Federal Regualtions of Pharmacy

Question 1

What is enforced by the Pure Food and Drug Act?

Answer 1

Sanitation. Prohibits adulteration and misbranding of any food or drugs

Question 2

What is Misbranding

Answer 2

Imporper lableing or non disclosure of whats in the product

Question 3

What is Adulteration?

Answer 3

Contents that are non-sanitary

Question 4

What is the Federal Food, Drug and Cosmetic Act?

Answer 4

required proof the drug safety for patients to take. Came from Sulfanilamide elixir that lead to 107 deaths

Question 5

What was the Durham- Humphrey Amendments?

Answer 5

established class of drug, OTC and Rx and authorized oral medication for refills

Question 6

What was the Kefauver- Harris Amendments?

Answer 6

establishment of the effectivness and informed consent of drugs for treatment. Came from Thalidomide in use of morning sickness that lead to flipper formed limbs in children.

Question 7

What is the Orphan Drug Act

Answer 7

gave incentive for companies to create and develope new drugs for rare conditions. Separate criteria based on limit population to study on and short timeline of deadly diseases.

Question 8

What is the FDA Modernization Act?

Answer 8

streamlined the approval process for new drugs; required labeling of “rx” on dispenced bottles

Question 9

What is FDA guidance?

Answer 9

restrict off label use

Question 10

What is adulteration?

Answer 10

contains unsafe color additives, putrid contents, prepared in unsanitary conditions, strength altered from preparation.

Question 11

What is Misbranding?

Answer 11

falsly labeled, inadequate labeling, missing required statements

Question 12

What is considered a drug?

Answer 12

Compounds recognized in the US pharmecopea; anything used to treat/diagnose/cure or prevent disease; compounds that affect any structure or system in the body;

Question 13

What are black box warnings?

Answer 13

any drug that has a side effect that may be life threatening must be listed on package insert in a black box.

Question 14

What is required on a non-drug label?

Answer 14

pharmacological category, intended uses, adequate directions, and drug facts

Question 15

What is required by the New Drug Application for a new drug?

Answer 15

must get FDA approval, needs IND request, reclinical animal studies, dectetion for adverse effects, determin efficacy, and safety.

Question 16

What is post marketing surveillance?

Answer 16

requres adverse reactions to be reported from a newly marketed drug,

Question 17

What are Phase 4 studies?

Answer 17

an extra phase of testing on only drugs when adverse event reporting is inadequate.

Question 18

What is phase 1 of drug trials?

Answer 18

low number of subjects to test for adverse reactons

Question 19

What is Phase 2 of drug trails?

Answer 19

higher number of subjects to determine effacacy data.

Question 20

What is Phase 3 of drug trails?

Answer 20

Determines saftey and effacacy in large population

Question 21

What is Risk Evaluation and Mitigation Strategy

Answer 21

the requirement of a med guide, specialty despencing guideline, required to make sure risk/benefit analysis is being addressed

Question 22

What is post market labeling?

Answer 22

requires manufactures to add stafey information and warnngs on products

Question 23

What is Medwatch?

Answer 23

A voluntary place to report adverse effects, product errors, and quality issues

Question 24

What became of the Drug Price Comparison and Patent Term Restoration Act?

Answer 24

expidited generic approval process, required the generic manufacturerer to show that it was bioequivalent, and same active ingredient. Also allowed for Brand name patent extensions and exclusive markets

Question 25

OTC drug review requires what for a OTC product to be approved?

Answer 25

therapeutic category listed, and it’s conformance to the monograph

Question 26

What is an example of a Class I FDCA drug recall?

Answer 26

anyh product that can cause serious adverse effects including death

Question 27

What is a FDCA Class II recall?

Answer 27

Any product that can cause a temporary adverse effect

Question 28

What is a FDCA Class III recall?

Answer 28

Product not likely to cause an adverse effect but may have a labeling issue

Question 29

What is a biologic?

Answer 29

any analogous protein (virus, serum, toxin, antitoxin) used for the prevention, treatment of cure of a disease

Question 30

What is biosimilar?

Answer 30

a product that is highly similar to compaired product in terms of saftey, purity, and potency, but may dffer in clinically inactive compounds

Question 31

What is bioequivalence?

Answer 31

same molar dose, same rate of activity at the same site of action,

Question 32

What is the Patient Protection and Affordable Care Act?

Answer 32

comprehensive health insurance

Question 33

what the “Biologics Price Competition and Innovation Act?

Answer 33

allows for biosimilarity in biologics, compairbale, and interchangeable, provide less expensivebiologics to patients

Question 34

What is totality of evidence?

Answer 34

analytical, phyisochemical, and biological charactorization of structure, function, animal data, PK?PD data, and efficacy and safety

Question 35

What are Permissable Differences in biologic?

Answer 35

delivery systems, reduced indications, less of different routes of administration