Federal Food, Drug, and Cosmetic Act (FDCA) Major Amendments Quiz

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What is evaluated in the FDA OTC Review process?

Efficacy of prescription drug products

Cost-effectiveness of OTC drug products

Quality of generic drug products

Safety and effectiveness of OTC drug products (correct)

Which of the following is NOT mentioned as a required element in OTC labeling?

Mineral oil

Ipecac syrup

Wintergreen oil

Ibuprofen tablets (correct)

What warning is specifically associated with products containing salicylates?

Warning regarding Reye's syndrome (correct)

Warning for gastrointestinal side effects

Warning about overdose risk

Warning for allergic reactions

In what quantity is Ipecac syrup mentioned to be sold according to the text?

30ml containers Signup and view all the answers

What must be done if an OTC dose differs from what is indicated on the product labeling?

A prescription would be required Signup and view all the answers

What type of packaging is required for OTC drugs to ensure safety?

Tamper Evident Packaging Signup and view all the answers

What major amendment established REMS and enhanced FDA's authority for post-marketing safety of drugs?

Food and Drug Administration Amendments Act Signup and view all the answers

Which act created an abbreviated approval pathway for 'biosimilar' biological drugs?

Biologics Price Competition and Innovation Act Signup and view all the answers

What does the Drug Quality and Security Act (DQSA) address in terms of compounding by pharmacies?

Large scale compounding under 503A regulations Signup and view all the answers

Which type of compounding is regulated by both the FDA and states, according to the Drug Quality and Security Act (DQSA)?

503B compounding Signup and view all the answers

What is the purpose of the FDA Memorandum of Understanding (MOU) with states mentioned in the text?

To address interstate distribution of compounded products Signup and view all the answers

Which act improved authority and funds specifically for foreign facility inspections?

FDA Safety and Innovation Act Signup and view all the answers

What was the reason behind Anderson Cancer Center receiving a $4.3 million fine?

Theft of an unencrypted laptop and two unencrypted USB thumb drives Signup and view all the answers

Which healthcare entity faced the largest health care data breach in U.S. history resulting in a $16 million fine?

Anthem Health Insurer Signup and view all the answers

What was the specific violation that led to Rite Aid Pharmacy receiving a $1 million fine?

Failure to dispose of records properly Signup and view all the answers

Why did Children’s Medical Center of Dallas receive a $3.2 million fine?

Loss of an unencrypted device and theft of a laptop Signup and view all the answers

What aspect was covered under Texas Privacy Laws (Texas 'HIPAA') according to the text?

Increased penalties and breach notification requirements Signup and view all the answers

Which entity faced consequences for failing to secure electronic patient data properly?

Children’s Medical Center of Dallas Signup and view all the answers

Which of the following was a key provision of the Durham-Humphrey Amendments to the FDCA in 1951?

Established two classes of drugs - prescription and over-the-counter Signup and view all the answers

Which of the following Acts provided incentives to develop drugs for rare diseases?

The Orphan Drug Act of 1983 Signup and view all the answers

What was the primary purpose of the Kefauver-Harris Amendments to the FDCA in 1962?

To establish an efficacy requirement for drug approval Signup and view all the answers

Which of the following Acts established the Abbreviated New Drug Application (ANDA) process for generic drug approval?

The Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman) Signup and view all the answers

Which of the following was a key provision of the Prescription Drug Marketing Act (PDMA) of 1987?

Banned the resale of prescription drugs purchased by hospitals Signup and view all the answers

Which of the following federal laws is primarily concerned with child-resistant packaging for prescription drugs and certain over-the-counter drugs?

Poison Prevention Packaging Act of 1970 (PPPA) Signup and view all the answers

According to the Poison Prevention Packaging Act of 1970 (PPPA), which of the following is an exemption from the requirement for child-resistant packaging?

All of the above Signup and view all the answers

Which federal agency is responsible for administering and enforcing the Federal Hazardous Substances Act of 1996?

Consumer Product Safety Commission (CPSC) Signup and view all the answers

According to the passage, which of the following statements is NOT true regarding the Federal Hazardous Communication Standard?

It applies to drugs in solid dosage form (tablets, capsules). Signup and view all the answers

Which federal law is primarily concerned with the expansion of Medicare and Medicaid programs?

Omnibus Budget Reconciliation Act of 1990 (OBRA-90) Signup and view all the answers

According to the passage, which of the following statements is true regarding the Federal Hazardous Substances Act of 1996?

It primarily applies to household products. Signup and view all the answers