The 1970 law behind child-resistant medicine caps

Between May 1967 and December 1970, pharmacies serving the military population around Fort Lewis and McChord Air Force Base in Washington State dispensed prescription drugs in containers that took two different motions, a push and a turn, to open. Over that period there were 27 reported ingestions by young children, where researchers had expected 210, according to the Consumer Product Safety Commission's guide to poison prevention packaging¹.

That study and a similar one in Ontario helped persuade Congress. On Dec. 30, 1970, President Nixon signed Public Law 91-601², the Poison Prevention Packaging Act, the law that put child-resistant closures on oral prescription drugs. Before the law, CPSC says, state death certificates at one point recorded about 500 deaths a year among children under 5 from swallowing drugs and household products.

The bargain struck in that law, a closure most young children cannot open and most adults can, still governs the vial a pharmacy hands across the counter. The test behind it has been rewritten once, to bring in older adults, and the list of covered products has kept growing.

Before the law

Poisoning by household products and medicines had long been considered by pediatricians the leading cause of injury among children under 5, the CPSC guide says¹. The first poison control center opened in Chicago in 1953, and a national clearinghouse for poisoning data followed in 1957. Congress passed the Hazardous Substances Labeling Act in 1960, which relied on warning labels, and later created National Poison Prevention Week, an idea a Missouri pharmacist named Homer George had started locally in 1950.

Labels and education did not bring the numbers down. In 1966, FDA Commissioner James Goddard called aspirin makers, poison control centers and public health officials together. One result was a voluntary agreement to limit children's aspirin to 36 tablets of 1¼ grains per container, a dose then generally accepted as not highly toxic. Another was a subcommittee on child-resistant packaging, which led to the Fort Lewis trial and the Ontario program, where a 10-year education campaign had made little difference until pediatricians and pharmacists switched prescription tablets and capsules into child-resistant containers.

What the 1970 law says

Section 2 of the act² defines "special packaging" as packaging "designed or constructed to be significantly difficult for children under five years of age to open or obtain a toxic or harmful amount of the substance contained therein within a reasonable time and not difficult for normal adults to use properly." The definition adds that it "does not mean packaging which all such children cannot open," an admission written into the law that some children will get through.

FDA enforced the act until 1973, when jurisdiction moved to the newly created CPSC. Aspirin was the first substance covered. The requirement for oral prescription drugs took effect on April 16, 1974, according to the CPSC guide¹, and the law also amended the Food, Drug, and Cosmetic Act so that a drug in packaging that violates a poison prevention rule is misbranded.

Two exceptions were written into the statute from the start, and both are still in 15 U.S.C. 1473³. A manufacturer of a covered over-the-counter product may sell one package size without child-resistant packaging, for older or disabled buyers, if it also sells compliant packages and labels the exception "This package for households without young children." And a prescription drug "may be dispensed in noncomplying packages only when directed in such order or when requested by the purchaser." The pharmacist cannot make that call alone. CPSC's guide notes that "pharmacists do not have the authority to specify that prescriptions be dispensed in non-complying packaging," and that plastic prescription vials should, as a general rule, not be reused for refills. Our guide on reading a prescription label covers the rest of what a pharmacy must print.

How a package is tested

Child resistance is measured with real children and real adults, under a protocol now in 16 CFR 1700.20⁴. Children aged 42 to 51 months are tested in pairs, in groups of 50 and up to 200 in all, with five minutes to open a package, then a single demonstration and five more minutes. Passing thresholds are in 16 CFR 1700.15⁵.

Sources: 16 CFR 1700.15 and 1700.20 (2025 edition); CPSC, Poison Prevention Packaging: A Guide for Healthcare Professionals (2005).

Older testers came in after CPSC's own testing turned up a problem. Many adults, especially seniors, could not open the packaging, and "children were being poisoned because adults could not use the packaging properly," the guide says. A 1986 study with poison control centers found children getting into drugs that belonged to their grandparents, often because closures were loose or left off. CPSC's 1995 rule moved adult testing to the 50-to-70 age band.

What the death data showed

Two CPSC studies by G.B. Rodgers measured the law's effect. The first, published in JAMA in 1996, analyzed child deaths from oral prescription drugs from 1964 through 1992. It found special packaging cut the death rate by up to 1.4 deaths per million children under 5, a reduction of up to 45 percent from projected levels, or about 24 fewer child deaths a year, as summarized in the CPSC guide¹. The second, on aspirin, found child-resistant packaging "was associated with a 34% reduction in the aspirin-related child mortality rate," about 90 fewer deaths from 1973 to 1990, according to the 2002 paper in the Archives of Pediatrics and Adolescent Medicine⁶.

Sources: CPSC, Poison Prevention Packaging: A Guide for Healthcare Professionals (2005); Rodgers, Archives of Pediatrics and Adolescent Medicine (2002).

The aspirin paper added a caution. Because the packaging's "effectiveness is only partial, further poison prevention strategies should be developed and instituted." CPSC listed the reasons ingestions continue: noncompliant packaging requested for prescriptions, the one allowed noncompliant size of over-the-counter products, defective closures, caps left off or contents moved to other containers at home, and violations by pharmacists or dispensing physicians.

Where the rules have gone since

Covered substances, listed in 16 CFR 1700.14⁷, now go well past aspirin. The prescription drug rule carries its own list of exemptions, 22 in effect, numbered up to 24 with two reserved. They include sublingual nitroglycerin, oral contraceptives in memory-aid dispenser packs, prednisone tablets in packages holding no more than 105 mg, and methylprednisolone tablets in packages holding no more than 84 mg. When drugs such as ibuprofen and naproxen moved from prescription to over-the-counter sale, they dropped out of the prescription rule, so in 2001 CPSC adopted a rule covering future prescription-to-OTC switches automatically, the guide says. Our piece on store-brand OTC medicines looks at that side of the shelf.

Congress has also used the same test for new products. The Child Nicotine Poisoning Prevention Act of 2015, signed Jan. 28, 2016, requires liquid nicotine containers to meet the 16 CFR 1700.15 standards, "as determined through testing in accordance with the method described in section 1700.20," under Public Law 114-116⁸. CPSC's current business guidance⁹ repeats the original bargain: one noncomplying size for some store-shelf products, and noncomplying packaging for prescriptions "upon the specific request of the prescribing doctor or the patient."

Hospitals sit partly outside the system, since the law covers household substances, and much of what they stock comes in the unit-dose packages used on medication carts. FDA's 2022 labeling guidance recommends that unit-dose packages that are not child-resistant say so on the carton, adding that "if dispensed for outpatient use, a child-resistant container should be used," according to the document¹⁰. Medicines that leave the pharmacy and go unused are another route to exposure, which our guide on disposing of unused medicines covers.

Young children still get into medicines. Finding and eating or drinking medicines without adult supervision "is the main cause of emergency visits for ADEs among children aged 5 years and younger," according to the CDC's medication safety data page¹¹, using its abbreviation for adverse drug events. More on the labels and packages this law shaped is on our Your medicine, explained desk.