Federal Practice Flashcards
(59 cards)
What was the first law to prohibit the distribution of food and drugs that were misbranded or adulterated?
Pure Food and Drug Act of 1906
*Replaced by Federal Food, Drug, and Cosmetic Act (FDCA) in 1938
What is the system that can be used as an electronic substitute for a DEA form when ordering schedule II substances?
Controlled Substance Ordering System (CSOS)
What agency is responsible for the federal Controlled Substances Act (CSA)?
Drug Enforcement Administration (DEA)
A pharmacist wants to know if generic warfarin tablets are bioequivalent to brand name Coumadin tablets. Where can this information be found?
The Orange Book
When a pharmacy submits a DEA Form 222 to purchase Schedule II controlled substances, who keeps the original copy of the DEA Form 222?
The supplier
The purchaser makes a copy of the DEA Form 222 for their records
Which DEA form must be completed and submitted to the DEA upon discovering a theft or significant loss of controlled substances?
DEA Form 106 - “Report of Theft or Loss of Controlled Substances”
What is the first application that must be submitted to the FDA before a drug can be administered to humans in order to start testing?
Investigational New Drug Application (IND)
Which phase of a clinical trial is first used to determine the efficacy of a drug?
Phase II
Phase I = assess drug properties, such as PK and adverse effects
Phase III = more comprehensive understanding of potential benefit + risks of drug in larger sample
Phase IV = post-marketing surveillance trials
What Act regulates the sale and recordkeeping requirements for prescription drug samples?
Prescription Drug Marketing Act (PDMA) of 1987
A manufacturer has a drug that is currently on the market, but they want to change the way the drug is produced. What type of application must be submitted to the FDA in order to request approval for this change?
Prior Approval Supplement
For changes related to location or process of manufacturing
Which FDA expedited review program is intended for drugs that treat serious conditions and fill an unmet medical need?
Fast track
Breakthrough therapy is for drugs that demonstrate improvement over available therapy
Accelerated approval is for drugs with long term endpoints that hard hard to measure during clinical trials, such as decrease in mortality or increase in survival
Priority review means FDA’s goal is to take action on the application within 6 months
Schedule II controlled substances CANNOT be transferred when:
Researcher wants to transfer excess Schedule II controlled substances to a PHARMACY to be dispensed
This is because researchers do not have DEA registration
A patient wants to refill a prescription but was not satisfied with the pharmacy that filled and dispensed the prescription the first time. The patient demands the prescription be returned so they can take it to a different pharmacy to obtain refills. The pharmacist should:
Offer to give a copy of the prescription to the patient, keep the original at the pharmacy, and recommend the patient request the prescription to be transferred to another pharmacy.
Once a pharmacy has filled and dispensed a medication, that prescription is legally owned by the pharmacy and the original prescription cannot be returned to the patient.
However, it is acceptable to make a copy; and the prescription can be transferred to another pharmacy if legal.
Examples of adulterated drugs:
A drug that contains decomposed substance
A drug that is not manufactured under required manufacturing standards
A drug that is stored in unsanitary conditions
A substance of the drug container leaches into the drug itself
A drug that is not pure or contains less than the listed amount of active ingredient
A drug that contains an unapproved color additive
What was the first law requiring drugs to be proven safe before being marketed?
Food, Drug, and Cosmetic Act (FDCA) in 1938
What set of regulations specifies the required minimum manufacturing standards for pharmaceutical products in the US?
Good Manufacturing Practice (GMP)
A drug has an NDC of 16103-0350-11. The 0350 represents:
The identity of the drug
First set is manufacturer
Second set is identity of drug
Third set is product package size
Which of the following is a Schedule II controlled substance?
Buprenorphine
Butabarbital
Mescaline
Pentobarbital
Modafinil
Pentobarbital
A prescription for lorazepam can be refilled a maximum of how many times within a 6 month period?
5 times
What is required on the manufacturer’s drug container label for an oral drug product?
Name and address of manufacturer
Name of drug
Net quantity packaged
Weights of each active ingredient
Manufacturer lot number
Expiration date
Special storage instructions if applicable
Federal legend (“Rx Only”)
A water-containing oral formulation that is compounded from commercially available drug products has a maximum BUD of ____ when refrigerated
14 days
Which of the following is a mid-level practitioner?
Physician
Dentist
Veterinarian
Optometrist
Podiatrist
Optometrist
Mid-level practitioners are practitioners other than:
Dentists
Physicians
Veterinarians
Podiatrists
Durable Medical Equipment (DME) must meet which standards?
Must be able to withstand repeated use
Be primarily for a medical purpose
Appropriate for home use
Federal investigations into thefts and robberies may take place per the Controlled Substances Registrant Protection Act (CSRPA) if the incident meets:
Cost to replace stolen substances is >$500
An employee obtains significant injury or was killed
Interstate or foreign commerce was involved in the execution of the crime
