, 2018 has an approved potency assay, that assay may be used. (e) (f) (2) (ii) One test every 6 months during the second year of storage; and (iii) One test annually thereafter throughout the proposed dating period. (3) (g) (1) Newly licensed products whose dating has not been confirmed; (2) Licensed products with confirmed dating but a major change to the product or to the potency test has occurred; and (3) Licensed products with confirmed dating in which a change in one or more of the stability criteria is requested. (h) (i)

official document · source cfr-2024 · id 9:§ 114.13