FDA Bar Code Label Rule for Drugs and Biologics

FDA issued a final rule requiring bar code labels for Human Drugs and Biologics. This rule discusses the information content of the labels and computer use of these labels in health care. Specific changes are made to the Drug (201), Blood (606) and Biologics (610) regulations to implement this labeling requirement. A copy of the rule including the preamble is at the link provided. Effective date of the rule is April 26, 2004 and drugs and biologics receiving approvals on or after that date must comply with the rule within 60 days after the drug approval date. Products approved prior to that date must comply by April 26, 2006.

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Agile Methods for Medical Device and Health IT Software

One day course that expands on the software risk management topics covered in our IEC 62304 and other Emerging Standards for Medical Device and HealthIT Software course. Essentially the same topics are covered but in greater depth with more attention to hands-on analysis of examples.

Email training@softwarecpr.com for more info.

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