《预防中毒包装法案》
Poison Prevention Packaging Act
作者信息
Bakshi Arjun, Patel Preeti
机构信息
Mercer University School of Medicine
出版信息
The Poison Prevention Packaging Act (PPPA) was established in 1970 by President Richard Nixon. The law’s primary goal is to ensure child safety by preventing accidental ingestion of harmful chemicals. The law states items such as prescription drugs, over-the-counter (OTC) drugs, household chemicals, and other hazardous products must utilize child-resistant packaging. The nature of this packaging would avert children of the age of five and younger from easy access and provide a protected container. This has proven to avoid inadvertent prescription poisonings. This law has impacted numerous parties, including children, the elderly, and persons with disabilities. However, retrospective concerns have been drawn that the elderly and the disabled may struggle to open their medication due to the packaging style. As a result, several supplemental changes have been enacted that allow certain medications to exempt the restrictions under the Poison Prevention Packaging Act. These changes have been made in the best interest of the patient, patient’s family, and national safety at the core of the discussion. As a direct result of the PPPA, children 5 years of age and under deaths decreased by 1.4 per million. As listed on the legislative portion on Title 15 of the United States Code of Commerce and Trade, the bill includes but is not limited to the following substances: The Commission has determined that the degree or nature of the hazard to children in the availability of the following substances, because of their packaging, is such that special packaging meeting the requirements of § 1700.20(a) is required to protect children from serious personal injury or serious illness resulting from the handling, using, or ingesting such substances, and the special packaging herein required is technically feasible, practicable, and appropriate for these substances: Any aspirin-containing preparation for human use in a dosage form intended for oral administration shall be packaged in accordance with the provisions of § 1700.15 (a), (b), and (c), except the following: (i) Effervescent tablets containing aspirin, other than those intended for pediatric use, provided the dry tablet contains not more than 15 percent aspirin and has an oral LD-50 in rats of 5 grams or more per kilogram of body weight. (ii) Unflavored aspirin-containing preparations in powder form (other than those intended for pediatric use) that are packaged in unit doses providing not more than 15.4 grains of aspirin per unit dose and that contain no other substance subject to the provisions of this section. : Nonemulsion type liquid furniture polishes containing 10 percent or more of mineral seal oil and/or other petroleum distillates and having a viscosity of less than 100 Saybolt universal seconds at 100 °F., other than those packaged in pressurized spray containers, shall be packaged in accordance with the provisions of § 1700.15 (a), (b), and (d). Liquid preparations containing more than 5 percent by weight of methyl salicylate, other than those packaged in pressurized spray containers, shall be packaged in accordance with the provisions of § 1700.15 (a), (b), and (c). Any preparation 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 (21 U.S.C. 801 et seq.) and that is in a dosage form intended for oral administration shall be packaged in accordance with the provisions of § 1700.15 (a), (b), and (c). Household substances in dry forms such as granules, powder, and flakes, containing 10 percent or more by weight of free or chemically unneutralized sodium and/or potassium hydroxide, and all other household substances containing 2 percent or more by weight of free or chemically unneutralized sodium and/or potassium hydroxide, shall be packaged in accordance with the provisions of § 1700.15 (a) and (b). Household substances in liquid form containing 10 percent or more by weight of turpentine shall be packaged in accordance with the provisions of § 1700.15 (a) and (b). Prepackaged liquid kindling and/or illuminating preparations, such as cigarette lighter fuel, charcoal lighter fuel, camping equipment fuel, torch fuel, and fuel for decorative or functional lanterns, which contain 10 percent or more by weight of petroleum distillates and have a viscosity of less than 100 Saybolt universal seconds at 100 °F., shall be packaged in accordance with the provisions of § 1700.15 (a) and (b). : Household substances in liquid form containing 4 percent or more by weight of methyl alcohol (methanol), other than those packaged in pressurized spray containers, shall be packaged in accordance with the provisions of § 1700.15 (a) and (b). Household substances containing 10 percent or more by weight of sulfuric acid, except such substances in wet-cell storage batteries, shall be packaged in accordance with the provisions of § 1700.15 (a) and (b). Any drug 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 shall be packaged in accordance with the provisions of § 1700.15 (a), (b), and (c). Household substances in liquid form containing 10 percent or more by weight of ethylene glycol packaged on or after June 1, 1974, except those articles exempted by 16 CFR 1500.83, shall be packaged in accordance with the provisions of § 1700.15 (a) and (b). With the exception of (i) Animal feeds used as vehicles for the administration of drugs, and (ii) those preparations in which iron is present solely as a colorant, noninjectable animal and human drugs providing iron for therapeutic or prophylactic purposes, and containing a total amount of elemental iron, from any source, in a single package, equivalent to 250 mg or more elemental iron in a concentration of 0.025 percent or more on a weight to volume basis for liquids and 0.025 percent or more on a weight to volume basis for liquids and 0.05 percent or more on a weight-to-weight basis for nonliquids (e.g., powders, granules, tablets, capsules, wafers, gels, viscous products, such as pastes and ointments, etc.) shall be packaged in accordance with the provisions of § 1700.15 (a), (b), and (c). Dietary supplements, as defined in § 1700.1(a)(3), that contain an equivalent of 250 mg or more of elemental iron, from any source, in a single package in concentrations of 0.025 percent or more on a weight-to-volume basis for liquids and 0.05 percent or more on a weight-to-weight basis for nonliquids (e.g., powders, granules, tablets, capsules, wafers, gels, viscous products, such as pastes and ointments, etc.) shall be packaged in accordance with the provisions of § 1700.15 (a), (b), and (c), except for the following: (i) Preparations in which iron is present solely as a colorant; and (ii) Powdered preparations with no more than the equivalent of 0.12 percent weight-to-weight elemental iron. These products come in topical form l preparations are sold with applicators (i.e., droppers or spray pumps) that require special packaging for the lifetime of the product. Prepackaged liquid solvents (such as removers, thinners, brush cleaners, etc.) for paints or other similar surface-coating materials (such as varnishes and lacquers) that contain 10 percent or more by weight of benzene (also known as benzol), toluene (also known as toluol), xylene (also known as xylol), petroleum distillates (such as gasoline, kerosene, mineral seal oil, mineral spirits, naphtha, and Stoddard solvent, etc.), or combinations thereof, and that have a viscosity of less than 100 Saybolt universal seconds at 100 °F., shall be packaged in accordance with the provisions of § 1700.15 (a) and (b). Preparations for human use in a dosage form intended for oral administration and containing in a single package a total of more than one gram acetaminophen shall be packaged in accordance with the provisions of § 1700.15 (a), (b), and (c), except the following - (i) Effervescent tablets or granules containing acetaminophen, provided the dry tablet or granules contain less than 15 percent acetaminophen, the tablet or granules have an oral LD-50 of 5 grams or greater per kilogram of body weight, and the tablet or granules contain no other substance subject to the provisions of this section. (ii) Unflavored acetaminophen-containing preparations in powder form (other than those intended for pediatric use) that are packaged in unit doses providing not more than 13 grains of acetaminophen per unit dose and that contain no other substance subject to this § 1700.14(a). Preparations for human use in a dosage form intended for oral administration and containing more than the equivalent of 66 mg diphenhydramine base in a single package shall be packaged in accordance with the provisions of § 1700.15 (a), (b), and (c), if packaged on or after February 11, 1985. Household glue removers in a liquid form containing more than 500 mg of acetonitrile in a single container. : Home permanent wave neutralizers, in a liquid form, contain more than 600 mg of sodium bromate or more than 50 mg of potassium bromate in a single container. Ibuprofen preparations for human use in a dosage form intended for oral administration and containing one gram (1,000 mg) or more of ibuprofen in a single package shall be packaged in accordance with the provisions of § 1700.15 (a), (b), and (c).
《预防中毒包装法案》(PPPA)于1970年由理查德·尼克松总统签署确立。该法律的主要目标是通过防止意外摄入有害化学物质来确保儿童安全。法律规定,处方药、非处方药(OTC)、家用化学品及其他危险产品必须采用儿童安全包装。这种包装的特性能够防止五岁及以下儿童轻易获取,并提供一个有保护作用的容器。这已被证明可避免意外的处方药物中毒情况发生。该法律对包括儿童、老年人和残疾人在内的众多群体产生了影响。然而,事后有人担心老年人和残疾人可能会因包装形式而难以打开他们的药物。因此,已颁布了几项补充性变更,允许某些药物豁免《预防中毒包装法案》的限制。这些变更是在以患者、患者家属及国家安全为核心讨论的前提下,出于患者的最佳利益而做出的。作为《预防中毒包装法案》的直接成果,五岁及以下儿童的死亡率每百万下降了1.4例。如美国《商业和贸易法典》第15编的立法部分所列出的,该法案涵盖但不限于以下物质:委员会已认定,鉴于以下物质的包装情况,其对儿童的危害程度或性质使得需要特殊包装以符合§1700.20(a)的要求,从而保护儿童免受因处理、使用或摄入此类物质而导致的严重人身伤害或重病,并且此处要求的特殊包装在技术上是可行的、切实可行的且适用于这些物质:任何供人类使用的、呈口服剂型的含阿司匹林制剂,应按照§1700.15(a)、(b)和(c)的规定进行包装,但以下情况除外:(i) 除用于儿科的泡腾片外,含阿司匹林的泡腾片,前提是干片含阿司匹林不超过15%,且在大鼠中的口服半数致死量为每千克体重5克或更多。(ii) 呈粉末形式(非用于儿科)的无香料含阿司匹林制剂,其单位剂量包装提供的阿司匹林不超过15.4格令,且不含本节规定的其他物质。:非乳液型液体家具上光剂,含有10%或更多的矿物密封油和/或其他石油馏出物,且在100°F时粘度小于100赛波特通用秒,除装在加压喷雾容器中的产品外,应按照§1700.15(a)、(b)和(d)的规定进行包装。含重量超过5%的水杨酸甲酯的液体制剂,除装在加压喷雾容器中的产品外,应按照§1700.15(a)、(b)和(c)的规定进行包装。任何供人类使用的、全部或部分由1970年《综合药物滥用预防和控制法案》(21 U.S.C. 801及后续条款)管制的物质组成且呈口服剂型的制剂,应按照§1700.15(a)、(b)和(c)的规定进行包装。干状家用物质,如颗粒、粉末和薄片,含有10%或更多重量的游离或化学未中和的氢氧化钠和/或氢氧化钾,以及所有其他含2%或更多重量的游离或化学未中和的氢氧化钠和/或氢氧化钾的家用物质,应按照§1700.15(a)和(b)的规定进行包装。含10%或更多重量松节油的液状家用物质,应按照§1700.15(a)和(b)的规定进行包装。预包装的液体引火和/或照明制剂,如打火机燃料、木炭打火机燃料、露营设备燃料、火炬燃料以及装饰或功能性灯笼燃料,含有10%或更多重量的石油馏出物且在100°F时粘度小于100赛波特通用秒,应按照§1700.15(a)和(b)的规定进行包装。:含4%或更多重量甲醇(木醇)的液状家用物质,除装在加压喷雾容器中的产品外,应按照§1700.15(a)和(b)的规定进行包装。含10%或更多重量硫酸的家用物质,除湿电池储存电池中的此类物质外,应按照§1700.15(a)和(b)的规定进行包装。任何供人类使用的、呈口服剂型且联邦法律要求仅由依法授权开具此类药物的从业者凭口头或书面处方配给的药物,应按照§1700.15(a)、(b)和(c)的规定进行包装。1974年6月1日及以后包装的、含10%或更多重量乙二醇的液状家用物质,除16 CFR 1500.83豁免的物品外,应按照§1700.15(a)和(b)的规定进行包装。 除以下情况外:(i) 用作药物给药载体的动物饲料,以及(ii) 铁仅作为着色剂存在的制剂,用于治疗或预防目的且在单个包装中提供来自任何来源的总量相当于250毫克或更多元素铁的非注射用动物和人类药物,对于液体,其浓度按重量体积比为0.025%或更高,对于非液体(如粉末、颗粒、片剂、胶囊、薄片、凝胶、粘性产品,如糊剂和软膏等),其浓度按重量重量比为0.05%或更高,应按照§1700.15(a)、(b)和(c)的规定进行包装。§1700.1(a)(3)所定义的膳食补充剂,在单个包装中含有来自任何来源的相当于250毫克或更多元素铁,对于液体产品,其浓度按重量体积比为0.025%或更高,对于非液体产品,其浓度按重量重量比为0.05%或更高(如粉末、颗粒、片剂、胶囊、薄片、凝胶、粘性产品(如糊剂和软膏等)),应按照§1700.15(a)、(b)和(c)的规定进行包装,但以下情况除外:(i) 铁仅作为着色剂存在的制剂;以及(ii) 重量重量比元素铁含量不超过0.12%的粉末制剂。这些产品为局部用制剂,配有涂抹器(如滴管或喷雾泵),产品在其整个使用期限内需特殊包装。用于油漆或其他类似表面涂层材料(如清漆和漆)的预包装液体溶剂(如去除剂、稀释剂、刷清洁剂等),含有10%或更多重量的苯(也称为安息香)、甲苯(也称为甲苯酚)、二甲苯(也称为二甲苯酚)