Session 4: Federal regulations & quality assurance
solved questions
what influence do state laws have in the pharmacy? Correct Answer.-
govern how pharmacists and pharmacy technicians practice pharmacy
state pharmacy boards can revoke, suspend, or place on probation the
licenses
Federal laws and the pharmacy Correct Answer.-oversee the development,
manufacturing, marketing, and distribution of medications.
Food and Drug administration (FDA) Correct Answer.-evaluates the
safety of drug products
Ensures the safety, efficacy and security of human and veterinarian
products.
reviews information supplied on MedWatch forms
reviews new drug and investigational drug applications
maintains REMS list
approves and clears all medical devices issues alerts
responsible for approval of veterinary medicine
responsible for regulating the manufacturing, marketing and distribution
of tobacco
regulates radiation-emitting products and safety
,Drug Enforcement Administration (DEA) Correct Answer.-enforces the
provisions of the controlled substances act (CSA)
as they pertain to the manufacturing, distributing and dispensing of
legally produced controlled substances
investigates and prepares for the prosecution of major violators of
controlled substance laws
manages a national drug intelligence program in cooperation with
federal, state, local and foreign officials
manages national drug intelligence program in cooperation with federal,
state, local foreign official
seizes and forfeits assests derived from traceable to or intended to be
used for illicit drug trafficking
United States Pharmacopeia (USP) Correct Answer.-Official public
*standards-setting authority* for all prescription and OTC medicines
and other health care products manufactured or sold in the US.
Establishes standards for food ingredients and dietary supplements.
Creates standards for the quality, purity, strength, and consistency of
these products; critical to public health.
publishes USP and national formulary (USP - NF) which contains
standards for chemical and biological drug substances, dosage forms,
compounded preparations, excipient, medical devises and dietary
supplements
drugs market by US must conform to USP - NF
,ESTABLISHES NON-STERILE COMPOUNDING REQUIREMENTS
UNDER USP <795> AND USP <797> TO INCLUDE infection control
establishes requirements for labeling of medications
The Joint Commission (TJC) Correct Answer.-addresses quality of patient
care and patient safety
establishes standards and accredits healthcare providers
TJC has been granted "deemed status" for participation in Medicare
addresses healthcare-associated infections, infection control and patient
safety concerns to include medication errors.
Occupational Safety and Health Administration (OSHA) Correct Answer.-
OSHA ensures safe and healthy working conditions by establishing and
enforcing standards and providing training, outreach, education and
assistance
responsible for requiring Safety Data Sheets (SDS) to be maintained in
pharmacy for medications and hazardous compounds
National Institute for Occupational Safety Health (NIOSH) Correct
Answer.-establishes a list of drugs that are deemed hazardous and require
special handling.
, State Board of Pharmacy BOP Correct Answer.-The regulatory state
agency that oversees the practice of pharmacy in a given state
define regulations affecting pharmacy and the roles, duties, and
expectations of pharmacists and pharmacy technicians in the state
establishes criteria for continuing education (CE) for pharmacists and
technicians to remain credentialed for their profession.
Has the authority to discipline pharmacies, pharmacies, and technicians
for improper behavior.
National Association of the Boards of Pharmacy (NABP) Correct
Answer.-composed of all states BOPs
no regulatory authority but meets to discuss current issues and trends in
the pharmacy that affect the practice of pharmacy
monitoring the reciprocation of pharmacist's licenses, administers both
the NAPLEX and MPJE exam for pharmacists
maintains CPE monitor system for completed CEs for pharmacists and
techs
1996 Health insurance portability and accountability act (HIPPAA)
Correct Answer.-the creation of national standards to protect sensitive
solved questions
what influence do state laws have in the pharmacy? Correct Answer.-
govern how pharmacists and pharmacy technicians practice pharmacy
state pharmacy boards can revoke, suspend, or place on probation the
licenses
Federal laws and the pharmacy Correct Answer.-oversee the development,
manufacturing, marketing, and distribution of medications.
Food and Drug administration (FDA) Correct Answer.-evaluates the
safety of drug products
Ensures the safety, efficacy and security of human and veterinarian
products.
reviews information supplied on MedWatch forms
reviews new drug and investigational drug applications
maintains REMS list
approves and clears all medical devices issues alerts
responsible for approval of veterinary medicine
responsible for regulating the manufacturing, marketing and distribution
of tobacco
regulates radiation-emitting products and safety
,Drug Enforcement Administration (DEA) Correct Answer.-enforces the
provisions of the controlled substances act (CSA)
as they pertain to the manufacturing, distributing and dispensing of
legally produced controlled substances
investigates and prepares for the prosecution of major violators of
controlled substance laws
manages a national drug intelligence program in cooperation with
federal, state, local and foreign officials
manages national drug intelligence program in cooperation with federal,
state, local foreign official
seizes and forfeits assests derived from traceable to or intended to be
used for illicit drug trafficking
United States Pharmacopeia (USP) Correct Answer.-Official public
*standards-setting authority* for all prescription and OTC medicines
and other health care products manufactured or sold in the US.
Establishes standards for food ingredients and dietary supplements.
Creates standards for the quality, purity, strength, and consistency of
these products; critical to public health.
publishes USP and national formulary (USP - NF) which contains
standards for chemical and biological drug substances, dosage forms,
compounded preparations, excipient, medical devises and dietary
supplements
drugs market by US must conform to USP - NF
,ESTABLISHES NON-STERILE COMPOUNDING REQUIREMENTS
UNDER USP <795> AND USP <797> TO INCLUDE infection control
establishes requirements for labeling of medications
The Joint Commission (TJC) Correct Answer.-addresses quality of patient
care and patient safety
establishes standards and accredits healthcare providers
TJC has been granted "deemed status" for participation in Medicare
addresses healthcare-associated infections, infection control and patient
safety concerns to include medication errors.
Occupational Safety and Health Administration (OSHA) Correct Answer.-
OSHA ensures safe and healthy working conditions by establishing and
enforcing standards and providing training, outreach, education and
assistance
responsible for requiring Safety Data Sheets (SDS) to be maintained in
pharmacy for medications and hazardous compounds
National Institute for Occupational Safety Health (NIOSH) Correct
Answer.-establishes a list of drugs that are deemed hazardous and require
special handling.
, State Board of Pharmacy BOP Correct Answer.-The regulatory state
agency that oversees the practice of pharmacy in a given state
define regulations affecting pharmacy and the roles, duties, and
expectations of pharmacists and pharmacy technicians in the state
establishes criteria for continuing education (CE) for pharmacists and
technicians to remain credentialed for their profession.
Has the authority to discipline pharmacies, pharmacies, and technicians
for improper behavior.
National Association of the Boards of Pharmacy (NABP) Correct
Answer.-composed of all states BOPs
no regulatory authority but meets to discuss current issues and trends in
the pharmacy that affect the practice of pharmacy
monitoring the reciprocation of pharmacist's licenses, administers both
the NAPLEX and MPJE exam for pharmacists
maintains CPE monitor system for completed CEs for pharmacists and
techs
1996 Health insurance portability and accountability act (HIPPAA)
Correct Answer.-the creation of national standards to protect sensitive
