NREMT Paramedic

Category - Operations

What Act regulates addictive medication?
  1. The Federal Food, Drug, and Cosmetic Act of 1938
  2. The Control Substances Act of 1970
  3. The Federal Food, Drug, and Cosmetic Act of 1950
  4. The Controlled Substance Act of 1975

Answer: B - The Controlled Substances Act of 1970 regulates addictive medication. Since 1970, the government has regulated addictive medications through the Controlled Substances Act. This act classifies addictive medication into five schedules, prohibits the refilling of prescriptions for Schedule II drugs, and requires that the original prescription be filled within 72 hours.

The CSA of 1970 also provides a mechanism for substances to be controlled (added to or transferred between schedules) or decontrolled (removed from control). The procedure for these actions is found in Section 201 of the Act (21U.S.C. §811).

As new substances are constantly being created or coming to market, the DEA is constantly updating the related schedule. Proceedings to add, delete, or change the schedule of a drug or other substance are initiated by the Drug Enforcement Administration (DEA), the Department of Health and Human Services (HHS), or by petition from any interested party, including:

The manufacturer of a drug

A medical society or association

A pharmacy association

A public interest group concerned with drug abuse

A state or local government agency

An individual citizen

In determining into which schedule a drug or other substance should be placed, or whether a substance should be decontrolled or rescheduled, certain factors are required to be considered. These factors are listed in Section 201 (c), [21 U.S.C. § 811 (c)] of the CSA as follows:


(1) Its actual or relative potential for abuse.

(2) Scientific evidence of its pharmacological effect, if known.

(3) The state of current scientific knowledge regarding the drug or other substance.

(4) Its history and current pattern of abuse.

(5) The scope, duration, and significance of abuse.

(6) What, if any, risk there is to public health.

(7) Its psychic or physiological dependence liability.

(8) Whether the substance is an immediate precursor of a substance already controlled under this subchapter.

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