General Course Fee: $119
This program in its entirety provides 5 hours (0.5 CEU) of ACPE CPE home study credit, AMA Category 2 CME, and CNE pharmacology credit.
Course Expiration Date
This program, United States Pharmacopeia (USP) Compliance in Medical and Pharmacy Practice- Practical and Legal Considerations Concerning the Safety of Compounded Sterile Preparations, was originally presented and recorded September 14, 2018 at a continuing education seminar for health professionals in Las Vegas, NV.
At the conclusion of this session, the participant will be able to:
- Review USP 795, 797, 800. 503 A and 503 B regulations as they relate to your practice area.
- Describe the components and operational processes which can protect all compounding and administration personnel when producing or handling compounded sterile drugs.
- Outline three major characteristics of a fully compliant compounding location (pharmacy, physical plant, medical office, hospital) driven by the USP regulatory guidance.
- Describe the critical regulatory characteristics of a fully compliant Hazardous Drug (HD) storage and handling plan.
- Describe the regulatory strategies and associated resources, supplies & components available which can protect all compounding and administration personnel in handling Compounded Sterile Preparations (CSPs) as outlined in current regulation.
- Describe collateral liability when prescribing Compounded Sterile Preparations (CSPs) or Hazardous Drugs (HDs).
Pharmacy Tech Objectives:
- Identify where Compounded Sterile Preparations (CSPs) or Hazardous Drugs (HDs) can be safely compounded based on USP guidance.
- Describe the major characteristics of a comprehensive sterile drug area cleaning process for compounding locations.
- Describe the required characteristics of a fully compliant compounding personnel training program.
Lou Diorio, RPh, FAPhA, Principal
LDT Health Solutions, Inc. Long Island University, Schwartz College of Pharmacy, Adjunct Professor of Pharmacy Practice, Alumni Executive Board, SC State Boards of Pharmacy Regulatory and Medication Safety, Consultant on IV and extemporaneous compounding, Coram Healthcare (SoluNet™ LLC), Former Manager of cGMP manufacturing operation.
James R. Schiffer, RPh. Esq.
Professor of Social and Administrative Sciences, Arnold and Marie Schwartz College of Pharmacy & Health Sciences, Brooklyn, NY, Partner, Allegaert Berger & Vogel LLP, New York City, NY . Practicing attorney on legal issues in healthcare.
- Register online by clicking here.
- Your emailed course confirmation will contain the pertinent information for completing this online learning course.
- Once registered, you may watch our self paced continuing education course on your computer or mobile device.
- Please use the links, included in your emailed confirmation, to download the course handout and complete the course post test and evaluation.
Requirements for Credit
For ACPE, ANCC or AMA Category 2 Credit, you must receive a score of 70% or greater on the multiple choice test and and complete the written course evaluation.
Please complete and test and evaluation online. ULS will receive notification of course completion, and will mail your statement of credit.*
*Pharmacists: Please ensure that we have your NABP# and date of birth on file. ACPE does not allow us to provide you with paper Statements of Credit. Should you need a paper statement of credit, you can access that information via CPE Monitor. All other professionals: An applicable paper Statement of Credit will be issued upon receipt of your post-conference paperwork.
Obtaining CE Credit
Once your course is completed and accreditation requirements have been met, ULS will receive notification of course completion, and email your statement of credit (physicians, physician assistants, nurses, nurse practitioners, and non-US health professionals), report credit to CPE Monitor (pharmacists) and report credit to other organizations that you specify such as CE Broker. Please provide all necessary reporting information at the time of registration.
Accreditation/ Target Audience
This course provides five (5) hours of AMA Category 2 credit.
American Osteopathic Association (AOA): This course provides five (5) hours of AMA Category 2 credit.
Members of the College of Family Physicians of Canada CFPC : This course provides five (5) hours of AMA Category 2 credit.
American Academy of Physician Assistants (AAPA): This course provides five (5) hours of AMA Category 2 credit.
American Nurses Credentialing Center (ANCC): Continuing education hours approved by ACPE meet the ANCC-accredited CNE criteria. This course provides pharmacology/pharmacotherapeutics Category 1 Continuing Education Hours for certification renewal. The same hours submitted to renew certification may be submitted to a State Board of Nursing for re-licensure.
National Certification Corporation (NCC): Recognizes any Nursing, Medical, Health Care or Other For Profit or Not for Profit Education Provider. Please contact NCC regarding approval.
American Academy of Nurse Practitioners Certification Program (AANPCP): National Certification Program for Nurse Practitioners accepts ACPE credit.
University Learning Systems is approved by the California Board of Registered Nursing, Provider Number CEP 11409.
Pharmacists and Pharmacist Technicians
University Learning Systems (ULS), is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a Provider of continuing pharmacy education. This ULS courses carries ACPE credit with the designation for pharmacists (P) and pharmacist technicians (T). Online courses are recognized as home study courses by ACPE.
Title: United States Pharmacopeia (USP) Compliance in Medical and Pharmacy Practice- Practical and Legal Considerations Concerning the Safety of Compounded Sterile Preparations
3 CONTACT HOURS ACPE UAN 0741-0000-18-026-H07-P,
0741-0000-18-026-H07-T, ACTIVITY: KNOWLEDGE
2 CONTACT HOURS ACPE UAN 0741-0000-18-027-H03-P,
0741-0000-18-027-H03-T , ACTIVITY: KNOWLEDGE
Canadian Council on Continuing Education in Pharmacy (CCCEP) accepts courses accredited by the Accreditation Council for Pharmacy Education (ACPE).
Other Health Professionals
Contact your respective board regarding approval.