Pharm Law lecture 3 Flashcards
What did pharmacy law look before 1900
Oversight on meds was slim to none
No requirement for efficacy and safety
Only notable law is regarding importation of drugs requiring US customs inspection to prevent adulterated drugs from entering country
What are patent medications (nostrum)
Heavily advertised products purported to cure numerous diseases with no regard to ingredients within or safety/effectiveness of ingredients
What book/article exposed patent medications
1905 The great american fraud and the jungle
When was the 1st law to pass regarding meds and drugs? What is it called?
1906: Pure Food and Drug act
First federal law regulating medications, it was limited to drugs moving in interstate commerce
What did the Pure and food act do?
Recognized the US pharmacopeia and national formulary as standard drug references
Defined misbranding and adulteration and assigned penalties to each practice
Established Bureau of chemistry and US department of agriculture, later changed to FDA
What does the official compendia consist of?
- US pharmacopeia (USP)
- National Formulary (NF)
- Homeopathic Pharmacopeia of the US (HPUS)
USP and NF drugs Merged to form USP-NF
Define adulteration
If the product inside the bottle is not what it is intended to be, then it is adulterated
Factors that make a drug adulterated
1) Product contains any poisonous or unsanitary ingredients
2) Strength, quality, purity differs from official comp
3) Strength differs from official compendium
4) Product is mixed with another substance to reduce quality or strength
5) Delayed, denied or limited inspection or refused entry to inspection
What are two banned devices that are adulterated
Prosthetic hair fibers, Powdered gloves
What are factors that make a device adulterated
1) device not in conformity with performance standards
2) Certain class III devices that do not have appropriate approval for use
3) Banned devices
4) Manufacture, packing, storage or installation of a device not conforming to applicable requirements or conditions
5) Failure to comply with requirements under which a device was exempted for investigational use
What are the three different classes of devices
Class I device- NOT used for supporting human life and/or preventing impairement of human health and do not present a potential unreasonable risk of illness or injury (Cotton ball, stethescope)
class II device- Moderate risk to use, require special controls to assure safety and effectiveness of devices (MRI machine, CT scan)
Class III device- High risk to use to support or sustain human life or preventing impairement of human health and do notpresent a potential unreasonable risk of illness or injury (hemodialysis, prosthetic mitral valve)
Define misbranding
Generally, is the packaging containing the product which it is iintended to be? If no, misbranded
What are factors that make a specific item misbranded
1) False or misleading labeling
2) Labeling that does not contain the manufacturer, packer, or distributor and an accurate statement of the quantity of the contents in terms of weight, measure or count
3) Required info is nor PROMINENTLY displayed or stated
4) Established name is not included (and atleast 1/2 has large as proprietary name)
5) Directions and required warnings not included on label
What is an established name? Proprietary name?
Established- Generic
Proprietary- brand
Name 6 more factors that can make a drug misbranded
- Not in compliance with official compendia standards for packaging
- If product is liable to deteriorate, unless it is packaged appropriatelt and notes expiration date
- If drug container is developed in a misleading way. imitation of another drug
- If use of drug as prescribed is dangerous to health
- if an ingredient is a color additive only
- If advertisements do not include required information
If a risk mitigation and evaluation strategy (REMS) is required and not approprtely addressed, is it adulterated or misbranded
Misbranded
If product identifier is required and not included, ( Rx- only or controlled substance markings) is it adulterated or misbranded
Misbranded
If 500 mg metformin tab does not possess the total strength it is represnted to contain in each tab according to compendim. Is it adulterated? Misbranded, both or neither
Adulterated
if an atorvastatin stock bottle lists the established name, but not proprietary is it misbranded or adulterated
neither, if we have established name, we do not have to have proprietary name
Can a drug be adulterated and misbranded?
If a product is stored outside its recommended temo, leading its label to fall off due to adhesive failure
An expired drug is counted put into a prescription bottle and then dispensed to patient
WHat happened to the 1906 law in 1911
It was challenged in court and the supreme court ruled that the pure food and drug act only prevented false statements on the drugs identity ad not false or misleading claims.
How did congress try to fix the 1911 law suit of the food and drug act
The SHerley Amendment in 1912
What is the sherley amendment of 1912? How effective was it?
Prohibits manufacturers from intentionally misleading claims about drugs effectiveness
The onus was onthe government to prove intent, which made this very difficult to enforce.
Many meds were allowed to remain on marker for years
What caused the overhaul of the 1906 food and drug act
Elixir sulfanilimide tragedy: 1937
What law came after the sulfanilimide tragedy in 1937?
Federal food, drug and cosmetic act of 1938
What did FEDERAL food, drug and cosmetic act enat?
Required NEW drugs to be shown safe before marketing
Repealed sherley amendment requirements to prove intent to defraud in drug misbranding case.
Authorized factor inspections
Required selected dangerous drugs to be administered under direction of a qualified expert
What are the 4 criteria of a drug according to federal food and drug and cosmetic act
a) Articles recognized in the official compendia
b) Articles intended for use in diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals
c) Articles (other than food) Intended to affect the structure or any function of the body of man or other animals
d) Articles intended for use as component of any articles specified in A, B or C
What did the court rule during 1950 alberty food products Co. v United states
The court rules that “in order for the labeling of a drug to bear “adequate directions for use”… it must among other things, state the purpose and conditions for which the drug was intended and sufficient information to enable a layman to intelligently and safely attempt self medication
What did the 1951 durham-humphrey amendment do?
Addressed meds that were not safe for use except under medical supervision, separating medications into two classes.
OTC meds could be labeled with “adequate directions for use”
Legend medications had to be dispensed under supervision of a health practitioner as a prescription drug and carry the statement “caution: federal law prohibits dispensing without prescription” If it doesnt have this label- misbranded
Also allowed verbal transmission of prescription and refills for prescription drugs
