Cosmetics vs Drugs Quiz

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Questions and Answers

What is the primary characteristic that differentiates cosmetics from drugs?

Cosmetics alter body functions in a significant way.

Cosmetics require FDA approval before being sold.

Cosmetics promote attractiveness without affecting body structure. (correct)

Cosmetics are intended to treat or prevent diseases.

Which statement correctly identifies homeopathy?

It is a method strictly regulated by the FDA for all drug products.

It involves treating symptoms with remedies that produce similar symptoms. (correct)

It is mainly focused on enhancing cosmetic appearances.

It uses high doses of synthetic drugs to treat diseases.

What would indicate that a cosmetic is classified as a drug?

It claims to treat or prevent a disease on its label. (correct)

It is approved for use by multiple manufacturers.

It can only be produced with natural ingredients.

It alters the appearance significantly.

What defines a single source drug product?

It is the only version available for an active ingredient approved by the FDA. Signup and view all the answers

What best describes multisource drug products?

They can come from several manufacturers using the same formulation. Signup and view all the answers

What is the maximum temperature for items classified as 'cold'?

No more than 8 degrees Celsius Signup and view all the answers

Which USP guideline involves preventing microbial contamination?

USP 797 Signup and view all the answers

What must be ensured regarding personnel involved in hazardous drug handling?

Minimized exposure to hazardous drugs Signup and view all the answers

What type of air flow is permitted in compounding area for hazardous drugs?

Negative air flow Signup and view all the answers

Which of the following compounds is considered a hazardous drug due to its carcinogenic properties?

Chemotherapy drugs Signup and view all the answers

Which guideline outlines requirements for quality nonsterile preparations?

USP 795 Signup and view all the answers

What is the disposal rule for hazardous waste pharmaceuticals regarding toilets and sinks?

Banned for hazardous waste Signup and view all the answers

What is the required minimum coding for products administered to patients in hospitals?

National Drug Code (NDC) Signup and view all the answers

What does the term 'non-creditable waste' refer to?

Unused IND returned to pharmacy Signup and view all the answers

What is the usual dosage of a specified medication for individuals over 1 year of age?

1 tablespoon (15 ml) Signup and view all the answers

What is required of the labeling for drugs that have a scientifically acceptable pregnancy exposure registry?

The label must contain a specified statement about the registry. Signup and view all the answers

Which of the following information is NOT required on drug labeling regarding lactation?

Recommendations for alternative medications during nursing Signup and view all the answers

What needs to be included in the labeling for females and males of reproductive potential?

Pregnancy testing or contraception recommendations Signup and view all the answers

What is the purpose of including maternal adverse reaction information on drug labeling?

To inform healthcare providers about potential risks during pregnancy Signup and view all the answers

Why does the FDA mandate the removal of pregnancy categories A, B, C, D, and X from drug labels?

To simplify drug labeling and reduce confusion Signup and view all the answers

What type of information related to drug usage during pregnancy should be included in the drug label?

Effects of the drug on labor or delivery Signup and view all the answers

What should be included in a drug's label regarding breast-feeding effects?

Effects of the drug on milk production Signup and view all the answers

What is one of the key elements that must be included in drug labeling intended for pregnant individuals?

A summary of both fetal and maternal adverse reactions Signup and view all the answers

What was a key aspect of the 1914 Harrison Narcotics Act?

It established a record-keeping requirement for opium. Signup and view all the answers

Which amendment defined prescription drugs as legend drugs?

Durham Humphrey Amendment Signup and view all the answers

What is a requirement of the Current Good Manufacturing Practices (CGMP)?

Manufacturers must follow minimum requirements for production. Signup and view all the answers

What does the Drug Price Competition and Patent Term Restoration Act primarily address?

It simplifies the process for generic drugs' approval. Signup and view all the answers

What are Class III medical devices required to do?

Have pre-market approval. Signup and view all the answers

What is misbranding as defined by the FD&C Act?

A drug that fails to meet FD&C labeling requirements. Signup and view all the answers

What kind of drugs are classified as OTC drugs?

Drugs considered safe for public use without supervision. Signup and view all the answers

According to labeling requirements for OTC drugs, what must be included?

Active and inactive ingredient details. Signup and view all the answers

What does the Orphan Drug Act promote?

The creation of drugs for rare diseases. Signup and view all the answers

What must be documented for a drug to be classified as 'new'?

It has not received general recognition as safe and effective. Signup and view all the answers

Which of the following represents a characteristic of adulterated drugs?

Holds substance with unknown quality. Signup and view all the answers

What does the Pregnancy and Nursing Labeling for OTC require?

Warnings recommending consultation with healthcare professionals. Signup and view all the answers

What is required on the bulk container prescription label?

Expiration date information. Signup and view all the answers

What distinguishes Legend drugs from other medications?

They are potentially harmful and require provider supervision. Signup and view all the answers

What must a drug product demonstrate in order to be considered therapeutically equivalent?

It must be bioequivalent and pharmaceutically equivalent. Signup and view all the answers

What does the term 'bioavailability' refer to?

The rate at which the active ingredient of a drug is available at the site of action. Signup and view all the answers

Which of the following is NOT a characteristic of a reference listed drug (RLD)?

It must be the first drug of its type to be approved. Signup and view all the answers

What does 'Class II' recall signify according to the FDA?

Products are likely to cause temporary or reversible health effects. Signup and view all the answers

What is true about biological products?

They are made from living organisms using recombinant technology. Signup and view all the answers

Which phase of clinical trials focuses on testing the efficacy of a drug in individuals who have the disease?

Phase II Signup and view all the answers

Under what condition may investigational drugs be used by the general population?

When a treatment protocol is submitted and no satisfactory alternatives exist. Signup and view all the answers

Which of the following is true regarding 'A' rated products in the Orange Book?

They may resolve bioequivalence problems either in vivo or in vitro. Signup and view all the answers

Which statement best describes child-resistant packaging regulations?

80% of children under 5 years old must be unable to open them. Signup and view all the answers

What is essential for a drug to qualify as a biosimilar?

It must be highly similar to the reference product with no clinical differences. Signup and view all the answers

What type of product is classified as a 'B product' according to the Orange Book?

A product that has problems with dosage form. Signup and view all the answers

What is a characteristic of 'pharmaceutical alternatives'?

They have the same moiety but differ in strengths and dosages. Signup and view all the answers

What does a Class III drug recall indicate?

The product is not likely to cause adverse health consequences. Signup and view all the answers

What kind of substances can tax-free alcohol be used for?

Scientific research and medicinal purposes. Signup and view all the answers

Study Notes

Federal Law Exam

The Harrison Narcotics Act of 1914 was the first federal law that prohibited the use of certain drugs without a prescription.
The FD&C Act was passed in 1938 to ensure the safety of food, drugs, and cosmetics.
The Sulfanilamide disaster prompted the creation of the original FD&C Act, which was insufficient, and only required safety, not effectiveness.
The FD&C Act has evolved, and currently requires labeling to include safety and effectiveness of drugs, food, and cosmetics.
- The FDA requires manufacturers, distributors, and 503B pharmacies to adhere to Current Good Manufacturing Practices (CGMP).
- Prescription drugs must be dispensed to individuals with a valid prescription or directly administered by a licensed practitioner.
The FD&C Act began the drug approval process, which requires a New Drug Application (NDA).
- There is a grandfather clause that exempts drugs that existed before the act, but few remain. Most drugs today are approved through an NDA or an Abbreviated New Drug Application (ANDA).

Durham Humphrey Amendment

Restricted the sale of certain drugs to prescription only, defining them as "legend drugs" to distinguish them from over-the-counter (OTC) medications.
Authorized refills on prescription drugs.

Kefauver Harris Amendment

Occurred after the Thalidomide disaster, which highlighted the need for more stringent regulations around drug safety and efficacy.
Required effectiveness before the drug could be marketed, and increased scrutiny of safety.
Defined the Current Good Manufacturing Practices (CGMP), which are minimum requirements for:
- Methods
- Facilities
- Processing
- Packaging
- Holding of a product.
- They apply to manufacturers, repackers, 503B pharmacies, hospitals that repackage, and pharmacy distribution centers that repackage.
The Kefauver Harris Amendment required informed consent for patients involved in drug trials and outlined regulations for prescription drug advertising.
- The Federal Trade Commission (FTC) regulates non-prescription drug advertising.

Medical Device Amendment

Defines a device as an instrument, apparatus, or implant that does not have a chemical action.
There are three classes of medical devices:
- Class I (Least regulated): Toothbrushes, stethoscopes, scissors, and needles.
- Class II (Needs to meet performance standards): Insulin syringes, electric heating pads, thermometers, etc.
- Class III (Must meet pre-market approval due to it be life-supporting or life-sustaining): Pacemakers, replacement heart valves, etc.

Drug Price Competition and Patent Term Restoration Act

Extended the ANDA to generic drugs, while maintaining the requirement of bioequivalency and bioavailability.
Extended patent life for brand drugs.
- A patent is a property right granted to the inventor of the drug through the US Patent and Trademark Office.
- The original patent term is 20 years from the first date of filing. Most manufacturers file for patent protection prior to marketing, making the effective term shorter.
The Act added a 5-year extension to the patent term, for a maximum of 14 years from the date of approval.

Prescription Drug Marketing ACT

Bans the sale of sample drugs.
Works to reduce health risks from the diversion of prescription drugs.
States license wholesale drug distribution.

Orphan Drug Act

Encourages and promotes the development of drugs to treat rare diseases and conditions.

Drug Efficacy Study Implementation Program (DESI)

Tested the effectiveness of drugs from 1938-1964.

Drug Quality and Security Act of 2013 (DQSA)

Originated from the 2012 fungal meningitis outbreak traced to a New England Compounding Center.
Established the Drug Supply Chain and Security Act, which tracks the distribution of drugs through a database.
Established the Compounding Drug Act:
- Defines conditions in which certain pharmacies are entitled to exemption from the FD&C, including FDA labeling requirement, FDA approval prior to market, and compliance with CGMP.
- 503A pharmacies are exempt from these requirements if they:
  - Do not compound large quantities in advance.
  - Do not compound copies of commercially available drugs.
  - Do not compound drugs that were removed from the market due to safety issues.
  - Do not compound without a prescription and without a valid medical use.
  - A patient-prescriber-pharmacist relationship must be established.
  - A licensed supervisor must finish compounding.
  - Must comply with the United States Pharmacopoeia Standards.
- 503B pharmacies remain exempt from these requirements EXCEPT for compliance with CGMP. These pharmacies:
  - Are inspected by the FDA on a risk-based schedule.
  - Provide information about compounded products to the FDA and report adverse events.
  - Can compound for office use and do not need a prescription.
  - Can compound large quantities in advance, but distribution to a wholesaler is prohibited.
  - Must have a supervising pharmacist.
  - May voluntarily register with the FDA.

Definition of a Drug

The FD&C defines a drug as:
- Articles recognized by the United States Pharmacopoeia.
- Articles intended for use in the diagnosis, cure, mitigation, treatment, and prevention of disease.
- Articles that affect the structure or function of the body.

Intended Use

The FDA considers various documentation from the manufacturer to determine if a product is a drug, such as labeling, websites, promotional pamphlets.
The manufacturer’s or distributor’s intent is key to determining if a product is a drug.

Legend Drugs

Drugs that require a licensed practitioner's supervision due to potential harm or toxicity.

Bulk Container Prescription Includes:

The name and address of the manufacturer, distributor, or packer.
The established name of the drug.
Ingredient information.
Instructions for inactive ingredients and other routes of administration, if other than oral usage.
The quantity expressed in weight or measure.
The total net quantity of the container.
A statement of recommended or usual dosage, or a reference to a package insert.
The statement "RX only" or "Caution: Federal law prohibits dispensing without a prescription."
An identifying lot or control number.
Directions for the pharmacist regarding the container usage.
Adequate information for use.
Expiration date.

New Drug

Any drug that has not been generally recognized as safe and effective by medical experts.

OTC Drug

Must be safe and effective for general use, without the need for supervision.
Should have a low potential for abuse and misuse.
Allows individuals to self-diagnose, treat, and manage certain conditions.
The safety margin must be sufficient enough to ensure the benefits of OTC availability outweigh the risks.

OTC Drug Labeling Requirement

Active ingredient.
Purpose.
Inactive ingredient.
Directions for use.
Warning signs.
Uses and indications.

Pregnancy and Nursing Labeling for OTC

Requires a warning statement: "If pregnant or breast-feeding, ask a health professional before use."

Over-the-Counter Labeling of Sodium, Calcium, Magnesium, Potassium Content

If the product is intended for oral use, the label must include the sodium, calcium, magnesium, and/or potassium content per dosage unit.

Adulteration

Includes:
- Putrid, filthy, decomposed substances.
- Substances held, prepped, or packaged in unsanitary conditions.
- Products manufactured contrary to CGMP.
- Products exposed to fire, water, or extreme temperatures (PA states).
- Drugs or substances with purity, quality, or strength that differs from what is stated on the label or in official compendia.
- Containers contaminated with poisonous or deleterious substances that may leak into the contents.
- Unsafe food coloring additives.
- Drugs or substances altered to reduce their quality or strength.

Misbranding

Includes:
- Dispensing or distributing a drug in violation of the FD&C labeling requirements.
- Labels that are false or misleading.
- Unlabeled or improperly packaged drugs, not adhering to compendial standards.
- Drugs misleadingly filled or imitative of another drug.
- Drugs subject to deterioration without a warning label.
- Drugs or devices that are harmful if used according to the labeled instructions.
- Drugs not packaged according to the Poison Prevention Packaging Act.
- The absence of an "RX only" warning.
- Pharmacists dispensing drugs without a prescription or refilling prescriptions without authorization.

Expiration Date

For non-sterile unit dose and single-unit dose prescriptions, pharmacists must:
- Affix a beyond-use date no later than one year.
- Unless stability data or manufacturer states otherwise.
For ordinary prescription vials, the beyond-use date is:
- No later than one year from the date dispensed or the manufacturer’s expiration date, whichever is earlier.

Dietary Supplement

Includes:
- Amino acids.
- Herbs.
- Minerals.
- Vitamins.
- Constituents, concentrates, metabolites, extracts, or combinations of the above.
Intended to supplement the diet by increasing dietary intake.

Claims for Dietary Supplements

Can claim to:
- Affect the structure or function of the body.
- Identify the mechanism used to maintain structure and function.
- Describe the benefits from consuming the supplement.
- Discuss benefits of nutrient deficiency disease, as long as the prevalence of the disease in the US is included in the claim.
- The label must contain the statement: "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease."

Cosmetics

The FD&C defines cosmetics as substances intended for cleansing, beautifying, promoting attractiveness, or altering the appearance without altering or affecting body structure or function.

Cosmetics as Drugs

A cosmetic is considered a drug if it is intended to treat or prevent disease or alter a body function.
To determine if a cosmetic is a drug, check the label for any claims related to treating or preventing disease.

Homeopathic Drug Products and Herbal Products

Defined as any drug labeled "homeopathic" and listed in the Homeopathic Pharmacopoeia of the United States.
Homeopathy is a practice that treats symptoms and diseases with remedies that produce similar symptoms in healthy persons (like treats like).
It aims to stimulate the body’s natural immune system to raise the general level of health and heal illness.

Single Source

A drug product approved by the FDA for its active ingredient, dosage form, route of administration, and strength.

Multisource

A drug product manufactured by several manufacturers.

Pharmaceutical Equivalence

Drug products similar in dosage form, strength, route of administration, and active ingredient.

Therapeutic Equivalence

Drug products that are pharmaceutical equivalents and bioequivalent.
To determine if a drug product is a therapeutic equivalent:
- Bioequivalent
- Pharmaceutical Equivalent
- Adequate labeling
- Approved safety and effectiveness
- Manufactured in compliance with current Good Manufacturing Practices (CGMP)

Bioavailability

The rate the active ingredient of a drug product is available at the site of action.

Bioequivalent

A drug product that is pharmaceutically equivalent, delivering the same result with the same pharmacokinetic properties.

Reference Listed Drug (RLD)

The standard to which all generic drugs are compared.
The RLD files a New Drug Application (NDA), and when the RLD expires, generic manufacturers file an Abbreviated New Drug Application (ANDA).
Generics must demonstrate the same results as the RLD.

Pharmaceutical Alternatives

Same moiety but different dosages, strengths, and complexities.

ORANGE BOOK

Provides information about products that offer the same therapeutic effects.

A - Products

Therapeutically equivalent to other pharmaceutically equivalent products.
- AA: Conventional dosage forms not presenting bioequivalence problems.
- AB: Actual or potential bioequivalence problems resolved in vitro or in vivo.

B - Products

Not therapeutically equivalent.
Problem with dosage form.

PA Substitution

A-products can be substituted unless they have a narrow therapeutic range (e.g., Coumadin and Lanoxin (NTI)).
B-products cannot be substituted.

Biological Product

Includes vaccines, various toxoids, skin-skin substances, and blood-blood products for transfusion.
Manufacturer license is issued by the Center for Biologics Evaluation and Research (CBER).

Biosimilars

Unique biological products derived from living organisms using recombinant technology.
Highly similar to the reference product.

Veterinary Product

Gain approval through the New Animal Drug Application (NADA).
In edible products, they must be free of unsafe residues.
Flea Control:
- Topical: EPA
- Oral: FDA

Prescription Drugs

Require a prescription.
Labeling, regulation, and advertising are regulated by the FDA.
Must be manufactured in compliance with CGMP.

OTC Drugs

Available without a prescription.
Labeling, regulation, and advertising are regulated by the FTC.
Must be manufactured in compliance with CGMP.

Homeopathic Drugs

Requires a prescription or is available OTC.
Labeling and regulation are subject to both FTC (OTC) and FDA (Rx) oversight.
Must be manufactured in compliance with CGMP.

Dietary Supplements

Do not require a prescription.
Labeling and regulation are regulated by the FTC.
Must be manufactured in compliance with CGMP.

Drug Approval Process

Before a new drug can be marketed, federal law requires submission and approval.
This process begins with submission of an Investigational New Drug (IND) application that includes:
- Name of the drug
- Composition
- Methods of manufacturing
- Quality control
- Preclinical non-human studies
- Pharmacological, pharmacokinetic, and toxicology studies
- Outline of proposed clinical studies
If the FDA does not reject the IND application within 30 days, clinical trials on humans may begin:
- Phase I: Small number of healthy individuals to determine pharmacology and toxicology, not efficacy.
- Phase II: Small number of individuals with the disease to test efficacy.
- Phase III: Larger number of individuals with the disease.
  - If results are favorable, an NDA is filed for approval.
- Phase IV: After FDA approval, post-marketing surveillance to monitor any adverse effects.

Expedited Approval

For serious life-threatening illnesses where the drug offers a therapeutic advantage over existing treatments.

Drug Recall

Class I: Exposure to the product results in serious adverse health effects or death.
Class II: The product may cause temporary or medically reversible effects, and the chance of serious adverse health effects is low.
Class III: Exposure to the product is unlikely to cause adverse health consequences.

Market Withdrawal

A product is removed from the market due to a minor violation, not subject to FDA legal action.

FDA Inspection

Inspections must be:
- Reasonably limited
- Within a reasonable time
- Conducted in a reasonable manner
Inspectors must present:
- Credentials
- Notice of Inspection

Approved Drugs Used For Unlabeled Indications

Unapproved medical devices may be used by a physician in life-threatening situations where:
- No alternative is available.
- No sufficient time to seek approval.
  - Use must be substantiated at a later time.
Discouraged by the FDA, prescribers may prescribe the drug for these unapproved indications using their professional discretion.

Investigational Drugs Used in the General Public

Investigational drugs can be used by the general population provided that:
- A treatment protocol is submitted to the FDA.
- The disease is serious or life-threatening.
- No comparable or satisfactory alternative exists.
- The drug is in a clinical trial seeking approval.

OTC Tamper Evident Packaging

Requires one or more barriers indicating tampering.
Difficult to duplicate.
Two-piece hard gelatin capsules must be sealed with tamper-evident technology.

Child Resistant Packaging

The Poison Prevention Packaging Act requires child-resistant caps on all legend drugs.
- 80% of children under 5 years old cannot open, and 90% of adults can open.
Patients or physicians can request non-child-resistant packaging (orally or in writing).
Products EXEMPT from Child-Resistant Packaging:
- Aerosol containers for inhalation therapy (inhalers)
- Oral contraceptives cyclically administered
- Sublingual nitroglycerin tablets
- Prednisone tablets not exceeding 105 mg
OTC products MUST comply with the PPPA's child-resistant packaging:
- Loperamide
- Diphenhydramine
- Acetaminophen
- Mouthwashes
- Naproxen

Tax-Free Alcohol

May be used for:
- Scientific
- Patient treatment
- Medicinal or mechanical purposes
Cannot be used for:
- Food
- Beverage

Ipecac Syrup

Available for sale without a prescription, provided that:
- Packaged in a quantity of 30 ml
- The label states:
  - "For emergency use to induce vomiting in poisoning. Before use, call a physician, poison control center, or hospital emergency room for advice."
  - "Warning - keep out of reach of children. DO NOT use in unconscious persons. DO NOT use with corrosives such as alkalies, strong acids, petroleum distillates."
- Usual dosage: 1 tablespoon (15 ml) over 1 year of age.

Temperature Ranges

Cold: Not more than 8 degrees Celsius
Cool: 8-15 degrees Celsius
Room Temp: Temperature in the work area
Controlled Room Temp: 15-30 degrees Celsius
Warm: 30-40 degrees Celsius
Excessive Heat: Above 40 degrees Celsius
Refrigerator: 2-8 degrees Celsius
Freezer: -20 to -10 degrees Celsius
Expired products must be removed from operating stock.

USP 795: Nonsterile Compounds

Standards for compounding quality nonsterile preparations.
Requirements for the compounding process, facilities, equipment, components, documentation, quality control, and training.

USP 797: Sterile Compounding

National standard for the process, testing, and verification of compounded sterile preparations.
Guidance for preventing microbial contamination and who is performing the compounding.
Nonsterile ingredients must be sterilized before administration.
Includes biologics, diagnostics, drugs, nutrients, and radiopharmaceuticals.

USP 800: Hazardous Drugs

According to the National Institute for Occupational Safety and Health (NIOSH), a hazardous drug exhibits one or more of the following six characteristics:
- Carcinogenicity
- Teratogenicity or other developmental toxicity
- Reproductive toxicity
- Organ toxicity
- Genotoxicity
There is no acceptable level of personnel exposure to hazardous drugs.

Personnel

The entity must have a designated person who is qualified and trained to be responsible for:
- Developing and implementing appropriate procedures.
- Overseeing entity compliance with this chapter and other applicable laws, regulations, and standards.
- Ensuring competency of personnel.
- Ensuring environmental control of the storage and compounding areas.
Minimize personnel exposure.

Air flow

No positive air flow is allowed.
- Laminar air flow (LAF)
- Compounding aseptic isolator (CAI)
Only negative airflow is allowed.

Garb

Personal protective equipment is based on the function being performed.
Includes gloves, gowns, head, hair, and sleeve covers, face and eye protection, respirators, and shoe covers.

Cleaning

Deactivation and disinfection with an oxidizer, cleaning with a germicidal detergent, and disinfection with sterile alcohol.

Administering Hazardous Drugs

Use Closed System Drug Transfer Devices.

USP 825: Radiopharmaceuticals

Outlines minimal standards for preparing, compounding, dispensing, and repackaging sterile and nonsterile radiopharmaceuticals.

EPA 2019 Disposal Rule

Bans the international disposal of hazardous waste pharmaceuticals via toilets, sinks, and drains.
- Exempts OTC nicotine patches, gum, and lozenges from the hazardous waste list.
Two categories of pharmaceutical waste:
- Potentially creditable waste: Unused, unadministered, and unexpired less than 1 year past the expiration date.
- Non-creditable waste: Removed from the container, returned to the pharmacy after payment, more than 1 year past expiration, refused by the patient after an attempt to administer, free samples, and unused IND.

Bar Code Rule

Requires bar coding, consisting of, at a minimum, the National Drug Code (NDC) number, on certain products administered to patients in hospitals to reduce medication errors.
Pharmacies can achieve certification.

Pregnancy (Including Labor and Delivery)

The FDA requires the removal of all pregnancy categories (A, B, C, D, and X) from all drug product labeling.
If the drug has a scientifically acceptable pregnancy exposure registry, the labeling must contain a specified statement about the registry.
The label must contain a summary of the drug's risks during pregnancy.
Include relevant information to help healthcare providers and counsel women:
- Disease-associated maternal, embryo, or fetal risk
- Dose adjustments during pregnancy and the postpartum period
- Maternal adverse reactions
- Fetal and neonatal adverse reactions
- The effect of the drug on labor or delivery

Lactation

The label must contain a summary of drug risks during lactation.
If the drug is systemically absorbed, it must include:
- Relevant information on the presence of the drug in human milk
- Effects of the drug on the breastfed child
- Effects of the drug on milk production
- Ways to minimize drug exposure in the breastfed child
- Available interventions for monitoring or mitigating adverse reactions
- Pertinent information about the data
- Risk-benefit statement, unless breastfeeding is contraindicated during drug therapy

Females and Males of Reproductive Potential

Labeling must include relevant information:
- Pregnancy testing or contraception required or recommended before, during, or after drug therapy.
- Data suggests drug-associated fertility.

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Description

Explore the key differences between cosmetics and drugs in this informative quiz. Test your knowledge on classifications, homeopathy, and drug product types. Understand the distinctions to better recognize product definitions.