Child-resistant packaging

Section 211.132 states that none of the requirements for special packaging (child-resistant packaging), as defined in Section 310.3 and required under the Poison Prevention Packaging Act of 1970, are affected. 

Under the Poison Prevention Packaging Act of 1970, any product that, if consumed by a child, could result in harm to the child must be packaged using components difficult for a child to open. This is referred to as child-resistant packaging. 

The packaging of certain dangerous chemicals (e.g. those labelled toxic , very toxic or corrosive must be fitted with child-resistant closures, or tactile danger warnings (for the blind) if sold to the public. 

In 1970 the Poison Prevention Packaging Act was passed. It provides for packaging designed and constructed to be difficult for young children to open within a reasonable time and that is not difficult for adults to use properly. Establishing child-resistance effectiveness in a flexible unitized package is considerably more complex and, in certain circumstances, more difficult than doing so with a child-resistant cap on a bottle [21]. 

Table 10 Child-Resistant Packaging Criteria for Consumer...

Table 14 Products Requiring Child-Resistant Packaging...

H. Forcino. Child resistant closures Do you pass the test Pharm. Med. Packaging News, 4, 41 (1996). 

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. 

Chicken test, 5 763-764 Chicory, as coffee substitute, 7 268 Child-resistant packaging, 18 28 Chile... 

Packaging. See also Food packaging Industrial materials packaging aluminum for, 2 339-340 aseptic, 18 32-33 child-resistant, 18 28 coffee, 7 259-260 consumer awareness of, 18 29 converting, 18 15-23 corrugated paperboard boxes, 18 16-20 cosmetics and pharmaceuticals, 28 24-30 effectiveness of, 28 28 electronic materials, 27 823-851 fiber drums and cans, 28 22 folding cartons, 18 21-22 food, 22 77... 

Methadone, used as an analgesic, may be dispensed in any licensed pharmacy. Methadone dispersible tablets are for oral administration only. This preparation contains insoluble excipients and therefore must not be injected. It is recommended that methadone dispersible tablets, if dispensed, be packaged in child-resistant containers and kept out of the reach of children to prevent accidental ingestion. 

Packaging requirements can include child resistant closures, the word POISON being embossed along the side of the packaging so that the container can be identified by visually impaired people or in the dark. 

Tamper/child resistant packaging Make sure all tamper resistant packaging is intact or do not purchase the product. Each product is allowed to have one dosage unit available that does not contain a child safe container in order to allow the elderly or infirmed patient to have the ease and accessibility to their medication... 

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. ... 

In addition to the material and the package style, the closure is critical to the proper performance of the packaging system. In fact, many of the novel characteristics of a container are housed in the closure-child-resistant packaging, tamper-evident seals, pour spouts, etc. Furthermore, without the proper selection of closure, even the most well-designed package is likely to fail. 

Fig. 2 Blister packages are a very common method of unit-dose packaging. Blister packages are ideally suited to satisfy requirements for being tamper resistant and child resistant. The lidding stock is often a multilayer film containing plastic, metal, paper, and adhesive components. (From Ref...

Unit-of-use containers, as with all other types of containers, are expected to meet the appropriate test requirements relating to the type of packaging material used and the requirements for child-resistant and senior-friendly packaging. 

The Consumer Product Safety Commission, which regulates child-resistant packaging for household substances, requires such packaging for any oral iron product that contains 250 mg or more iron per container. In addition, the FDA s proposed regulations would require manufacturers to wrap iron tablets and capsules containing more than 30 mg per dosage unit in individual units, such as in blister packs. 

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