1. Pharmacy Laws
Poison prevention act of 1970
to reduce accidental poisoning
requires most OTC and prescriptions be packaged in
child resistant containers.
this means 80% of kids under 5 cannot open and 90%
of adults can open.
exceptions--single time dispense
requested by patient in writing
OTC must have different size for elderly with warning
on package
drugs for institutionalized patients if dispensed by employee
inhalation aerosols, contraceptives taken cyclically, prednisone
under 105mg/package, sublingual nitroglycerin

2. Pharmacy Laws
Occupational Safety and Health act of 1970
OSHA
ensure job safety and health standards
for employees.
reporting for job-related injury and illness
reduce workplace hazards
audits to ensure compliance
covers air contaminants, flammable,
and combustible
liquids, eye/skin protection.
requires MSDS (material safety data sheet)
provided by seller

3. Pharmacy Laws
Drug listing act of 1972
each drug gets 11 digit number for identification.
NDC number (national drug code)
1-5= manufacturer
next 4= drug product
final 2= package size and packaging

4. Pharmacy Laws
Orphan drug act of 1983
orphan drugs=medication for rare cases.
under 200,000 worldwide cases.
tax incentives and exclusive licensing for
manufactures

5. Pharmacy Laws
Drug price competition and patient term
restoration act of 1984
encourage new and generic creation by streamlining
the process for generic drug approval and extending
patent licenses.

6. Pharmacy Laws
Prescription drug marketing act of 1987
prohibits reimportation of a drug into US except by
manufacturer.
drug samples distributed only by prescriber request.
requires label on veterinary drugs.

7. Pharmacy Laws
Ominbus budget reconciliation act of 1987
OBRA-87
Medicare and Medicaid revisions for long term care
facilities and pharmacy.
residents must be free of unnecessary medications.
no antipsychotics unless patient has specific condition.
need diagnosis for antipsychotic indication.
must use drug holidays and behavioral modification to
see if drug can be discontinued.
long term care facilities must have consultant
pharmacist.
no significant medication errors.
medications stored and locked according to laws.