Drug Schedules
Strongest potential for abuse, no use in the medical field
Indication
What the drug is intended to treat
Monograph
Comprehensive information on a medications actions within that class of drug
1990 Nutrition Labeling and Education Act
Requires a nutrition facts panel on most packaged food products
C-ll
Must be locked up because of high abuse potential, no refills
Category B
Animals studies have failed to demonstrate risk to fetus
Contraindications
Who should not take the medication
Drug Diversion
The intentional misuse of a drug intended for medical purposes
1914 Harrison Narcotic Act
Enacted in the United States in parallel with international treaties to curb recreational use of opium
C-V
Kept over-the-counter in some states because of low potential use, 5 refills in 6 months, exempt narcotics
Category D
Positive evidence of human fetal risk, but potential benefits may warrant use of drug
Adverse Reactions
Reactions reported other than the intend treatment
National Drug Code
1951 Durham-Humphrey Amendment
Required labels on prescription drugs, Required a doctor's order and supervision for certain drugs
C-lll
Less abuse potential, 5 refills in 6 months
Human studies have failed to demonstrate risk to fetus in 1st trimester
Dosage and Administration
How to take it and how often you should
Form 225
To manufacturer or distribute controlled substance
1967 Fair Packaging and Labeling Act
Requires that all consumer commodities be labeled to disclose net contents, identity, and name/place produced
C-IV
Less abuve than C-III, 5 refills in 6 months
Category C
Animal studies have shown an adverse effect on the fetus. Potential benefits may warrant use of drug in pregnant women
Drug Interactions
Form 41
Returns to reverse distributor
1962 Kefauver-Harris Amendments
Enacted in an attempt to ensure the safety and effectiveness of all new drugs on the market