Chapter 1
Define Law
What are requirements for human conduct that apply to all people within their jurisdiction.
The Food, Drug, and Cosmetic Act (FDCA) aims to protect consumers from these two types of illegal products
What is misbranded and adulterated products?
The Controlled Substances Act creates a "closed system" of distribution for controlled substances and is enforced by this agency
What is the Drug Enforcement Administration?
This 1951 amendment to the FDCA established the two classes of drugs: prescription and OTC
What is the Durham-Humphrey Amendment?
This is the acronym for the health information covered by HIPAA that relates to a patient's health status and could identify the patient
What is PHI? (Protected Health information)
What are the U.S. Constitution, legislatures, administrative agencies, and courts?
This 1994 Act created the special food category of "dietary supplements" and allows them to be marketed without premarket approval
What is the Dietary Supplement Health and Education Act (DSHEA)?
These drugs have a high potential for abuse, a currently accepted medical use, and their abuse may lead to severe physical or psychological dependence.
What are schedule II drugs?
A prescription for a controlled substance is only considered valid if it is issued for this purpose
What is a legitimate medical purpose?
A pharmacy must provide patients with one of these, outlining how their health information may be used and disclosed
What is a "Notice of Privacy Practices"?
Orphan drugs and vaccines are examples of these necessary commodities that private entities won't supply because there is no incentive
What are public goods?
A product is considered a drug if the supplier makes this type of claim about it
What is a therapeutic claim (or a claim that it can diagnose, cure, mitigate, treat, or prevent a disease)?
A pharmacy's DEA registration must be renewed this often
What is every 3 years?
In an emergency, a pharmacist may dispense a Schedule II drug on an oral prescription, but the prescriber must provide a written, signed prescription to the pharmacy within this timeframe.
What is seven days?
This 1990 law established requirements for prospective drug use review (Pro-DUR), patient counseling, and patient profiles for Medicaid patients
What is the Omnibus Budget Reconciliation Act of 1990 (OBRA '90)?
This term describes the situation when a consumer is uninformed about the true value of a good, such as with prescription-only drugs
What is information asymmetry?
The FDA is housed under this executive department
What is the Department of Health and Human Services (HHS)?
Under this act, the sale of pseudoephedrine is limited to 3.6 grams per day and 9 grams within a 30-day period
What is the Combat Methamphetamine Epidemic Act of 2005?
A practitioner can issue multiple Schedule II prescriptions on the same day as long as the total quantity does not exceed this supply limit
what is a 90 day supply?
HIPAA allows the use and disclosure of PHI without authorization for these three purposes, abbreviated as TPO
What are Treatment, Payment, and Operations?
This legal principle, meaning "to stand by things decided," makes judicial opinions binding on lower courts in the same jurisdiction
What is stare decisis
Under the "Park Doctrine," these individuals have an affirmative duty to be aware of and correct violations of the FDCA
Who are corporate officers?
This is the total number of dosage units of controlled substances a pharmacy may distribute to another practitioner without registering as a distributor
What is 5% of all controlled substances dispensed by the pharmacy during a calendar year?
The Ryan Haight Act defines a valid internet prescription as one issued by a practitioner who has conducted at least one of these
What is an in-person medical evaluation of the patient?
If a breach of PHI affects more than 500 individuals, the covered entity must notify the affected individuals, the media, and this federal agency immediately
What is HHS (Department of Health and Human Services)?