FDA Issues Guidance on Labeling of Injectable Drugs and Biologics
The Food and Drug Administration on Oct. 2 issued a guidance document on the labeling of injectable medical products for human use. The guidance sets out appropriate package type terms and discard statements for injectable drugs, biologics and combination products…
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packaged in multiple-dose, single-dose, and single-patient-use containers, respectively. “FDA believes that consistent use of correct package type terms and discard statements for injectable medical products for human use will promote their proper use and provide a foundation for educational efforts to reduce the transmission of blood borne pathogens,” it said.