Federal Law Quiz 1

Title 21 (food and drug) of the Code of Federal Regulations (21 CFR)

published by FDA/HHS, and link is on Ohio Board of Pharmacy webpage under “Laws and rules”

DEA (Drug Enforcement Agency)

“pharmacist manual”, set of guidelines for how pharmacy is to practice regarding controlled substances

Pure Food and Drug Act of 1906

prohibited interstate sale of adulterated and misbranded food and drugs, led to the creation of the modern day FDA

Labeling issues addressed in the Pure Food and Drug Act of 1906

• labels cannot be false or misleading about ingredients

• no requirement to disclose ingredients

• 11 dangerous ingredients were identified but could be used as long as listed

Sulfanilamide tragedy of 1937

• elixir sulfanilamide was marketed as a wonder drug for various ailments

• killed over 105 people

• led to the creation of the FFDCA

Federal Food, Drug, and Cosmetic Act of 1938 (FFDCA, FDCA, FD&C)

set of laws passed by Congress in 1938 which gave authority to the US Food and Drug Administration to oversee the safety of food, drugs, and cosmetics

• still foundational for how we practice today

FD&C Requirements

• drug labels must include directions for safe use

• required pre-market approval for new drugs to ensure safety

• prohibited false therapeutic claims for drugs

• authorized factory inspections

• fda given regulatory authority over medical devices and cosmetics for the first time

• devices also addressed

Adulteration

• contains any poisonous or deleterious substance which may render it injurious to users, when used as directed

• harmful even when used as directed

Misbranded

• if a label is “false or misleading in any particular”

• if missing poison prevention or tamper-resistant packaging

• otc products without “adequate directions for use”

• does not meet fda regulations regarding standard of identity, quantity, or fill