Pharmacy Law

Sterile Compounding Certificate Program | June 18–20, 2026

2025-12-15T16:08:04-06:00December 15th, 2025|Categories: Certificate Program, Compliance, compounding, compounding training, Continuing Education, Documentation, Hazardous drug handling, Pharmaceutical Training, Pharmacist Training, Pharmacy Law, Pharmacy Technician, Quality Assurance, Regulatory Issues, Sterile Compounding, USP 797, USP 800|Tags: , , , , , , |

The Comprehensive Sterile Compounding Certificate Program is a live, in-depth training program designed for pharmacists and pharmacy technicians involved in sterile compounding. This certificate-based course provides a structured, practice-focused review of sterile compounding standards, regulatory requirements, documentation, training, and quality systems to support safe and compliant operations.

Participants will examine the legal and regulatory framework governing sterile compounding, including applicable FDA guidance and key USP standards such as USP <797> and USP <800>. Emphasis is placed on understanding how these requirements translate into daily practice and inspection readiness.

The program includes detailed instruction on documentation, quality assurance and quality control programs, policies and procedures (SOPs), and personnel training and competency requirements. Attendees will review expectations for facility design, environmental monitoring, equipment, and workflow as they relate to sterile compounding compliance.

A focused module on hazardous drug handling addresses facility requirements, engineering controls, PPE, personnel training, and assessment of risk, with alignment to current safety and regulatory expectations.

This certificate program combines didactic instruction and application-based learning, offering attendees the opportunity to strengthen their sterile compounding knowledge while reinforcing compliance, safety, and best practices.

Advance your sterile compounding knowledge and compliance skills with this comprehensive, certificate-based training program for pharmacists and pharmacy technicians. Registration is below.

What attendees said:

  • “This class was super helpful in increasing my knowledge and technique in the lab. I highly recommend it.”
  • “It’s a great class! Anyone want to get into sterile or the ones already doing it, should really consider taking this class.”
  • “With nearly 20 years of sterile compounding practice and exposure, this course reinforced my knowledge and skills in this area. I am more confident after this course.”
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Fundamental Compounding with Pharmacy Law | March 19–21, 2026

2025-12-15T15:58:45-06:00December 15th, 2025|Categories: Continuing Education, Compliance, compounding, compounding training, Hazardous drug handling, Pharmaceutical Training, Pharmacist Training, Pharmacy Law, Pharmacy Practice, Pharmacy Technician, Regulatory Issues, USP 795, USP 800|Tags: , , , , , , |

Fundamental Compounding with Pharmacy Law is a live, multi-day compounding course designed for pharmacists, pharmacy technicians, and pharmacy professionals seeking a strong foundation in both compounding practices and regulatory compliance. This course integrates compounding principles with pharmacy law to support safe, compliant, and high-quality compounding operations.

Participants will review the regulatory framework governing pharmacy compounding, including applicable federal and state considerations and key United States Pharmacopeia (USP) standards. Emphasis is placed on documentation, quality assurance, policies and procedures, and compliance requirements essential to day-to-day compounding practice.

The course includes instruction and hands-on training in common nonsterile dosage forms, such as capsules, molded dosage forms, and topical preparations. Participants will learn proper techniques, equipment use, quality control measures, and best practices to support consistency and patient safety.

A dedicated session on hazardous drug handling addresses requirements for facilities, engineering controls, PPE, and personnel training, with alignment to applicable USP standards and safety expectations.

This program combines didactic instruction and application-based learning to reinforce compounding knowledge, regulatory awareness, and practical skills in a structured, in-person environment.

Build a strong foundation in compounding and pharmacy law with this comprehensive, live training designed for pharmacists, pharmacy technicians, and pharmacy professionals. Registration is below.

What attendees said:

  • “The ACA Fundamentals of Compounding Course was one of the best decisions I’ve made for my pharmacy. The small, hands-on setting, focus on USP 795/800, and opportunity to network with both new and experienced compounders made it invaluable. Highly recommend!”
  • “The instructor effectively highlighted important topics and used real-world examples to support learning. The small class size made it easy to ask questions and have open discussions.”
  • “The class was great. The networking with other pharmacists from different areas was great. I was immediately able to take the knowledge learned and apply it in my store.”
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The American College of Apothecaries (ACA) is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. ACA has accredited this application/certificate-based program for 21 contact hours (2.1 CEUs) of continuing education credit for pharmacists and pharmacy technicians.

Nonsterile Compounding Home Study | 11-Hour PTCB-Recognized CE

2025-12-15T12:49:15-06:00August 20th, 2025|Categories: Continuing Education, Community Pharmacy, Compliance, compounding, compounding training, DEA, FDA, Hazardous drug handling, Home Study, Medication Safety, Patient Care, Patient Safety, Pharmaceutical Training, Pharmacist Training, Pharmacy Law, Pharmacy Practice, Pharmacy Technician, Policies & Procedures, Professional Development, Professional Growth, Regulatory Issues, SOPs, USP 795|Tags: , , , , , |

This knowledge-based, enduring home study is designed for compounding pharmacists and pharmacy technicians seeking a comprehensive foundation in nonsterile compounding practices. The program provides a broad overview of nonsterile compounding, with a strong focus on regulatory compliance, standards, dosage forms, and pharmaceutical calculations essential to safe and effective compounding.

Participants will review the regulatory landscape governing nonsterile compounding, including applicable federal and state considerations and key United States Pharmacopeia (USP) standards, with emphasis on USP <795>. The program also addresses the roles and responsibilities of compounding personnel, facility and equipment requirements, documentation, quality assurance, and patient safety considerations.

The curriculum includes in-depth discussions of the most common nonsterile dosage forms prepared by compounders, such as solutions, suspensions, topical preparations, capsules, suppositories, transdermal preparations, and tablet triturates. Each section explores formulation principles, preparation techniques, and quality control measures relevant to practice.

A dedicated pharmaceutical calculations module provides detailed explanations and practical examples to help learners develop proficiency in calculations commonly used in compounding. This module serves as a guide to reinforce accuracy, consistency, and confidence in compounding calculations.

This 11-hour knowledge-based home study is a PTCB-Recognized Education/Training Program, ensuring a quality and standardized learning experience for pharmacy technicians. The program is offered in a self-paced, text-based format and does not include a video component, allowing learners to complete the material on their own schedule.

Build a strong foundation in nonsterile compounding and strengthen your skills in compliance, dosage forms, and pharmaceutical calculations—registration is below.

What participants said:

  • “Covered all of the material in an effective manner.”
  • “Several topics were covered in detail.”
  • “I could complete the program at my own pace, which allowed me to take the time needed to fully process and understand the material.”

Note: It is not necessary to create a Lecture Panda account to register for this home study.

The American College of Apothecaries (ACA) is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. ACA has accredited this knowledge-based program for 11 contact hours (1.1 CEUs) of continuing education credit for pharmacists and pharmacy technicians.

2025 American College of Apothecaries Conference & Expo

2025-10-31T02:13:11-05:00April 28th, 2025|Categories: Continuing Education, ACA Fellows Benefit, Administration/Management, Community Pharmacy, Compliance, compounding, DEA, Ethics, FDA, Fellows and Members, Fellows Benefit, Member Benefits, networking, News Release, Pain Management, Patient Care, Patient Safety, Personal Development, Pharmacists, Pharmacy Law, Pharmacy Practice, Pharmacy Technicians, Preceptor/Mentor Training, Professional Development, Professional Growth, Public/Community Health, Regulatory Issues, Revenue, Risk Management, Sports Medicine, Telemedicine / Telepharmacy, USP 795, USP 797, USP 800, Veterinary Compounding, Webinar|Tags: , , , , , , |

It’s time to pack your bags and polish your business cards — the 2025 ACA Annual Conference & Expo is where independent pharmacy meets unforgettable opportunity!

📍 Memphis, TN | September 25–27, 2025

Join us at the legendary Peabody Hotel for the 2025 ACA Annual Conference & Expo — where independent pharmacy professionals come together to connect, learn, and grow.

Your registration includes:
• Continuing Education credit (except guest registration)
• Thursday Night Welcome Reception & Dinner
• All conference meals

• Full access to the exhibition hall

This is your chance to network with pharmacy leaders, discover the latest trends, and showcase your brand in a dynamic, in-person setting. With educational sessions, social events, and all meals included, this is more than a conference — it’s where pharmacy takes care of business!

Speakers Include:

Philip Cowley, PharmD
Kathy Campbell, PharmD
Jessica Beal, PharmD
Jennifer Adams, PharmD, EdD, FAPhA, FNAP
Sue Paul, RPh
L. Michelle Woosley, PharmD, MBA, CMAP

Reserve your spot today and be part of something meaningful!

2025 ACE Save The Date Rectangle
Reservations
The Peabody Memphis – The “South’s Grand Hotel”

The Peabody Memphis is legendary for its charm, elegance, gracious hospitality, and rich history. This Memphis icon, opened in 1869, is listed on the National Register of Historic Places and is world-famous for its five resident Mallard ducks, who march daily through the lobby at 11am and 5pm.

Nestled in the heart of downtown, this AAA Four-Diamond hotel offers a one-of-a-kind experience just blocks from Beale Street, the Memphis Rock ‘n Soul Museum, Fed-Ex Forum, Sun Studio, and the Orpheum Theatre.  The Peabody Memphis offers two Restaurants, two Bars, Spa, and a Deli with ice cream and desserts.

THE PEABODY MEMPHIS
149 Union Avenue, Memphis TN 38103

Group Rate: $249 plus taxes and fees
Room Block Deadline: Monday, August 25, 2025, at 5:00 pm CDT

To make your reservations, click the button below or contact Susan Decker, ACA Director of Conferences at 434-989-5938 or susan@acainfo.org.

Individuals will guarantee reservations with a credit card or deposit equal to the first night’s room and tax.

2025 Sponsors and Exhibitors

AirClean
Boiron
Gates
RX Insider
Topi CLICK
ZRT Lab

ACA WEBINAR: DSCSA – 13 Year Implementation & 2024 Update

2025-10-31T12:24:01-05:00January 22nd, 2025|Categories: Continuing Education, Compliance, FDA, On-Demand Webinars, Pharmacy Law, Professional Development, Supply Chain Management|Tags: , , , , , |

📢 Missed the Webinar? Catch it On-Demand!

Webinar Title: DSCSA – 13 Year Implementation & 2024 Update
Accreditation: 1-hour CE (0.1 CEUs) for Pharmacists & Pharmacy Technicians

The DSCSA, enacted in 2013, is nearing full implementation! This on-demand webinar covers:

✅ Key DSCSA requirements for transaction information (TI) and transaction statements (TS)
✅ Steps to implement electronic traceability at the package level
✅ Strategies to ensure compliance with regulatory audits and inspections
✅ Best practices for identifying and reporting suspect products

FDA Enforcement Deadline: November 27, 2026 – Don’t wait to start preparing!

DSCSA 13 Year Implementation & 2024 Update — Webinar Graphic

Learn how to meet these requirements and stay ahead of PBM audits. Watch now and ensure your pharmacy is ready for the future of supply chain compliance.  

Speaker:

Martha M. Rumore, PharmD, Esq, MS, LLM, FAPhA is a pharmacist-attorney in Frier Levitt’s Life Sciences Department. She is also a registered patent attorney and leads the firm’s Intellectual property team. She has broad and in-depth healthcare and regulatory experience. Her practice focuses on intellectual property (patents, trademarks, copyrights, trade secrets) and healthcare law, Food, Drug, Device & Cosmetic law (all facets-483s to clinical trials to registrations and product approval), pharmacy law and regulatory issues, 503A/503B compounding, Board of Pharmacy (licensing and disciplinary matters), PBM audits, and DSCSA supply chain compliance. Dr. Rumore has over 25 years of health-system, pharmaceutical industry, and law firm experience in the area of Food, Drug & Cosmetic Law, and pharmaceutical intellectual property Dr. Rumore is fluent in cGMPs, GCPs, writing and reviewing Clinical Trial Agreements (CTAs), Investigator brochures, manuscripts, labeling & advertising review, NDAs, study reports, and documents for regulatory submissions. She often prepares legal memoranda on healthcare/FDA matters and conducts Mock State Board of Pharmacy and FDA inspections for compounding pharmacies. Dr. Rumore has practiced both pharmacy and law. She has actual experience as a compounding pharmacist. She regularly counsels on Section 503A and state-specific compounding requirements, assesses compounding practices for state and federal regulatory compliance, including USP 797/795/800, medical necessity documentation, advertising & promotion, reimbursement issues, infrastructure, and preparing compounding policies and procedures that provide clear guidelines, standards, and training for staff.  Previously, she was at the Director level in  Drug Regulatory Affairs/Compliance in the pharmaceutical industry and hospital pharmacy. She taught Pharmacy Law, Drug Regulatory Affairs, and Food Drug & Cosmetic Law at several New York Colleges of Pharmacy and currently teaches Food, Drug & Cosmetic Law at Maurice A. Deane School of Law at Hofstra University. She is a frequent lecturer and has over 200 publications and presentations.


The American College of Apothecaries (ACA) is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. ACA has accredited this knowledge-based program for 1.0 contact hour (0.1 CEUs) of continuing education credit for pharmacists and pharmacy technicians.

WEBINAR: DSCSA—13 Year Implementation and 2024 Update

2025-10-31T07:41:18-05:00September 10th, 2024|Categories: Webinar, Pharmacy Law, Regulatory Issues|Tags: , , |

Date and Time of Activity
Tuesday, October 1, 2024
11 am EDT/ 10 am CDT/ 9 am  MDT/ 8 am PDT

Pharmacy professionals play a crucial role in protecting patient from drugs that may be counterfeit, stolen, contaminated, or otherwise harmful.

Enacted in 2013, DSCSA is taking over 13 years to implement. Pharmacies need to prepare for the DSCSA requirements with a November 27, 2026 FDA enforcement implementation to receive or exchange transaction information electronically and conduct package level verification. The implementation of systems to produce serialized transaction information in a readily retrievable manner and develop SOPs for regulatory or trading partner transaction data requests will take time, and pharmacies should start today, if they have not already, to ensure compliance with the new enforcement implementation date. That said, despite the DSCSCA granting an exemption for small dispensers until November 27, 2026, pharmacies should be aware of their obligations to make appropriate purchases and maintain inventory purchase information in accordance with their Pharmacy Benefit Manager (“PBM”) Provider Manuals and Agreements. PBMs continue to audit pharmacies to ensure their sourcing of inventory is valid and despite any exemption granted by the DSCSA, such audit measures are expected to continue.

Activity Description:

In this webinar, we will review the phased in implementation and provide update of 2024 and beyond.

At the completion of this activity, the participant will be able to:

  • Identify the DSCSA requirements for receiving, validating, and storing DSCSA Transaction Information (TI) and Transaction Statements (TS).
  • Describe the procedures for implementing electronic operability at the package level for traceability.
  • Identify the regulatory requirements and documentation needed for compliance with audit records, inspections, and other inquiries.
  • Explain the processes for verifying product legitimacy, including methods for quarantining, investigating, and reporting suspect products.
DSCSA - 13 Implementation and 2024 Update

Don’t miss this opportunity to improve your ability to implement best practices to protect patients from drugs that may be counterfeit, stolen, contaminated, or otherwise harmful.

Click below to register:


The American College of Apothecaries (ACA) is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. ACA has accredited this knowledge-based program for 1.0 contact hour (0.1 CEUs) of continuing education credit for pharmacists and pharmacy technicians.

Speaker:

Martha M. Rumore, PharmD, Esq, MS, LLM, FAPhA is a pharmacist-attorney in Frier Levitt’s Life Sciences Department. She is also a registered patent attorney and leads the firm’s Intellectual property team. She has broad and in depth healthcare and regulatory experience. Her practice focuses on intellectual property (patents, trademarks, copyrights, trade secrets) and healthcare law, Food, Drug, Device & Cosmetic law (all facets-483s to clinical trials to registrations and product approval), pharmacy law and regulatory issues, 503A/503B compounding, Board of Pharmacy (licensing and disciplinary matters), PBM audits, and DSCSA supply chain compliance. Dr. Rumore has over 25 years of health-system, pharmaceutical industry, and law firm experience in the area of Food, Drug & Cosmetic Law and pharmaceutical intellectual property Dr. Rumore is fluent in cGMPs, GCPs, writing and reviewing Clinical Trial Agreements (CTAs), Investigator brochures, manuscripts, labeling & advertising review, NDAs, study reports, and documents for regulatory submissions. She often prepares legal memoranda on healthcare/FDA matters and conducts Mock State Board of Pharmacy and FDA inspections for compounding pharmacies. Dr. Rumore has practiced both pharmacy and law. She has actual experience as a compounding pharmacist. She regularly counsels on Section 503A and state-specific compounding requirements, assesses compounding practices for state and federal regulatory compliance, including USP 797/795/800, medical necessity documentation, advertising & promotion, reimbursement issues, infrastructure, and preparing compounding policies and procedures that provide clear guidelines, standards, and training for staff. Previously, she was at the Director level in Drug Regulatory Affairs/Compliance in the pharmaceutical industry and hospital pharmacy. She taught Pharmacy Law, Drug Regulatory Affairs, and Food Drug & Cosmetic Law at several New York Colleges of Pharmacy and currently teaches Food, Drug & Cosmetic Law at Maurice A. Deane School of Law at Hofstra University. She is a frequent lecturer and has over 200 publications and presentations.

ACA WEBINAR: Legal Insights into Peptide & Semaglutide Compounding: Navigating FDA, State Boards, and Telemedicine

2025-10-31T12:26:56-05:00February 8th, 2024|Categories: compounding, Pharmacy Law, Regulatory Issues, Telemedicine / Telepharmacy|Tags: , , , |

Equip yourself with essential knowledge about the management and distribution of 503A compounded products, the intellectual property intricacies in peptide and semaglutide compounding, and understanding the FDCA and recent FDA guidance. Moreover, you will be able to assess the regulatory landscape effectively, ensuring your practices are in line with state laws and regulations.

Activity Description:

As the landscape of compounding peptides and semaglutide continues to evolve rapidly, a multitude of legal challenges and opportunities arise. This session aims to shed light on the pivotal developments and regulatory nuances in this dynamic sector. Our speakers will delve into critical topics such as the FDA’s current stance on peptide compounding, recent pronouncements from state Boards of Pharmacy, and the intricate legalities surrounding  brand manufacturers. Additionally, the webinar will explore the burgeoning realm of telemedicine and its implications for compounders, along with guidance on navigating the complexities of bulk chemical ingredients.

Legal Insights Into Peptide & Semaglutide Compounding ON DEMAND GRAPHIC

Don’t miss out on this opportunity to enhance your professional skills and understanding of semaglutide and peptide compounding!

Click below to register:

At the completion of this activity, the participant will be able to:

  • Discuss the management and distribution of 503A compounded products among DSCSA trading partners,
    encompassing transfers, dispensing, and oversight by state Boards of Pharmacy, particularly focusing on
    semaglutide and peptide compounding.
  • Evaluate the intricacies of intellectual property in peptide and semaglutide compounding and advertising.
  • Analyze the key aspects of the FDCA and recent FDA guidance on compounding peptides and semaglutide,
    including the legal trends involving compound semaglutide, manufacturer enforcement efforts, and the impact
    on telemedicine arrangements.
  • Assess the regulatory landscape by comparing state laws concerning pharmacies’ compensation and feesharing
    with prescribing physicians, within the context of compounded semaglutide and telemedicine practices.


The American College of Apothecaries (ACA) is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. ACA has accredited this knowledge-based program for 1.0 contact hour (0.1 CEUs) of continuing education credit for pharmacists and pharmacy technicians.

Speakers:

Martha M. Rumore, PharmD, Esq, MS, LLM, FAPhA is a pharmacist-attorney in Frier Levitt’s Life Sciences Department. Her practice focuses on healthcare law; Food, Drug Cosmetic law; pharmacy law and regulatory issues; PBM issues; as well as pharmaceutical and medical device intellectual property including trademark, copyright, trade secret and all aspects of patent law (due diligence, prosecution, opinion work, litigation, and transactional matters). Dr. Rumore has over 15 years of law firm experience in the area of Food, Drug & Cosmetic Law and pharmaceutical intellectual property, counseling on early market opportunities for pharmaceutical clients particularly in the area of ANDA and 510K applications and all facets of Paragraph IV litigation.

Matthew J. Modafferi, Esq is a seasoned litigation and trial attorney with experience in healthcare law.  He focuses his practice on white collar defense and investigations, and complex civil litigation. As a Partner in Frier Levitt’s Healthcare and Life Sciences Litigation Department, Matthew’s practice is dedicated to representing healthcare clients in litigation matters including healthcare fraud, qui tam, and False Claims Act matters. Matthew also helps clients successfully navigate DEA inspections and investigations, state and federal OIG investigations, and government self-disclosures. Matthew previously worked as an Assistant United States Attorney in the Civil Division at the U.S. Attorney’s Office for the Eastern District of New York.  During his time as a federal prosecutor, Matthew represented the United States and its agencies in various affirmative and defensive matters, appearing before both the Eastern District of New York and the Second Circuit Court of Appeals. He successfully defended Executive Branch policies and initiatives, and prosecuted health care fraud qui tam and other False Claims Act cases.

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