ACCEPTABLE TAMPER-RESISTANT PACKAGING -- FDA POLICY GUIDE

The following chart is excerpted from FDA's new compliance guideline: "Tamper-Resistance Packaging Requirements for Certain OTC Human Products." Copies of the complete guideline may be obtained from FDA's Docket Management Branch (HFA-305) at the Rockville, MD location. 1. FILM WRAPPERS. A transparent film with distinctive design is wrapped securely around a product container. The film must be cut or torn to open the container and remove the product. The wrapper must have an identifying characteristic (e.g., a pattern, name, registered trademark, logo, or picture) that cannot be readily duplicated. Tinted wrappers and cellophane with overlapping end flaps are not acceptable. 2. BLISTER OR STRIP PACKS. Dosage units (for example, capsules or tablets) are individually sealed in clear plastic or foil. The individual compartment must be torn or broken to obtain the product. The backing materials cannot be readily separated from the blisters or easily replaced without leaving evidence of tampering. 3. BUBBLE PACKS. The product and container are sealed in plastic and mounted in or on a display card. The plastic must be torn or broken to remove the product. The backing material cannot be readily separated from the bubble or easily replaced without leaving evidence of tampering. 4. HEAT SHRINK BANDS OR WRAPPERS. Bands or wrappers with a distinctive design (e.g., a pattern, name, registered trademark, logo, or picture) are shrunk by heat to seal the union of the cap and container. A distinctive design that is proprietary and different for each product size is recommended. Cellulose wet shrink seals are not acceptable. 5. FOIL, PAPER, OR PLASTIC POUCHES. The product is enclosed in an individual pouch that must be torn or broken to obtain the product. The pouch should have a distinctive design (e.g., a pattern, name, registered trademark, logo, or picture). 6. BOTTLE MOUTH INNER SEALS. Paper, thermal plastic, polystyrene foam, plastic film, foil, or combinations thereof, with a distinctive design (e.g., a pattern, name, registered trademark, logo, or picture) is sealed to the mouth of a container under the cap. The seal must be torn or broken to open the container and remove the product. 7. TAPE SEALS. Paper or foil with a distinctive design is sealed over all carton flaps or a bottle cap. The seal must be torn or broken to open the container and remove the product. Tape seals are acceptable only if they contain a unique feature that makes it apparent if the seals have been removed and reapplied. 8. BREAKABLE CAPS. The container is sealed by a plastic or metal cap that either breaks away completely when removed from the container or leaves part of the cap attached to the container. The cap, or a portion thereof, must be broken in order to open the container and remove the product. The cap cannot be reapplied in its original state. 9. SEALED METAL TUBES OR PLASTIC BLIND-END HEAT-SEALED TUBES. Both ends of the tube are sealed. The mouth or blind-end must be punctured to obtain the product. A tube with a crimped end is acceptable if the crimped end cannot be breached by unfolding and refolding without showing visible evidence of tampering. 10. SEALED CARTONS. Sealed paperboard cartons as currently available in the marketplace (e.g., cartons sealed by gluing the end flaps together) are unacceptable. However, the Agency recognizes the future technological advances may provide sealed paperboard packages that meet the intent of the TRP regulation. 11. AEROSOL CONTAINERS. Aerosol containers are believed to be inherently tamper-resistant because of their particular design. Direct printing of the label on the container (e.g., lithographing), is preferred to using a paper label which could be removed and substituted. 12. CANS (BOTH ALL-METAL AND COMPOSITE). The top and bottom of a composite can must be joined to the can walls in such a manner that they cannot be pulled apart and reassembled without visible evidence of entry. Rather than attaching a separate label, direct printing of the label onto the can (e.g., lithographing) is preferred. In asking for cost information, FDA noted that a Proprietary Association survey of its 25 member companies in August 1986 estimated that providing two tamper-resistant packaging features for two-piece hard gelatin capsule products would result, for large companies, in a "one time capital costs plus first-year recurring costs of $ 568,000." The survey estimated that smaller companies, with annual sales of less than $ 20 mil. would incur "similar costs of $ 93,000," and "costs for all P-A member firms would approximate $ 26.4 mil." FDA noted that as many as 100 additional small companies that do not belong to P-A are also engaged in the manufacture of hard gelatin capsule products, and if the $ 93,000 figure were applied to them, total industry costs would approach $ 36 mil. The agency explained that it is interested in cost information because, since 1986, "many manufacturers of unsealed, two-piece hard gelatin capsule products have voluntarily shifted to alternative noncapsule or sealed capsule products." Others, FDA added, "have voluntarily upgraded packaging to provide two tamper resistant features."