compounding

NAPRA Overview of Non-sterile Compounding Home Study

2024-08-20T11:04:30-05:00August 8th, 2024|Categories: Compliance, compounding, Continuing Education, Home Study, Pharmacy Practice|Tags: , , , , , , |

What is the NAPRA Non-Sterile Compounding Home Study?

This home study program is a 6.0-hour (0.6 CEUs) knowledge-based course tailored for pharmacy professionals involved in the compounding of non-sterile preparations. This course provides an in-depth look at the standards and best practices necessary to ensure the safety and quality of compounded medications. Participants will learn to evaluate their practice against NAPRA’s standards, develop service-related procedures, and implement effective quality controls.

Why Should You Enroll?

  1. Understand NAPRA’s Standards: Gain a thorough understanding of NAPRA’s model standards for non-sterile preparations. These standards are essential for maintaining high-quality compounding practices and ensuring patient safety.
  2. Practical Application: Learn how to apply these standards in your daily practice. The course offers insights into evaluating and enhancing your compounding procedures, which is critical for maintaining compliance and ensuring the best outcomes for patients.
  3. Develop and Implement Procedures: The program will guide you through the process of developing robust service-related procedures and implementing quality controls. This is essential for minimizing errors and enhancing the overall safety of compounded medications.
  4. Enhance Patient Safety: With a focus on quality and safety, the course will help you establish and maintain high standards in your compounding practices, ensuring that patients receive medications that are both safe and effective.
  5. Earn CEs: Completing this course awards you 6.0-hours (0.6 CEUs) of continuing education credit, contributing to your professional development and credential maintenance.

The NAPRA Overview of Non-Sterile Compounding Home Study provides an opportunity to enhance your knowledge and skills, ensuring that you can deliver the highest quality care to your patients. Don’t miss out on this chance to advance your professional expertise and maintain your commitment to safety and excellence in pharmacy practice. Register today and take a significant step towards mastering non-sterile compounding!

About NAPRA

The National Association of Pharmacy Regulatory Authorities (NAPRA) is a key organization in Canada, representing the provincial and territorial pharmacy regulatory authorities. NAPRA’s model standards and guidance documents are crucial resources for pharmacy professionals. They outline best practices for various aspects of pharmacy practice, including non-sterile compounding, to ensure the highest levels of safety and efficacy.

2024 COMPOUNDING TRAINING COURSES ARE OPEN FOR REGISTRATION!

2024-06-19T07:57:04-05:00June 19th, 2024|Categories: compounding, compounding training, Continuing Education, Member Benefits, networking, News Release, Pharmaceutical Training, Veterinary Compounding|Tags: , , , , , |

In the field of pharmacy, compounding plays a crucial role in providing personalized medications tailored to individual patient needs. Whether you’re a seasoned pharmacist or a pharmacy student eager to expand your skills, attending a compounding course can be very beneficial.

Investing in a compounding course is not just about acquiring technical skills—it’s about elevating the standard of care and advancing pharmacy practice. Whether you’re driven by a passion for patient-centered care, professional growth, or entrepreneurial opportunities, attending a compounding course equips you with the knowledge, skills, and confidence to excel in the art and science of pharmaceutical compounding.

Take the initiative to expand your expertise and make a difference in patient health outcomes by enrolling in a compounding course today!

*Apply the code SPRING to enjoy a $70 discount on any pharmaceutical compounding course. Remember—ACA and ACVP members save an additional $200 off non-member prices.  Also, members sending 2 or more staff to the same class save even more!

Click below to view ACA’s pharmaceutical compounding home page:

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

2024-10-01T12:01:25-05:00February 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.

Compounding Clarity: Decoding USP Standards in Pharmacy Practice Bundle

2023-07-28T09:22:49-05:00July 27th, 2023|Categories: compounding, Continuing Education, USP 795, USP 797, Veterinary Compounding|Tags: , , , , , |

The Compounding Clarity: Decoding USP Standards in Pharmacy Practice Bundle is accredited for 3.0 contact hours (0.3 CEUs) of continuing education credit for pharmacists and pharmacy technicians.

Included Webinars: 

GFI #256: How it affects compounding for veterinary patients – 2023 / 0.5 CE
This webinar will help veterinary compounders understand the requirements of GFI-256 and why such a document is necessary in the current federal landscape. Pharmacists and technicians will learn when FDA intends to use enforcement discretion regarding the compounding of animal drugs using bulk drug substances and how to comply with these requirements. They will also learn how they can nominate drugs to the list for compounding office stock drugs used for nonfood-producing animals.

Understanding the revision to USP <795> Pharmaceutical Compounding – Nonsterile Preparations – 2023 / 0.5 CE
This webinar will help pharmacists and technicians understand and prepare for changes to USP <795> Pharmaceutical Compounding – Nonsterile Preparations that will go into effect on November 1, 2023. The webinar will include differentiating dosage forms that may be compounded as nonsterile preparations and how to assign beyond-use dates as well as reviewing changes to facility, personnel, and documentation requirements.

Preparing for change: Key aspects of revised USP <797> Pharmaceutical Compounding – Sterile Preparations / 1 CE
This webinar will help pharmacists and technicians understand and prepare for changes to USP <797> Pharmaceutical Compounding – Sterile Preparations that will take effect on November 1, 2023. The webinar will include an overview of requirements including the transition to Category 1, Category 2, and Category 3 compounded sterile preparations and what each of these entails. Topics covered include requirements for facility and equipment, environmental monitoring, personnel training, and competency, documentation, and quality management.

Interpreting and Applying USP Compounded Preparation Monographs in Pharmacy Practice: Recipes for Quality / 1 CE
Since 1820, USP has published Compounded Preparation Monographs (CPMs) with the goal of standardizing quality-assured formulas for the most commonly used compounded preparations for humans and animals. While most pharmacy professionals are aware of these monographs, many do not understand the significance and utility of each of the sections of a monograph. Join this webinar to learn where to find and how to interpret the meaning and intent of these unique “recipes” and how to apply them to your veterinary pharmacy practice.

Thanks to our partnership with the American College of Veterinary Pharmacy

Our Speakers: 

Gigi Davidson, RPh, DICVP, FACVP, FSVHP is the former Director of Clinical Pharmacy at the NC State University College of Veterinary Medicine where she practiced veterinary pharmacy for 35 years.  Ms. Davidson received a pharmacy degree from UNC-Chapel Hill in 1983 and earned Diplomate status in the International College of Veterinary Pharmacy in 2001. She was inducted into the Phi Zeta Honor Society in 2006 as an honorary member for distinguished advancement of veterinary science. Gigi is a past President of the Society of Veterinary Hospital Pharmacists and of the American College of Veterinary Pharmacists. Ms. Davidson is the ACVP delegate to the American Pharmacists Association House of Delegates. Ms. Davidson was the Chair of the United States Pharmacopeia Compounding Expert Committee from 2010-2020 and continues to serve as a member. Gigi is the recipient of USP’s Beal Award when in 2015 she became the first female and first veterinary recipient of that award. She has many publications in peer-reviewed scientific journals, and her primary area of research interest is the stability, safety, and efficacy of compounded therapies in non-human species. Her research interests in retirement include drug disposition in honey bees and the pharmacological action of plant pollens and nectars on honey bee colonies.

Brenda Jensen CPhT, CNMT, MBA owns Compounding Consultants, LLC in Sioux Falls, SD. She has helped hundreds of compounding facilities across the country improve compounding quality and safety. Brenda is currently president-elect of the American College of Veterinary Pharmacists, serves on the Board of Directors for the American College of Apothecaries Research and Education Foundation, is a peer reviewer for Pharmacy Technician’s Letter, is a member of the APhA House of Delegates, and also teaches compounding courses for the American College of Apothecaries. She was previously the coordinator for the APhA Compounding Special Interest Group and served on the Board of Directors for the International Academy of Compounding Pharmacists and the Pharmacy Compounding Foundation. Brenda began volunteering for USP in 2013 and is currently Chair of the 2020–2025 Compounding Expert Committee.

Compounding Faculty Meeting: “Focus of a DEA Inspection on a Compounding Pharmacy (503A)”

2023-08-24T16:48:37-05:00July 26th, 2023|Categories: Community Pharmacy, compounding, DEA, Pharmacy Practice|Tags: , , , , |

Date:  Wednesday, August 23, 2023
Time:  12:30 PM Eastern / 11:30 AM Central / 10:30 AM Mountain / 9:30 AM Pacific

Topic: What DEA Requires?

Host:  Ernie Gates  

Panelists: Carlos M. Aquino, an Associate with Gates Healthcare Associates, is an experienced consultant specializing in DEA compliance for pharmacies, hospitals, health clinics, medical practitioners, drug manufacturers and distributors.

Join us for a 1 hour webinar on ““Focus of a DEA Inspection on a Compounding Pharmacy (503A)”.

LEARNING OBJECTIVES
Pharmacist
– Describe role of DEA Diversion Control Division
– Review how to prepare for a DEA inspection
– Explain what are the DEA required records
– Discuss the security of controlled substances
– Identify the need for a Pharmacy Due Diligence Policy 

Pharmacy Technician
– Review the elements of a DEA inspection
– Explain what records are required to be readily available
– Recall the element of the evaluation of security for CS
– Identify what a pharmacist must know to prevent diversion of prescriptions for controlled substances

This meeting will not offer CE. 

This meeting is open to all Pharmacy Professionals, FREE for ACA Members, $10 for non-members, registration is required.

In addition, members of the Compounding Faculty will have exclusive access to an online community.

Did you miss the meeting!

Click Here for Video
Click Here for Audio

 

Our Speaker:

Carlos M. Aquino, is President and Founder of PharmaDiversion, LLC and an Associate with Gates Healthcare Associates.  A former DEA agent and supervisor, Carlos  is an experienced consultant specializing in DEA compliance for pharmacies, hospitals, health clinics, medical practitioners, drug manufacturers and distributors.

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Faculties: American College of Apothecaries

2023-07-27T15:14:20-05:00July 19th, 2023|Categories: compounding, Member Benefits, networking, Nutrition|Tags: , , , , |

Overview:
One of the American College of Apothecaries’ strengths is the open sharing of ideas — which historically has been accomplished through in-person meetings. ACA is augmenting these meetings by establishing expert faculties that will assemble using digital technology — including Zoom, Microsoft Teams, email, and online forums. Participation in faculty meetings is intended to increase member engagement, thus facilitating peer-to-peer networking and relationship building.

Member in all classes:
Faculty participation is optional and offered to ACA members at all individual membership levels, which include our Fellows, pharmacists, student pharmacists, pharmacy technicians, pharmacy marketers, and affiliates. Faculties will thus seasoned pharmacy professionals to interact and share their expertise and experiences with others who have high interest levels and are in the process of establishing their expertise. Each faculty will elect a Chair and Chair-Elect who will serve for one-year terms.

Initially two faculties:
1. Compounding Faculty
2. Nutrition & Wellness Faculty

Meetings of faculty:
Meetings of faculty will focus on topics about which members are passionate — and could include but not limited to discussions of specific products, techniques and methods, concepts, issues, and opportunities. Because meetings will not involve the awarding of continuing education credit, the discussions will not be restricted by ACPE guidelines. Hence, speakers at meetings of faculty could include representatives or organizations that provide proprietary items to our members.

Founding faculty sponsors:
ACA is seeking financial support of organizations that are aligned with the expertise and interests of one or more of our faculties — and that desire to be designated “Founding Faculty Sponsor”.

*For additional information please contact:
Linda Cathey, Faculty Membership Coordinator — linda@acainfo.org

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