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- The pharmacy fills an application on line. As part of
the application the pharmacy agrees to the PCAB®
Principles of Compounding and Rules.
- A PCAB® Surveyor and a consulting expert
is assigned to the pharmacy. The surveyor contacts the pharmacy
to set up an in-pharmacy survey.
- The pharmacy is requested to complete on-line, at a minimum,
a. the pharmacy profile,
b. ownership information
c. state license information for the pharmacy (Standard
1.10) and
d. the pharmacist-in-charge for each state (Standard 1.20).
This information is sent to NABP for verification.
- When the pharmacy is notified of the appointment of a
surveyor and consulting expert, it is asked to notify PCAB®
of any known or potential conflicts within 5 days. Any conflicts
that are not disclosed within this time period are deemed
waived.
- The survey is usually scheduled within 30 days of the
initial surveyor contact, but the exact date by the pharmacy
and the surveyor at a time convenient for the both.
- Within approximately one week of the in-pharmacy survey,
the surveyor sends in the initial report to PCAB®
and the consulting expert for review.
- The Consulting expert adds a report and recommendation,
based upon surveyor's finding and report. The Consulting
Expert's report and recommendation are sent to the surveyor
and PCAB®.
- PCAB® makes all decisions regarding PCAB
Accreditation.
- Primary consideration for accreditation is given to the
actual compounding procedures and practices found in the
pharmacy. The PCAB® Board believes that what
a pharmacy does is the best judge of its quality practices.
- PCAB® also believes that written standard
operating procedures and policies are important for maintaining
quality practices over a period of time.
- PCAB Accreditation may be awarded to the pharmacy upon
a finding and determination that the pharmacy's practices
meet or exceed all PCAB® Standards, Rules
and Principles, even if documentation is not yet complete.
- If any area of practice is found not in compliance, accreditation
will be delayed until all standards are met. In this case
the surveyor will assist the pharmacy to meet PCAB®
Standards by informing the pharmacy of the areas in which
improvement or change is needed.
- PCAB's Mission Statement includes bringing all compounding
pharmacy up to national standards.
- If the pharmacy's practices meet PCAB®
Standards, but policies and procedures are found wanting,
PCAB® Accreditation may, in PCAB's sole discretion,
be granted. The pharmacy will be notified of the areas to
be corrected and/or completed. All documentation must be
uploaded within a specific period of time in order to maintain
accreditation. Additional review and recommendations by
the surveyor and consulting expert may be required before
with the time period given. If the pharmacy fails to meet
requirements within that time, accreditation may be withdrawn.
- PCAB® Accreditation can usually be awarded
within 90 days of the initial application.
- When a pharmacy earns the designation of a PCAB Accredited™
compounding pharmacy, the public is notified through the
public website at www.pcab.org. A summary of the pharmacy's
PCAB Accreditation Report is posted in PDF form at that
location.
- The PCAB® Accreditation Report Summary
will list the pharmacy's scope of compounding and any additional
requirements or documentation needed along with the date
of the next scheduled review and in-pharmacy survey.
- Once a pharmacy earns PCAB Accreditation it may use
the trademarked designation "PCAB Accredited™ compounding
pharmacy" and the PCAB Seal. The pharmacy must link to the
PCAB® web pages and its accreditation report
summary.
- A pharmacy that has earned PCAB® Accreditation,
will receive public relations and advertising material,
including press release and templates of letters to patients,
physicians, veterinarians, regulators and others announcing
the pharmacy's new status and its importance.
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