Controlled Substances
Rx labels
Package inserts
Drug Safety
Federal Acts
100

This form is a triplicate form required for ordering or transferring schedule II drugs.

What is DEA form 222
100
This information given by, and about, the patient is required in a prescription label.
What are first and last name, spelled correctly of course.
100
This is usually the first thing listed in the patient package insert.
The brand name, and the generic name of the drug
100
These are studies that help us evaluate the safety, as well as efficacy, or a drug.
What are clinical trials
100
Brought about child resistant containers, and strove to reduce poisoning of children taking prescription medicines.
What is the Poison Prevention Packaging Act of 1970
200
These drugs have no perceived medicinal value, and the pose most risk of abuse to society.
What are C-Is
200
These go on prescriptions to indicate any supplementary information regarding safe administration, use, or storage of the medication.
What are auxiliary, or cautionary and advisory labels
200
This section details what the uses for which the FDA has approved for this drug.
What are indications and usage
200
This regulatory body oversees the safety of all drugs for sale in the United States.
What is the FDA, or Food and Drug Administration
200
Restricted distribution of prescription drugs to legitimate sources, and required wholesalers to be state licensed.
What is the Prescription Drug Marketing Act of 1987
300
The federal law that created schedules for high risk of abuse substances.
What is The Controlled Substances Act (CSA)
300
A prescription label should have this information pertaining to the drug.
What are name of the drug, it's strength, and the quantity
300
This section lists all observed side effects, not just the dangerous ones.
What is adverse reactions
300
This program allows any patient, doctor, or pharmacy personnel to report safety problems concerning any drug, or medical device.
What is the FDAs MedWatch
300
Separated legend drugs from non-legend drugs, and have the FDA power to seize misbranded or adulterated drugs.
What is the Durham-Humphrey Amends of 1951
400
Anabolic steroids belong in this schedule.
What is C-III
400
Every prescription must be assigned it's own unique number, and these are generated by the pharmacy every time a new prescription is ordered. Some times referred to as a serial number, but more often called this.
What is a prescription number
400
This section tells of situations or conditions that signal that this drug should NOT be used.
What is contraindications
400
These are the strictest warnings put in the labels of certain drugs concerning their safety of use.
What are black box warnings
400
Introduced the National Drug Code (NDC) number.
What is the Drug Listing Act of 1972
500
Opium is among drugs in the CS schedule.
What is C-II
500
For controlled substances in schedules II through IV the FDA requires this warning be written somewhere in the label.
"CAUTION: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed."
500
This section of a package insert covers possible serious side effects that may occur.
What is warnings
500
When a drug, substance, or other medical device/equipment is deemed unsafe or has manufacturing problems.
What is a recall
500
Required manufacturers to include package inserts and directions for use, and provided legal status for the FDA.
What is the Food, Drug and Cosmetic Act of 1938
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