Guidance for Industry on Bar Code Label Requirements-Questions and Answers; Availability
other · Food and Drug Administration · Rule · Published 2006-10-05 · 71 FR 58739
Document
Document number
E6-16436
Federal Register citation
71 FR 58739
CFR reference
21 CFR 201
Type
Rule
Action
Notice of availability.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2006-10-05
HHS docket
Docket No. 2005D-0202
Abstract
The Food and Drug Administration (FDA) is announcing the availability of additional questions and answers that are being incorporated into the final guidance document entitled "Guidance for Industry: Bar Code Label Requirements--Questions and Answers." This final guidance is dated October 2006. The additional questions and answers relate to blood and blood components intended for transfusion and requirements that their container labels bear certain machine- readable information. These requirements were part of the final rule on bar code label requirements for human drugs published on February 26, 2004.