1906

Pure Food and Drug Act

1914

Harrison Narcotic Act

1938

Federal Food, Drug, and Cosmetic Act

1952

Durham Humphrey Amendments

1962

Kewfauver-Harris Amendments

1970

Poison Prevention Packaging Act

1970

Controlled Substances Act

1990

Omnibus Budget Reconciliation Act (OBRA-90)

Anabolic Steriods Control Act

1997

FDA Modernization Act

Pure Food and Drug Act (PFDA)

 (1906)

Required all foods/drugs to meet a set standard of strength and purity

Harrison Narcotic Act

Federal Food, Drug, and Cosmetic Act

(FFDCA)

(1938) Required that maufacturers must prove their products safe and effective; granted FDA limited recall ability

Durham-Humphrey Amendments to FFDCA

(1952) Clarified Rx and OTC drugs based on if they were habit-forming, narcotic, hypnotic, or pot. harmful

"Caution: Federal law prohibits dispensing without a prescription" (Sch. II-IV)

Kewfauver-Harris Amendments to FFDCA

(1962) Required drug manufacturers to prove safety and efficacy of products before FDA approval

Hazardous Substances Labeling Act

(1970)

Included Poison Prevention Packaging Act and Controlled Substances Act (CSA)

Poison Prevention Packaging Act

(1970) Required child-proof packaging

Controlled Substances Act (CSA)

(1970) Classified drugs based on abuse potential

(Schedule I, II, III, IV, V)

Joint Commission on Accreditation of Health Care Organizations

(JCAHO)

Mission is to improve quality of care provided to general public

Omnibus Budget Reconciliation Act (OBRA-90)

(1990) Required pharmacists to offer counseling to pts. regarding medications

Anabolic Steriods Control Act

FDA Modernization Act

(1997) Changed legend requirements to "Rx Only"; phased in Feb. 2003

Schedule I

High abuse potential; no medical use in USA; only legal use in investigational purposes

(e.g. heroin, hallucinogens, marijuana, opiates derivatives)

Schedule II

High abuse potential; accepted medical use; non-refillable; strict rules regarding partial filling; script valid for 60 days; only prescribed if no alternative available; DEA and State Board must be contacted if suspsected theft

(e.g. morphine, methylphenidate, methadone, hydromorphone)

Schedule III

Less abuse potental than II, may be refilled up to 5x 6 mo. after script if authorized; partial filling allowed; must be done within 6 mo.

(e.g. hydrocodone with APAP, APAP and coedine)

Schedule IV

Less pot. for abuse than III with similar rules

(e.g. benzodiazepines, meprobamate, and proxyphene)

Schedule V

Filing Method 1

Legend file, Schedule II-V file, and Schedule II file (must be kept seperate)

Filing Method 2

Legend File, Schedule II-V file (must have all schedules II-V stamped with a 1" red C)

Filing Method 3

Schedule II file, Schedule II-V File (other record must contain Schedule II ONLY)

Rules of Controlled Substances

-Required to main tain recods for 2 years

-Must be readiliy available

-Not required to be on-site, but easilly accessable

-Use stricter law btwn Fed and State

DEA Number

Prescriber # needed for all outpt Rxs for controlled substances

DEA # Verification

-Add first, third and fifth

-Add second, fourth, and sixth x2

-Add result

Last digit of sum should correspond w/ last digit

Includes type of prescriber and initial of dr. last name

DEA Form 222

C II order form (mandated by DEA regulations)

Investigational Drug Testing

4 phases before released for public use

Testing Phase I

Drug initially introduced to humans

Testing Phase II

Drug tested for effectiveness and safety (close pt monitoring)

Testing Phase III

Trails of effectiveness and indications are done; adverse effects studies

Testing Phase IV

Post-marketing trials performed, long term trials tested, no control groups used

Post-Investigational Testing

Any leftovers must be returned by the person(s) responsible for the drug