Transcript Federal Food, Drug and Cosmetic Act – 1938 Tylenol

Bristol Plymouth
Practical Nurse Program
Mrs. Janet L. Terra, R.N., C.
Section 1
Hour 2
Friends, the
ingredients
in this
bottle will
cure all that
ails you!
Drug Standards
Purity
Strength
Safety and Toxicity
1906 - Federal Food, Drug and
Cosmetic Act
Set Legal Standards for Drugs
United States Pharmacopoeia
USP [NF]
Federal Food, Drug and
Cosmetic Act – 1938
• A statement accurately
describing the
package’s contents
Each tablet contains
acetominopen 325 mg.
Federal Food, Drug and
Cosmetic Act – 1938
• The usual names of
the drug(s), both
official and non –
official
Tylenol ®
acetominophen, USP
Federal Food, Drug and
Cosmetic Act – 1938
• Indication of the
presence, quantity, and
proportion of other
drugs
Active ingredients
Inactive ingredients
Federal Food, Drug and
Cosmetic Act – 1938
• A warning of habit –
forming drugs in the
product and their
effects
Warning:
Federal Food, Drug and
Cosmetic Act – 1938
• The names of the
manufacturer,
packager and
distributor
Distributed by
McNeil Consumer
Healthcare
Fort Washington, PA
Federal Food, Drug and
Cosmetic Act – 1938
• Directions for use and
warnings against
unsafe use, including
recommendations for
dosage levels and
frequency
Recommended dose
Not to exceed 8 tablets
in 24 hours, or as
directed by a doctor
Federal Food, Drug and
Cosmetic Act – 1938
• A statement on all new
drugs not yet approved
for interstate
commerce
Caution: New Drug –
Limited by Federal
Law to Investigational
Use
Other Important Acts and
Laws
1952
Durham – Humphrey Amendment
Prescription vs OTC Drugs
1962
Kefauver – Harris Amendment
Truth in Advertising
Laws Specific to Narcotics
1914
1970
Harrison Narcotic Act
First Narcotic Control Act
Comprehensive Drug Abuse
Prevention and Control Act
Controlled Substances Act
1970 Controlled Substances
Act
• Double Lock
1970 Controlled Substances
Act
• Shift Narcotic
Count
6
1970 Controlled Substances
Act
6/23/02
Meperidine 50
mg po q4h prn
back pain
Les Lurnett, MD
6/26/02 Renew
Meperidine 50
mg po q4h prn
back pain
Les Lurnett, MD
• Time Limits on
Prescriptions
Drug Nomenclature
Drugs may have similar names
Don’t be confused
Xanax
used to alleviate anxiety
Zantac
used to prevent ulcers
Zocor
cholesterol lowering agent
Zoloft
anti - depressant
Drug Nomenclature
CH3
Chemical Name
N
8-Chloro-1-methyl-6-phenyl-4Hs-triazolo [4,3-a] [1,4] benzodiazepine
Official Name
CL
N
alprazolam, USP
Trade (Brand) Name
Xanax ®