Poison Prevention Packaging Act of 1970

Last updated
Poison Prevention Packaging Act of 1970
Great Seal of the United States (obverse).svg
Long titleAn Act to amend the Federal Hazardous Substances Act to provide for child resistant packaging to protect children from serious personal injury or serious illness resulting from handling, using, or ingesting a hazardous substance, and for other purposes.
NicknamesFederal Hazardous Substances Act Amendment of 1970
Enacted bythe 91st United States Congress
EffectiveDecember 30, 1970
Citations
Public law 91-601
Statutes at Large 84  Stat.   1670
Codification
Titles amended
U.S.C. sections created 15 U.S.C. ch. 39A § 1471 et seq.
U.S.C. sections amended
Legislative history
  • Introduced in the Senate as S. 2162 by Warren Magnuson (DWA) on May 6, 1970
  • Committee consideration by Senate Interstate and Foreign Commerce
  • Passed the Senate on May 11, 1970 (Passed)
  • Passed the House on December 7, 1970 (Passed)
  • Reported by the joint conference committee on December 15, 1970; agreed to by the Senate on December 16, 1970 (Agreed) and by the House on December 16, 1970 (Agreed)
  • Signed into law by President Richard M. Nixon on December 30, 1970

The Poison Prevention Packaging Act of 1970 (PPPA); (Pub. L. 91-601, 84 Stat. 1670-74) was signed into law by U.S. President Richard Nixon on December 30, 1970. It was enacted by the 91st United States Congress. This law required the use of child-resistant packaging for prescription drugs, over-the-counter (OTC) drugs, household chemicals, and other hazardous materials that could be considered dangerous for children.

Contents

Background

Before the PPPA was enacted, unintentional poisonings by both medicines and common household products were considered by most pediatricians to be the leading cause of injury to children aged 5 and under. At that time there were about 500 deaths per year being reported for children aged 5 and under due to accessibility of these chemicals. [1] The purpose of the PPPA was to protect children from ingesting harmful chemicals and prescription medications by accident. After the PPPA was implemented, deaths in children aged 5 and under went down by 1.4 per million. This represented a reduction in the rate of fatalities, up to 45%, from projections of deaths without the presence of child-proof packaging and equated to an average of 24 fewer deaths in children annually. [2]

In 1957, the National Clearinghouse for Poison Control Centers was established with the goal in mind to collect data from different individual poison control centers and provide them with the information needed on the many types of household products involved in childhood poisonings. [1]

Some of the earliest attempts at controlling the problem of poisonings in children came about after World War II. In 1960, the Food and Drug Administration (FDA), in association with the American Medical Association (AMA), drafted what became known as the Hazardous Substances Labeling Act. This law stated that certain products, identified as "hazardous substances" within the meaning of the law, had to carry on their labels specific statements of caution. [1]

Exceptions and exemptions

There are some exceptions to the child-resistant packaging. There were concerns about accessibility of medications to the elderly and handicapped. As such, a manufacturer may package any over-the-counter household substance, subject to a PPPA standard, in a single-size package if the manufacturer also supplies such a substance in packages that comply with such a standard and if the packages of such substance that do not meet such standard bear conspicuous labeling stating: "This package for households without young children" (or "Package Not Child-Resistant" for small packages). [3] As a result, with the exception of prescription drugs, manufacturers of certain household products that are regulated under the PPPA have the option of marketing one size in a conventional package as long as that same product is supplied in a popular-sized package, which is child-resistant. [1]

Some of the main products that are exempted from the PPPA include the following:

Substances requiring special packaging

There is a long list of substances that fall under the authority of the PPPA. These substances include, but are not limited to

  1. Aspirin. Any aspirin-containing product intended for oral administration by humans
  2. Furniture polish. Non-emulsion type liquid furniture polishes containing 10% or more of mineral seal oil and/or other petroleum distillates, other than those packaged in pressurized spray containers.
  3. Methyl salicylate. Liquid preparations containing more than 5% by weight of methyl salicylate, other than those packaged in pressurized spray containers.
  4. Controlled drugs. Any product intended for human use that consists in whole or in part of any substance subject to control under the Comprehensive Drug Abuse Prevention and Control Act of 1970 and that is in a dosage form intended for oral administration.
  5. Sodium and/or potassium hydroxide. Household substances in dry forms such as granules, powder, and flakes containing 10% or more by weight of free or chemically deneutralized sodium and/or potassium hydroxide.
  6. Turpentine. Household substances in liquid form containing 10% or more by weight of turpentine.
  7. Kindling and/or illuminating preparations. Prepackaged liquid kindling and/or illuminating preparations, such as lighter fuel for cigarettes, charcoal, torches, and others, which contain 10% or more by weight of petroleum distillates.
  8. Methyl alcohol (methanol). Household substances in liquid form containing 4% or more by weight of methyl alcohol (methanol), other than those packaged in pressurized spray containers.
  9. Sulfuric acid. Household substances containing 10% or more by weight or sulfuric acid, except substances in wet-cell storage batteries.
  10. Prescription drugs. Any drug that is intended for human use that is in a dosage form intended for oral administration and that is required by Federal law to be dispensed only by or upon an oral or written prescription of a practitioner licensed by law to administer such drug except for the following:
    1. Sublingual and chewable forms of isosorbide dinitrate in dosage strengths of 10 mg or less.
    2. Erythromycin ethylsuccinate granules for oral suspension and oral suspensions in packages containing no more than 8 grams of the equivalent of erythromycin.
    3. Anhydrous cholestyramine in powder form.
    4. 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 no more than 50 milliequivalents of potassium per unit dose.
    5. Sodium fluoride drug preparations including liquid and tablet forms containing no more than 110 mg of sodium fluoride per package.
    6. Betamethasone tablets packaged in manufacturers' dispenser packages containing no more than 12.6 mg of betamethasone.
    7. Prednisone in tablet form, when dispensed in packages containing no more than 105 mg.
    8. Methylprednisone in tablet form in packages containing no more than 84 mg of the drug.
    9. Colestipol in powder form in packages containing no more than 5 grams of the drug.
    10. Conjugated estrogen tablets when dispensed in mnemonic packages containing no more than 32 mg of the drug.
  11. Ethylene glycol. Household substances in liquid form containing 10% or more by weight of ethylene glycol packaged on or after June 1, 1974.
  12. Acetaminophen. Any product that is intended for human use in a dosage form intended for oral administration and containing in a single package a total of more than 1 gram of acetaminophen except for the following:
    1. Unflavored acetaminophen containing preparations in powder form, other than those intended for pediatric use, that are packaged in unit doses providing no more than 13 grains of acetaminophen per unit dose.
  13. Ibuprofen. Any product that is intended for human use in a dosage form intended for oral administration and containing 1 gram or more of ibuprofen in a single package. [5]

Related Research Articles

<span class="mw-page-title-main">Recreational use of dextromethorphan</span> Cough suppressant drug susceptible to misuse.

Dextromethorphan, or DXM, a common active ingredient found in many over-the-counter cough suppressant cold medicines, is used as a recreational drug and entheogen for its dissociative effects. It has almost no psychoactive effects at medically recommended doses. However, dextromethorphan has powerful dissociative properties when administered in doses well above those considered therapeutic for cough suppression. Recreational use of DXM is sometimes referred to in slang form as "robo-tripping", whose prefix derives from the Robitussin brand name, or "Triple Cs", which derives from the Coricidin brand whose tablets are printed with "CC+C" for "Coricidin Cough and Cold". However, this brand presents additional danger when used at recreational doses due to the presence of chlorpheniramine.

<span class="mw-page-title-main">Tablet (pharmacy)</span> Drug delivery form in which the ingredients are solidified for later consumption

A tablet is a pharmaceutical oral dosage form or solid unit dosage form. Tablets may be defined as the solid unit dosage form of medication with suitable excipients. It comprises a mixture of active substances and excipients, usually in powder form, that are pressed or compacted into a solid dose. The main advantages of tablets are that they ensure a consistent dose of medicine that is easy to consume.

<span class="mw-page-title-main">Paracetamol</span> Common medication for pain and fever

Paracetamol (acetaminophen) is a non-opioid analgesic and antipyretic agent used to treat fever and mild to moderate pain. It is a widely used over the counter medication. Common brand names include Tylenol and Panadol.

<span class="mw-page-title-main">Dihydrocodeine</span> Opioid

Dihydrocodeine is a semi-synthetic opioid analgesic prescribed for pain or severe dyspnea, or as an antitussive, either alone or compounded with paracetamol (acetaminophen) or aspirin. It was developed in Germany in 1908 and first marketed in 1911.

<span class="mw-page-title-main">Potassium iodide</span> Ionic compound (KI)

Potassium iodide is a chemical compound, medication, and dietary supplement. It is a medication used for treating hyperthyroidism, in radiation emergencies, and for protecting the thyroid gland when certain types of radiopharmaceuticals are used. In the third world it is also used for treating skin sporotrichosis and phycomycosis. It is a supplement used by people with low dietary intake of iodine. It is administered orally.

<span class="mw-page-title-main">Excedrin (brand)</span> Over-the-counter headache pain reliever

Excedrin is an over-the-counter headache pain reliever, typically in the form of tablets or caplets. It contains paracetamol (acetaminophen), aspirin, and caffeine. It was manufactured by Bristol-Myers Squibb until it was purchased by Novartis in July 2005 along with other products from BMS's over-the-counter business. As of March 2015, GSK holds majority ownership of Excedrin through a joint venture transaction with Novartis. On 18 July 2022, GSK spun off its consumer healthcare business to Haleon.

<span class="mw-page-title-main">Dextropropoxyphene</span> Withdrawn opioid medication

Dextropropoxyphene is an analgesic in the opioid category, patented in 1955 and manufactured by Eli Lilly and Company. It is an optical isomer of levopropoxyphene. It is intended to treat mild pain and also has antitussive and local anaesthetic effects. The drug has been taken off the market in Europe and the US due to concerns of fatal overdoses and heart arrhythmias. It is still available in Australia, albeit with restrictions after an application by its manufacturer to review its proposed banning. Its onset of analgesia is said to be 20–30 minutes and peak effects are seen about 1.5–2.0 hours after oral administration.

A polypill or single pill combination (SPC) is a type of drug combination consisting of a single drug product in pill form and thus combines multiple medications. The prefix "poly" means "multiple", referring to the multiplicity of distinct drugs in a given "pill". In precise usage, a pill is a polypill if it contains at least 4 drugs. An occasional synonym is combopill. A polypill is commonly targets treatment or prevention of chronic conditions.

<span class="mw-page-title-main">Losartan</span> Blood pressure medication

Losartan, sold under the brand name Cozaar among others, is a medication used to treat high blood pressure (hypertension). It is in the angiotensin receptor blocker (ARB) family of medication, and is considered protective of the kidneys. Besides hypertension, it is also used in diabetic kidney disease, heart failure, and left ventricular enlargement. It comes as a tablet that is taken by mouth. It may be used alone or in addition to other blood pressure medication. Up to six weeks may be required for the full effects to occur.

An enteric coating is a polymer barrier applied to oral medication that prevents its dissolution or disintegration in the gastric environment. This helps by either protecting drugs from the acidity of the stomach, the stomach from the detrimental effects of the drug, or to release the drug after the stomach. Some drugs are unstable at the pH of gastric acid and need to be protected from degradation. Enteric coating is also an effective method to obtain drug targeting. Other drugs such as some anthelmintics may need to reach a high concentration in a specific part of the intestine. Enteric coating may also be used during studies as a research tool to determine drug absorption. Enteric-coated medications pertain to the "delayed action" dosage form category. Tablets, mini-tablets, pellets and granules are the most common enteric-coated dosage forms.

<span class="mw-page-title-main">Corvalol</span> Tranquilizer based with herbs Valerian, hops, peppermint & phenobarbital, a barbiturate

Corvalol is a tranquilizer based on the herb valerian root, as well peppermint oil Mentha piperita and hop extract Humulus lupulus and the barbiturate phenobarbital, popular in Eastern Europe and the former Soviet Union as a heart medication. It is available as a transparent liquid with a characteristic strong aroma, and as white bi-concave scored tablets. While not available for sale in the Western countries, Corvalol is sometimes brought over from Eastern Europe for self-administration to other countries of residence. Corvalol contains documented amounts of psychoactive chemicals, and may interact with other prescription medications that a person is taking.

<span class="mw-page-title-main">Dipipanone</span> Opioid analgesic drug

Dipipanone, sold under the brand names of Pipadone and Diconal is a strong opioid analgesic drug, used for acute pain by mouth (PO) for adults. It is often used in instances where morphine is indicated but cannot be used due to the patient being allergic to morphine. In analgesic potency 25 mg dipipanone is approximately equivalent to 10 mg morphine.

<span class="mw-page-title-main">Co-dydramol</span> Combination drug

Co-dydramol (BAN) is a non-proprietary name used to denote a particular compound analgesic, a combination of dihydrocodeine tartrate and paracetamol. Co-dydramol tablets are used for the relief of moderate pain. Co-dydramol is part of a series of combination drugs available in the UK and other countries including co-codaprin.

<span class="mw-page-title-main">Pill splitting</span>

Pill-splitting refers to the practice of splitting a tablet or pill to provide a lower dose of the active ingredient, or to obtain multiple smaller doses, either to reduce cost or because the pills available provide a larger dose than required. Many pills that are suitable for splitting come pre-scored so that they may easily be halved.

Dosage forms are pharmaceutical drug products in the form in which they are marketed for use, with a specific mixture of active ingredients and inactive components (excipients), in a particular configuration, and apportioned into a particular dose. For example, two products may both be amoxicillin, but one is in 500 mg capsules and another is in 250 mg chewable tablets. The term unit dose can also sometimes encompass non-reusable packaging as well, although the FDA distinguishes that by unit-dose "packaging" or "dispensing". Depending on the context, multi(ple) unit dose can refer to distinct drug products packaged together, or to a single drug product containing multiple drugs and/or doses. The term dosage form can also sometimes refer only to the pharmaceutical formulation of a drug product's constituent drug substance(s) and any blends involved, without considering matters beyond that. Because of the somewhat vague boundaries and unclear overlap of these terms and certain variants and qualifiers within the pharmaceutical industry, caution is often advisable when conversing with someone who may be unfamiliar with another person's use of the term.

<span class="mw-page-title-main">Hydrocodone/paracetamol</span> Combination pain relief drug

Hydrocodone/paracetamol is the combination of the pain medications hydrocodone and paracetamol (acetaminophen). It is used to treat moderate to severe pain. It is taken by mouth. Recreational use is common in the United States.

<span class="mw-page-title-main">Codeine</span> Opiate and prodrug of morphine used to treat pain

Codeine is an opiate and prodrug of morphine mainly used to treat pain, coughing, and diarrhea. It is also commonly used as a recreational drug. It is found naturally in the sap of the opium poppy, Papaver somniferum. It is typically used to treat mild to moderate degrees of pain. Greater benefit may occur when combined with paracetamol (acetaminophen) or a nonsteroidal anti-inflammatory drug (NSAID) such as aspirin or ibuprofen. Evidence does not support its use for acute cough suppression in children. In Europe, it is not recommended as a cough medicine in those under 12 years of age. It is generally taken by mouth. It typically starts working after half an hour, with maximum effect at two hours. Its effects last for about four to six hours. Codeine exhibits abuse potential similar to other opioid medications, including a risk of habituation and overdose.

<span class="mw-page-title-main">Paracetamol poisoning</span> Toxicity due to paracetamol overdose

Paracetamol poisoning, also known as acetaminophen poisoning, is caused by excessive use of the medication paracetamol (acetaminophen). Most people have few or non-specific symptoms in the first 24 hours following overdose. These symptoms include feeling tired, abdominal pain, or nausea. This is typically followed by absence of symptoms for a couple of days, after which yellowish skin, blood clotting problems, and confusion occurs as a result of liver failure. Additional complications may include kidney failure, pancreatitis, low blood sugar, and lactic acidosis. If death does not occur, people tend to recover fully over a couple of weeks. Without treatment, death from toxicity occurs 4 to 18 days later.

<span class="mw-page-title-main">Hydrocodone/ibuprofen</span> Combination drug

Hydrocodone/ibuprofen (INNs), sold under the brand name Vicoprofen, is a fixed-dose combination analgesic medication used in short-term therapy to relieve severe pain. Vicoprofen combines the analgesic and antitussive properties of hydrocodone with the analgesic, anti-inflammatory, and antipyretic properties of ibuprofen. In contrast to hydrocodone/acetaminophen combination analgesics such as Vicodin, this hydrocodone/ibuprofen avoids some of the liver toxicity which may occur from acetaminophen, but still presents significant dangers in hydrocodone overdose, namely respiratory depression. Vicoprofen is supplied in a fixed dose combination tablet which contains hydrocodone bitartrate, USP 7.5 mg with ibuprofen, USP 200 mg. Additional strengths of generic Vicoprofen are now available, in combinations of 5 mg/200 mg and 10 mg/200 mg respectively.

<span class="mw-page-title-main">Benzhydrocodone</span> Chemical compound

Benzhydrocodone (INN) is an opioid prodrug of the morphinan class. Its chemical structure consists of hydrocodone coupled with benzoic acid. Benzhydrocodone itself is inactive and acts as a prodrug to hydrocodone upon cleavage of the benzoate portion of the molecule.

References

  1. 1 2 3 4 "The History of Poison Prevention" (PDF). Arizona State Board of Pharmacy. Archived from the original (PDF) on April 13, 2012. Retrieved April 24, 2013.
  2. "Poison Prevention Packaging Act of 1970". Federal Pharmacy Law. rx-wiki.org. Retrieved April 24, 2013.
  3. "Poison Prevention Packaging: A Guide For Healthcare Professionals" (PDF). U.S. Consumer Product Safety Commission. 2005. Retrieved April 24, 2013.
  4. Suzanne Barone, Ph.D. (March 16, 2005). "PPPA Petitions for Exemption" (PDF). U.S. Consumer Product Safety Commission. Retrieved April 24, 2013.
  5. "16 CFR 1700" . Retrieved April 24, 2013.