Tamper-evident

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. 

Consumer Preferences. Studies into consumer preferences for tamper-evident (TE) packaging have consistentiy revealed that consumers prefer products that are resistant to tampering and have shelf-visible features. The same studies have indicated that a consumer is willing to pay slightly more than a competing brand that is not TE, indicating consumer awareness of packaging. 

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. 

Glass or plastic bottles that have plastic or aluminum closures are tested for removal torque. The removal torque represents the force required to remove the closure from the bottle. Closures are also evaluated to ensure that they have been properly appHed and that they are tamper evident. Crown closures are also evaluated to ensure proper appHcation. 

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. 

If the tamper-evident feature chosen to meet the requirements in paragraph (b) of this section uses an identifying characteristic, that characteristic is required to be referred to in the labeling statement. For example, the labeling statement on a bottle with a shrink band could say "For your protection, this bottle has an imprinted seal around the neck. ... 

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. 

The integrity of the container and its closure should be discussed. Factors such as child resistance or tamper evidence, etc., should be discussed. The PhEur includes a requirement for certain types of product to be supplied in tamper proof container-closure system-s—which is not possible if the product is to be used by a patient ... 

The information on the container and the development pharmaceutics is to cover the qualitative composition (polymeric and other), closure type and method of operation, tightness of the closure, dosing device information, tamper evidence and child resistance, stability of the product in the container, the method of administration of the medicinal product, any sterilization procedures, the ability of the container to protect the contents from external factors,... 

The packaging systems used were discussed in some detail in several EPARs. The number of products requiring a desiccant of some type is quite a high proportion of the total. In many cases both blister packs (of various compositions) and bottles (glass or plastics) were used for the same product. Effectiveness in protecting light-sensitive active ingredients and products is mentioned in the EPARs. Child resistance and tamper evidence is also mentioned. 

Container composition and tamper evidence is discussed in the EPARs. There is also discussion of containers in cases where special systems such as two-compartment cartridges are used. Any particular points relating to multiple withdrawals of doses from the container will also be included. Special issues relating to pen injectors will be included. 

There are two EPARs for eyedrops. Specific issues considered for these include container composition and tamper evidence, the optimization of the formulation and manufacture, preservative and preservation issues, and justification for the use of nonterminal sterilization processes. Many of the points concerning active ingredients and excipients are similar to those discussed above. Changes in formulation during the development process (e.g., for carbomers or surfactants) are mentioned. Particle size controls for suspension products are discussed. 

Cosmetic manufacturing, magnesium carbonate in, 15 391 Cosmetic packaging, 1 <8 24-30 design of, 18 24-25 FDA role in, 18 26-27 product tampering and, 18 25-26 tamper-evident features of, 18 27-28 Cosmetic products... 

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

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