Tennessee Pharmacists Association

Earlier this month, the Food and Drug Administration (FDA) announced its plans to take enforcement action against manufacturers and distributors of unapproved drugs containing codeine. The Summary of this issue in the Federal Register is reprinted below; click here to read the full FDA Notice in the Federal Register.

A concise and thorough explanation of the Notice can be found in this PharmaceuticalOnline.com article, “FDA Pursues Manufacturers and Distributors of Unapproved Drugs with Codeine.”

The Tennessee Pharmacists Association is disseminating this information at the request of the Tennessee Board of Pharmacy.


From the Federal Register:

Unapproved and Misbranded Oral and Injectable Drugs Labeled for Prescription Use Containing Codeine Sulfate, Codeine Phosphate, or Dihydrocodeine Bitartrate; Enforcement Action Dates

The Food and Drug Administration (FDA or the Agency) is announcing its intention to take enforcement action against unapproved and misbranded oral and injectable drug products labeled for prescription use and containing codeine sulfate, codeine phosphate, or dihydrocodeine bitartrate, and against persons who manufacture or cause the manufacture or distribution of such products in interstate commerce. Prescription drug products containing these ingredients pose serious risks, including the risk of addiction, and some unapproved drug products may lack warnings or other information required in the labeling of approved drug products that is important for safe use. These unapproved drug products compete with approved drug products and thus pose a direct challenge to the drug approval system. This document covers the following unapproved drug products labeled for prescription use: Single-ingredient codeine sulfate oral tablets and solutions, single-ingredient codeine phosphate injection products, fixed-dose combination products containing codeine phosphate, and fixed-dose combination products containing dihydrocodeine bitartrate. A new drug containing codeine sulfate, codeine phosphate, or dihydrocodeine bitartrate requires an approved new drug application (NDA) or abbreviated new drug application (ANDA) to be legally marketed.