Podcast
Questions and Answers
What does the term 'package' specifically exclude in its definition?
What does the term 'package' specifically exclude in its definition?
- Containers designed for convenience of storage
- Any product container that is reusable
- Shipping containers used solely for transporting substances (correct)
- Any outer container used for marketing purposes
What is the primary purpose of special packaging as defined in the content?
What is the primary purpose of special packaging as defined in the content?
- To reduce the overall cost of packaging
- To make packaging aesthetically pleasing for consumers
- To ensure children under 5 cannot open it at all
- To prevent children from obtaining toxic amounts of the substance (correct)
Which criteria must the Consumer Product Safety Commission consider when establishing standards for special packaging?
Which criteria must the Consumer Product Safety Commission consider when establishing standards for special packaging?
- The sensory appeal of the household substance
- Prior legal claims against manufacturers
- The potential attractiveness of the packaging to children (correct)
- Consumer feedback on existing packaging
Under what circumstances can the Commission establish regulations for special packaging?
Under what circumstances can the Commission establish regulations for special packaging?
What type of packaging is excluded from being labeled as special packaging?
What type of packaging is excluded from being labeled as special packaging?
What constitutes 'labeling' in the context of household substances?
What constitutes 'labeling' in the context of household substances?
What is the significance of the effective date stated in the regulations regarding child protection packaging standards?
What is the significance of the effective date stated in the regulations regarding child protection packaging standards?
Why must the Commission consider manufacturing practices when establishing packaging standards?
Why must the Commission consider manufacturing practices when establishing packaging standards?
Which organization holds the authority under the Poison Prevention Packaging Act of 1970?
Which organization holds the authority under the Poison Prevention Packaging Act of 1970?
What does the term 'Act' refer to in the context of this regulation?
What does the term 'Act' refer to in the context of this regulation?
Which entity is designated as the 'Commission' in the definitions provided?
Which entity is designated as the 'Commission' in the definitions provided?
What is the definition of a 'dietary supplement' according to this regulation?
What is the definition of a 'dietary supplement' according to this regulation?
Which of the following best describes a 'household substance' as per the definitions provided?
Which of the following best describes a 'household substance' as per the definitions provided?
Under which act is the definition of a 'hazardous substance' referenced for household substances?
Under which act is the definition of a 'hazardous substance' referenced for household substances?
What type of products are excluded from the definition of 'dietary supplement'?
What type of products are excluded from the definition of 'dietary supplement'?
What is the primary purpose of the Poison Prevention Packaging Act of 1970?
What is the primary purpose of the Poison Prevention Packaging Act of 1970?
What is the maximum duration after which the effective date for a standard can be implemented as per section 9 of the act?
What is the maximum duration after which the effective date for a standard can be implemented as per section 9 of the act?
Which of the following labeling statements is required on noncomplying packages as per § 1700.5?
Which of the following labeling statements is required on noncomplying packages as per § 1700.5?
Which of the following substances is included in the definition of a 'household substance'?
Which of the following substances is included in the definition of a 'household substance'?
Under what condition can noncomplying packaging be used for household substances?
Under what condition can noncomplying packaging be used for household substances?
What is the minimum type size for lettering on packages with a principal display panel area of more than 25 square inches?
What is the minimum type size for lettering on packages with a principal display panel area of more than 25 square inches?
How should the required labeling statement be formatted according to § 1700.5?
How should the required labeling statement be formatted according to § 1700.5?
What is the purpose of implementing noncomplying packaging requirements?
What is the purpose of implementing noncomplying packaging requirements?
What action must the Commission take if an earlier effective date is determined to be in the public interest?
What action must the Commission take if an earlier effective date is determined to be in the public interest?
What is the required height of the labeling statement for packages with a principal display panel area of 7 square inches or less?
What is the required height of the labeling statement for packages with a principal display panel area of 7 square inches or less?
What must occur after the promulgation of a standard for it to take effect?
What must occur after the promulgation of a standard for it to take effect?
Which aspect is NOT a requirement for the labeling of noncomplying packages?
Which aspect is NOT a requirement for the labeling of noncomplying packages?
What percentage by weight of turpentine in a household substance necessitates special packaging requirements?
What percentage by weight of turpentine in a household substance necessitates special packaging requirements?
Which of the following substances requires packaging in accordance with provisions when it contains 4 percent or more by weight?
Which of the following substances requires packaging in accordance with provisions when it contains 4 percent or more by weight?
What specific dosage form is an exception to the packaging requirements for prescription drugs under federal law?
What specific dosage form is an exception to the packaging requirements for prescription drugs under federal law?
Which household substance, when containing 10 percent or more by weight, must follow packaging specifications outlined in § 1700.15 (a) and (b)?
Which household substance, when containing 10 percent or more by weight, must follow packaging specifications outlined in § 1700.15 (a) and (b)?
Which of these is NOT included in the exceptions for prescription drugs regarding packaging stipulations?
Which of these is NOT included in the exceptions for prescription drugs regarding packaging stipulations?
For household substances containing sodium or potassium hydroxide, what is the minimum weight percentage that triggers special packaging requirements?
For household substances containing sodium or potassium hydroxide, what is the minimum weight percentage that triggers special packaging requirements?
Which of the following types of liquid preparations must be packaged according to § 1700.15 (a) and (b) if they contain 10 percent or more by weight of petroleum distillates?
Which of the following types of liquid preparations must be packaged according to § 1700.15 (a) and (b) if they contain 10 percent or more by weight of petroleum distillates?
What is the maximum concentration of sodium fluoride in liquid forms to be exempt from packaging requirements?
What is the maximum concentration of sodium fluoride in liquid forms to be exempt from packaging requirements?
What is the viscosity requirement for liquid kindling preparations to be subject to specified packaging regulations?
What is the viscosity requirement for liquid kindling preparations to be subject to specified packaging regulations?
Which household substance must be packaged under the provisions of § 1700.15 (a) and (b) if containing 10 percent or more by weight?
Which household substance must be packaged under the provisions of § 1700.15 (a) and (b) if containing 10 percent or more by weight?
What is the method for determining the area of the principal display panel for a rectangular package?
What is the method for determining the area of the principal display panel for a rectangular package?
Which of the following best describes the area to be calculated for cylindrical containers?
Which of the following best describes the area to be calculated for cylindrical containers?
When calculating the area of a principal display panel, which feature should be excluded?
When calculating the area of a principal display panel, which feature should be excluded?
What substitute statement may be used if the principal display panel is too small for the required labeling statement?
What substitute statement may be used if the principal display panel is too small for the required labeling statement?
What is the packaging requirement for nonemulsion liquid furniture polishes containing 10 percent or more of mineral seal oil?
What is the packaging requirement for nonemulsion liquid furniture polishes containing 10 percent or more of mineral seal oil?
For which of the following substances is special packaging not required?
For which of the following substances is special packaging not required?
Which of the following is a requirement for replaceable statements on small principal display panels?
Which of the following is a requirement for replaceable statements on small principal display panels?
What is the required packaging for aspirin-containing preparations for human use?
What is the required packaging for aspirin-containing preparations for human use?
What aspect of a container's surface is considered when identifying its principal display panel area?
What aspect of a container's surface is considered when identifying its principal display panel area?
Which is NOT considered part of the area of the principal display panel?
Which is NOT considered part of the area of the principal display panel?
What is the minimum percentage by weight of compounds that requires prepackaged liquid solvents for paints to adhere to specific packaging provisions?
What is the minimum percentage by weight of compounds that requires prepackaged liquid solvents for paints to adhere to specific packaging provisions?
Which of the following acetaminophen preparations are exempt from specific packaging provisions?
Which of the following acetaminophen preparations are exempt from specific packaging provisions?
What is the threshold amount of diphenhydramine that mandates special packaging requirements?
What is the threshold amount of diphenhydramine that mandates special packaging requirements?
Which of the following products must adhere to special packaging requirements due to acetonitrile content?
Which of the following products must adhere to special packaging requirements due to acetonitrile content?
What is the maximum quantity of sodium bromate allowed in home permanent wave neutralizers to avoid special packaging?
What is the maximum quantity of sodium bromate allowed in home permanent wave neutralizers to avoid special packaging?
Which of the following describes the conditions under which ibuprofen preparations need to follow specific packaging provisions?
Which of the following describes the conditions under which ibuprofen preparations need to follow specific packaging provisions?
What is the specific quantity of loperamide in a single package that requires compliance with specific packaging regulations?
What is the specific quantity of loperamide in a single package that requires compliance with specific packaging regulations?
Under what condition is mouthwash exempt from special packaging provisions regarding ethanol content?
Under what condition is mouthwash exempt from special packaging provisions regarding ethanol content?
What is the allowable amount of lidocaine in a single package before special packaging requirements kick in?
What is the allowable amount of lidocaine in a single package before special packaging requirements kick in?
Which of the following drugs must be packaged according to the provisions of § 1700.15 (a), (b), and (c) due to containing high amounts of elemental iron?
Which of the following drugs must be packaged according to the provisions of § 1700.15 (a), (b), and (c) due to containing high amounts of elemental iron?
What is the maximum allowable amount of Norethindrone Acetate Tablets that can be dispensed in mnemonic packaging?
What is the maximum allowable amount of Norethindrone Acetate Tablets that can be dispensed in mnemonic packaging?
Which of the following substances is exempt from the packaging provisions outlined for iron-containing drugs?
Which of the following substances is exempt from the packaging provisions outlined for iron-containing drugs?
Which type of preparation containing iron is specifically excluded from the requirements for packaging outlined in § 1700.15?
Which type of preparation containing iron is specifically excluded from the requirements for packaging outlined in § 1700.15?
What is the maximum amount of Erythromycin ethylsuccinate that can be contained in a package?
What is the maximum amount of Erythromycin ethylsuccinate that can be contained in a package?
Which of the following drugs requires adherence to special packaging requirements outlined in § 1700.14(a)(10)?
Which of the following drugs requires adherence to special packaging requirements outlined in § 1700.14(a)(10)?
At what concentration must dietary supplements containing iron be packaged according to § 1700.15?
At what concentration must dietary supplements containing iron be packaged according to § 1700.15?
Which of the following drugs has a specific maximum weight requirement of 3.75 grams in powder form for packaging?
Which of the following drugs has a specific maximum weight requirement of 3.75 grams in powder form for packaging?
What is the maximum tablet amount of Methylprednisolone that can be dispensed according to the specified packaging regulations?
What is the maximum tablet amount of Methylprednisolone that can be dispensed according to the specified packaging regulations?
Which preparation is packaged as a solution of glycerol and water and is regulated under § 1700.14?
Which preparation is packaged as a solution of glycerol and water and is regulated under § 1700.14?
What is the packaging requirement for dibucaine products containing more than 0.5 mg in a single package?
What is the packaging requirement for dibucaine products containing more than 0.5 mg in a single package?
Which of the following substances requires packaging compliance with § 1700.15 for contents exceeding 50 mg in a single retail package?
Which of the following substances requires packaging compliance with § 1700.15 for contents exceeding 50 mg in a single retail package?
How much minoxidil in a single retail package triggers the need for special packaging?
How much minoxidil in a single retail package triggers the need for special packaging?
For liquid household products containing methacrylic acid, what percentage specifies the need for special packaging?
For liquid household products containing methacrylic acid, what percentage specifies the need for special packaging?
What classification applies to OTC drug products intended for oral administration that contain previously prescription-only ingredients?
What classification applies to OTC drug products intended for oral administration that contain previously prescription-only ingredients?
What is the threshold volume for fluoride-containing household substances that necessitates compliance with packaging requirements?
What is the threshold volume for fluoride-containing household substances that necessitates compliance with packaging requirements?
In what scenario is the special packaging requirement for OTC drug products waived?
In what scenario is the special packaging requirement for OTC drug products waived?
What should be true for absorbent materials containing methacrylic acid within a dispenser to be exempt from packaging requirements?
What should be true for absorbent materials containing methacrylic acid within a dispenser to be exempt from packaging requirements?
What needs to be followed if an OTC drug product's active ingredient was previously prescription-only?
What needs to be followed if an OTC drug product's active ingredient was previously prescription-only?
Which statement accurately defines the term 'active ingredient' under the specified regulations?
Which statement accurately defines the term 'active ingredient' under the specified regulations?
Study Notes
Overview of Poison Prevention Packaging (Part 1700)
- The Poison Prevention Packaging Act was enacted on December 30, 1970, to protect children from serious injuries due to hazardous household substances.
- Authority for this regulation is granted to the Consumer Product Safety Commission (CPSC) under the Consumer Product Safety Act.
Key Definitions
- Household Substance: Includes hazardous substances as defined in the Federal Hazardous Substances Act and any substance commonly used or stored in households.
- Special Packaging: Designed to be difficult for children under 5 to open, while remaining accessible to normal adults.
- Labeling: Refers to all forms of written or graphic matter on a household substance or its package.
Establishment of Standards
- The CPSC may establish special packaging standards if it determines that the substance poses a hazard to children.
- Standards must be technically feasible and suitable for the specific household substances considered.
- Factors considered include reasonable safety standards and available scientific data on childhood accidents and injuries.
Packaging Regulations
- New child protection packaging standards cannot take effect sooner than 180 days from their regulation announcement and must be applied only to products packaged after that date.
- Manufacturers can create noncomplying packages for elderly or handicapped individuals under certain labeling conditions, ensuring they are not suitable for homes with young children.
Labeling of Noncomplying Packages
- Clear labeling is required, including messages like "This Package for Households Without Young Children."
- Labeling standards incorporate size specifications based on the area of the principal display panel of the package.
- In cases where the package is too small for the full warning, a substitute statement, "Package Not Child-Resistant," may be applied.
Substances Requiring Special Packaging
- Specific substances identified that must follow special packaging requirements include:
- Aspirin: Generally requires special packaging, with exceptions for certain low-dose preparations.
- Controlled drugs: Must be packaged under the special requirements if intended for oral administration.
- Household Chemicals: Such as sodium hydroxide, methyl salicylate, turpentine, and sulfuric acid, each having specific packaging regulations.
Important Exemptions
- Certain forms of prescription drugs and specific household substances are exempt from special packaging if they meet defined criteria.
- Exemptions include specific dosage forms of nitroglycerin and hormonal therapies in controlled packaging.
Implementation and Compliance
- Compliance with the defined packaging standards is mandatory for manufacturers and packers.
- Ongoing studies and consultations are utilized to update and refine packaging requirements as needed based on new data and societal safety needs.
These notes encapsulate essential information regarding the Poison Prevention Packaging Act, dosage forms, specific substances, and essential regulatory considerations aimed at reducing risks to children from hazardous household materials.### Iron-Containing Drugs
- Noninjectable animal/human drugs with 250 mg or more of elemental iron must comply with packaging standards.
- Specific concentrations: liquids require 0.025% iron (w/v), non-liquids require 0.05% (w/w).
- Exemptions for preparations where iron is used only as a colorant or powdered forms with ≤0.12% iron.
Dietary Supplements
- Supplements with 250 mg or more elemental iron must adhere to stringent packaging regulations.
- Concentration thresholds for supplements remain the same as for iron-containing drugs.
Paint Solvents
- Liquids with ≥10% of specific solvents (benzene, toluene, xylene, etc.) must be packaged following established guidelines.
Acetaminophen
- Preparations containing over 1 gram of acetaminophen need to adhere to special packaging rules.
- Exemptions for effervescent formulations meeting specific criteria and unit-dose powders containing ≤13 grains.
Diphenhydramine
- Products with >66 mg diphenhydramine require compliance with packaging standards since February 1985.
Glueremovers
- Liquid glue removers containing more than 500 mg of acetonitrile must follow packaging regulations.
Permanent Wave Neutralizers
- Liquid products containing >600 mg sodium bromate or >50 mg potassium bromate must comply with packaging standards.
Ibuprofen
- Preparations with ≥1,000 mg ibuprofen need special packaging compliance.
Loperamide
- Products containing >0.045 mg loperamide must be packaged according to specific guidelines.
Mouthwash
- Mouthwash containing ≥3 grams of ethanol requires special packaging unless it meets specific composition and dispensing criteria regarding flavored oils and pump actuations.
Lidocaine and Dibucaine
- Lidocaine products with >5.0 mg and dibucaine products with >0.5 mg must be packaged following established regulations.
Naproxen and Ketoprofen
- Naproxen preparations with ≥250 mg and ketoprofen preparations with >50 mg must comply with packaging standards.
Fluoride
- Household products containing >50 mg fluoride or >0.5% concentration must adhere to packaging requirements.
Minoxidil
- Preparations with >14 mg minoxidil must comply with packaging rules, including related applicator devices.
Methacrylic Acid
- Liquids with >5% methacrylic acid must follow packaging regulations, except for those in specific absorbent dispensers.
Over-the-Counter Drug Products
- OTC drugs with previously prescribed active ingredients require special packaging regardless of concentration changes.
- Active ingredient defined as any component for pharmacological effects or bodily function.
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Description
This quiz covers the Poison Prevention Packaging Act of 1970, including definitions and key components of the regulations established to protect consumers. Test your knowledge on the Act and its implications for packaging and safety standards. Learn about the role of the Consumer Product Safety Commission in enforcing these regulations.
