Child-resistant closures

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. 

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

Immediately mix 1 part of the 20 mg/mL initial solution with 1 part of either Mylanta Double Strength Liquid, Extra Strength Maalox Plus Suspension, or Maalox TC Suspension for a final dispensing concentration of 10 mg/mL. For patient home use, dispense the admixture in flint-glass or plastic bottles with child-resistant closures. This admixture is stable for 30 days under refrigeration at 2° to 8°C (36° to 46°F). 

Current good manufacturing practice requirements for the control of drug product containers and closures are included in 21 CFR Parts 210 and 211. The U.S. Food and Drug Administration (FDA) requirement for tamper-resistant closures is included in 21 CFR 211.132 and the Consumer Product Safety Commission requirements for child-resistant closures are included in 16 CFR 1700. 

Zerit (stavudine) for oral solution is supplied as a dye-free, fruit-flavored powder in bottles with child-resistant closures providing 200 mL a 1 mg/mL stavudine solution on constitution with water per label instructions. 

Adding or changing a child-resistant closure, changing from a metal to plastic screw cap, or changing from a plastic to metal screw cap. 

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. 

Child-resistant closure Metering valve Stopper... 

Description of tamper-evidence and child-resistant closure. 

As well as protecting the product, the package can also protect the public through the use of child-resistant closures (CRCs) or tamper-evident packs. 

There has been criticism that child-resistant closures are difficult to remove by the elderly. This is true for many of the devices, but on the other hand there is no doubt that CRCs have been effective in preventing poisoning in children. For example, the number of analgesic poisonings in children in the UK reduced from 626 in 1974 to 181 in 1977 after introduction of the requirement for use of CRCs. 

Although there are no EU requirements for child-resistant closures for medicines, there are directives (91/442 and 90/35) which require containers for products that are toxic or corrosive to be made child-resistant. For pharmaceutical products individual countries have introduced requirements for example, the Pharmaceutical Society of Great Britain requires in its code of practice that all solid and liquid preparations be dispensed in reclosable child-resistant containers, unless ... 

A bottle can only be judged by the effectiveness of its closure. The subject of closures, briefly discussed above, is now dealt with more fully. The specific suitability of glass as a recipient of a closuring system may be as one use or multi-use types. The latter should be easy to apply, open and effectively reclose until such time as all the product is used. This ideal may clash with the requirements of a child-resistant closure, but this is adequately covered if the word easy is applied to adults and a phrase such as difficult to open by children is added. With a child-resistant closure it is important that an adult finds it easy to reclose, as failure to do this defeats the very objective that one is trying to achieve. The one-use closure is widely used in the pharmaceutical industry and is in some instances specially designed to prevent reuse. 

Finally, containers can be diaphragm sealed using heat (including induction sealing) or adhesive either as the sole closuring means (i.e. peelable tops for unit dose preparations) or in conjunction with any of the other closures previously mentioned. Diaphragms can be a useful means of forming a tamper-evident seal, e.g. used in conjunction with a child-resistant closure. 

Another requirement which is likely to become of increasing importance with aerosols is the demand for child-resistant and tamper-evident closures. Although current FDA legislation only requires such closures to be applied to oven cleaners, it may well be extended to other aerosol products including some pharmaceuticals, and a number of approved child-resistant closures are already available. Most of these closures rely on the user either replacing the overcap or rotating the cap to a safe position for their effectiveness. 

Child-resistant closures—initially dating back to the Poisons Prevention Act introduced in the USA in 1970 cover both reclosable and non-reclosable systems—(see below). 

UK legislation currently covers aspirin-and paracetamol-based products and a series of household/chemical products introduced from 1 December 1987. For solid dose dispensed medicines there is a scheme which requires pharmacies to use child-resistant systems unless they are not required by the patient (i.e. elderly, arthritic, infirm, etc.). Child-resistant closures are also required on certain liquid products. 

Containers must be clean, sound and fit for the intended purpose. Where possible pharmacies will fit child resistant closures (CRCs) and these must be used for medicines containing aspirin and paracetamol. Fluted bottles must be used for medicines that are for external use only. Patient information leaflets or summary of product characteristics must be included. Their content is set out by law. 

Adding or changing a child-resistant closure, changing from a metal to plastic screw cap, or changing from a plastic to metal screw cap Changing from one plastic container to another of the same type of plastic (e.g., high-density polyethylene container to another high-den-sity polyethylene container)... 

Overseas studies have shown that child resistant packaging (CRP), especially child resistant closures (CRCs), is an effective means of reducing the unnecessary morbidity and mortality associated with childhood poisoning [IS,16]. 

Until recently, there was little evidence as to whether blister packs were as effective in preventing poisonings as child resistant closures. However, a recent study in the United Kingdom found that medications involved in poisonings were most frequently packed in containers without child resistant closures (63%) or transparent blisters (20%). Conversely, child resistant closures, foil strips, sachets and opaque blister packs had low associations with poisoning incident [17]. 

A comprehensive review estimated that child resistant closures on prescription medicines have prevented over 200,0(X) accidental ingestions during 1974-1978 and saved, on average, 26 children s lives a in the United States. The ingestion rate per thousand children has declined from 5.7 cases to 3.5 during the same period. Child resistant closures are now accepted and widely used in the USA [18]. 

The United Kingdom introduced legislation in 1974 requiring some pharmaceutical products, such as junior aspirin, to be fitted with child resistant closures. One year later the legislation was extended to cover adult aspirin. Admissions to hospital for children under 5 years with aspirin poisoning showed a dramatic reduction of 85% during the period 1975 to 1978 [16]. 

In 1982 the legislation was extended to include toxic substances found in and around the home, and in January 1989, it was made a professional requirement for United Kingdom pharmacists to use child resistant closures for dispensed medicines. 

Unfortunately, this campaign does not address the issue of child resistant packaging for scheduled toxic substances. The Toxic Substances Board (an advisory committee to the Minister of Health) recommended that the Ministry adq)t their proposed draft legislation amending the Toxic Substances Regulations such that child resistant closures would be required for certain scheduled chemicals including pesticides with container capacities <2.5 1. Currently, this remains unactioned. 

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. 

Tamper-evident closures are used to prevent customers from opening containers before they buy them. Several tamper-evident features were originally introduced including neck bands, tamper-rings, and shrink wrapping. More recently, a number of new tamper-evident and child-resistant closures (CRC) have been introduced. 

Child safety some preparations should be dispensed with a child-resistant closure (see also Sect. 24.4.20). 

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