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Continuing Education
Coming Soon
CE Pharmacy Law Ethics
The course reviews State Pharmacy Practice Acts, DSHEA, FDA drug approval, pharmacist scope, and technician delegation, equipping pharmacists with current legal and ethical knowledge required for compliant practice and license renewal.
Who Should Take This
Licensed pharmacists, including those in community, hospital, and ambulatory settings, who have at least one year of practice experience and must meet state continuing‑education requirements, will benefit. It helps them stay current on regulatory changes, ethical duties, and scope‑of‑practice boundaries to ensure safe, lawful patient care.
What's Included in AccelaStudy® AI
Adaptive Knowledge Graph
Practice Questions
Lesson Modules
Console Simulator Labs
Exam Tips & Strategy
20 Activity Formats
Course Outline
65 learning goals
1
State Pharmacy Practice Acts
3 topics
Licensure and regulatory framework
- Identify the key components of state pharmacy practice acts including licensure requirements, renewal cycles, and disciplinary procedures for pharmacists.
- Explain the role of state boards of pharmacy in regulating pharmacy practice including rulemaking authority, inspection powers, and enforcement mechanisms.
- Differentiate between state and federal pharmacy regulations and determine which authority prevails when conflicts arise between jurisdictional requirements.
Interstate practice and reciprocity
- Describe reciprocity and transfer processes for pharmacist licensure across state lines including NABP e-Profile requirements.
- Analyze scenarios involving multistate pharmacy practice to determine compliance obligations under different state practice acts.
Continuing education requirements
- Identify continuing education requirements for pharmacist license renewal including mandatory topic areas such as law, patient safety, and controlled substances.
- Explain ACPE accreditation standards for continuing pharmacy education and distinguish between knowledge-based and application-based CE activities.
- Analyze a pharmacist's CE portfolio to identify deficiencies and recommend a plan to meet all state renewal requirements before the deadline.
2
DSHEA and Dietary Supplement Regulation
2 topics
DSHEA framework and labeling
- Identify the provisions of the Dietary Supplement Health and Education Act of 1994 including the definition of dietary supplements and manufacturer responsibilities.
- Explain the difference between structure-function claims and drug claims on dietary supplement labels and the FDA's enforcement authority for each.
- Describe current Good Manufacturing Practices for dietary supplements including identity testing, purity standards, and adverse event reporting requirements.
Pharmacist counseling on supplements
- Analyze potential interactions between commonly used dietary supplements and prescription medications to counsel patients appropriately.
- Evaluate the evidence base for popular dietary supplement claims using critical appraisal of clinical trial data and systematic reviews.
- Design a patient counseling approach for dietary supplement use that addresses safety concerns, drug interactions, and realistic outcome expectations.
- Identify FDA recall and safety alert mechanisms for dietary supplements including MedWatch reporting and mandatory serious adverse event notification.
3
FDA Drug Approval Process
2 topics
Drug development phases and pathways
- Identify the phases of clinical trials from Phase I through Phase IV and the primary objectives of each phase in the FDA drug approval process.
- Explain the New Drug Application and Abbreviated New Drug Application pathways including bioequivalence requirements for generic drugs.
- Describe accelerated approval pathways including Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval designations and their eligibility criteria.
Post-market surveillance and REMS
- Identify Risk Evaluation and Mitigation Strategies and their components including medication guides, communication plans, and elements to assure safe use.
- Explain FDA post-market surveillance mechanisms including MedWatch, the FDA Adverse Event Reporting System, and post-marketing study requirements.
- Analyze the pharmacist's role in REMS programs including patient enrollment verification, dispensing restrictions, and mandatory adverse event monitoring.
- Evaluate the impact of FDA safety communications and label changes on pharmacy dispensing practices and patient counseling obligations.
- Design a pharmacy workflow for tracking and implementing REMS requirements across multiple medications simultaneously in a community pharmacy setting.
4
Pharmacist Scope of Practice
2 topics
Clinical services authority
- Identify the expanding scope of pharmacist practice including collaborative practice agreements, prescriptive authority, and provider status legislation.
- Explain the legal framework for pharmacist-provided medication therapy management including documentation requirements and billing procedures.
- Describe pharmacist authority for immunization administration including training requirements, protocol specifications, and emergency use authorizations.
- Analyze the legal and ethical boundaries of pharmacist clinical decision-making when patient needs conflict with prescriber orders or institutional policies.
Pharmacist liability and duty of care
- Identify the elements of pharmacist professional liability including duty, breach, causation, and damages in the context of dispensing and counseling errors.
- Explain the pharmacist's duty to warn about contraindications, drug interactions, and therapeutic duplications when dispensing prescription medications.
- Analyze malpractice case scenarios involving pharmacist dispensing errors to determine liability and identify system-level safeguards that could prevent recurrence.
- Design a comprehensive risk management program for a community pharmacy addressing documentation, counseling, dispensing verification, and error reporting.
5
Pharmacy Technician Delegation and Supervision
2 topics
Delegation rules and technician roles
- Identify tasks that may be delegated to pharmacy technicians versus those requiring direct pharmacist performance under state practice acts.
- Explain the pharmacist-to-technician ratio requirements and supervision standards mandated by various state boards of pharmacy.
- Describe pharmacy technician certification requirements including PTCB and ExCPT examinations, state registration, and continuing education obligations.
Advanced technician practice
- Identify emerging advanced pharmacy technician roles including tech-check-tech programs, immunization administration, and point-of-care testing under pharmacist oversight.
- Analyze the legal and patient safety implications of expanding pharmacy technician scope including liability allocation between supervising pharmacist and technician.
- Evaluate tech-check-tech verification programs by comparing error rates, efficiency gains, and regulatory compliance requirements across implementing states.
- Design a training and competency assessment program for advanced pharmacy technician roles that ensures patient safety and regulatory compliance.
6
USP Standards and Quality Assurance
2 topics
USP chapters and compliance
- Identify the major USP chapters relevant to pharmacy practice including USP 795 for nonsterile compounding, USP 797 for sterile compounding, and USP 800 for hazardous drugs.
- Explain the legal enforceability of USP standards and their incorporation by reference into state pharmacy practice acts and federal regulations.
- Describe USP drug monograph standards including identity, strength, quality, purity, and packaging requirements for pharmaceutical products.
- Analyze pharmacy compliance gaps against USP chapter requirements and prioritize corrective actions based on patient safety risk.
Quality assurance programs
- Identify quality assurance metrics for pharmacy operations including dispensing accuracy rates, medication error rates, and patient satisfaction scores.
- Explain continuous quality improvement methodologies applicable to pharmacy practice including Plan-Do-Study-Act cycles and root cause analysis.
- Design a quality assurance program for a pharmacy that integrates USP standards compliance, error tracking, staff training, and continuous improvement processes.
7
Ethics of Compounding
2 topics
Compounding vs manufacturing
- Identify the legal distinction between pharmacy compounding under Section 503A and outsourcing facility manufacturing under Section 503B of the FD&C Act.
- Explain the ethical obligations of pharmacists when compounding including ensuring medical necessity, using appropriate ingredients, and maintaining quality standards.
- Analyze ethical dilemmas in compounding pharmacy including conflicts of interest, off-label compounding, and patient autonomy in requesting compounded preparations.
Compounding safety lessons
- Describe the New England Compounding Center tragedy and its impact on pharmacy compounding regulation including the Drug Quality and Security Act of 2013.
- Evaluate the ethical responsibilities of pharmacists in reporting compounding quality concerns and the consequences of failing to act on known safety issues.
- Design an ethical decision-making framework for compounding pharmacists that balances patient access, quality assurance, regulatory compliance, and professional integrity.
8
Medication Therapy Management
2 topics
MTM service delivery
- Identify the five core elements of medication therapy management services as defined by CMS including medication therapy review, personal medication record, medication-related action plan, intervention and referral, and documentation.
- Explain the comprehensive medication review process including medication reconciliation, identification of medication-related problems, and development of individualized care plans.
- Describe the legal and regulatory framework for pharmacist-provided MTM services including Medicare Part D requirements and state-level billing authorization.
MTM outcomes and optimization
- Analyze patient medication profiles to identify drug-related problems including therapeutic duplication, drug interactions, suboptimal dosing, and adherence barriers.
- Evaluate the clinical and economic outcomes of MTM programs including medication adherence improvement, hospitalization reduction, and cost-effectiveness measures.
- Design a comprehensive MTM program for a pharmacy practice site including patient identification criteria, workflow integration, documentation systems, and outcome tracking.
- Identify barriers to MTM implementation including time constraints, reimbursement limitations, prescriber collaboration challenges, and patient engagement strategies.
9
Patient Privacy and Pharmacy Ethics
2 topics
HIPAA compliance in pharmacy
- Identify HIPAA Privacy Rule requirements applicable to pharmacy practice including protected health information, minimum necessary standard, and patient access rights.
- Explain pharmacy-specific HIPAA scenarios including prescription pickup by authorized representatives, insurance claim submissions, and law enforcement requests for patient information.
- Analyze HIPAA breach scenarios in pharmacy settings to determine reporting obligations, mitigation steps, and potential penalties under the HITECH Act.
Professional ethics and conscience
- Describe the APhA Code of Ethics and its application to contemporary pharmacy practice dilemmas including conscience clauses and duty-to-dispense obligations.
- Analyze ethical conflicts between pharmacist conscience rights and patient access to legally prescribed medications including emergency contraception and opioid prescriptions.
- Evaluate the ethical implications of pharmacist involvement in drug supply chain integrity including counterfeit drug detection and Drug Supply Chain Security Act compliance.
- Design an ethics training program for pharmacy staff that addresses common ethical dilemmas, conscience clause policies, and professional responsibility standards.
Scope
Included Topics
- State pharmacy practice acts including licensure, renewal, disciplinary procedures, reciprocity, and continuing education requirements for pharmacists and technicians.
- Dietary Supplement Health and Education Act provisions, structure-function claims versus drug claims, current Good Manufacturing Practices for supplements, and pharmacist counseling on supplement safety.
- FDA drug approval process including clinical trial phases, NDA and ANDA pathways, accelerated approval designations, REMS programs, and post-market surveillance through MedWatch and FAERS.
- Pharmacist scope of practice including collaborative practice agreements, prescriptive authority, medication therapy management authority, immunization administration, and provider status legislation.
- Pharmacy technician delegation rules, supervision requirements, certification standards, technician-to-pharmacist ratios, and advanced technician roles including tech-check-tech programs.
- USP standards for pharmacy practice including USP 795, 797, and 800 chapters, drug monograph requirements, and quality assurance program development.
- Ethics of compounding including Section 503A versus 503B distinctions, the NECC tragedy and resulting Drug Quality and Security Act, ethical decision-making frameworks for compounding pharmacists.
- Medication therapy management including CMS core elements, comprehensive medication review, documentation requirements, billing, clinical and economic outcomes measurement.
- Patient privacy in pharmacy including HIPAA Privacy Rule, protected health information, breach notification, and the APhA Code of Ethics addressing conscience clauses and duty to dispense.
Not Covered
- Advanced pharmaceutical chemistry, drug formulation science, or industrial-scale drug manufacturing processes beyond pharmacist-level understanding.
- Detailed insurance benefit design, pharmacy benefit management operations, or formulary development beyond MTM and dispensing contexts.
- International pharmacy law and practice standards outside the United States regulatory framework.
- Clinical pharmacology research methodology or clinical trial design beyond understanding the FDA approval process.
- Veterinary pharmacy law or compounding for non-human patients.
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