Flashcards in Chapter 1 - Consumer Safety And Drug Regulations Deck (10)
Over-the-counter medication (OTC)
Medication available without a prescription
• 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
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
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
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)
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
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 III
- 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)
• 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.