Poison Prevention Packaging Regulations

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Questions and Answers

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?

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?

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?

When the hazard to children is significant and packaging adjustments are feasible Signup and view all the answers

What type of packaging is excluded from being labeled as special packaging?

Standard household packaging that is not child-resistant Signup and view all the answers

What constitutes 'labeling' in the context of household substances?

Any written, printed, or graphic matter associated with the substance Signup and view all the answers

What is the significance of the effective date stated in the regulations regarding child protection packaging standards?

It specifies when the new packaging standards must be implemented Signup and view all the answers

Why must the Commission consider manufacturing practices when establishing packaging standards?

To assess the feasibility of implementing new standards Signup and view all the answers

Which organization holds the authority under the Poison Prevention Packaging Act of 1970?

The Consumer Product Safety Commission Signup and view all the answers

What does the term 'Act' refer to in the context of this regulation?

The Poison Prevention Packaging Act of 1970 Signup and view all the answers

Which entity is designated as the 'Commission' in the definitions provided?

Consumer Product Safety Commission Signup and view all the answers

What is the definition of a 'dietary supplement' according to this regulation?

A preparation in varying forms that supplements dietary intake of essential nutrients Signup and view all the answers

Which of the following best describes a 'household substance' as per the definitions provided?

Any substance used in homes that includes hazardous materials or foods Signup and view all the answers

Under which act is the definition of a 'hazardous substance' referenced for household substances?

Federal Hazardous Substances Act Signup and view all the answers

What type of products are excluded from the definition of 'dietary supplement'?

Conventional food Signup and view all the answers

What is the primary purpose of the Poison Prevention Packaging Act of 1970?

To ensure safe packaging for hazardous household substances Signup and view all the answers

What is the maximum duration after which the effective date for a standard can be implemented as per section 9 of the act?

1 year Signup and view all the answers

Which of the following labeling statements is required on noncomplying packages as per § 1700.5?

This Package for Households Without Young Children Signup and view all the answers

Which of the following substances is included in the definition of a 'household substance'?

A substance stored in a portable container for heating purposes Signup and view all the answers

Under what condition can noncomplying packaging be used for household substances?

If complying packaging is also supplied Signup and view all the answers

What is the minimum type size for lettering on packages with a principal display panel area of more than 25 square inches?

1⁄4 inch Signup and view all the answers

How should the required labeling statement be formatted according to § 1700.5?

In distinct contrast to other matter Signup and view all the answers

What is the purpose of implementing noncomplying packaging requirements?

To provide accessibility for elderly or handicapped persons Signup and view all the answers

What action must the Commission take if an earlier effective date is determined to be in the public interest?

Publish the reason in the FEDERAL REGISTER Signup and view all the answers

What is the required height of the labeling statement for packages with a principal display panel area of 7 square inches or less?

1⁄16 inch Signup and view all the answers

What must occur after the promulgation of a standard for it to take effect?

It should not take effect sooner than 180 days Signup and view all the answers

Which aspect is NOT a requirement for the labeling of noncomplying packages?

The statement must be in a circular format Signup and view all the answers

What percentage by weight of turpentine in a household substance necessitates special packaging requirements?

10 percent or more Signup and view all the answers

Which of the following substances requires packaging in accordance with provisions when it contains 4 percent or more by weight?

Methyl alcohol Signup and view all the answers

What specific dosage form is an exception to the packaging requirements for prescription drugs under federal law?

Cyclically administered oral contraceptives Signup and view all the answers

Which household substance, when containing 10 percent or more by weight, must follow packaging specifications outlined in § 1700.15 (a) and (b)?

Turpentine Signup and view all the answers

Which of these is NOT included in the exceptions for prescription drugs regarding packaging stipulations?

Liquid potassium supplements Signup and view all the answers

For household substances containing sodium or potassium hydroxide, what is the minimum weight percentage that triggers special packaging requirements?

2 percent or more Signup and view all the answers

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?

Charcoal lighter fuel Signup and view all the answers

What is the maximum concentration of sodium fluoride in liquid forms to be exempt from packaging requirements?

0.5 percent Signup and view all the answers

What is the viscosity requirement for liquid kindling preparations to be subject to specified packaging regulations?

Less than 100 Saybolt seconds Signup and view all the answers

Which household substance must be packaged under the provisions of § 1700.15 (a) and (b) if containing 10 percent or more by weight?

Sulfuric acid Signup and view all the answers

What is the method for determining the area of the principal display panel for a rectangular package?

The product of height times width of one entire side. Signup and view all the answers

Which of the following best describes the area to be calculated for cylindrical containers?

40 percent of the product of height and circumference. Signup and view all the answers

When calculating the area of a principal display panel, which feature should be excluded?

Shoulders and necks of bottles or jars. Signup and view all the answers

What substitute statement may be used if the principal display panel is too small for the required labeling statement?

Package Not Child-Resistant. Signup and view all the answers

What is the packaging requirement for nonemulsion liquid furniture polishes containing 10 percent or more of mineral seal oil?

Shall be packaged according to established guidelines. Signup and view all the answers

For which of the following substances is special packaging not required?

Furniture polishes not containing mineral oils. Signup and view all the answers

Which of the following is a requirement for replaceable statements on small principal display panels?

Must comply with size, placement, and conspicuousness rules. Signup and view all the answers

What is the required packaging for aspirin-containing preparations for human use?

Must comply with the provisions of § 1700.15. Signup and view all the answers

What aspect of a container's surface is considered when identifying its principal display panel area?

The surface most likely to be examined. Signup and view all the answers

Which is NOT considered part of the area of the principal display panel?

The bottom of the package. Signup and view all the answers

What is the minimum percentage by weight of compounds that requires prepackaged liquid solvents for paints to adhere to specific packaging provisions?

10 percent Signup and view all the answers

Which of the following acetaminophen preparations are exempt from specific packaging provisions?

Effervescent tablets with less than 15 percent acetaminophen Signup and view all the answers

What is the threshold amount of diphenhydramine that mandates special packaging requirements?

66 mg Signup and view all the answers

Which of the following products must adhere to special packaging requirements due to acetonitrile content?

Household glue removers Signup and view all the answers

What is the maximum quantity of sodium bromate allowed in home permanent wave neutralizers to avoid special packaging?

600 mg Signup and view all the answers

Which of the following describes the conditions under which ibuprofen preparations need to follow specific packaging provisions?

If containing 1 gram or more Signup and view all the answers

What is the specific quantity of loperamide in a single package that requires compliance with specific packaging regulations?

0.045 mg Signup and view all the answers

Under what condition is mouthwash exempt from special packaging provisions regarding ethanol content?

Includes nonremovable pump dispensers with specific flavoring oils Signup and view all the answers

What is the allowable amount of lidocaine in a single package before special packaging requirements kick in?

5.0 mg Signup and view all the answers

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?

Iron-containing drugs providing 250 mg or more elemental iron Signup and view all the answers

What is the maximum allowable amount of Norethindrone Acetate Tablets that can be dispensed in mnemonic packaging?

50 mg Signup and view all the answers

Which of the following substances is exempt from the packaging provisions outlined for iron-containing drugs?

Animal feeds with iron as a vehicle Signup and view all the answers

Which type of preparation containing iron is specifically excluded from the requirements for packaging outlined in § 1700.15?

Preparations where iron is solely a colorant Signup and view all the answers

What is the maximum amount of Erythromycin ethylsuccinate that can be contained in a package?

16 grams Signup and view all the answers

Which of the following drugs requires adherence to special packaging requirements outlined in § 1700.14(a)(10)?

Mebendazole Signup and view all the answers

At what concentration must dietary supplements containing iron be packaged according to § 1700.15?

Both A and B Signup and view all the answers

Which of the following drugs has a specific maximum weight requirement of 3.75 grams in powder form for packaging?

Colesevelam hydrochloride Signup and view all the answers

What is the maximum tablet amount of Methylprednisolone that can be dispensed according to the specified packaging regulations?

84 mg Signup and view all the answers

Which preparation is packaged as a solution of glycerol and water and is regulated under § 1700.14?

Sacrosidase (sucrase) Signup and view all the answers

What is the packaging requirement for dibucaine products containing more than 0.5 mg in a single package?

They must be packaged in accordance with § 1700.15 (a) and (b). Signup and view all the answers

Which of the following substances requires packaging compliance with § 1700.15 for contents exceeding 50 mg in a single retail package?

Naproxen Signup and view all the answers

How much minoxidil in a single retail package triggers the need for special packaging?

More than 14 mg. Signup and view all the answers

For liquid household products containing methacrylic acid, what percentage specifies the need for special packaging?

Greater than 5 percent. Signup and view all the answers

What classification applies to OTC drug products intended for oral administration that contain previously prescription-only ingredients?

They must be packaged in compliance with § 1700.15 provisions. Signup and view all the answers

What is the threshold volume for fluoride-containing household substances that necessitates compliance with packaging requirements?

More than 50 milligrams of elemental fluoride. Signup and view all the answers

In what scenario is the special packaging requirement for OTC drug products waived?

If the drug contains just OTC ingredients. Signup and view all the answers

What should be true for absorbent materials containing methacrylic acid within a dispenser to be exempt from packaging requirements?

No free liquid should exist within the device. Signup and view all the answers

What needs to be followed if an OTC drug product's active ingredient was previously prescription-only?

It must follow the provisions of § 1700.15 (a), (b), and (c). Signup and view all the answers

Which statement accurately defines the term 'active ingredient' under the specified regulations?

Components intended to provide pharmacological activity. Signup and view all the answers

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.