Latest revision as of 17:35, 12 October 2011

The Poison Prevention Packaging Act (PPPA) of 1970 was signed into law on December 30, 1970 by President Richard M. Nixon. Before the PPPA was enacted poisonings by common household substances, including medicines, had long been considered by pediatricians to be the leading cause of injuries among children under 5 years of age. After the PPPA and the implementation of standards to prevent poisonings, the Consumer Product Safety Commission (CPSC) reported that child-resistant packaging reduced the oral prescription medicine-related death rate by up to 1.4 deaths per million children under age 5 years. This represented a reduction in the rate of fatalities of up to 45% from levels that would have been projected in the absence of child-resistant packaging requirements, and equated to about 24 fewer child deaths annually.

The purpose of the PPPA was to give to the CPSC authority to require "special packaging" of household products and drugs to protect children from serious injury or illness. Manufacturers are required to perform tests to ensure that children under 5 years of age would find the packaging significantly difficult to open. In these tests, pairs of children aged 42 to 51 months are selected and given 5 minutes in which to open the packages. If the children cannot open the package, they are then given a visual demonstration and another 5 minutes in which to open the package. The package is considered to be child-resistant if not more than 20% of the 200 children tested can open the package. Adults are also tested with the same packages. Adults are likewise given a 5-minute period to open and properly close the package. If 90% of the 100 adults tested can open and close the child-resistant package, it passes.

The PPPA affects pharmacy practice and manufacturing of OTC and prescription medications in many ways. Failure to comply with packaging requirements or any of the applicable regulations is considered a misbranding violation under the FDC Act. A pharmacist could be prosecuted and imprisoned for not more than 1 year or sentenced to pay a fine of not more than $1000, or both.

All legend drugs and controlled dangerous substances must be packaged in a child-resistant container, with limited exceptions. Pharmacists should be familiar with their responsibilities under the PPPA . OTC products also require child-resistant packaging, with one exception. Manufacturers may market one size of an OTC product for the elderly or handicapped in noncompliant containers, provided that the package states, "This Package for Households Without Young Children."

Exceptions to child-resistant packaging for prescription drugs

1. Patient requests non-child-resistant packaging.
2. Physician requests non-child-resistant packaging.
3. Sublingual dosage forms of nitroglycerin.
4. Sublingual and chewable forms of isosorbide dinitrate in dosage strengths of 10 mg or less.
5. Erythromycin ethylsuccinate granules for oral suspension and oral suspensions in packages containing not more than 8 grams of the equivalent of erythromycin.
6. Cyclically administered oral contraceptives in manufacturers' mnemonic (memory-aid) dispenser packages that rely solely upon the activity of one or more progestogen or estrogen substances.
7. Anhydrous cholestyramine in powder form.
8. All unit dose forms of potassium supplements, including individually-wrapped effervescent tablets, unit dose vials of liquid potassium, and powdered potassium in unit-dose packets, containing not more than 50 milliequivalents of potassium per unit dose.
9. Sodium fluoride drug preparations including liquid and tablet forms, containing not more than 110 milligrams of sodium fluoride (the equivalent of 50 mg of elemental fluoride) per package or not more than a concentration of 0.5 percent elemental fluoride.
10. Betamethasone tablets packaged in manufacturers' dispenser packages, containing no more than 12.6 milligrams betamethasone.
11. Pancrelipase preparations in tablet, capsule, or powder form.
12. Prednisone in tablet form, when dispensed in packages containing no more than 105 mg.
13. Mebendazole in tablet form in packages containing not more than 600 mg.
14. Methylprednisolone in tablet form in packages containing not more than 84 mg.
15. Colestipol in powder form in packages containing not more than 5 grams of the drug.
16. Erythromycin ethylsuccinate tablets in packages containing no more than the equivalent of 16 grams erythromycin.
17. Conjugated Estrogens Tablets, U.S.P., when dispensed in mnemonic packages containing not more than 32.0 mg of the drug.
18. Norethindrone Acetate Tablets, U.S.P., when dispensed in mnemonic packages containing not more than 50 mg of the drug.
19. Medroxyprogesterone acetate tablets.
20. Sacrosidase (sucrase) preparations in a solution of glycerol and water.
21. Hormone Replacement Therapy Products that rely solely upon the activity of one or more progestogen or estrogen substances.
22. Products intended for topical application.
23. Products in dosage forms not intended for oral administration.

Pharmacist guidelines and responsibilities under the PPPA

1. The pharmacist is responsible for ensuring packaging of required drugs in child-resistant containers.
2. Prescription drugs provided by the manufacturer in child-resistant containers may be dispensed directly to the patient in that container.
3. In general, plastic vials, which have previously been dispensed to the patient, cannot be reused for refills.
4. Institutionalized patients are not required to receive child-resistant containers, but drugs for home use must comply with the PPPA.
5. The CPSC recommends that pharmacists obtain a written authorization from patients for conventional packaging, although such is not a requirement.

See also

Federal pharmacy law

References

1. Pharmacy Times, A Review of Federal Legislation Affecting Pharmacy Practice, Virgil Van Dusen , RPh, JD and Alan R. Spies , RPh, MBA, JD, PhD, https://secure.pharmacytimes.com/lessons/200612-01.asp
2. Strauss's Federal Drug Laws and Examination Review, Fifth Edition (revised), Steven Strauss, CRC Press, 2000
3. Food and Drug Administration, Legislation, http://www.fda.gov/RegulatoryInformation/Legislation/default.htm
4. Food and Drug Administration, History, http://www.fda.gov/AboutFDA/WhatWeDo/History/default.htm
5. 16 CFR 1700.14, January 1, 2010, http://edocket.access.gpo.gov/cfr_2010/janqtr/16cfr1700.14.htm