Federal Regualtions of Pharmacy Flashcards
What is enforced by the Pure Food and Drug Act?
Sanitation. Prohibits adulteration and misbranding of any food or drugs
What is Misbranding
Imporper lableing or non disclosure of whats in the product
What is Adulteration?
Contents that are non-sanitary
What is the Federal Food, Drug and Cosmetic Act?
required proof the drug safety for patients to take. Came from Sulfanilamide elixir that lead to 107 deaths
What was the Durham- Humphrey Amendments?
established class of drug, OTC and Rx and authorized oral medication for refills
What was the Kefauver- Harris Amendments?
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.
What is the Orphan Drug Act
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.
What is the FDA Modernization Act?
streamlined the approval process for new drugs; required labeling of “rx” on dispenced bottles
What is FDA guidance?
restrict off label use
What is adulteration?
contains unsafe color additives, putrid contents, prepared in unsanitary conditions, strength altered from preparation.
What is Misbranding?
falsly labeled, inadequate labeling, missing required statements
What is considered a drug?
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;
What are black box warnings?
any drug that has a side effect that may be life threatening must be listed on package insert in a black box.
What is required on a non-drug label?
pharmacological category, intended uses, adequate directions, and drug facts
What is required by the New Drug Application for a new drug?
must get FDA approval, needs IND request, reclinical animal studies, dectetion for adverse effects, determin efficacy, and safety.
What is post marketing surveillance?
requres adverse reactions to be reported from a newly marketed drug,
What are Phase 4 studies?
an extra phase of testing on only drugs when adverse event reporting is inadequate.
What is phase 1 of drug trials?
low number of subjects to test for adverse reactons
What is Phase 2 of drug trails?
higher number of subjects to determine effacacy data.
What is Phase 3 of drug trails?
Determines saftey and effacacy in large population
What is Risk Evaluation and Mitigation Strategy
the requirement of a med guide, specialty despencing guideline, required to make sure risk/benefit analysis is being addressed
What is post market labeling?
requires manufactures to add stafey information and warnngs on products
What is Medwatch?
A voluntary place to report adverse effects, product errors, and quality issues
What became of the Drug Price Comparison and Patent Term Restoration Act?
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
OTC drug review requires what for a OTC product to be approved?
therapeutic category listed, and it’s conformance to the monograph
What is an example of a Class I FDCA drug recall?
anyh product that can cause serious adverse effects including death
What is a FDCA Class II recall?
Any product that can cause a temporary adverse effect
What is a FDCA Class III recall?
Product not likely to cause an adverse effect but may have a labeling issue
What is a biologic?
any analogous protein (virus, serum, toxin, antitoxin) used for the prevention, treatment of cure of a disease
What is biosimilar?
a product that is highly similar to compaired product in terms of saftey, purity, and potency, but may dffer in clinically inactive compounds
What is bioequivalence?
same molar dose, same rate of activity at the same site of action,
What is the Patient Protection and Affordable Care Act?
comprehensive health insurance
what the “Biologics Price Competition and Innovation Act?
allows for biosimilarity in biologics, compairbale, and interchangeable, provide less expensivebiologics to patients
What is totality of evidence?
analytical, phyisochemical, and biological charactorization of structure, function, animal data, PK?PD data, and efficacy and safety
What are Permissable Differences in biologic?
delivery systems, reduced indications, less of different routes of administration
