Laws, Regulations, And Controlled Substances

Pharmacy Law, Scheduled Drugs, and Pregnancy Medication Classifications

FDA (Food and Drug Administration)

Regulates the safety and effectiveness of drugs, biological products, and medical devices.

DEA (Drug Enforcement Administration)

Enforces the controlled substances laws and regulations.

FTC (Federal Trade Commission)

Regulates advertising of prescription drugs.

CMS (Centers for Medicare & Medicaid Services)

Ensures the proper dispensing of drugs through Medicare and Medicaid programs.

Pure Food and Drug Act of 1906:

• Ensures drugs are free from adulteration or misbranding.

• Required accurate labeling of drugs and food

Harrison Narcotic Act of 1914

required narcotics manufacturers, sellers, and distributors to register with the Bureau of Internal Revenue under the U.S. Treasury Department

Food, Drug, and Cosmetic Act (FDCA) of 1938

Mandate drug manufacturers to submit evidence of new drugs' safety and effectiveness before marketing and distribution to the general public.

Durham-Humphrey Amendment of 1951:

established a distinction between prescription (legend) and over-the-counter (OTC) drugs, requiring prescription drugs to carry the statement "Caution: Federal law prohibits dispensing without a prescription"

Kefauver-Harris Amendment of 1962:

required that manufacturers prove the effectiveness of drug products before they go on the market, and afterwards report any serious side effects

Controlled Substances Act (CSA) of 1970

established federal U.S. drug policy, regulating the manufacture, importation, possession, use, and distribution of certain substances, while also expanding federal law enforcement pertaining to controlled substances

Drug Enforcement Administration (DEA)

• Enforces regulations surrounding controlled substances.

• Issues DEA numbers to healthcare professionals for prescribing controlled substances.

Schedule I

High potential for abuse and no accepted medical use (e.g., heroin, LSD)

Schedule II

High potential for abuse but has accepted medical uses (e.g., morphine, oxycodone, methadone).

Schedule III

Moderate potential for abuse, accepted medical use (e.g., anabolic steroids, codeine with aspirin).

Schedule IV

Lower potential for abuse, accepted medical use (e.g., diazepam, alprazolam).

Schedule V

Low potential for abuse, accepted medical use (e.g., cough preparations with less than 200 mg of codeine per 100 mL).

Schedule I (C-I) DRUGS

Heroin, LSD, MDMA (ecstasy), marijuana (federally illegal).

Schedule II (C-II DRUGS

Morphine, oxycodone, fentanyl, methadone, hydrocodone

Schedule III (C-III) drugs

Anabolic steroids, ketamine, codeine (in combination with acetaminophen), buprenorphine

Schedule IV (C-IV) Drugs

Diazepam (Valium), alprazolam (Xanax), lorazepam (Ativan), clonazepam.

Schedule V (C-V)

Lomotil, cough preparations containing less than 200 mg of codeine per 100 mL, ezogabine

Category A

• Definition: Controlled studies show no risk to the fetus in the first trimester.

• Examples: Levothyroxine, folic acid.

Category B

• Definition: Animal studies show no risk, but there are no well-controlled studies in humans or animal studies show risk, but humans do not show risk.

• Examples: Amoxicillin, acetaminophen, insulin.

Category C

• Definition: Animal studies show an adverse effect, but there are no adequate studies in humans, or studies in humans and animals are unavailable. The drug should only be used if the potential benefit justifies the potential risk to the fetus.

• Examples: Dextromethorphan, most antidepressants (SSRIs), ciprofloxacin.

Category D

• Definition: There is positive evidence of human fetal risk, but the potential benefits may outweigh the risks in certain situations.

• Examples: Lithium, phenytoin, warfarin.

Category X

• Definition: Studies in animals or humans have demonstrated fetal abnormalities or risks, and the drug is contraindicated during pregnancy.

• Examples: Isotretinoin (Accutane), thalidomide, methotrexate