Pharmacy law

1096- Food and Drug Act of 1906

all drugs must be properly labeled with truthful information

1914- Harrison Narcotic Act

introduced the control of the distribution and use of narcotics.
ex. Opium


banned false claims required packet inserts (PPI) and if the drug is
addictive it must show a warning sign.

1951- Durham-Humphrey Amendment

introduced the - "Caution: Federal law prohibits the dispensing
of this drug without a prescription". This law defined two
specific categories for medications: prescription and over-the-counter.

1960- Federal Hazardous substance Act.

all hazardous materials should be handled with care and disposed of
in a specifically marked container.

1962- Kefauver- Harris amendment

It introduced requirements for drug manufacturers to provide proof of
the effectiveness and safety of their drugs before they could be
approved. It also required drug advertising to disclose accurate
information about side effects and efficacy of treatments.

1970 - Poison Prevention Packaging Act

child proof packaging is require for all drugs
*some exceptions

1970- Controlled substances Act

regulates the manufacture, distribution, and sales of drugs that
carry a risk of dependence or abuse.

1983 - Orphan Drug Act

regulates orphan drugs; medication used for specific diseases
ex; ALS

1984- Drug Price Competition and Patent Term Restoration Act

( ANDA ) allowed manufactured to make generics

1990- Omnibus Budget Reconciliation Act (OBRA)

This federal law requires pharmacists to review Medicaid recipients'
entire drug profile before filling their prescriptions. (counsel)

1997- FDA modernization Act

updated the Durham - Humphry amendment so nos labels must-read
"RX only

2006- Dietary supplement and Non prescription drug consumer act

requires manufacturers to repost adverse reactions

1990- Anabolic Steroid Act

made testostorene a controlled substance ( CIII ) and illegal for
trainer to recoment it

1996- Health insurance and Portability act (HIPPA)

privacy of the patient

2005 - The combat Methamphetamine Epidemic act

regulates over the counter sales of ephedrine and pseudoephedrine.