What event caused the FDCA to come about?
107 deaths from diethylene glycol (auto antifreeze) as a vehicle for
sulfanilamide elixir
The FDCA said labels had to include what?
Adequate directions for use Habit forming
warnings
Which drugs were exempt to the FDCA?
Those marketed prior to 1938
Act prohibited foods and drugs distributed through interstate
commerce from being adulterated or misbranded:
Pure Food and Drug Act of 1906
Any new drug had to be proven safe when used according to label
directions corresponds to which law?
FDCA of 1938
Under Durham-Humphrey Nonprescription drugs were defined as:
products not requiring medical supervision for safe use
require �adequate directions for use� on the label from the
manufacturer
Provided for better classification of medical devices according to
their specific function
Medical Device Amendment of 1976
Who can sell, distribute, exchange or give to any person a hypodermic
syringe or needle designed or marketed primarily for human use?
Only a pharmacist, intern, or extern
Which law was adopted as a result of public concern about thalidomide
causing serious birth defects?
Kefauver-Harris Amendment of 1962
Over-the-counter, non-prescription drug products must:
Be safe for use without medical supervision Be for
conditions suitable for self-diagnosis Have adequate
written directions for self-use
True or False: By law, claims in advertisements, including OTC
medicines, must be truthful and cannot be misleading or unfair.
TRUE
Kefauver-Harris Amendment of 1962 is also known as what?
Drug Efficacy Amendment
Established performance standards and pre-market approval
Medical Device Amendment of 1976
Did not require manufacturers to list ingredients or directions for
use corresponds to which law?
Pure Food and Drug Act of 1906
The FTC enforces OTC advertising by what 3 basic standards?
An advertiser needs to have prior substantiation that an
objective claim in an ad is true before they run the
advertisement. Under its deception policy, the FTC looks to
real life situations and how consumers would interpret an
advertisement...if the overall ad seeks to mislead informed choice
through misrepresentations or omissions, the FTC can act against the
advertiser. Under its unfairness policy, FTC may act against
ads that cause substantial consumer harm that are not outweighed by
a consumer or competitive benefit or where a consumer could not
reasonably avoid the harm.
Did the Pure Food and Drug Act regulate cosmetics or medical devices?
No
In GA, where must syringes be kept in a pharmacy?
Behind prescription counter In prescription
department
Required all new drugs marketed in US to be shown as safe and effective:
Kefauver-Harris Amendment of 1962
Often contaminated, not consistent in strength, and poorly labeled
relates to which law?
Pure Food and Drug Act of 1906
List some examples of Medical Devices:
tongue depressors arm slings physiologic
monitors pumps X-ray systems implants
Required devices be manufactured in accordance with GMP
Medical Device Amendment of 1976
Were drugs that were approved between 1938 and 1962 required to be
tested and proven both safe and effective?
Yes
True or False: NO needle and/or syringe shall be sold if there is
reasonable cause to believe that it will be used for an unlawful purpose.
TRUE
Signed into FEDERAL law under the USA Patriot Act in 2006
Combat Methamphetamine Epidemic Act of 2005
Created Good Manufacturing Practice (GMP) requirements
Kefauver-Harris Amendment of 1962
Outlined record keeping and reporting requirements
Medical Device Amendment of 1976
The Combat Methamphetamine Epidemic Act limits purchasers to what
amount of PSE products in 1 day?
No more than 3.6 grams
This was the first law that addressed safety and applied to cosmetics
and medical devices in addition to foods and drugs:
FDCA of 1938
Provided for the regulation of prescription drug advertising by the FDA
Kefauver-Harris Amendment of 1962
Amendment to 1938 FDCA established two classes of drugs:
Durham-Humphrey Amendment of 1951
Prescription advertising is regulated by whom?
FDA
What were the 2 classes of drugs created by Durham-Humphrey?
Prescription or "Legend" drugs
Non-prescription or Over-the-counter drugs
Restricts the sale of psuedoephedrine and applies to all cough and
cold products that contain ephedrine, pseudoephedrine (PSE), or
phenylpropanolamine (PPA)
Combat Methamphetamine Epidemic Act of 2005
Non-prescription advertising is regulated by whom?
Federal Trade Commission (FTC)
Which law provided for oral prescriptions and prescription refills
Durham-Humphrey Amendment of 1951
Durham-Humphrey described prescription drugs as what?
requiring medical supervision for safe use did not
require �adequate directions for use� on the manufacturer�s
label
Adequate directions for use was satisfied for legend drugs under
Durham-Humphrey how?
By the pharmacist placing the prescribers directions on the label of
the dispensed product
Durham-Humphrey required that legends drugs must have what on the
manufacturer's label?
Caution: Federal law prohibits dispensing without a prescription�
The Combat Methamphetamine Epidemic Act limits purchasers to what
amount of PSE products in a 30 day period?
No more than 9 grams
The Combat Methamphetamine Epidemic Act limits purchasers to what
amount of PSE products in a 30 day period for mail-order?
No more than 7.5 grams
Required informed consent for research subjects in clinical
investigations and reporting of adverse reactions
Kefauver-Harris Amendment of 1962
Non-liquid forms of PSE must be sold in what?
Blister packs
What is the maximum amount of dosage units per pack for non-liquid
forms of PSE?
No more than 2 dosage units per pack
In GA, PSE containing products must be kept where?
Behind the Pharmacy counter (in the pharmacy prescription department)
In GA, it is required that all PSE prescription sales are tracked
prior to the sale using what?
Real-time electronic logging system
True or False: Pharmacists do not have to apply reasonable means to
determine that the product being purchased is for a legitimate medical purpose
False; MUST
Who must approve all sales and transactions of PSE containing products?
Pharmacists
What is required for the approval of selling a PSE containing product
in GA?
Legitimate purpose Age verification (18 yo) with valid
I.D.
True or False: After transactions have been approved, other pharmacy
personnel may be directed by the pharmacist to complete the transaction
TRUE