FDA’s Deadline Nears for all Prescription, Over-the-Counter Medication Bar Code Labeling

Bar coding for all prescription and over-the-counter medications — which are commonly used and dispensed in the acute-care setting — will be required as of April 26, marking the end of a two-year implementation period for the FDA’s 2004 rule. Medications that are FDA cleared on or after April 26 must be bar code labeled within 60 days of their approval date.
Drug manufacturers, repackers, relabelers and private label distributors will be responsible for affixing human- and machine-readable bar code labels on all unit-dose medications, encoding the National Drug Code (NDC) on both the medication’s packaging as well as any overwrap.
The FDA has estimated that the rule will prevent more than 500,000 medication errors and save more than $93 billion in healthcare costs over the next 20 years.
The rule applies to most drug products, as well as blood and biological products, and bar codes must conform to EAN (European Article Numbering), UCC (Uniform Code Council) or HIBCC (Health Industry Business Communications Council) format standards.
Products that are exempt from the bar code rule include section 510 animal drugs, as well as prescription drug samples, allergenic extracts, intrauterine contraceptive devices regulated as drugs, medical gases, radiopharmaceuticals, low density polyethylene form fill and seal containers that are not packaged with an overwrap and prescription drugs sold directly to patients. Also exempted are Section 510 (g) hospital compounded drugs and drugs used in clinical trials.