Imprint Codes for Oral Medications

What are Imprint Codes?

All approved prescription and over-the-counter solid, oral dosage form medications in the U.S. are required by the Food and Drug Administration (FDA) to have a unique imprint. This also applies to biological drug products and homeopathic drug products, unless otherwise exempted in the FDA Code of Federal Regulations 206.7.

The purpose of regulating imprinting is to enable pill identification of the ingredients, strength and manufacturer by health care providers, patients and law enforcement officials. Patients may need to know what a drug is if they have dropped it or mixed them up in a pill box or case, found it in their household, or to double check a medication that may have a had a generic substitution.

Why Do Drugs Have Unique Imprint Codes?

The unique imprint, when used in conjunction with the product's size, shape, and color, permits the identification of the drug product, the active ingredient(s), strength, and the manufacturer or distributor of the product. An imprint is defined as any single letter, number, or combination of letters and numbers, including words, company names, National Drug Code, mark, symbol, logo or monogram. The drug manufacturer determines the unique imprint for specific drug products.

Identification of the drug product requires identification of its active ingredients and its dosage strength. Inclusion of a letter or number in the imprint, while not required, is encouraged as a more effective means of identification than a symbol or logo by itself. Homeopathic drug products are required only to bear an imprint that identifies the manufacturer and their homeopathic nature. The purpose of regulating imprinting is to enable identification of the pill ingredients and drug manufacturer by law enforcement officials, health care providers and patient.

What if a Pill or Capsule Does Not Have an Imprint or Unique Code?

A solid oral dosage form drug product that does not meet the requirement for imprinting and is not exempt from the requirement may be considered adulterated and misbranded and may be an unapproved new drug as defined by the FDA. Also, if a pill or capsule has no imprint and is not an approved medication it may be a vitamin or other dietary supplement, illegal drug of abuse, foreign medication or even candy.

Do Illegal Drugs, or Other Drugs of Abuse Have Imprint Codes?

Some illegal drugs, such as Ecstasy, come in tablet formulations of various colors and contain an imprint or design that is appealing to a younger age group, such as a flower, a smiley face, or other common logo. In addition, other drugs of abuse such as LSD, are often concealed in candy like Sweet Tarts by placing a drop of the drug on the candy. LSD is also commonly placed on sheets of paper imprinted with a design, and then smaller squares of the paper are cut out for illicit trafficking. These imprints, because they are manufactured illegally, are not available for identification in the Pill Identification Wizard.

Prescription medications that are commonly abused, such painkillers, anti-anxiety benzodiazepines, or stimulants can be identified with through the Pill Identification Wizard by entering the imprint codes, colors or shapes.

Patients should contact their doctor or pharmacist immediately if they cannot identify their medication.

Definitions

  • Debossed means imprinted with a mark below the dosage form surface.
  • Drug product means a finished dosage form, e.g., a tablet or capsule that contains a drug substance, generally, but not necessarily, in association with one or more other ingredients.
  • Embossed means imprinted with a mark raised above the dosage form surface.
  • Engraved means imprinted with a code that is cut into the dosage form surface after it has been completed.
  • Imprinted means marked with an identification code by means of embossing, debossing, engraving, or printing with ink.
  • Solid oral dosage form means capsules, tablets, or similar drug products intended for oral use.

Reference:

  1. U.S. Food and Drug Administration. CFR - Code of Federal Regulations Title 21, Volume 4, Revised April 1, 2012 (cite: 21CFR 206.1, 206.3, 206.7, 206.10) Accessed December 16, 2012.

Last updated: 2013-08-27 by Leigh Anderson, PharmD

Hide
(web3)