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M2 Federal Regulation of Meds & Devices Exam Questions And Correct Answers
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M2 Federal Regulation of Meds & Devices ExamQuestions And Correct Answers
pure food and drug act of 1906
acknowledgement of prevalent problems in food and medications
concern about unsanitary/ improperly labelled foods and drugs
pure food and drug act of 1906
Prohibited adulteration and misbranding of foods and drugs in interstate commerce
- DID NOT include that misbranding includes false or misleading efficacy claims
pure food and drug act of 1906
This led to pure food and drug act of 1912
Made the government to prove fraudulent intent
food, drug, and cosmetic act (FDCA) of 1938
For no new drug marketing until it was safe for use described on the label, and
approved by the FDA
food, drug, and cosmetic act (FDCA) of 1938
The definitions of adulteration and misbranding were enlarged
Labels to bear "adequate directions for use" and warnings relating to the narcotic and
habit-forming tendencies of certain drugs
food, drug, and cosmetic act (FDCA) of 1938
,exempted drugs marketed before 1938 to be proven safe
added cosmetics and devices
Durham-Humphrey Amendment of 1951
-founded prescription and over the counter classes*
"caution: federal law prohibits dispensing without a prescription"
Durham-Humphrey Amendment of 1951
- pharmacist placing label of directions on prescription satisfies "adequate directions
for use"
Durham-Humphrey Amendment of 1951
--authorized oral prescriptions and refills of prescription medications (calling in Rx)
Kefauver-Harris Amendment of 1962
- thalidomide led to this
--drugs must be proven safe and effective
FDA granted authority over prescription drug advertising
Kefauver-Harris Amendment of 1962
GMPs established
informed consent of research subjects and reporting of adverse drug reactions in
clinical trials
Medical Device Amendments of 1976
devices classified as
premarket approval
performance standards
Medical Device Amendments of 1976
GMP regulations
Record and reporting requirements
Drug
1. "Articles recognized in the official compendium or any supplement of the official
, compendium"
United States
Pharmacopeia(USP)
National Formulary (NF)
Homeopathic Pharmacopeia of the United States
Drug
2. AND intended for use in the diagnosis, cure, mitigation, treatment, or prevention of
disease in man or other animal
Drug
3. AND article (other than food) intended to affect the structure or any function of the
body in man or other animal
Drug
4. AND articles intended for use as a component of any article specified in any of the
above bullet points
Cosmetic
articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or
otherwise applies to the human body or any part thereof for cleansing, beautifying,
promoting attractiveness, or altering the appearance, AND articles intended for use as
a component of any such articles
- except that such term shall NOT include soap
Cosmetic
articles can be a drug AND a cosmetic
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