Manufacture and Wholesale Distribution Flashcards
T/F: FDA focuses on regulating manufacturers of food, drugs and cosmetics and does not regulate the practice of medicine or the practice of pharmacy
True
What did the Food and Drug Act of 1906 do
Prohibited the marketing of contaminated and misbranded food and drugs
What did the Federal Food, Drug and Cosmetic Act[FD&C Act] of 1938 do
Compelled manufacturers to demonstrate to the FDA the safety of new drugs before they hit the market
What act created the differences between OTCs and prescription drugs
Durham‐Humphrey Amendment of 1951
What amendment caused a new drug application before a company could market a new drug and be allowed to issue good manufacturing practice guidelines governing how drugs were to be manufactured. Inspection of
drug manufacturers was mandated every 2 years
Kefauver‐Harris Amendment of 1962
T/F: All drugs must have tamper resisting packaging
True
What makes a drug a drug
1) Homeopathic Pharmacopoeia
2) diagnosis, cure, mitigation, treatment or prevention of disease
3) non-food article intended to affect structure or function of the body
What makes a “legend drug” RX drug different from an OTC drug
Cannot be made safe by including adequate directions for use
How can a pharmacist cause a drug to be misbranded
1) A pharmacist dispenses without a RX or authorized refill
2) A product is dispensed pursuant to a valid prescription, but is dispensed without the proper RX label
T/F: Drugs can be compounded for office use
False: This is no longer okay
What is the “triad” needed for compounding to be considered okay
A patient-doctor-pharmacist relationship: A doctor must
prescribe or order the compounded product for a patient in order for the pharmacist to compound
What is anticipatory compounding
pharmacist compounds small amounts of drug before receiving prescription, based on previously filled valid prescriptions within an established practitioner -
patient - pharmacist relationship, and the RX is kept on file
When are the only TWO exceptions a drug is compounded for “office use”
They have a patient specific prescription and are simply delivering the compounded product to the doctor’s office
Anticipatory compounding
When would a pharmacist be able to compound a commercially available drug
For an individual patient need that the pharmacist has documented and talked to a prescriber about, there is a drug shortage and the commercially available drug is not present
What are pharmacies called that compound but are not patient specific, what law regulates them
Outsourcing Facilities (voluntary), 503B- exempt from NDA and labeling requirements but must still adhere to cGMP requirements
