Compounded Sterile Preparations Pharmacy ensures that sterile preparations meet the clinical needs of patients, satisfying quality, safety, and environmental control requirements in all phases of preparation, storage, transportation, and administration in compliance with established standards, regulations, and professional best practices. Currently there are more than 1,200 BPS Board Certified Sterile Compounding Pharmacists.
NOTE: All BPS specialty certification examinations reflect current, best practices, at the time they are constructed – practice guidelines used for the Spring examination are those that are current as of January 1 of the testing year. Practice guidelines for the Fall examination are those that are current as of July 1 of the testing year.
The COVID-19 pandemic has caused a serious shortage of Personal Protective Equipment (PPE) in most of the United States and around the world. The overwhelming burden of severely ill patients in some parts of the U.S. have also led to significant disruptions in customary health care procedures. In response to these realities, waivers and temporary changes have been issued by regulatory and standard setting organizations including the United States Pharmacopoeia, the Food and Drug Administration, and the Centers for Medicare & Medicaid Services.
The BPS content outline for the examination in Compounded Sterile Preparations Pharmacy refers to “knowledge of standards related to sterile preparation (e.g., United States Pharmacopeia…)”. [Domain 1, Task 2]. Please be aware that the BPS examination in Compounded Sterile Preparations Pharmacy is based upon usual and customary standards and regulations, and test items will NOT reflect temporary changes made to accommodate the COVID-19 pandemic.
Current Status of USP Chapters: USP released new versions of Chapters <795> Pharmaceutical Compounding – Nonsterile Compounding and <797> Pharmaceutical Compounding – Sterile Preparations on June 1, 2019 and they were scheduled to become effective December 1, 2019, along with USP Chapter <800> Hazardous Drugs – Handling in Healthcare Settings.
Chapter <800> became official on December 1, 2019, however, chapter <800> is considered informational by USP and not compendially applicable. The scheduled implementation of compounding chapters <795> and <797> were postponed by USP pending an appeal related to concerns about issues related to certain content in some of the chapters. A hearing on the appeal was held January 20-21, 2020.
The Appeals Panel has granted the appeals to General Chapters <795> and <797> and is remanding the chapters to the Compounding Expert Committee (CMP EC) with the recommendation for further engagement on the issues raised concerning the beyond-use date provisions. The currently official chapters of <795> (last revised in 2014) and <797> (last revised in 2008) remain official.
Please note that this information is offered by BPS to help reduce confusion regarding USP Chapters <797> and <800>, and that there are other standards and regulations that are applicable to the Compounding Sterile Preparations examination.
For the content outline for the BPS Compounded Sterile Preparations Pharmacy examination, click here.
For updates and timelines on the status of revisions to USP Chapters, check this USP web page: https://www.usp.org/compounding.
BPS Board Certification in Compounded Sterile Preparations Pharmacy program is a credential for pharmacists who have met the eligibility criteria and who in their unique practice are responsible for ensuring that sterile preparations meet the clinical needs of patients, satisfying quality, safety, and environmental control requirements in all phases of preparation, storage, transportation, and administration in compliance with established standards, regulations, and professional best practices.
The purpose of the BPS Board Certification in Compounded Sterile Preparations Pharmacy program is to validate a pharmacist’s advanced knowledge and experience to:
- Ensure quality patient care;
- Improve therapeutic outcomes;
- Assure safety; and
- Supervise, train, and ensure competency of all personnel involved in sterile compounding.
Pharmacists who, meet all of the eligibility criteria including passing the examination will be awarded the credential titled: Board Certified Sterile Compounding Pharmacist (BCSCP).
An applicant for board certification in Compounded Sterile Preparations Pharmacy must demonstrate all of the requirements listed below prior to sitting for the initial certification examination. Once all of the requirements below are met, an applicant will be deemed eligible to sit for the Compounded Sterile Preparations Pharmacy specialty certification examination. If an applicant achieves a passing score on the Compounded Sterile Preparations Pharmacy certification examination, they may use the designation Board-Certified Sterile Compounding Pharmacist, or BCSCP.
- Graduation from a pharmacy program accredited by the Accreditation Council for Pharmacy Education (ACPE) or a program outside the U.S. that qualifies the individual to practice in the jurisdiction.
- A current, active license/registration to practice pharmacy in the U.S. or another jurisdiction.
- Demonstration of practice experience through 4,000 hours of post-licensure or post-registration practice experience1 in Compounded Sterile Preparations Pharmacy. The 4,000 hours may be earned in a variety of settings, such as accredited Compounded Sterile Preparations Pharmacy residency programs2. Practice hours in the activities listed in the Compounded Sterile Preparations Pharmacy Content Outline will be accepted as practice experience on an hour-for-hour basis.
1All applicants intending to demonstrate eligibility for any BPS certification examination utilizing the practice experience pathway must provide an attestation from their employer, on company letterhead, that verifies this experience accurately represents at least 50% of time spent in some or all of the activities defined by the applicable certification content outline. In addition, this practice experience must have occurred within the seven years immediately preceding the application. For more information, click here. A sample employer verification letter is available here: Sample.
2American Society of Health-System Pharmacists (ASHP)-accredited/candidate status PGY1 pharmacy residency, residencies accredited under the ASHP Accreditation Standard for International Pharmacy Practice Residency Programs, or Canadian Pharmacy Residency Board (CPRB)-accredited Year 1 pharmacy residency.
The rationale for the appropriateness of the requirements for BPS certification programs are based upon the following:
- BPS recognizes individuals who graduate from a recognized school or college of pharmacy within the candidate’s jurisdiction. Those jurisdictions recognize and evaluate programs on the extent to which it accomplishes its stated goals and is consistent with the concept that pharmacy is a unique, personal service profession in the health science field. In the United States, the responsibility for recognizing schools and colleges of pharmacy falls to the Accreditation Council for Pharmacy Education (ACPE).
- The rationale for requiring licensure or registration of pharmacists within their jurisdiction is based upon the fact that for public protection, all pharmacists must be licensed or registered. This is considered a baseline requirement to be a pharmacist specialist. In the United States, BPS recognizes the licensure process administered by the National Association of Boards of Pharmacy (NABP). The National Association of Boards of Pharmacy (NABP) aims to ensure the public’s health and safety through its pharmacist license transfer and pharmacist competence assessment programs. NABP’s member boards of pharmacy are grouped into eight districts that include all 50 United States, the District of Columbia, Guam, Puerto Rico, the Virgin Islands, Bahamas, and all 10 Canadian provinces.
- The experiential component is required to help assure practical application of components of the specialty knowledge being certified. There are multiple pathways to meet the practice experience requirement.
- Passing the BPS pharmacy specialty examination helps assure knowledge consistent with the validated content outline for the BPS specialty.
The appropriateness of the BPS program requirements are consistent with the Council on Credentialing in Pharmacy’s Resource Paper titled: Scope of Contemporary Pharmacy Practice: Roles, Responsibilities, and Functions of Pharmacists and Pharmacy Technicians.
For the BCSCP certification examination, please refer to the Compounded Sterile Preparations Pharmacy Content Outline found in the BCSCP Examination Specifications document for details.
- Domain 1: Standards, Regulations, and Best Practices (15% of examination)
- Domain 2: Facilities, Equipment, and Environmental Control (20% of examination)
- Domain 3: Compounded Sterile Preparations (30% of examination)
- Domain 4: Patient Care (15% of examination)
- Domain 5: Quality Management (20% of examination)
Pharmacists who earn the designation Board Certified Sterile Compounding Pharmacist® (BCSCP) will be required to maintain their certification over a seven year period by completing one of the following professional development activities:
- Option One: Recertification Examination
Achieve a passing score on the 100-item recertification examination (administered by BPS), based on the content outline for the Compounded Sterile Preparations Specialty in the final year of the certification cycle;
- Option Two: Continuing Education
Earn 100 hours of continuing education credit provided by the professional development programs offered by the American Pharmacists Association (APhA) and/or the American Society of Health-System Pharmacists (ASHP). The Compounding Sterile Preparations Pharmacy Preparatory Review and Recertification Course offered by any of the approved providers may only be completed for recertification credit up to two times, in nonconsecutive years, during the seven-year recertification cycle.
For full details regarding recertification, please refer to the BPS Recertification Guide.
Board Certified Sterile Compounding Pharmacists® are also required to pay the BPS Annual Certification Maintenance fee of $125 each year for years one through six and a $400 recertification fee in year seven. Individuals with more than one BPS certification will only be assessed one BPS Annual Certification Maintenance Fee each year.