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Over-the-counter medication (OTC)

(P. 592)

Medication available without a prescription


Drug standards

(P. 4)

• Are rules set to assure consumers that they get what they pay for.

• must be of uniform strength, quality and purity.

• federally approved requirements


1906 Pure Food and Drug Act


In 1906, government attempt to establish consumer protection in the manufacture of drugs and Foods.

• United States pharmacopeia (USP)
• National formulary (NF)

Today it is in one book - USP/NF


Orphan Drugs

(P. 7)

1983 orphan Drug Act gives pharmaceutical companies financial incentives to develop medications for diseases that affect only a small number of people.


National Drug Code (NDC) Directory

(P. 5)

Was established in 1972. This provided the FDA with a list of all drugs manufactured for commercial distribution. Each drug is identified by in NDC number, made up of three parts:

• first part is 5 numbers and identifies the manufacturer.

• second part is 4 numbers and identifies the drug.

• third part is two digits and identifies the package size.

Example: 00406-0123-01 ( it is common practice to Omit a leading zero in the first and second part of the NDC number.


Omnibus Budget Reconciliation Act (OBRA) of 1990

(P. 7)

This act mandates that all OTC drugs a patient is taking must be documented as part of the medical record. Also, mandates pharmacists provide drug use review and patient counseling before dispensing prescriptions to a patient.


Drug Enforcement Administration (DEA)

(P. 7)

The 1970s controlled substance act established the Drug Enforcement Administration (DEA) as a Bureau of the Department of Justice to enforce the provisions of the act.

• set much tighter controls on a specific group of drugs: those that were being abused by Society; the ACT indicates that such substances needed to be controlled.


1970 Controlled Substances

(P. 7)

Established the Drug Enforcement Administration (DEA)

• isolated the abused and addicting drugs into 5 levels, or schedules; medical value, harmfulness, potential for abuse or addiction:

- C I
- C II
- C IV
- C V

• demanded security and accountability of.

• set limitations on the use of prescription; guidelines established for each of the 5 schedules of substances.

• demanded that each prescriber of these substances register with the DEA and obtain DEA regulation number to be present all controlled substances; also drug manufacturers.


Food and Drug Administration (FDA)

(P. 9)

• overseas testing of all proposed new drugs before they are released into the U.S. market.

• inspecting plants where Foods, drugs, medical devices, or Cosmetics are made.

• reviewing new drug applications and petitions for food additives.

• Investigating and removing unsafe drugs from the market.

• ensuring proper labeling of foods, cosmetics, and drugs.


1938 Federal Food, Drug, and cosmetic act and Amendments of 1951, 1962 and 1972

(P. 5)

• Established the Food and Drug Administration (FDA) under the Department of Health and Human Services to enforce the provisions of the Act.

• Established more specific regulations to prevent adulteration of (tampering with) drugs, foods and cosmetics:

• All labels must be accurate and must include a listing of all active and inactive ingredients.

• All new products must be approved by the FDA before public release.

• Warning labels must be present on certain preparations, for example, "may cause drowsiness".

• Certain drugs must be labeled with the legend (inscription): caution-federal law prohibits dispensing without a prescription.

• Prescription and non-prescription drugs must be shown to be effective as well as safe.

• In 1972, National Drug Code (NDC) Directory