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FDA Requires Tamper-Evident Packaging for O-T-C Drugs

Date: Dec 01, 1999


The Food and Drug Administration (FDA) now prohibits use of the term tamper-resistant to describe packaging for over-the-counter (O-T-C) human drug products. Such packaging must now be described as tamper-evident (T-E).

Effective November 6, 2000, the new regulations also require labels to refer to all T-E features, including those on the secondary package and the immediate container or closure.

Finally, effective November 4, 1999, FDA is requiring two-piece, hard gelatin capsules to be sealed using a T-E technology. For these products, the label must also make reference to the capsule sealing.

The labeling modifications apply to all O-T-C drug products, except dermatological, denitrifices, insulin or lozenges. Also exempt are ammonia inhalant and crushable glass ampules, containers of compressed medical oxygen or aerosol products that depend upon a liquified or compressed gas to expel the contents from the container. The sealing requirements do not apply to vitamins and dietary supplements since they are not considered O-T-C drugs.

According to FDA, the term "tamper-evident" more accurately characterizes the role of packaging in protecting consumers. Listing tamper-evident features on the labels will help ensure that consumers have the information needed to police product purchases for evidence of tampering.

The sealing requirement for two-piece hard gelatin capsules is necessary because of its vulnerability to tampering. However, the Agency has concluded that such technological advances are simply not sufficient alone for this product, and is, therefore, requiring the same labeling as other O-T-C products to heighten the sensitivities of consumers to the potential for product tampering. Although it has been several years since the last tampering tragedy occurred, FDA is hopeful that these changes will help prevent future incidents.

The final rule can be found in the November 4, 1998, edition of the Federal Register (63 Fed. Reg. 59463).

The following article by George Misko appeared in Food & Drug Packaging for December 1998. For further information, please contact Mr. Misko at 202-434-4170 or by e-mail at misko@khlaw.com.