FDA New Drug Approval
This phase of clinical trials happens AFTER it has been approved by the FDA for additional safety and efficacy data and to determine new uses for a drug.
What is Phase IV
A drug whose label is false or misleading or if the label is missing required information it is considered…
Misbranded
This Chapter applies to any person, partnership, corporation or business engaging in the wholesale distribution of human or animal prescription drugs either into, out of, or within this State.
False, just human prescription drugs
What are outsourcing facilities licensed under and by whom?
Section 503b by the FDA
This is the goal and study size for phase 3 of a clinical trial
To study safety and efficacy in a large sample size of individuals with the disease
If a product is counterfeit, diverted, or stolen, is intentionally adulterated to cause serious harm or death, or is the subject of a fraudulent transaction it is considered what?
Illegitimate Product
"Transaction" in general means the transfer of product between persons in which a change of ownership occurs. The term transaction does not include: The distribution of blood or blood components intended for transfusion
True, also does not include dispensing the product pursuant to a prescription or distributed product sample from the manufacturer
If a drug is prescription or legend drug must be labeled with what statement:
Caution: Federal law prohibits dispensing without a prescription, Caution: Federal law restricts this drug to use by or on the order of, a licensed veterinarian, or Rx Only
These are the two FDA designations that can expedite the review of a new drug intended to treat a serious or life-threatening illness?
What is Fast track (drugs that could significantly help people with a serious illness, but for which there are currently no effective treatments) and breakthrough therapy (drugs that show much better results than existing treatments for a serious illness)
What does a pregnancy Category C risk mean?
No animal reproductive studies were done or animal studies showed an adverse effect to a fetus. No adequate well-controlled studies have been conducted in pregnant women. Only should be used when risks outweigh the benefits.
Veterinary prescription drug wholesale distributors must be licensed as such in this State and annually renew their license. Veterinary prescription drug wholesale distributors located in this State will be inspected by the Board.
False, they MAY be licensed and inspected, not required to.
Which act instituted in 2010 requires that medical product manufacturers disclose non trivial payments (travel, gifts, entertainment, meals) to prescribers and teaching hospitals.
The Physician Payment Sunshine Act
This is the name of the voluntary reporting system that allows health care professionals to report adverse effects, product errors, and product quality issues directly to the FDA.
What is MedWatch
What does the first segment of a National Drug Code identify?
The manufacturer or distributor.
All current wholesale distributor licensees and all applicants for licensure as a third party logistics provider or wholesale distributor must submit security in the amount of ten thousand dollars ($10,000.00) to the Board.
False, they must provide $100,000 security/bond to ensure payment of any administrative penalty from the Board
Do medical oxygen distributors have to be licensed? If so, what is one difference in licensing requirements?
Yes, they do not need VAWD (Verified-Accredited Wholesale Distributors) accreditation.
What are two reasons an approved drug may become a new drug?
Drug contains a new substance, a new combination of approved drugs, proportion of ingredients in combination is changed, there is a new intended use, or the dosage, method, or duration of administration or application is changed.
"Manufacturer's Exclusive Distributor" means an individual or entity who purchased the product indirectly from the manufacturer and is one of many distributors of that manufacturer's product to a subsequent repackager, wholesale distributor, or dispenser.
Is this the correct definition of Manufacturer’s Exclusive distributor? If not, what would make it correct?
Indirect to direct and one of many distributors to sole or only 1.
Distributors must have a procedure for the disposing and destruction of containers, labels and packaging to ensure that the containers, labels and packaging cannot be used in counterfeiting activities, including all necessary documentation, maintained for a minimum of two (2) years
True
What are 2 requirements outsourcing facilities must follow to compound?
Under direct supervision of a licensed pharmacist (or done by), compound in accordance with cGMP, pharmacists must be certified by compounding certification program approved by the Board of Pharmacy, label compounds with required information, compound only with bulk drug substances that meet FDA standards (drugs must appear on FDA shortage list).
A pharmacist received a prescription for Vyvanse and substituted a generic drug pursuant to state law. The pharmacist labeled the dispensed lisdexamfetamine using the brand name Vyvanse. Explain whether the pharmacist has violated the FDCA.
This medication is misbranded. Under the FDCA the brand can be dispensed as generic. However, the generic cannot be dispensed as the brand.