The Food, Drug, and Cosmetic Act, as amended, states in Section 502 that a drug or device shall be deemed to be misbranded unless its labeling bears adequate directions for use. The law does not specify that these adequate directions must physically accompany the drug product. Prescription drug packages are required to contain adequate written information for use pursuant to 21 CFR 201.100. Because of this regulation that requires pharmacists to dispense drugs from bottles with package inserts, the industry has evolved a complex series of costly operations and controls. If initial labeling for a new product is produced, the text is generally converted from a word processing file.
Type is set from the desktop publishing file.
Proofs are printed. Proofs are read, approved and returned to printer. Labeling is printed. Labeling is folded. Labeling is warehoused until needed on the manufacturing line.