Unit and Unit Dose Packages of Drugs

(and proprietary name if to be shown)
Dosage Form (if special or other than oral)
Strength of Dose and Total Contents Delivered
(e.g., number of tablets and their total dose)
Special Notes (e.g., refrigerate)
Expiration Date
Control Number

  1. Nonproprietary and proprietary names. The nonproprietary name and the strength should be the most prominent part of the package label. It is not necessary to include the proprietary name, if any, on the package. The name of the manufacturer or distributor should appear on the package. In addition, the name of the manufacturer of the finished dosage form should be included in the product labeling. The style of type should be chosen to provide maximum legibility, contrast, and permanence.
  2. Dosage form. Special characteristics of the dosage form should be a part of the label, e.g., extended release. Packages should be labeled as to the route of administration if other than oral, e.g., topical use. In a package containing an injection, the acceptable injectable route(s) of administration should be stated on both outer and inner packages, i.e., both on the syringe unit and carton (if any).
  3. Strength. Strength should be stated in accordance with terminology in the American Hospital Formulary Service. The metric system should be used, with dosage forms formulated to provide the rounded-off figures in the USP table of approximate equivalents and expressed in the smallest whole number. Micrograms should be used through 999, then milligrams through 999, then grams. Thus, 300 mg, not 5 gr, nor 325 mg, nor 0.3 g; 60 mg, not 1 gr, nor 0.06 g, nor 64.5 mg, nor 65 mg; 400 mcg, not 1/150 gr, nor 0.4 mg, nor 0.0004 g; mL (milliliters) should be used instead of cc (cubic centimeters).
  4. Strength of dose and total contents delivered. The total contents and total dose of the package should be indicated. Thus, a unit dose package containing a 600-mg dose as two 300-mg tablets should be labeled “600 mg (as two 300-mg tablets).” Likewise, a 500-mg dose of a drug in a liquid containing 100 mg/mL should be labeled “Delivers 500 mg (as 5 mL of 100 mg/mL).”
  5. Special notes. Special notes such as conditions of storage (e.g., refrigerate), preparation (e.g., shake well or moisten), and administration (e.g., not to be chewed) that are not obvious from the dosage form designation are to be included on the label.
  6. Expiration date. The expiration date should be prominently visible on the package. If the contents must be reconstituted prior to use, the shelf life of the final product should be indicated. Unless stability data warrant otherwise, expiration dates should fall during January and July to simplify recall procedures.

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Aug 27, 2016 | Posted by in GENERAL & FAMILY MEDICINE | Comments Off on Unit and Unit Dose Packages of Drugs
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