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Section 1

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- states license wholesale drug distributors - restriction on drug samples - hospitals and other hospital entities cannot resell their drug purchases

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Date created

Mar 1, 2020

Cards (49)

Section 1

(49 cards)

- states license wholesale drug distributors - restriction on drug samples - hospitals and other hospital entities cannot resell their drug purchases

Front

Prescription Drug Marketing Act

Back

1. Establishing continuity of decisions 2. Expediting judicial decision-making

Front

purposes of stare decisis

Back

You work at General Hospital, and you receive a call from McClaskey Drug Store wanting to purchase Kangacillin, since the hospital price is much cheaper than the retail price. (McClaskey Drug Store is ethical and will pass the savings on to the patient!) Which act prohibits the General Hospital from reselling of pharmaceuticals?

Front

Rx Drug Marketing Act

Back

- prescription drug amendment - two classes of drugs (prescription and OTC) - labels of prescription drugs have to have legend - verbal transmission of prescriptions - authorized refills on prescriptions

Front

Durham-Humphrey Amendment

Back

violation of statute

Front

criminal

Back

A pharmaceutical manufacturer develops a new product called Roocixumab. The manufacturer is now ready to begin testing in animals. Which federal agency controls the process for new drug application?

Front

FDA

Back

You often hear prescription drugs called legend drugs. Which act created this? (Caution: Federal Law prohibits dispensing without a prescription.)

Front

Durham-Humphrey Amendment (Rx Drug Amendment)

Back

The Food and Drug Administration (FDA)

Front

a federal agency charged with enforcing regulations against selling and distributing adulterated, misbranded, or hazardous food and drug products

Back

lawsuit between 2 private parties

Front

civil

Back

- safety - extended control to cosmetics and therapeutic devices - new drugs had to be safe prior to marketing - expanded misbranding an adulteration definitions - labels must contain adequate directions for use

Front

Federal Food, Drug, and Cosmetic Act

Back

Financial incentives for manufacturers of medications for the treatment of rare diseases or conditions

Front

Orphan Drug Act

Back

- 2 parts Title 1: - strengthens FDA oversight over sterile compounding and shipping - comply with current good manufacturing processes Title 2: - drug products must be traced from manufacturer to pharmacies

Front

Drug Quality and Security Act

Back

Which drug is NOT grandfathered into the Food, Drug and Cosmetic Act?

Front

Phenytoin

Back

Required drug manufacturers to pay application fees when submitting a new drug application

Front

Prescription Drug User Free Act

Back

Roociximab was recently approved. What act added 5 years onto new product patent life?

Front

Waxman-Hatch Amendment (Drug Price Competition and Patent Term Restoration Act)

Back

- deals with labeling (mis-branding) - prohibits interstate commerce of misbranded and adultered foods, drinks, and drugs - basis of the law was regulation of product labeling - drugs defined in strength, quality, and purity in USP-NF - Alcohol, heroin and cocaine have to be labeled - prohibits false and fraudulent efficacy claims

Front

Pure Food and Drug Act

Back

- research - proof of effectiveness must be shown before approval - established Good Manufacturing Practices - prescription drug advertising was placed under the supervision of the FDA - established a procedure for new drug applications and for investigational drug procedures - required informed consent of research subject - required reporting of adverse drug reactions during research projects

Front

Kefauver-Harris Amendment

Back

The Federal Trade Commission

Front

a federal agency established in 1914 to investigate and stop unfair business practices and antitrust violations

Back

As the clinical coordinator at General Hospital, you get a call from a sales rep from Kanga Therapeutics, stating they have a new product, Tigeroxacin. Which act ensures this drug is safe?

Front

FDCA

Back

federal laws require that all patients be offered counseling by a pharmacist when a prescription medication is dispensed. If the state of Missouri passed a law that requires all OTC and prescription products to require counseling, which law must you follow?

Front

state law bc they don't conflict, and the state law is stricter

Back

Who develops and administers policies for all controlled drugs?

Front

DEA

Back

The sales rep for Amazing Pharmaceuticals come in, and leaves you samples. You find out that McClaskey Drug Store can use them, and you offer to sell them at a great price! Which act does this violate?

Front

Rx Drug Marketing Act

Back

- drug price - extended to the abbreviated new drug application (ANDA) process

Front

Waxman-Hatch Act

Back

A new federally funded prescription plan will pay a $5 dispensing fee to pharmacists for all prescriptions. Which agency has jurisdiction over this?

Front

CMS

Back

FDA issues a recall on filgrastim 300mcg/ml vials since they came in a box labelled as pre-filled syringes (PFS). Which act does this violate?

Front

Pure Food and Drug Act

Back

As Pharmacist-in-Charge, you have just learned that your drug wholesaler has been bought out by a company out of state. Which federal agency will oversee the wholesaler to ensure consumers are protected?

Front

FTC

Back

- blocks importing of adultered products - FDA can preform inspections outside of USA - Detecting and reducing drug shortages - improving prescription drug diversion info between the states - counterfeit medications containing fentanyls

Front

FDA Safety and Innovation Act

Back

You have a patient newly diagnosed with Ebola. The FDA recently approved a new IV antiviral, roocyclovir through a quicker process than other medications. What act allowed for this faster approval?

Front

FDA Modernization Act

Back

As the clinical coordinator at General Hospital, you are responsible for the Investigational Drug Service (drugs in clinical trials that have not been approved yet by the FDA). What act added informed consent of patients and increased reporting of adverse events for investigational drugs?

Front

Kefauver-Harris Amendment (Drug Efficacy Amendment)

Back

You are the PIC, and a new drug wholesaler has come into town. Which act required the licensing of drug wholesalers?

Front

Rx Drug Marketing Act

Back

Increased FDA oversight of compounding and 'track-and-trace' requirements

Front

Drug Quality and Security Act

Back

Required devices to: obtain premarket approval, set performance standards, conform to GMP, and established recordkeeping and reporting

Front

Medical Device Amendment of 1976

Back

Kangacodone is a new controlled substance that has recently been approved for use in adults in the US. You cannot remember what schedule it is classified. What agency website can you go to look it up?

Front

DEA

Back

A patient comes to you with a magazine advertisement for Losealot, a product that is all natural and has the claim of weight loss. What act allows this product to be available?

Front

Dietary Supplement Health and Education Act

Back

You fill a prescription for morphine for a new hospice patient. What act required a prescription for morphine?

Front

Harrison Narcotic Act

Back

The US congress recently passed a law requiring that pharmacists offer to counsel patients at any time when they receive a prescription. What type of law is this?

Front

statutory law

Back

federal laws (U.S. Congress), state constitutions, state legislation, ordinances

Front

statutory law

Back

- enhanced responsibilities and authorization to regulate drug safety - mandate label changes according to safety - require clinical trial data reporting and registries - require post-marketing clinical studies - risk evaluation and mitigation strategies - thalidomide -isotretinoin

Front

FDA Amendments Act

Back

You received an email from your supplier of ibuprofen that the shipment you received yesterday did not have the strength on the label. Which act does this violate?

Front

Pure Food and Drug Act

Back

The patent on roosartan is expiring at the end of this month. Which act allowed that generic drug manufacturers only submit proof of bioavailability to the FDA?

Front

Waxman-Hatch Amendment (Drug Price Competition and Patent Term Restoration Act)

Back

Which act was a result of the sulfanilamide tragedy?

Front

FDCA

Back

The Drug Enforcement Administration

Front

The government agency responsible for administering and enforcing the Controlled Substances Act.

Back

- abuse of opium and cocaine at the end of the 19th century reached epidemic proportions - local governments began prohibiting opium dens and opium importation - HNA restricted the manufacturer and sale of marijuana, cocaine, heroin, and morphine - required taxation for those involved in any aspect of narcotic use - licensed physicians and pharmacists - required accurate inventory to be maintained

Front

Harrison Narcotic Act

Back

A patient comes into your pharmacy, and asks you about getting the doc to prescribe a medication that has not been approved in the US, however, is available in Europe. Which act(s) would you reflect upon to counsel the patient?

Front

- Kefauver-Harris Amendment (Drug Efficacy Amendment) - Food, Drug and Cosmetic Act (FDCA

Back

violation of a statute or regulation that warrants investigation

Front

admin. action

Back

You receive a prescription for tigerbarbital. Which act requires that habit-forming drugs contain warnings?

Front

FDCA

Back

- laws made by courts - judicial opinion - courts often must interpret the meaning and application of the statutes

Front

common law

Back

The Centers for Medicare & Medicaid Services (CMS)

Front

responsible for reimbursement policies and procedures for pharmacies and other healthcare providers participating in the Medicare and Medicaid programs

Back

Bearconazole, is an antifungal agent that was prescription and now has been approved for OTC use. Which act defined prescription products and OTC?

Front

Durham-Humphrey Amendment (Rx Drug Amendment)

Back