Long title | An 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. |
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Nicknames | Federal Hazardous Substances Act Amendment of 1970 |
Enacted by | the 91st United States Congress |
Effective | December 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 |
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Legislative history | |
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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.
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]
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:
There is a long list of substances that fall under the authority of the PPPA. These substances include, but are not limited to
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.