PTCE LAWS AND REGULATIONS
PURE FOOD & DRUG ACT (1906) - Answer Prohibited interstate transport or sale of adultered
& misbranded food or drugs
FOOD, DRUG, COSMETIC ACT (1938) - Answer Food & drug administration (FDA) was created
under this act requiring all drug applications to be filed with the FDA
DURHAM HUMPHREY ACT (1951) - Answer An amendment to FDA in 1938 to make drugs
separated into 2 categories: Prescription and non Prescription. Requiring medications to have
adequate directions for use
KEFAUVER-HARRIS AMENDMENT (1962) - Answer Requires all medications in the US to be
pure safe and effective
COMPREHENSIVE DRUG ABUSE PREVENTION & CONTROL ACT (1970) - Answer (DEA) created
and placed under direct supervision of the DOJ that controlled substances be divided accoringly
in 5 different schedules
POISON PREVENTION PACKAGING ACT (1970) - Answer Enacted to reduce accidental
poisoning in children. OTC and prescription drugs must use childproof containers.
OCCUPATIONAL SAFETY & HEALTH ADMINISTRATION (OSHA 1970) - Answer Ensures safe and
healthful work place for all employees. Requires reporting system for job related injuries and
illness
DRUG LISTING ACT (1972) - Answer Each drug must be assigned an 11 digit NDC number in
which it can be identified
FEDERAL PRIVACY ACT (1974) - Answer Regulates what personal info the government can
collect and how it will be used
ORPHAN DRUG ACT (1983) - Answer Medications for treatment of diseases or conditions
which there are fewer than 200,000 cases in the world
HATCH- WAXMAN ACT (1984) - Answer Encouraged creation of generic & new medications by
streamlining the process for generic drug approval
PURE FOOD & DRUG ACT (1906) - Answer Prohibited interstate transport or sale of adultered
& misbranded food or drugs
FOOD, DRUG, COSMETIC ACT (1938) - Answer Food & drug administration (FDA) was created
under this act requiring all drug applications to be filed with the FDA
DURHAM HUMPHREY ACT (1951) - Answer An amendment to FDA in 1938 to make drugs
separated into 2 categories: Prescription and non Prescription. Requiring medications to have
adequate directions for use
KEFAUVER-HARRIS AMENDMENT (1962) - Answer Requires all medications in the US to be
pure safe and effective
COMPREHENSIVE DRUG ABUSE PREVENTION & CONTROL ACT (1970) - Answer (DEA) created
and placed under direct supervision of the DOJ that controlled substances be divided accoringly
in 5 different schedules
POISON PREVENTION PACKAGING ACT (1970) - Answer Enacted to reduce accidental
poisoning in children. OTC and prescription drugs must use childproof containers.
OCCUPATIONAL SAFETY & HEALTH ADMINISTRATION (OSHA 1970) - Answer Ensures safe and
healthful work place for all employees. Requires reporting system for job related injuries and
illness
DRUG LISTING ACT (1972) - Answer Each drug must be assigned an 11 digit NDC number in
which it can be identified
FEDERAL PRIVACY ACT (1974) - Answer Regulates what personal info the government can
collect and how it will be used
ORPHAN DRUG ACT (1983) - Answer Medications for treatment of diseases or conditions
which there are fewer than 200,000 cases in the world
HATCH- WAXMAN ACT (1984) - Answer Encouraged creation of generic & new medications by
streamlining the process for generic drug approval
