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Instructions For Completing And Application For Waiver To Store Records Offsite Form. This is a California form and can be use in Board Of Pharmacy Statewide.
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Tags: Instructions For Completing And Application For Waiver To Store Records Offsite, 17A-21, California Statewide, Board Of Pharmacy
California State Board of Pharmacy
1625 N. Market Blvd, Suite N219, Sacramento, CA 95834
Phone (916) 574-7900
Fax (916) 574-8618
STATE AND CONSUMER SERVICES AGENCY
DEPARTMENT OF CONSUMER AFFAIRS
GOVERNOR EDMUND G. BROWN JR.
Instructions for Completing an
Application for Waiver To Store Records Offsite
NOTE TO APPLICANT: If waiver is approved, store approved waiver in the pharmacy with
the self-assessment form.
California law requires pharmacies and other licensed facilities to maintain records and other
documentation of the acquisition and distribution of dangerous drugs and dangerous devices
for three years. Additional requirements exist in federal law. California law requires that
these records be retained in readily retrievable form. Specific provisions regarding the
storage and maintenance of records are found in various California laws, including:
Business and Professions Code sections 4081, 4105, 4333
Health and Safety Code sections 11159, 11164, 11179, 11205
Code of Regulations, Division 17, Title 16, sections 1707, 1707.1, 1717.4, 1718
The Board of Pharmacy is authorized to grant waivers to allow offsite storage of records
under specific provisions provided in California Code of Regulations section 1707. The
attached form is the application for the waiver for offsite storage of pharmacy records. Other
board-licensed facilities may obtain waiver applications by contacting the board. A copy of
the regulation is attached for your information.
All records stored offsite must be kept in a secure area to prevent unauthorized access.
Examples of reasonable storage areas are at records maintenance facilities or commercial
storage centers. The licensee must be able to produce the records within two business days
upon the request of the board or another authorized officer of the law. The board requests
that the waiver, if approved, be kept in the pharmacy.
All prescription records for non-controlled substances must be kept in the pharmacy for one
year from the date of dispensing. All prescription records for controlled substances must be
kept in the pharmacy for two years from the date of dispensing.
A waiver for offsite storage of records is not needed if the records will be kept in a storage
area at the same address or adjoining the licensed premises.
The Board of Pharmacy will review the information you provide on the attached form. If the
waiver for offsite storage of records is approved, a signed copy of the form will be returned to
you within 30 days. However, until you receive a board-signed copy of the form, offsite
storage of records is not authorized.
A new waiver for offsite storage of records is needed if the records are moved to a different
offsite location.
17A-21
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1707
Waiver Requirements for Offsite Storage of Records
(a)
Pursuant to subdivision (e) of Section 4105 of the Business and Professions Code and
subdivision (c) of Section 4333 of the Business and Professions Code, a waiver shall be
granted to any entity licensed by the board for offsite storage of the records described in
subdivisions (a), (b) and (c) of Section 4105 of the Business and Professions Code unless the
applicant has, within the preceding five years, failed to produce records pursuant to Section
4081 of the Business and Professions Code or has falsified records covered by Section 4081
of the Business and Professions Code.
(b)
An entity that is granted a waiver pursuant to subdivision (a) shall:
(1)
maintain the storage area so that the records are secure, including from unauthorized
access; and
(2)
be able to produce the records within two business days upon the request of the board
or an authorized officer of the law.
(c)
In the event that a licensee fails to comply with the conditions set forth in subdivision (b), the
board may cancel the waiver without a hearing. Upon notification by the board of cancellation
of the waiver, the licensee shall maintain all records at the licensed premises.
(d)
A licensee whose waiver has been cancelled pursuant to the provisions set forth in subsection
(c) may reapply to the board when compliance with the conditions set forth in subsection (b)
can be confirmed by the board.
(e)
Notwithstanding any waiver granted pursuant to subdivision (a), all prescription records for non
controlled substances shall be maintained on the licensed premises for a period of one year
from the date of dispensing.
(f)
Notwithstanding any waiver granted pursuant to subdivision (a), all prescription records for
controlled substances shall be maintained on the licensed premises for a period of two years
from the date of dispensing.
(g)
Notwithstanding the requirements of this section, any entity licensed by the board may store
the records described in subdivisions (a), (b) and (c) of Section 4105 of the Business and
Professions Code in a storage area at the same address or adjoining the licensed premises
without obtaining a waiver from the board if the following conditions are met:
(1)
The records are readily accessible to the pharmacist-in-charge (or other pharmacist on
duty, or exemptee) and upon request to the board or any authorized officer of the law.
(2)
The storage area is maintained so that the records are secure and so that the
confidentiality of any patient-related information is maintained.
Note: Authority cited: Section 4005, Business and Professions Code. Reference: Sections 4081,
4105 and 4333, Business and Professions Code.
17A-21 (Rev 7/04)
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