NHA Exam Study Guide- Pharmacy
Law and Regulations
What is the purpose of the Controlled Substances Act (CSA)? - Answer-To regulate the manufacture,
importation, possession, and distribution of controlled substances .
What is the DEA responsible for in pharmacy practice? - Answer-The DEA enforces laws related to
controlled substances, including preventing diversion and abuse.
What is the purpose of DEA form 222? - Answer-To order and transfer schedule II controlled substances.
How often must pharmacies renew their DEA registration? - Answer-Every three years.
What is the maximum number of refills allowed for Schedule III and IV drugs? - Answer-Up to 5 refills
within 6 moths of the prescription date.
What is the main function of HIPPA in pharmacy? - Answer-To Protect patient privacy and ensure the
confidentiality of protected health information (PHI).
What is the purpose of the Poison Prevention Packaging act (PPPA)? - Answer-To require child resistant
packaging for prescription and over the counter drugs to prevent accidental ingestion by children.
What information must be included on a prescription label? - Answer-Patient name, prescriber name,
drug name, strength, dosage instructions, pharmacy name, address, and prescription number.
What is the Omnibus Budget Reconciliation Act (OBRA) of 1990? - Answer-It requires pharmacists to
offer counseling to Medicaid patients about their medications.
, What is the role of the FDA in pharmacy practice? - Answer-The FDA regulates the approval,
manufacture, and labeling of prescription and over-the-counter medications.
What is the purpose of DEA Form 41? - Answer-To document the destruction of controlled substances.
What is the Combat Mehthamphetamine Epidemic Act (CMEA) of 2005? - Answer-A law that regulates
the sale of pseudoephedrine and ephedrine to prevent their use in the production of
methamphetamine.
What is the function of the State Board of Pharmacy (BOP)? - Answer-To regulate the practice of
pharmacy within each state, including licensing pharmacists and technicians and enforcing state
pharmacy laws.
What is the significance of Schedule I controlled substances? - Answer-These substances have no
accepted medical use and a high potential for abuse (e.g. heroin, LSD).
What must a pharmacy do if controlled substances are stolen or lost? - Answer-Complete and submit
DEA Form 106 to report the theft or significant loss of controlled substances.
How long must controlled substances records be kept? - Answer-At least 2 years, per federal law (state
laws may vary).
What is purpose of the drug Supply Chain Security Act (DSCSA)? - Answer-To create a system for tracing
prescription drugs as they move through the supply chain to ensure safety and prevent counterfeit
drugs.
What are the labeling requirements for Schedule II prescriptions? - Answer-Labels must include the
phrase "Caution: Federal law prohibits the transfer of this drug to any person other than the patient for
whom it was prescribed."
Law and Regulations
What is the purpose of the Controlled Substances Act (CSA)? - Answer-To regulate the manufacture,
importation, possession, and distribution of controlled substances .
What is the DEA responsible for in pharmacy practice? - Answer-The DEA enforces laws related to
controlled substances, including preventing diversion and abuse.
What is the purpose of DEA form 222? - Answer-To order and transfer schedule II controlled substances.
How often must pharmacies renew their DEA registration? - Answer-Every three years.
What is the maximum number of refills allowed for Schedule III and IV drugs? - Answer-Up to 5 refills
within 6 moths of the prescription date.
What is the main function of HIPPA in pharmacy? - Answer-To Protect patient privacy and ensure the
confidentiality of protected health information (PHI).
What is the purpose of the Poison Prevention Packaging act (PPPA)? - Answer-To require child resistant
packaging for prescription and over the counter drugs to prevent accidental ingestion by children.
What information must be included on a prescription label? - Answer-Patient name, prescriber name,
drug name, strength, dosage instructions, pharmacy name, address, and prescription number.
What is the Omnibus Budget Reconciliation Act (OBRA) of 1990? - Answer-It requires pharmacists to
offer counseling to Medicaid patients about their medications.
, What is the role of the FDA in pharmacy practice? - Answer-The FDA regulates the approval,
manufacture, and labeling of prescription and over-the-counter medications.
What is the purpose of DEA Form 41? - Answer-To document the destruction of controlled substances.
What is the Combat Mehthamphetamine Epidemic Act (CMEA) of 2005? - Answer-A law that regulates
the sale of pseudoephedrine and ephedrine to prevent their use in the production of
methamphetamine.
What is the function of the State Board of Pharmacy (BOP)? - Answer-To regulate the practice of
pharmacy within each state, including licensing pharmacists and technicians and enforcing state
pharmacy laws.
What is the significance of Schedule I controlled substances? - Answer-These substances have no
accepted medical use and a high potential for abuse (e.g. heroin, LSD).
What must a pharmacy do if controlled substances are stolen or lost? - Answer-Complete and submit
DEA Form 106 to report the theft or significant loss of controlled substances.
How long must controlled substances records be kept? - Answer-At least 2 years, per federal law (state
laws may vary).
What is purpose of the drug Supply Chain Security Act (DSCSA)? - Answer-To create a system for tracing
prescription drugs as they move through the supply chain to ensure safety and prevent counterfeit
drugs.
What are the labeling requirements for Schedule II prescriptions? - Answer-Labels must include the
phrase "Caution: Federal law prohibits the transfer of this drug to any person other than the patient for
whom it was prescribed."
