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PCAB Accreditation for Pharmacies William A. Stuart RPh Hartley Medical Long Beach, Ca. 888-671-2888 [email protected]
PCAB Accreditation for Pharmacies
William A. Stuart RPh
Hartley Medical
Long Beach, Ca.
888-671-2888
William A. Stuart RPh
Univ. of Arizona 1985: Sterile Compounding
Long Term Care & Home Care
Total Parenteral Nutrition
IV Antibiotics + Pain Management
16 Years in Intra-Spinal Therapies
27 Years Sterile Compounding
Certified In Aseptic Compounding
Certified in FDA Endotoxin Testing
Member CPHA, ASHP, PDA, IACP, AAPS
PCAB Defined
A compilation of standards addressing quality assurance, quality control and quality improvement.
PCAB Founders& Board of Directors:
APhA
USP
IACP
NABP
NCPA
NHIA
National Council of State Pharmacy Association Executives
Mission
A compilation of standards addressing quality assurance, quality control and quality improvement.
PCAB Particulars
Established 2004, 1st Accreditation 2006
Over 150 Accredited Pharmacies
Approximately 18% denied
Evolving Organization
Process
Preparation
Application
On-Site Survey (1 -2 days)
Accreditation Outcome
Parameters of Survey
Regulatory Compliance
Personnel
Facilities & Equipment
Chemicals, Components and Completed
Compounded Preparations
Compounding Records
Beyond Use Dating, Potency & Sterility
Completed Compounded Preparations
Prescriber Communication and Patient Education
Total Quality Management
Regulatory Compliance
Review State Licensure
State(s) Rules & Regulations
State Boards
USP
Personnel Licensure
Personnel
Duties and Responsibilities
Training
Assessing Competency
Documentation
Job Descriptions
Responsibilities of Compounding Personnel
USP 797 States 14 areas of responsibility are cited:
Emphasis on training and education
Emphasis on compounding accuracy
Emphasis on avoiding contamination
Emphasis on patient safety
Facilities and Equipment
Sufficient Space & Equipment
Equipment Maintenance
Clean
Calibrated
Sterile & Non-Sterile
Staff Training
Reference Material
Chemical Components & Completed Compounded Preparations
Suppliers & Procurement
Procedures for Ordering & Receipt
Certificate of Analysis: Staff Knowledge
Highest Quality API’s ( USP / NF)
Storage
Compounding Process
Master Formulation Record
Compounding Process Record
Ingredients (NDC, Lot, Exp Date)
Process
Equipment
Maintenance & Disposition of Records
Beyond Use Dating, Stability & Sterility
Documentation of BUD
Published Studies / Internal Findings
Compliance with 795 / 797
Compounding Environment
Completed Compounded Preparations
Packaging, Labeling, Administration, Dispensing and Delivery
Internal and External Recalls
Practitioner & Patient Education
MD: Compounded Preparations for Office
Patient Education & Consultation
Goal is Safe and Effective Use of Therapy
Quality Assurance and Continuous Quality Improvement
Develop Plans Reviewed Annually Addresses Specific Criteria
Sterility BET Content Strength Environment Staff
Continuous Improvement
Continuous Quality Improvement
Develop SOP
Commitment
Every Aspect of Compounding & Dispensing
Collect / Trend Testing Data
Re-assess Policies / Programs Annually
Benefits of Accreditation
Recognition
AMA
Veterans Administration
Hospitals
Insurance Carrier: Pharm. Mutual
Boards of Pharmacy
Improvement of Quality of Care
Reduction of Risk
More Information
http://www.pcab.org/pharmacists
Review FAQ’s
Joe Cabaleiro R.Ph.
Executive Director
Telephone: 866.377.5104 ex. 804
