Tamper-evident packaging

Every developed nation has experienced product tampering incidents. The principal difference between domestic and foreign incidents is the motive of the tamperers. In the United States, typically random tampering without prior threat occurs whereas outside the United States, extortion prior to injury occurs, with money appearing to be the primary motive. Most developed nations are either implementing or modifying their rules on the use of tamper-evident packaging. Some features as they are used in the United States would have to be modified or the use of a secondary feature required to meet the standards of various other countries. 

The FDA has passed a rule (21 CFR 211.132) (3) requiring the use of tamper-evident packaging on all over-the-counter (OTC) dmgs and some cosmetics (qv), while ignoring other products they regulate (2). Table 1 offers examples of such packaging forms. 

Product tampering may be a foreseeable possibility and manufacturers have a responsibility to protect consumers against such possible acts. If a product iu an adulterated form could harm a consumer, manufacturers have the responsibiUty of protecting the product and consumer against such acts, meaning the use of tamper-evident packaging transcends FDA regulations. 

Cost to the Industry. When compared to the potential expense for defending a single claim of tampering, the cost of effective tamper-evident packaging becomes insignificant. Many firms simply caimot afford the cost of responding to product tampering claims, especially if the firm is a small one with a limited or totally related product line where the reputation of the entire product line can be affected by adverse pubHcity on one item. LiabiUty insurance caimot return lost customer confidence. 

J. L. Rosette, "Development of an Index For Rating the Effectiveness of Tamper-Evident Packaging Eeatures," Masters Thesis, California Coast University, Santa Ana, Calif., 1985. 

J. L. Rosette, Improving Tamper-Evident Packaging Technomic Publishing Co., Inc., Lancaster, Pa., 1992. 

Sec. 211.132 Tamper-evident packaging requirements for over-the-counter (OTC) human drug... 

In addition to the tamper-evident packaging feature described in paragraph (b)(1) of this section, any two-piece, hard gelatin capsule covered by this section must be sealed using an acceptable tamper-evident technology. 

The reasons that the drug product s compliance with the tamper-evident packaging or labeling requirements of this section is unnecessary or cannot be achieved. 

Tamper-evident packaging, 18 26, 27-28 Tamper-resistant packaging regulations, 18 686... 

Product Security Tamper-evident packaging closures and security tags should be used. Containers that appear to have been opened or otherwise altered by unauthorized persons should not be used until the purity of the substance has been confirmed. 

CFR Part 211, [Docket No. 92N-0314], Tamper-evident packaging requirements for over-the-counter human drug products. Federal Register, 63 (No. 213), Nov. 4 1998, 59, 463-59,471. 

The CPSC was created by Congress in 1972 and assumed, as one of its roles, the enforcement of the U.S. Poison Prevention Packaging Act of 1970 (16 C.F.R. 1700). " Since then, the regulatory breadth of CPSC has grown, but its impact on packaging still primarily pertains to the closures. The CPSC regulations can be found in 16 C.F.R. and specifically provide requirements for child-resistant and tamper-evident packaging systems. ... 

The use of tamper-evident packaging makes it clear to the patient that he is the first person to open the container. 

The use of plastics in modern pharmaceutical packaging products is described. Aspects covered include the continual quest for an ideal material and process, properties, machinery and selection criteria (FDA approval, tamper-evident packaging, product-package compatibility, sterilisation, polymer additives, smart design and environmentally-friendly packaging). 

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