(The Role of Technicians)
True or False
Technicians may obtain patient health information.
True
This section of the package insert provides information about what a medication is used to treat.
Indications and Usage
This act requires each drug to have a unique number.
Drug Listing Act of 1972
True or False
The FDA can enforce the laws surrounding illegal drug substances
False
True or False
In an outpatient setting, medication guides are required with all outpatient meds.
True
True or False
Technicians are allowed to work in a pharmacy without a Pharmacist.
False
Prescribing medication for an unapproved indication is the definition of this.
Off Label
This act allows manufactures to submit ANDAs to market generic drugs.
Hatch-Waxman Act of 1984
Over the counter medication approval is a responsibility of this group.
FDA
The size and package code are identified by this segment of numbers on an NDC.
Last segment
Meeting the minimal level of competency to practice as a technician is granted by this.
Licensure
Medication’s markings, shape and color are found in this section.
How Supplied/Storage and Handling
This act requires a pharmacist to consult with a patient about what the prescriptions is.
The Omnibus Reconciliation Act of 1990
This agency is the governing enforcer of the Controlled Substance Act.
Drug Enforcement Administration
When ingredients are not listed on the label causing a recall of a dietary supplement, the product is considered to be this.
Adulterated
A state board list of people working as a technician is considered this.
Registration
Often referred to as the Orange Book, this drug information source provides generic substitution equivalence ratings.
Approved Drug Products with Therapeutic Equivalence Evaluations
This act requires supplements to be treated more like drugs than foods.
Dietary Supplement Health and Education Act of 1994
This state group regulates and enforces the practice of pharmacy laws in each state to protect the health safety and welfare of patients.
Board of Pharmacy
A falsely labeled over the counter medication is considered to be this.
Misbranded
These are the 2 names of the organizations that offer a certified pharmacy technician exam.
HNA and PTCB
Brand and generic medications are therapeutically equivalent when these 3 things are identical.
Ingredients, strength, and dosage
This Act governs patient privacy and sharing of patient information.
The Health Portability and Accountability Act of 1996
Package standards for protecting children from accidental poising from medication is created by this regulatory agency.
Consumer Product Safety Commission
For a generic medication to be a pharmaceutical equivalent to a brand name, the medication must be identical in what 5 ways.
Active ingredients, strength, dosage form and route of administration.