Imprinting of Solid Oral Dosage Form Drug Products for Human Use; Clarification
other · Food and Drug Administration · Rule · Published 1995-04-21 · Effective 1995-09-13 · 60 FR 19846
Document
Document number
95-9951
Federal Register citation
60 FR 19846
CFR reference
21 CFR 206
Type
Rule
Action
Final rule; clarification.
Category
other
Sub-agency
Food and Drug Administration
Publication date
1995-04-21
Effective date
1995-09-13
HHS docket
Docket Nos. 88P-0380 and 89P-0163
Abstract
The Food and Drug Administration (FDA) is amending its regulations requiring the imprinting of solid oral dosage form drug products for human use. This final rule clarifies FDA's intent regarding the effective date for drug products introduced or delivered for introduction into interstate commerce.