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Law Chapter 3
Terms in this set (31)
What did the Durham-Humphrey Amendment do?
1.Established criteria for distinguishing prescription drugs from OTC
2. establishes oral prescriptions and refills
What did the Durham-Humphrey amendment do with pharmacy labeling?
specified minimum info that must be on Rx label. before this, the bottle dispensed had to have everything the manufacturer had on their bottle
Why is the USP and FDA inconsistent with BUD laws?
USP says 1 year from dispense
FDA says 6 months
(or manufacturer exp. date if shorter)
What are the 3 methods of switching a prescription drug to OTC?
1. SNDA product switch
2. Petition product switch
3. adding or amending an OTC drug monograph; affects all products in the class
What are 3rd class drugs?
behind the counter, nonprescription
What are behind the counter drugs?
class of drugs that can only be sold from the pharmacy department
What are behind the counter drugs only sold from behind the counter?
based on the rationale that more dangerous drugs are being switched and would allow even more drugs to be switched
What should be considered when an oral prescription is given?
Who calling in the prescription? Who authorized the prescription (MD, DO)?
States can determine who may prescribe independently or in collaborative practice.
Describe the journey of Plan B
1. approved 1999
2. citizen petition requesting OTC Switch in 2001 and an SNDA in 2003
3. approved as OTC in 2006 for women 18 and older to be sold behind the counter
4. 2006 lawsuit with the FDA ordered age to be reduced to 17 and FDA to reconsider petition
Plan B continued
5. 2011 SNDA for drug to be sold OTC without age or point of sale restriction
6. 2011 age restriction eliminate
7. 2013 FDA ordered to make Plan B OTC without restriction
What is conscientious objection?
refers to whether a pharmacist has a right to refuse to dispense prescription when a moral or religious objection exists.
What is the court ruling on conscientious objection?
courts have held that a pharmacist cannot obstruct a patient's legal right to receive medications, but requiring pharmacists to dispense violates 1st amendment rights
Medications guides are required by the FDA to be given to consumers for what drugs?
drugs the FDA has determined as posing "serious and significant concerns"
Pharmacies compounding for their patients pursuant to prescription are exempt from FDCA manufacturing provisions.
What happended with FDAMA?
lined out 9 activities that could cross the line from compounding to manufacturing. Said FDA couldn't not consider compounding as "new drugs"
Compounding Quality Act of 2013
compounders of sterile products can voluntarily register as "outsourcing facilities." products are exempt from misbranding if they register
Jimbo comes in and says, "compound together my OTC aspirin and tylenol."
Are you manufacturing or compounding?
Gray area. If you created a new drug, you are manufacturing and its probably misbranded and mislabeled.
Can pharmacists substitute brands with generics?
differs by state, but usually. Labelling must be accurate and labeled as the generic and not the brand
What does the orange book do?
evaluates products on the basis of bioequivalence
products contain the same active ingredients and are identical in strength and dosage form
Bioequivalent drugs are NOT generally considered therapeutically equivalent.
False. They are
What is the rating system in the Orange Book?
A and B
Define a drug with a narrow therapeutic index.
Drugs with less than a two-fold difference between median lethal dose and median effective dose or two-fold difference between minimum toxic concentrations and minimum effective concentrations
Prescription Drug Marketing Act did what to wholesalers?
1. required licensing of wholesalers
2. can't reimport Rx drugs
3. prohibits resale of Rx drugs by hospitals or healthcare facility
4. bans sale, trade, or purchase of Rx samples
Can the FDA search without a warrant?
FDA can come inspect a pharmacy to see if they are manufacturing or compounding without a warrant. Can they inspect anything else while they are there?
yes. they can extend the search when probable cause exists
Where is tax-paid alcohol used?
compounding or community pharmacies
Where is tax-free alcohol used?
hospitals for medicinal, mechanical, and scientific purposes in treatment of inpatients only. Charities can use for outpatient if they do not charge.
Poison prevention packaging Act
established standards for child-resistant containers
Exemptions to Poison Prevention Packaging Act
1. prescriber requests
2. patient requests
3. institutionalized patients
4. Certain drugs like SL nitro and chewable isosorbide
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