Zdrowie i gospodarka · 7.09.2010
Draft Guidance for Industry: Bar Code Label Requirements-Questions and Answers (Question 12 Update); Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled "Guidance for Industry: Bar Code Label Requirements--Questions and Answers (Question 12 Update)" dated August 2010. This draft guidance provides you, manufacturers of a licensed vaccine, with advice concerning compliance with the bar code label requirements. In this guidance, FDA is proposing to amend our response to question 12 (Q12) in the "Bar Code Label Requirements-- Questions and Answers" guidance dated October 2006 (Bar Code Guidance), to provide recommendations to manufacturers of licensed vaccines in connection with the use of alternative coding technologies. When this guidance is finalized, we intend to incorporate the revised response to Q12 into the Bar Code Guidance, but otherwise continue with our recommendations for bar code label requirements as currently provided in the Bar Code Guidance.