regulatory compliance

COMPOUNDING SIG: To 503B or Not to 503B: That is the Question?

2026-10-07T16:23:22-05:00September 15th, 2026|Categories: 503B, Business, Compliance, compounding, Compounding SIG, FDA, Outsourcing Facility, Pharmacy Law, Pharmacy Practice, Regulatory Issues|Tags: , , , , , , , , , , , , , , , , , , , , , , |

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Should your pharmacy consider 503B outsourcing? What are the opportunities, costs, and regulatory considerations?

Join us for a discussion of the 503B outsourcing facility model and how it differs from traditional pharmacy compounding. We’ll explore the current 503B market, capital and operational requirements, regulatory differences, and important considerations for pharmacies evaluating whether 503B may be right for their business.

The discussion will also include a separate look at controlled substances and the additional regulatory requirements and considerations that apply.

Whether you are considering entering the 503B space, partnering with a 503B facility, or simply want to better understand the differences, this SIG will provide valuable insight to help you make informed decisions.

Join us for this informative and timely discussion on one of the important questions facing compounding pharmacies today.

Erik Tosh, RPh, FACA, brings more than 40 years of pharmacy experience and nearly five decades of experience in healthcare, with a career spanning hospital pharmacy, independent community pharmacy, pharmaceutical compounding, and industry leadership. His extensive compounding experience includes serving as Director of Operations for a large sterile compounding facility that later became registered as a 503B outsourcing facility. In that role, he oversaw operations that included production, regulatory and compliance activities, purchasing, shipping, and the preparation of high-risk compounded medications for hospitals across the United States.

Tosh later served as Vice President of Compounding Support Services at Letco Medical, where he led compounding support initiatives, developed continuing education programs, provided technical training, and worked closely with professional pharmacy organizations. He retired in 2021.

In addition to his industry experience, Tosh has served as adjunct faculty at Western University College of Pharmacy and has presented ACPE-accredited education on pharmaceutical compounding. He is a past President and Chairman of the International Academy of Compounding Pharmacists and has contributed to professional publications including Remington: The Science and Practice of Pharmacy and the International Journal of Pharmaceutical Compounding.

Considering the move to 503B? Join us for a discussion of what it takes to start or transition to a 503B Outsourcing Facility. We’ll begin with an overview of the key considerations involved, then open the conversation for attendees to ask questions, share experiences, and exchange perspectives.

This meeting will not offer CE.

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Hazardous Drug Handling Continuing Education for Pharmacy Personnel | 6-Hour PTCB-Recognized CE

2026-03-19T14:15:55-05:00February 20th, 2026|Categories: Continuing Education, Compliance, Hazardous drug handling, Home Study, Patient Safety, Pharmaceutical Training, Pharmacy Practice, Regulatory Issues, USP 800|Tags: , , , , , , , , , , , , , , , , |

Hazardous Drug Handling – Primer for Pharmacy Personnel is a 6-hour (0.6 CEUs) knowledge-based home study designed for pharmacists and pharmacy technicians who handle hazardous drugs in any practice setting.

This program reviews key requirements under USP <800>, including engineering controls, negative pressure rooms, PPE, cleaning and decontamination procedures, hazardous drug dispensing, receiving and transport, disposal requirements, medical surveillance, and wipe sampling. Participants will also review the NIOSH list and understand how to assess risk and develop compliant SOPs within their facility.

The course emphasizes practical steps to reduce occupational exposure and strengthen documentation and training practices.

This home study is PTCB-Recognized as an Education/Training Program and may help pharmacy technicians prepare for the CPhT-Adv Advanced Certification in Hazardous Drug Management.

Strengthen hazardous drug handling practices and reinforce USP <800> compliance through structured training designed to protect both patients and pharmacy personnel.

What participants said:

  • “informative, concise, and easy to comprehend.”
  • “I can take and apply this knowledge in my current pharmacy.”
  • “It was very organized and easy to follow.”

Registration is below

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 6 contact hours (0.6 CEUs) of continuing education credit for pharmacists and pharmacy technicians.

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