Pharmacy Law Basics
This 1906 law was the first to prevent the sale of misbranded or adulterated drugs.
Pure Food and Drug Act
This agency enforces laws about controlled substances
DEA (Drug Enforcement Administration)
Controlled substances with no accepted medical use in the U.S. fall into this DEA schedule
What is Schedule I
This type of recall involves products that could cause serious harm or death
Class I recall
This federal law protects patient privacy and restricts access to PHI
HIPAA
This act introduced the concept of prescription vs. OTC drugs.
Durham-Humphrey Amendment
This agency regulates vaccines and immunization schedules.
CDC (Centers for Disease Control and Prevention)
This DEA form is used to order Schedule II medications.
Form 222
MedWatch reports adverse drug reactions to this agency.
FDA
These values guide how professionals behave within the pharmacy workplace.
ethics
This 1983 act incentivized the creation of drugs for rare diseases.
Orphan Drug Act
This agency oversees drug labeling and manufacturing standards
FDA (Food and Drug Administration)
This act limited the sale of pseudoephedrine and required ID and a signature log
Combat Methamphetamine Epidemic Act
This program is used to minimize risk for high-risk drugs like Clozapine and Accutane
REMS (Risk Evaluation and Mitigation Strategy)
This nine-character code is required to prescribe controlled substances.
DEA number
This act created the drug scheduling system and formed the DEA.
Comprehensive Drug Abuse Prevention and Control Act
This agency ensures safe workplaces and creates SDS requirements.
OSHA (Occupational Safety and Health Administration)
This inventory system continuously tracks all controlled substance transactions.
perpetual inventory
This law required that all medications intended for household use be in child-resistant packaging.
Poison Prevention Packaging Act
The principle that patient information should only be accessed on a “need-to-know” basis.
Minimum Necessary Rule
This act mandated pharmacists must counsel Medicaid patients on new prescriptions.
OBRA ‘90 (Omnibus Budget Reconciliation Act)
This organization accredits healthcare facilities and monitors look-alike/sound-alike drug safety
The Joint Commission
The person responsible for signing DEA Form 222 in the pharmacy.
pharmacist (or DEA-registered individual)
This document must be given with estrogen-containing medications like Premarin
Patient Package Insert (PPI)
These three pieces of information must always be on a prescription label.
pharmacy info, patient info, and prescription number
This 1962 amendment required proof of drug effectiveness before approval.
Kefauver-Harris Amendment
This agency helps regulate infection protocols and publishes vaccine requirements.
CDC (Centers for Disease Control and Prevention)?
This form is required to report theft or loss of a controlled substance.
DEA Form 106
A drug with inaccurate labeling but no serious health risk would be this class of recall.
Class III recall
The imprint code on a tablet allows for this.
drug identification
This act created abbreviated pathways for generic drug approval.
Hatch-Waxman Act (Drug Price Competition and Patent Term Restoration Act)
This agency works to track counterfeit or unsafe medications through the DSCSA.
FDA (under the Drug Supply Chain Security Act)
The number of times Schedule III or IV drugs may be refilled within 6 months.
5 times
This type of equivalence means a generic drug has the same active ingredients, form, and strength.
pharmaceutical equivalence
This distinction explains how morals differ from ethics.
morals being personal beliefs, and ethics being professional values
This law requires all drugs to meet USP-NF standards
Pure Food and Drug Act of 1906
This agency verifies internet pharmacies through the VIPPS program.
NABP (National Association of Boards of Pharmacy)
A pharmacy must renew this form every 3 years to dispense controlled substances
What is Form 224a
This FDA-required document gives patients critical drug safety info for certain high-risk meds.
MedGuide
Under HIPAA, patients have this right if they believe their privacy was violated.
right to file a complaint