PTCB PHARMACY LAWS AND
REGULATIONS WITH ELABORATED
QUESTIONS AND ANSWERS
Pure Food and Drug Act - ANSWER-prohibited the interstate distribution or sale of adulterated or
misbranded food or drugs.
Food, Drug, and Cosmetic Act - ANSWER-required all drug manufacturers to file a New Drug Application
(NDA) with the FDA before any drug could be approved or disapproved for the market. The
manufacturers also had to ensure the purity, safety, packaging, and strength of a medication.
Durham-Humphrey Amendment - ANSWER-separated drugs into 2 categories: legend and nonlegend
(prescription and non prescription). required all legend drugs to have a prescription. also allowed verbal
prescriptions to be taken over the phone and refills to be called in from a physician's office.
Kefauver-Harris Amendment - ANSWER-required that all medications, both prescription and
nonprescription, be pure, effective, and safe to use on humans. Also placed prescription drug
advertising under the supervision of the FDA.
Controlled Substances Act - ANSWER-requires the pharmaceutical industry to keep records and maintain
security measures for certain medications. divided controlled substances into five classes/schedules.
DEA Form 222 - ANSWER-required by the controlled substances act for the ordering of schedule II drugs.
DEA form 41 - ANSWER-must be submitted to the DEA for destruction of outdated or damaged
controlled substances.
DEA form 106 - ANSWER-must be submitted to the DEA after the discovery of a theft of controlled
substances
, Poison Prevention Packaging Act - ANSWER-created standards for child resistant packaging. It mandates
that containers be manufactured to be very difficult for young children to open. a child resistant
container is one that cannot be opened by 80% of children younger than five years, but can be opened
by 90% of adults.
Occupational Safety and Health Act - ANSWER-established to prevent workplace disease and injuries.
requires the use of Material Safety Data Sheets (MSDS) which are completed by manufacturers and
provide info about the chemical in detail.
Drug Listing Act - ANSWER-assigns a unique and permanent drug code to each medication known as the
National Drug Code (NDC) which identifies the manufacturer, medication, and type of packaging.
Federal Hazardous Substance Act - ANSWER-involves the use and disposal of hazardous material in the
pharmacy mainly in the hospital setting—or, more specifically, the IV room where intravenous solutions
are being prepared. Any drug involving human blood or the treatment of cancer, such as anti-neoplastic
drugs, must be discarded in a well-recognized puncture container marked as "Hazardous Substances."
Orphan Drug Act - ANSWER-offers financial incentives to organizations that develop and market orphan
drugs. These are medications that are used for the treatment of a disease or condition that affects fewer
than 200,000 patients.
Drug Price Competition and Patent Term Restoration Act - ANSWER-encouraged the creation of new
medications by extending patent licenses. It also helped with the increasing costs of drug prices by
streamlining the generic drug approval process.
Prescription Drug Marketing Act - ANSWER-prohibits the sale or distribution of samples to anyone other
than those who are licensed to prescribe them. Additionally, it prohibits the reimportation of a drug into
the U.S. by anyone except the manufacturer.
REGULATIONS WITH ELABORATED
QUESTIONS AND ANSWERS
Pure Food and Drug Act - ANSWER-prohibited the interstate distribution or sale of adulterated or
misbranded food or drugs.
Food, Drug, and Cosmetic Act - ANSWER-required all drug manufacturers to file a New Drug Application
(NDA) with the FDA before any drug could be approved or disapproved for the market. The
manufacturers also had to ensure the purity, safety, packaging, and strength of a medication.
Durham-Humphrey Amendment - ANSWER-separated drugs into 2 categories: legend and nonlegend
(prescription and non prescription). required all legend drugs to have a prescription. also allowed verbal
prescriptions to be taken over the phone and refills to be called in from a physician's office.
Kefauver-Harris Amendment - ANSWER-required that all medications, both prescription and
nonprescription, be pure, effective, and safe to use on humans. Also placed prescription drug
advertising under the supervision of the FDA.
Controlled Substances Act - ANSWER-requires the pharmaceutical industry to keep records and maintain
security measures for certain medications. divided controlled substances into five classes/schedules.
DEA Form 222 - ANSWER-required by the controlled substances act for the ordering of schedule II drugs.
DEA form 41 - ANSWER-must be submitted to the DEA for destruction of outdated or damaged
controlled substances.
DEA form 106 - ANSWER-must be submitted to the DEA after the discovery of a theft of controlled
substances
, Poison Prevention Packaging Act - ANSWER-created standards for child resistant packaging. It mandates
that containers be manufactured to be very difficult for young children to open. a child resistant
container is one that cannot be opened by 80% of children younger than five years, but can be opened
by 90% of adults.
Occupational Safety and Health Act - ANSWER-established to prevent workplace disease and injuries.
requires the use of Material Safety Data Sheets (MSDS) which are completed by manufacturers and
provide info about the chemical in detail.
Drug Listing Act - ANSWER-assigns a unique and permanent drug code to each medication known as the
National Drug Code (NDC) which identifies the manufacturer, medication, and type of packaging.
Federal Hazardous Substance Act - ANSWER-involves the use and disposal of hazardous material in the
pharmacy mainly in the hospital setting—or, more specifically, the IV room where intravenous solutions
are being prepared. Any drug involving human blood or the treatment of cancer, such as anti-neoplastic
drugs, must be discarded in a well-recognized puncture container marked as "Hazardous Substances."
Orphan Drug Act - ANSWER-offers financial incentives to organizations that develop and market orphan
drugs. These are medications that are used for the treatment of a disease or condition that affects fewer
than 200,000 patients.
Drug Price Competition and Patent Term Restoration Act - ANSWER-encouraged the creation of new
medications by extending patent licenses. It also helped with the increasing costs of drug prices by
streamlining the generic drug approval process.
Prescription Drug Marketing Act - ANSWER-prohibits the sale or distribution of samples to anyone other
than those who are licensed to prescribe them. Additionally, it prohibits the reimportation of a drug into
the U.S. by anyone except the manufacturer.
