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with a beyond use date or the beyond use date is not correct, the
container must immediately be discarded.
Authority cited: Sections 4005 and 4127, Business and
Professions Code. Reference: Sections 4005, 4036, 4037, 4051,
4052, and 4127, Business and Professions Code.
1751.10. Sterile Compounding Reference Materials.
In any pharmacy engaged in compounding sterile injectable
drug products, there shall be current and appropriate reference
materials regarding the compounding of sterile injectable
products located in or immediately available to the pharmacy.
Authority cited: Sections 4005 and 4127, Business and
Professions Code. Reference: Sections 4005, 4036, 4037, 4051,
4052, and 4127, Business and Professions Code.
REFERENCED TITLE 24, PART 2, CHAPTER 12, REGULATIONS
1250.4. Compounding Area for Parenteral Solutions.
The pharmacy shall have a designated area for the preparation
of sterile products for dispensing which shall:
1. In accordance with Federal Standard 209(b), Clean Room and
Work Station Requirements, Controlled Environment, as
approved by the Commission, Federal Supply Service, General
Services Administration meet standards for class 100 HEPA (high
efficiency particulate air) filtered air such as laminar air flow
hood or clean room.
2. Have non-porous and cleanable surfaces, walls, floors and
floor coverings.
3. The pharmacy shall be arranged in such a manner that the
laminar-flow hood is located in an area which is exposed to
minimal traffic flow, and is separate from any area used for bulk
storage of items not related to the compounding of parenteral
solution. There shall be sufficient space, well separated from the
laminar-flow hood area, for the storage of bulk materials,
equipment and waste materials.
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4. A sink with hot and cold running water must be within the
parenteral solution compounding area or adjacent to it.
5. Any pharmacy that compounds sterile injectable products
from one or more nonsterile ingredients must compound the
medication in one of the following environments:
•
5.1 An ISO class laminar airflow hood within an ISO class 7
cleanroom. The cleanroom must have a positive air
pressure differential relative to adjacent areas.
•
5.2 An ISO class 5 cleanroom.
•
5.3 A barrier isolator that provides an ISO class 5
environment for compounding.
Note: For additional pharmacy mechanical standard
requirements, see Chapter 5, California Mechanical Code.
505.5. Pharmacies: Compounding Area for Parenteral Solutions.
The pharmacy shall have a designated area for the preparation
of sterile products for dispensing which shall:
1. Be ventilated in a manner not interfering with laminar air
flow.
505.5.1. Pharmacies: Laminar Flow Biological Safety Cabinet.
In all pharmacies preparing parenteral cytotoxic agents, all
compounding shall be conducted within a certified Class II Type A
or Class II Type B vertical laminar air flow hood with bag in-bag
out design. The pharmacy must ensure that contaminated air
plenums that are under positive air pressure are leak tight.
Article 7.5 Furnishing for Home Administration
1752. Furnishing to Parenteral Patient at Home.
Subject to all provisions of this article, a pharmacist may carry
and furnish to a patient at home dangerous drugs, other than
controlled substances, and devices for parenteral therapy when
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the dangerous drug or device is one currently prescribed for the
patient.
Authority cited: Section 4005, Business and Professions Code.
Reference: Section 4005, Business and Professions Code.
1753. Furnishing to Home Health Agencies and Licensed
Hospices.
Subject to the following conditions, a licensed pharmacy may
furnish to a home health agency licensed under provisions of
Chapter 8 (commencing with section 1725 of Division 2 of the
Health and Safety Code) or to a hospice licensed under provisions
of Chapter 8.5 (commencing with section 1745 of Division 2 of
the Health and Safety Code) dangerous drugs for parenteral
therapy other than controlled substances, in a portable container
for furnishing to patients at home for emergency treatment or
adjustment of parenteral drug therapy by the home health
agency or licensed hospice.
(a) The pharmacy, having ownership and responsibility for the
portable containers, shall ensure that each portable container is:
(1) furnished by a registered pharmacist;
(2) sealed in such a manner that a tamper-proof seal must be
broken to gain access to the drugs;
(3) under the effective control of a registered nurse, pharmacist
or delivery person at all times when not in the pharmacy;
(4) labeled on the outside of the container with a list of the
contents;
(5) maintained at an appropriate temperature according to
United States Pharmacopeia Standards (1995, 23rd Revision), and
protected at all times from extreme temperatures that could
damage the contents.
(b) The portable container may contain up to:
(1) 1000mL of 0.9% sodium chloride intravenous infusion in
containers of a size determined by the pharmacy;
(2) 1000mL of 5% dextrose in water injection in containers of a
size determined by the pharmacy;
522
(3) two vials of urokinase 5000 units;
(4) Each of the following items shall be in sealed, unused
containers; the furnishing pharmacy may select any or all of
these dangerous drugs in up to five dosage units for inclusion in
the sealed, portable container:
(A) heparin sodium lock flush 100 units/mL;
(B) heparin sodium lock flush 10 units/mL;
(C) epinephrine HCl solution 1:1,000;
(D) epinephrine HCl solution 1:10,000;
(E) diphenhydramine HCl 50mg/mL;
(F) methylprednisolone 125mg/2mL;
(G) normal saline, preserved, up to 30 mL vials;
(H) naloxone 1mg/mL 2 mL;
(I) droperidol 5mg/2mL;
(J) prochlorperazine 10mg/2mL;
(K) promethazine 25mg/mL;
(L) dextrose 25gms/50mL;
(M) glucagon 1mg/mL;
(N) insulin (human) 100 units/mL;
(O) bumetamide 0.5mg/2mL;
(P) furosemide 10mg/mL;
(Q) EMLA Cream 5 gm tube;
(R) Lidocaine 1 percent 30mL vials.
(5) The pharmacy shall ensure that the specific dangerous drugs
and quantities to be included in the portable container are listed
in the home health agency's or licensed hospice's policies and
procedures.
(c) The pharmacy shall not supply a portable container to a
home health agency or licensed hospice which does not:
(1) implement and maintain policies and procedures for:
(A) the storage, temperature stability and transportation of the
portable container;
(B) the furnishing of dangerous drugs from the portable
container upon the written or oral authorization of a prescriber;
and
523
(C) a specific treatment protocol for the administration of each
medication contained in the portable container.
(2) have the policies, procedures and protocols reviewed and
revised (as needed) annually by a group of professional personnel
including a physician and surgeon, a pharmacist and a registered
nurse.
(d) A copy of these policies, procedures and protocols shall be
maintained by the furnishing pharmacy from each home health
agency or licensed hospice for which the pharmacy furnishes
portable containers.
(e) In cases where a drug has been administered to a patient
pursuant to the oral order of a licensed prescriber, the pharmacy
shall ensure that the oral order is immediately written down by
the registered nurse or pharmacist and communicated by copy or
fax within 24 hours to the furnishing pharmacy, with a copy of
the prescriber-signed document forwarded to the dispensing
pharmacy within 20 days.
(f) The pharmacy shall ensure that within seven days (168 hours)
after the seal has been broken on the portable container, the
home health agency's director of nursing service or a registered
nurse employed by the home health agency or licensed hospice
returns the container to the furnishing pharmacy. The furnishing
pharmacy shall then perform an inventory of the drugs used from
the container, and if the container will be reused, must restock
and reseal the container before it is again furnished to the home
health agency or licensed hospice.
(g) The furnishing pharmacy shall have written policies and
procedures for the contents, packaging, inventory monitoring,
labeling and storage instructions of the portable container.
(h) The furnishing pharmacy shall ensure that the home health
agency or licensed hospice returns the portable containers to the
furnishing pharmacy at least every 60 days for verification of
product quality, quantity, integrity and expiration dates, or within
seven days (168 hours) after the seal has been broken.
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(i) The furnishing pharmacy shall maintain a current inventory
and record of all items placed into and furnished from the
portable container.
Authority cited: Sections 4005 and 4057, Business and
Professions Code. Reference: Sections 4040, 4057, 4081 and
4332, Business and Professions Code.
1754. Obligations of a Pharmacy Furnishing Portable
Containers.
(a) A licensed pharmacy shall not issue portable containers to
any home health agency or licensed hospice unless the home
health agency or licensed hospice complies with provisions of
section 1753.
(b) A licensed pharmacy shall cease to furnish portable
containers to a home health agency or licensed hospice if the
home health agency or licensed hospice does not comply with
provisions of section 1753.
Authority cited: Sections 4005 and 4057, Business and
Professions Code. Reference: Sections 4040, 4057, 4081 and
4332, Business and Professions Code.
Article 8. Prohibitions and Discipline
1760. Disciplinary Guidelines.
In reaching a decision on a disciplinary action under the
Administrative Procedure Act (Government Code section 11400
et seq.) the board shall consider the disciplinary guidelines
entitled “Disciplinary Guidelines” (Rev. 2/2017), which are hereby
incorporated by reference. Deviation from these guidelines and
orders, including the standard terms of probation, is appropriate
where the board, in its sole discretion, determines that the facts
of the particular case warrant such a deviation--the presence of
mitigating factors; the age of the case; evidentiary problems.
525
Authority cited: Sections 315, 315.2, 315.4 and 4005, Business
and Professions Code; and Section 11400.20, Government Code.
Reference: Sections 315, 315.2, 315.4, 4300-4313, Business and
Professions Code; and Sections 11400.20 and 11425.50(e),
Government Code.
1761. Erroneous or Uncertain Prescriptions.
(a) No pharmacist shall compound or dispense any prescription
which contains any significant error, omission, irregularity,
uncertainty, ambiguity or alteration. Upon receipt of any such
prescription, the pharmacist shall contact the prescriber to
obtain the information needed to validate the prescription.
(b) Even after conferring with the prescriber, a pharmacist shall
not compound or dispense a controlled substance prescription
where the pharmacist knows or has objective reason to know
that said prescription was not issued for a legitimate medical
purpose.
Authority cited: Section 4005, Business and Professions Code.
Reference: Section 4005, Business and Professions Code; and
Section 11153, Health and Safety Code.
1762. Unprofessional Conduct Defined.
In addition to those acts detailed in Business and Professions
Code Section 4301, the following shall also constitute
unprofessional conduct:
(a) Including or permitting to be included any of the following
provisions in an agreement to settle a civil dispute arising from
the licensee's practice, whether the agreement is made before or
after the filing of an action:
(1) A provision that prohibits another party to the dispute from
contacting, cooperating, or filing a complaint with the board; or,
(2) A provision that requires another party to the dispute to
attempt to withdraw a complaint the party has filed with the
board.
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(b) Failure or refusal to comply with any court order issued in
the enforcement of a subpoena, mandating the release of
records to the board.
(c) Commission of any act resulting in the requirement that a
licensee or applicant registers as a sex offender. The board may
revoke the license of any licensee and deny the application of any
applicant who is required to register as a sex offender pursuant
to Section 290 of the Penal Code or any other equivalent federal,
state or territory's law that requires registration as a sex
offender.
Note: Authority: Section 4005, Business and Professions Code.
Reference: Sections 726, 4300 and 4301, Business and
Professions Code.
1764. Unauthorized Disclosure of Prescriptions.
No pharmacist shall exhibit, discuss, or reveal the contents of
any prescription, the therapeutic effect thereof, the nature,
extent, or degree of illness suffered by any patient or any medical
information furnished by the prescriber with any person other
than the patient or his or her authorized representative, the
prescriber or other licensed practitioner then caring for the
patient, another licensed pharmacist serving the patient, or a
person duly authorized by law to receive such information.
Authority cited: Section 4005, Business and Professions Code.
Reference: Section 4040 and 4301, Business and Professions
Code.
1765. Commissions, Gratuities, and Rebates.
An unlawful commission, gratuity or rebate prescribed by this
article and Business and Professions Code Section 650 includes
the rendering by a pharmacist or pharmacy of consultant
pharmaceutical services such as those required pursuant to Title
22, Division 5, Chapters 3 and 4 (skilled nursing facilities and
intermediate care facilities) to a licensed health care facility for
no cost, nominal cost, or below reasonable cost, if that
527
pharmacist or pharmacy obtains patients, clients or customers
and/or their prescription orders from that licensed facility or
entity. The determination of the value of consultant
pharmaceutical services rendered shall include, but not be
limited to, the value of all goods and services furnished by the
pharmacist or pharmacy to a licensed health care facility.
Authority cited: Section 4005, Business and Professions Code.
Reference: Sections 650 and 4301, Business and Professions
Code.
1766. False or Misleading Advertising.
No pharmacist or permit holder shall violate Section 17500 of
the Business and Professions Code.
Authority cited: Section 4005, Business and Professions Code.
Reference: Sections 651, 4301 and 17500, Business and
Professions Code.
1768. Denial of Application--Reapplication.
(a) Where the board has denied an application for a license, the
earliest date on which the applicant may reapply for a license is
one year after the effective date of the denial.
(b) All competent evidence of rehabilitation presented will be
considered upon a reapplication. The board shall use the criteria
listed in section 1769 when considering evidence of
rehabilitation.
Authority cited: Section 4005, Business and Professions Code.
Reference: Sections 480, 486 and 489, Business and Professions
Code.
1769. Criteria for Rehabilitation.
(a) In addition to any other requirements for licensure, when
considering the approval of an application, the board or its
designee may require an applicant to be examined by one or
more physicians and surgeons or psychologists designated by the
board if it appears that the applicant may be unable to safely
528
practice due to mental illness or physical illness affecting
competency. An applicant's failure to comply with the
examination requirement shall render his or her application
incomplete. The board shall pay the full cost of such examination.
The board shall seek that the evaluation be conducted within 60
days of the date the applicant is advised that an examination is
required. The board shall receive the examiner's evaluation
within 60 days of the date the examination is completed. The
report of the examiner shall be made available to the applicant.
If after receiving the report of the evaluation, the board
determines that the applicant is unable to safely practice, the
board may deny the application.
(b) When considering the denial of a facility or personal license
under Section 480 of the Business and Professions Code, the
board, in evaluating the rehabilitation of the applicant and his
present eligibility for licensing or registration, will consider the
following criteria:
(1) The nature and severity of the act(s) or offense(s) under
consideration as grounds for denial.
(2) Evidence of any act(s) committed subsequent to the act(s) or
crime(s) under consideration as grounds for denial under Section
480 of the Business and Professions Code.
(3) The time that has elapsed since commission of the act(s) or
crime(s) referred to in subdivision (1) or (2).
(4) Whether the applicant has complied with any terms of
parole, probation, restitution or any other sanctions lawfully
imposed against the applicant.
(5) Evidence, if any, of rehabilitation submitted by the applicant.
(c) When considering the suspension or revocation of a facility
or a personal license on the ground that the licensee or the
registrant has been convicted of a crime, the board, in evaluating
the rehabilitation of such person and his present eligibility for a
license will consider the following criteria:
(1) Nature and severity of the act(s) or offense(s).
(2) Total criminal record.
529
(3) The time that has elapsed since commission of the act(s) or
offense(s).
(4) Whether the licensee has complied with all terms of parole,
probation, restitution or any other sanctions lawfully imposed
against the licensee.
(5) Evidence, if any, of rehabilitation submitted by the licensee.
Note: Authority cited: Section 4005, Business and Professions
Code. Reference: Sections 4030, 4200 and 4400, Business and
Professions Code.
1770. Substantial Relationship Criteria.
For the purpose of denial, suspension, or revocation of a
personal or facility license pursuant to Division 1.5 (commencing
with Section 475) of the Business and Professions Code, a crime
or act shall be considered substantially related to the
qualifications, functions or duties of a licensee or registrant if to a
substantial degree it evidences present or potential unfitness of a
licensee or registrant to perform the functions authorized by his
license or registration in a manner consistent with the public
health, safety, or welfare.
Authority cited: Sections 481, 4005, Business and Professions
Code. Reference: Sections 4300, 4309 and 4301, Business and
Professions Code.
1771. Posting of Notice of Suspension.
Any holder of a pharmacy permit whose permit is suspended
shall post a notice provided by the Board of the Board's
suspension order in a location conspicuous to the public. Such
notice shall remain posted during the entire period of actual
suspension. Failure to post the notice of suspension as required
herein shall be a ground for further disciplinary action.
Authority cited: Section 4005, Business and Professions Code.
Reference: Section 4005, Business and Professions Code.
530
1772. Disciplinary Condition of Suspension.
Unless otherwise directed by the Board in its sole discretion, any
pharmacist who is serving a period of licensure suspension shall
not enter any pharmacy prescription area or engage in any
pharmacy-related service.
Authority cited: Section 4005, Business and Professions Code.
Reference: Section 4300, Business and Professions Code.
1773. Disciplinary Conditions of Probation of Pharmacist.
(a) Unless otherwise directed by the Board in its sole discretion,
any pharmacist who is serving a period of probation shall comply
with the following conditions:
(1) Obey all laws and regulations substantially related to the
practice of Pharmacy;
(2) Report to the Board or its designee quarterly either in person
or in writing as directed; the report shall include the name and
address of the probationer's employer. If the final probation
report is not made as directed, the period of probation shall be
extended until such time as the final report is made;
(3) Submit to peer review if deemed necessary by the Board;
(4) Provide evidence of efforts to maintain skill and knowledge
as a pharmacist as directed by the Board;
(5) Inform all present and prospective employers of license
restrictions and terms of probation. Probationers employed by
placement agencies must inform all permittees in whose
premises they work of license restrictions and terms of
probation.
(6) Not supervise any registered interns nor perform any of the
duties of a preceptor;
(7) The period of probation shall not run during such time that
the probationer is engaged in the practice of pharmacy in a
jurisdiction other than California.
(b) If ordered by the Board in an administrative action or agreed
upon in the stipulated settlement of an administrative action, any
531
registered pharmacist who is serving a period of probation shall
comply with any or all of the following conditions;
(1) Take and pass all or any sections of the pharmacist licensure
examination and/or attend continuing education courses in
excess of the required number in specific areas of practice if
directed by the Board;
(2) Provide evidence of medical or psychiatric care if the need
for such care is indicated by the circumstances leading to the
violation and is directed by the Board;
(3) Allow the Board to obtain samples of blood or urine (at the
pharmacist's option) for analysis at the pharmacist's expense, if
the need for such a procedure is indicated by the circumstances
leading to the violation and is directed by the Board;
(4) If and as directed by the Board, practice only under the
supervision of a pharmacist not on probation to the Board. The
supervision directed may be continuous supervision, substantial
supervision, partial supervision, or supervision by daily review as
deemed necessary by the Board for supervision, partial
supervision, or supervision by daily review as deemed necessary
by the Board for the protection of the public health and safety.
(5) Complete an ethics course that meets the requirements of
section 1773.5
(c) When the circumstances of the case so require, the Board
may impose conditions of probation in addition to those
enumerated herein by the terms of its decision in an
administrative case or by stipulation of the parties.
Authority cited: Section 4005, Business and Professions Code.
Reference: Section 4300, Business and Professions Code.
1773.5. Ethics Course Required as Condition of Probation.
When directed by the board, a pharmacist or intern pharmacist
may be required to complete an ethics course that meets the
requirements of this section as a condition of probation, license
reinstatement or as abatement for a citation and fine. Board
532
approval must be obtained prior to the commencement of an
ethics course.
(a) The board will consider for approval an ethics course that at
minimum satisfies the following requirements:
(1) Duration. The course shall consist of a minimum of 22 hours,
of which at least 14 are contact hours and at least 8 additional
hours are credited for preparation, evaluation and assessment.
(2) Faculty. Every instructor shall either possess a valid
unrestricted California professional license or otherwise be
qualified, by virtue of prior training, education and experience, to
teach an ethics or professionalism course at a university or
teaching institution.
(3) Educational Objectives. There are clearly stated educational
objectives that can be realistically accomplished within the
framework of the course.
(4) Methods of Instruction. The course shall describe the
teaching methods for each component of the program, e.g.,
lecture, seminar, role-playing, group discussion, video, etc.
(5) Content. The course shall contain all of the following
components:
(A) A background assessment to familiarize the provider and
instructors with the factors that led to the prospective
candidate's referral to the class.
(B) A baseline assessment of knowledge to determine the
participant's knowledge/awareness of ethical and legal issues
related to the practice of pharmacy in California, including but
not limited to those legal and ethical issues related to the specific
case(s) for which the participant has been referred to the
program.
(C) An assessment of the participant's expectations of the
program, recognition of need for change, and commitment to
change.
(D) Didactic presentation of material related to those areas that
were problems for the participants based upon the results of the
533
background assessments and baseline assessments of
knowledge.
(E) Experiential exercises that allow the participants to practice
concepts and newly developed skills they have learned during the
didactic section of the class.
(F) A longitudinal follow-up component that includes (1) a
minimum of two contacts at spaced intervals (e.g., 6 months and
12 months) within one year after course completion or prior to
completion of the participant's probationary period if probation
is less than one year, to assess the participant's status; and
(2) a status report submitted to the division within 10 calendar
days after the last contact.
(6) Class Size. A class shall not exceed a maximum of 12
participants.
(7) Evaluation. The course shall include an evaluation method
that documents that educational objectives have been met - e.g.
written examination or written evaluation - and that provides for
written follow-up evaluation at the conclusion of the longitudinal
assessment.
(8) Records. The course provider shall maintain all records
pertaining to the program, including a record of the attendance
for each participant, for a minimum of 3 years and shall make
those records available for inspection and copying by the board
or its designee.
(9) Course Completion. The provider shall issue a certificate of
completion to a participant who has successfully completed the
program. The provider shall also notify the board or its designee
in writing of its determination that a participant did not
successfully complete the program. The provider shall fail a
participant who either was not actively involved in the class or
demonstrated behavior indicating a lack of insight (e.g.,
inappropriate comments, projection of blame). This notification
shall be made within 10 calendar days of that determination and
shall be accompanied by all documents supporting the
determination.
534
Authority cited: Section 4005, Business and Professions Code.
Reference: Section 4300, Business and Professions Code.
1774. Disciplinary Conditions of Probation of Permit.
(a) Unless otherwise directed by the Board, any pharmacy
permit which is on probation to the Board shall be subject to the
following conditions:
(1) Obey all laws and regulations substantially related to the
practice of pharmacy;
(2) The permit, through its officer, partners or owners, shall
report to the Board or its designees quarterly, either in person or
in writing as directed; if the final probation report is not made as
directed, the period of probation shall be extended until such
time as the final report is made;
(3) Cooperate with the Board in its inspectional program;
(4) Post or circulate notice of conditions of probation so that
they are available to all employees involved in pharmacy
operations;
(5) Submit the operation of the pharmacy to peer review if
deemed necessary by the Board;
(6) Provide evidence that owners or officers are knowledgeable
in the laws pertaining to pharmacy if deemed necessary by the
Board.
(b) When the circumstances of the case so require, the Board
may impose conditions of probation in addition to those
enumerated herein by the terms of its decision in an
administrative case or by stipulation of the parties.
Authority cited: Section 4005, Business and Professions Code.
Reference: Section 4300, Business and Professions Code.
535
Article 9. Citations and Fines
1775. Issuing Citations.
(a) The executive officer or his/her designee may issue a citation
which may contain either or both an administrative fine and an
order of abatement for:
(1) A violation of the Pharmacy Law (Business and Professions
Code 4000 et seq.).
(2) A violation of a regulation adopted by the board.
(3) A violation of the Confidentiality of Medical Information Act
(Civil Code 56 et seq.).
(4) Defaulting on a United States Department of Health and
Human Services education loan.
(5) A violation of other statutes or regulations for which the
board may issue a citation.
(b) Each citation shall be in writing and shall describe with
particularity the nature and facts of the violation, including a
reference to the statute or regulations alleged to have been
violated. The citation shall be served upon the individual
personally or by certified mail.
(c) A citation must inform the cited person or entity that if
he/she or it desires a hearing to contest the finding of a violation,
that hearing shall be requested by written notice to the board
within 30 days of the issuance of the citation. If a hearing is not
requested pursuant to this article, payment of any fine shall not
constitute an admission of the violation charged.
Authority cited: Sections 125.9, 148, 685 and 4005, Business and
Professions Code; and Section 56.36, Civil Code. Reference:
Sections 125.9, 148 and 685, Business and Professions Code; and
Section 56.36, Civil Code.
1775.1. Amount of Fines.
(a) The fine for violating the Pharmacy Law or regulations
adopted pursuant thereto shall not exceed the amount specified
in Section 125.9 of the Business and Professions Code, except for
536
a fine issued pursuant to Section 4067 or Section 4127.4 of the
Business and Professions Code.
(b) The fine for violating the Confidentiality of Medical
Information Act shall not exceed the amount specified in Section
56.36 of the Civil Code.
(c) The fine for defaulting on a United States Department of
Health and Human Services education loan shall not exceed
$2,500.
(d) Failure of a person or entity cited to pay a fine within 30 days
of the date of assessment, unless the citation is being appealed,
may result in disciplinary action by the board. When a citation is
not contested and a fine is not paid, the full amount of the fine
shall be added to the fee for renewal of the license and the
license shall not be renewed without payment of the renewal fee
and fine.
Authority cited: Sections 125.9, 148, 685 and 4005, Business and
Professions Code; and Section 56.36, Civil Code. Reference:
Sections 125.9, 148, 685, 4067 and 4127.4, Business and
Professions Code; and Section 56.36, Civil Code.
1775.2. Factors Considered.
In assessing the amount of an administrative fine, except
violations of the Confidentiality of Medical Information Act and
when assessing a fine pursuant to Business and Professions Code
section 685, the following factors shall be considered:
(a) The gravity of the violation.
(b) The good or bad faith of the cited person or entity.
(c) The history of previous violations.
(d) Evidence that the violation was or was not willful.
(e) The extent to which the cited person or entity has
cooperated with the board's investigation.
(f) The extent to which the cited person or entity has mitigated
or attempted to mitigate any damage or injury caused by the
violation.
(g) Other matters as may be appropriate.
537
(h) The number of violations found in the investigation.
Authority cited: Sections 125.9, 148, 685 and 4005, Business and
Professions Code; and Section 56.36, Civil Code. Reference:
Sections 125.9, 148 and 685, Business and Professions Code; and
Section 56.36, Civil Code.
1775.3. Compliance with Orders of Abatement.
(a) If a cited person or entity who has been issued an order of
abatement is unable to complete the correction within the time
set forth in the citation because of conditions beyond his/her or
its control after the exercise of reasonable diligence, the person
or entity cited may request, from the board, an extension of time
in which to complete the correction. Such a request shall be in
writing and shall be made within the time set forth for
abatement.
(b) When an order of abatement is not contested or if the order
is appealed and the person or entity cited does not prevail,
failure to abate the violation charged within the time specified in
the citation shall constitute a violation and failure to comply with
the order of abatement. An order of abatement shall either be
personally served or mailed by certified mail. Failure to comply
with an order of abatement shall constitute a ground for
revocation or suspension of the license, permit, or registration.
Authority cited: Sections 125.9, 148 and 4005, Business and
Professions Code. Reference: Sections 125.9 and 148, Business
and Professions Code.
1775.4. Contested Citations.
(a) Any person or entity served with a citation may contest the
citation by appealing to the board in writing within 30 days of the
issuance of the citation. Appeals shall be conducted pursuant to
the adjudication provisions of the Administrative Procedure Act.
(Government Code Section 11500 et seq.)
(b) In addition to requesting a hearing, as provided for in
subdivision (a), the person or entity cited may, within 14 calendar
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days after service of a citation, submit a written request for an
informal office conference. The person or entity cited may
contest any or all aspects of the citation. The informal office
conference will be conducted by the executive officer or his/her
designee within 30 calendars days of receiving the request.
(c) The executive officer or his/her designee shall hold an
informal office conference upon request as provided for in
subdivision (b) with the person or entity cited and their legal
counsel or authorized representative if they desire
representation at the informal office conference. At the
conclusion of the informal office conference, the executive
officer or his/her designee may affirm, modify or dismiss the
citation, including any administrative fine levied or order of
abatement issued. The executive officer or his/her designee shall
state in writing the reasons for their action and serve or send by
certified mail, a copy of their findings and decision to the person
or entity cited within 14 calendar days from the date of the
informal office conference. This decision shall be deemed to be a
final order with regard to the citation issued, including the
administrative fine levied and/or an order of abatement.
(d) The person or entity cited does not waive their request for a
hearing to contest a citation by requesting an informal office
conference after which the citation is affirmed by the executive
officer or his/her designee. If the citation is dismissed after the
informal office conference, the request for a hearing on the
matter of the citation shall be deemed to be withdrawn. If the
citation, including any administrative fine levied or order of
abatement, is modified, the citation originally issued shall be
considered withdrawn and a new citation issued. If a hearing is
requested for the subsequent citation, it shall be requested
within 30 days of the issuance of the subsequent citation.
Authority cited: Sections 125.9, 148 and 4005, Business and
Professions Code. Reference: Sections 125.9 and 148, Business
and Professions Code.
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Article 9.1. Prescription Drug Take-Back Services
1776. Prescription Drug Take-Back Services: Authorization
Pharmacies, hospitals/clinics with onsite pharmacies,
distributors and reverse distributors licensed by the board may
offer, under the requirements in this article, specified
prescription drug take-back services through collection
receptacles and/or mail back envelopes or packages to provide
options for the public to discard unwanted, unused or outdated
prescription drugs. Each entity must comply with regulations of
the federal Drug Enforcement Administration (DEA) and this
article.
Only California-licensed pharmacies, hospitals/clinics with onsite
pharmacies, and drug distributors (licensed wholesalers and
third-party logistics providers) who are registered with the DEA
as collectors and licensed in good standing with the board may
host a pharmaceutical take-back receptacle as authorized under
this article.
Authority cited: Section 4005, Business and Professions Code.
Reference: Sections 4005, 4026.5, and 4301, Business and
Professions Code and Section 1317.40, Title 21 Code of Federal
Regulations.
1776.1. Pharmacies
(a) Pharmacies may provide take-back services to the public.
Retail pharmacies and hospital/clinics with onsite pharmacies
may maintain collection receptacles in their facilities. Pharmacies
may offer drug take-back services as specified in section 1776.4
in skilled nursing facilities licensed under Health and Safety Code
section 1250(c).
(b) There are multiple federal, state and local requirements
governing the collection and destruction of dangerous drugs.
Pharmacies are expected to know and adhere to these
requirements when operating a prescription drug take-back
program.
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(c) For purposes of this article, prescription drugs means
dangerous drugs as defined by Business and Professions Code
section 4022, which includes controlled substances. Controlled
substances may be commingled in collection receptacles or mail
back envelopes or packages with other dangerous drugs.
(d) Once drugs are deposited into a collection receptacle or mail
back envelopes or packages by a consumer, they are not to be
removed, counted, sorted or otherwise individually handled.
(e) The collection receptacle shall contain signage that includes:
(1) The name and phone number of the responsible pharmacy;
(2) Medical sharps and needles (e.g., insulin syringes) shall not
be deposited; and
(3) Consumers may deposit prescription drugs including
Schedule II-V controlled substances.
(f) Prescription drugs that are eligible for collection as part of
drug take-back services maintained by pharmacies are only those
prescription drugs that have been dispensed by any pharmacy or
practitioner to a consumer. Dangerous drugs that have not been
dispensed to consumers for use (such as outdated drug stock in a
pharmacy, drug samples provided to a medical practitioner or
medical waste) may not be collected as part of a pharmacy’s drug
take-back service.
(g) As part of its drug take-back services, a pharmacy shall not:
(1) Review, accept, count, sort, or otherwise individually handle
any prescription drugs from consumers.
(2) Accept or possess prescription drugs from skilled nursing
facilities, residential care homes, health care practitioners or any
other entity.
(3) Dispose of quarantined, recalled or outdated prescription
drugs from pharmacy stock.
(h) A pharmacy must be registered with the federal DEA as a
collector for purposes of maintaining a prescription drug take-
back collection receptacle. Such pharmacies cannot employ
anyone convicted of a felony related to controlled substances, or
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anyone who has had a DEA permit denied, surrendered or
revoked.
(i) Any pharmacy that maintains a drug take-back collection
receptacle as authorized in this article shall notify the board in
writing within 30 days of establishing the collection program.
Additionally:
(1) Any pharmacy that ceases to maintain a drug take-back
collection receptacle shall notify the board in writing within 30
days.
(2) Any pharmacy maintaining a collection receptacle shall
disclose to the board that it provides such services annually at
the time of renewal of the pharmacy license, and shall identify all
locations where its collection receptacles are located.
(3) Any tampering with a collection receptacle or theft of
deposited drugs shall be reported to the board in writing within
14 days.
(4) Any tampering, damage or theft of a removed liner shall be
reported to the board in writing within 14 days.
(j) If the pharmacy ceases to maintain a registered collection
receptacle, the pharmacy must notify the DEA within 30 days.
(k) A pharmacy shall not provide take-back services to
consumers if, in the professional judgment of the pharmacist-in-
charge, the pharmacy cannot comply with the provisions of this
article or the DEA rules.
(l) A pharmacy shall not provide take-back services to
consumers if the pharmacy or the pharmacist-in-charge is on
probation with the board, and, if the pharmacy had previously
provided take-back services, the pharmacist-in-charge shall notify
the board and the DEA as required in subsections (i) and (j),
above.
Authority cited: Section 4005, Business and Professions Code.
Reference: Section 4005 and 4022, Business and Professions
Code and Sections 1301.71, 1317.30, 1317.40, Title 21 Code of
Federal Regulations.
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1776.2. Pharmacies Offering Mail Back Envelope or Package
Services
(a) Pharmacies that provide prescription drug take-back services
may do so by providing preaddressed mailing envelopes or
packages to allow a consumer to return prescription drugs to an
authorized DEA destruction location.
(b) All envelopes and packages must be preaddressed to a
location registered with the DEA as a collector. The pharmacy is
responsible for ensuring that all preaddressed envelopes and
packages it makes available to the public are preaddressed for
delivery to facilities that comply with this section.
(c) The preaddressed envelopes and packages must be water
and spill proof, tamper evident, tear resistant and sealable. The
exterior shall be nondescript and not include markings that
indicate the envelope or package contains prescription drugs.
Postage shall be prepaid on each envelope or package.
(d) The preaddressed envelope and package shall contain a
unique identification number for each envelope and package,
and instructions for users that indicate the process to mail back
drugs.
(e) A pharmacy shall not accept any mail back packages or
envelopes that contain drugs unless they are registered as a
collector and have an onsite method of destruction that complies
with the DEA requirements. Instead, consumers shall be directed
to mail the envelopes or packages.
Authority cited: Section 4005, Business and Professions Code.
Reference: Section 4005, Business and Professions Code and
Section 1317.70, Title 21 Code of Federal Regulations.
1776.3. Collection Receptacles in Pharmacies
(a) A pharmacy may maintain a collection receptacle for the
public to deposit their unwanted prescription drugs for
destruction. The pharmacy is responsible for the management
and maintenance of the receptacle. The receptacle shall be
substantially constructed, with a permanent outer container and
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a removable inner liner. The collection receptacle shall be locked
at all times to prevent access to the inner liner.
(b) A pharmacy maintaining a collection receptacle must
securely fasten the receptacle to a permanent structure so it
cannot be removed. The receptacle shall be installed in an inside
location. Except as provided in subsection (c), the receptacle is
visible to pharmacy or DEA registrant employees, but not located
in or near emergency areas, nor behind the pharmacy’s counter.
(c) In hospitals/clinics with a pharmacy on the premises, the
collection receptacle must be located in an area that is regularly
monitored by pharmacy or DEA registrant employees and not in
the proximity of any emergency or urgent care areas. When no
pharmacy or DEA registrant employees are present, the
collection receptacle shall be locked so that drugs may not be
deposited into the collection receptacle.
(d) The receptacle shall include a small opening that allows
deposit of drugs into the inside of the receptacle directly into the
inner liner, but does not allow for an individual to reach into the
receptacle’s contents. During hours when the pharmacy is closed,
the collection receptacle shall not be accessible to the public for
deposit of drugs. The pharmacy shall lock the deposit opening on
the collection receptacle.
(e) A pharmacy shall direct consumers to directly deposit drugs
into the collection receptacle. A pharmacy shall not accept,
count, sort or otherwise handle prescription drugs from
consumers.
(f) A liner as used in this article shall be made of material that is
certified by the manufacturer to meet the American Society for
Testing Materials (ASTM) D1709 standard test for impact
resistance of 165 grams (drop dart test), and the ASTM D1922
standards for tear resistance of 480 grams in both parallel and
perpendicular planes.
(1) The liner shall be waterproof, tamper evident and tear
resistant.
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(2) The liner shall be opaque to prevent viewing or removal of
any contents once the liner has been removed from a collection
receptacle. The liner shall be clearly marked to display the
maximum contents (for example, in gallons). The liner shall bear
a permanent, unique identification number established by the
pharmacy or pre-entered onto the liner by the liner’s
manufacturer or distributor.
(g) The liner shall be removable as specified in this section. The
receptacle shall allow the public to deposit prescription drugs
into the receptacle for containment into the inner liner, without
permitting access to or removal of prescription drugs already
deposited into the collection receptacle and liner. Once a
prescription drug or any other item is placed in the collection
receptacle, the prescription drug or item cannot be removed,
counted, sorted or otherwise individually handled.
(h) If the liner is not already itself rigid or already inside of a
rigid container when it is removed from the collection receptacle,
the liner must be immediately, without interruption, placed in a
rigid container for storage, handling and transport. A rigid
container may be disposable, reusable, or recyclable. Rigid
containers shall be leak resistant, have sealable tight-fitting
covers, and be kept clean and in good repair.
(i) The liner may be removed from a locked collection receptacle
only by or under the supervision of two employees of the
pharmacy. Upon removal, the liner shall be immediately, without
interruption, sealed and the pharmacy employees shall record, in
a log, their participation in the removal of each liner from a
collection receptacle. Liners and their rigid containers shall not
be opened, x-rayed, analyzed or penetrated at any time by the
pharmacy or pharmacy personnel.
(j) Liners and their rigid containers that have been filled and
removed from a collection receptacle must be stored in a
secured, locked location in the pharmacy no longer than 14 days.
(k) The pharmacy shall make and keep the records specified in
1776.6.
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(l) The pharmacy shall ensure the sealed inner liners and their
contents are shipped to a reverse distributor's registered location
by common or contract carrier (such as UPS, FEDEX or USPS) or
by licensed reverse distributor pick-up at the licensed pharmacy's
premises.
(m) The collection receptacle shall contain signage that includes:
(1) The name and phone number of the responsible pharmacy;
(2) Medical sharps and needles (e.g., insulin syringes) shall not
be deposited; and
(3) Consumers may deposit prescription drugs including
Schedule II-V controlled substances.
Authority cited: Section 4005, Business and Professions Code.
Reference: Section 4005, Business and Professions Code and
Sections 1304.22, 1317.05, 1317.60, and 1317.75, Title 21 Code
of Federal Regulations.
1776.4. Drug Take-Back Services in Skilled Nursing Facilities
A pharmacy may offer drug take-back services in skilled nursing
facilities licensed under Health and Safety Code section 1250(c)
as authorized by this article.
(a) Skilled nursing facility employees or person lawfully entitled
to dispose of the resident decedent’s property may dispose of
unwanted or unused prescription drugs by using mail back
envelopes or packages. The pharmacy shall require skilled
nursing facility employees to keep records noting the specific
quantity of each prescription drug mailed back, the unique
identification number of the mail back package and the
preaddressed location to which the mail back envelope is sent.
(b) Only pharmacies and hospitals/clinics with onsite
pharmacies may establish collection receptacles in skilled nursing
facilities for the collection and ultimate disposal of unwanted
prescription drugs. A pharmacy and hospital/clinic with an onsite
pharmacy maintaining a collection receptacle in a skilled nursing
facility shall:
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(1) Be registered and maintain registration with the DEA as a
collector.
(2) Notify the board in writing within 30 days of establishing a
collection receptacle.
(3) Notify the board in writing within 30 days when they cease
to maintain the collection receptacle.
(4) Notify the board in writing within 14 days of any tampering
of the collection receptacle or theft of deposited drugs.
(5) Notify the board in writing within 14 days of any tampering,
damage or theft of a removed liner.
(6) List all collection receptacles it maintains annually at the
time of renewal of the pharmacy license.
(d) Within three business days after the permanent
discontinuation of use of a medication by a prescriber, as a result
of the resident’s transfer to another facility or as a result of
death, the skilled nursing facility may place the patient’s
unneeded prescription drugs into a collection receptacle. Records
of such deposit shall be made in the patient’s records, with the
name and signature of the employee discarding the drugs.
(e) A collection receptacle must be located in a secured area
regularly monitored by skilled nursing facility employees.
(f) The collection receptacle shall be securely fastened to a
permanent structure so that it cannot be removed. The collection
receptacle shall have a small opening that allows deposit of drugs
into the inside of the collection receptacle and directly into the
inner liner, but does not allow for an individual to reach into the
receptacle’s contents.
(g) The receptacle shall be securely locked and substantially
constructed, with a permanent outer container and a removable
inner liner.
(1) The liner shall comply with provisions in this article. The
receptacle shall allow deposit of prescription drugs into the
receptacle for containment into the inner liner, without
permitting access to or removal of prescription drugs already
deposited into the collection receptacle and liner. Once a
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prescription drug or any other item is placed in the collection
receptacle, the prescription drug or item cannot be removed,
sorted, counted, or otherwise individually handled.
(2) If the liner is not already itself rigid or already inside of a rigid
container when it is removed from the collection receptacle, the
liner must be immediately placed in a rigid container for storage,
handling and transport. A rigid container may be disposable,
reusable, or recyclable. Rigid containers shall be leak resistant,
have sealable tight-fitting covers, and be kept clean and in good
repair.
(h) A liner as used in this article shall be made of material that is
certified by the manufacturer to meet American Society for
Testing Materials (ASTM) D1709 standard test for impact
resistance of 165 grams (drop dart test), and the ASTM D1922
standards for tear resistance of 480 grams in both parallel and
perpendicular planes.
(1) The liner shall be waterproof, tamper evident and tear
resistant.
(2) The liner shall be opaque to prevent viewing and discourage
removal of any contents once the liner has been removed from a
collection receptacle. The liner shall be clearly marked to display
the maximum contents (for example, in gallons). The liner shall
bear a permanent, unique identification number.
(i) The collection receptacle shall contain signage that includes:
(1) The name and phone number of the responsible pharmacy;
(2) Medical sharps and needles (e.g., insulin syringes) shall not
be deposited; and
(3) Consumers may deposit prescription drugs including
Schedule II-V controlled substances.
(j) Once deposited, the prescription drugs shall not be counted,
sorted or otherwise individually handled.
(k) The installation, removal, transfer and storage of inner liners
shall be performed only by:
(1) One employee of the authorized collector pharmacy and one
supervisory level employee of the long-term care facility (e.g., a
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charge nurse or supervisor) designated by the authorized
collector, or
(2) By or under the supervision of two employees of the
authorized collector pharmacy.
(l) Sealed inner liners that are placed in a container may be
stored at the skilled nursing facility for up to three business days
in a securely locked, substantially constructed cabinet or a
securely locked room with controlled access until transfer to a
reverse distributor for destruction.
(m) Liners still housed in a rigid container may be delivered to a
reverse distributor for destruction by common or contract carrier
or by reverse distributor pickup at the skilled nursing facility.
(n) A pharmacy maintaining a collection receptacle in a skilled
nursing facility shall make and keep the records as specified in
1776.6.
Authority cited: Section 4005, Business and Professions Code.
Reference: Sections 4005, Business and Professions Code and
Sections 1304.22, 1317.05, 1317.40, 1317.60, 1317.75, 1317.80,
and 1317.95, Title 21 Code of Federal Regulations.
1776.5. Reverse Distributors
(a) A licensed reverse distributor (either a reverse wholesaler or
a reverse third-party logistics provider) registered with the DEA
may accept the sealed inner liners of collection receptacles at the
reverse distributor’s registered location by common or contract
carrier pick-up, or by reverse distributor pick-up at the collector’s
authorized collection location. Once received, the reverse
distributor shall establish records required by this section.
(b) A licensed reverse distributor may not open, survey, or
otherwise analyze the contents of inner liners. All liners shall be
destroyed by an appropriately licensed and registered DEA
reverse distributor in a manner that makes the drugs
irretrievable.
(c) If a reverse distributor picks up the sealed inner liners from
the collector’s authorized location, at least two employees of the
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reverse distributor shall be present. If the sealed inner liners are
delivered to the reverse distributor via common or contract
carrier, at least one employee of the reverse distributor shall
accept the receipt of the inner liners at the reverse distributor’s
registered location.
(d) A reverse distributor shall not employ as an agent or
employee anyone who has access to or influence over controlled
substances, any person who has been convicted of any felony
offense related to controlled substances or who at any time had
a DEA registration revoked or suspended, or has surrendered a
DEA registration for cause.
(e) For each sealed liner or mail back envelopes or packages
received pursuant to federal Title 21 CFR section 1317.55, the
reverse distributor shall maintain records of the number of
sealed inner liners or mail back envelopes or packages, including
the:
(1) Date of acquisition;
(2) Number and the size (e.g., five 10-gallon liners, etc.);
(3) Unique Identification number of each liner or
envelope/package;
(4) The method of delivery to the reverse distributor, the
signature of the individuals delivering the liners to the reverse
distributor, and the reverse distributor’s employees who received
the sealed liner;
(5) The date, place and method of destruction;
(6) Number of packages and inner liners received;
(7) Number of packages and inner liners destroyed;
(8) The name and signature of the two employees of the
registrant that witnessed the destruction.
(e) For liners only, the information specified in subsection (e)(1)-
(8) above shall be created at the time of receipt and at the time
of destruction.
Authority cited: Section 4005, Business and Professions Code.
Reference: Sections 4005, Business and Professions Code and
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Section 1301.71, 1304.21, 1304.22, 1317.15, 1317.55, and
1317.95, Title 21 Code of Federal Regulations.
1776.6. Record Keeping Requirements for Board Licensees
Providing Drug Take-Back Services
Each entity authorized by this article to collect unwanted
prescription drugs from consumers shall maintain the records
required by this article for three years.
(a) For pharmacies maintaining collection receptacles, the
pharmacy shall make and keep the following records for each
liner:
(1) Date each unused liner is acquired, its unique identification
number and size (e.g., 5 gallon, 10 gallon). The pharmacy shall
assign the unique identification number if the liner does not
already contain one.
(2) Date each liner is installed in a collection receptacle, the
address of the location where each liner is installed, the unique
identification number and size (e.g., 5 gallon, 10 gallon), the
registration number of the collector pharmacy, and the names
and signatures of the two employees that witnessed each
installation.
(3) Date each inner liner is removed and sealed, the address of
the location from which each inner liner is removed, the unique
identification number and size (e.g., 5 gallon, 10 gallon) of each
inner liner removed, the registration number of the collector
pharmacy, and the names and signatures of the two employees
that witnessed the removal and sealing.
(4) Date each sealed inner liner is transferred to storage, the
unique identification number and size (e.g., 5 gallon, 10 gallon) of
each inner liner stored, and the names and signatures of the two
employees that transferred each sealed inner liner to storage.
(5) Date each sealed inner liner is transferred for destruction,
the address and registration number of the reverse distributor or
distributor to whom each sealed inner liner was transferred, the
unique Identification number and the size (e.g., 5 gallon, 10
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gallon) of each liner transferred, and the names and signatures of
the two employees who transferred each sealed inner liner to
the reverse distributor or distributor, or the common carrier who
delivered it, the company used, and any related paperwork
(invoice, bill of lading).
Authority cited: Section 4005, Business and Professions Code.
Reference: Sections 4005, Business and Professions Code and
Section 1304.22, Title 21 Code of Federal Regulations
Article 10. Dangerous Drug Distributors
1780. Minimum Standards for Wholesalers and Third-Party
Logistics Providers.
The following minimum standards shall apply to all wholesale
and third-party logistics provider establishments for which
permits have been issued by the Board:
(a) A wholesaler and third-party logistics provider shall store
dangerous drugs in a secured and lockable area.
(b) All wholesaler and third-party logistics provider premises,
fixtures and equipment therein shall be maintained in a clean and
orderly condition. Wholesale and third-party logistics provider
premises shall be well ventilated, free from rodents and insects,
and adequately lighted. Plumbing shall be in good repair.
Temperature and humidity monitoring shall be conducted to
assure compliance with the standards set forth in the latest
edition of the United States Pharmacopeia.
(c) Entry into areas where prescription drugs are held shall be
limited to authorized personnel.
(1) All facilities shall be equipped with an alarm system to detect
entry after hours.
(2) All facilities shall be equipped with a security system that will
provide suitable protection against theft and diversion. When
appropriate, the security system shall provide protection against
theft or diversion that is facilitated or hidden by tampering with
computers or electronic records.
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(3) The outside perimeter of the premises shall be well-lighted.
(d) All materials must be examined upon receipt and before
shipment.
(1) Upon receipt, each outside shipping container shall be
visually examined for identity and to prevent the acceptance of
contaminated prescription drugs or prescription drugs that are
otherwise unfit for distribution. This examination shall be
adequate to reveal container damage that would suggest
possible contamination or other damage to the contents.
(2) Each outgoing shipment shall be carefully inspected for
identity of the prescription drug products and to ensure that
there is no delivery of prescription drugs that have been
damaged in storage or held under improper conditions.
(e) The following procedures must be followed for handling
returned, damaged and outdated prescription drugs.
(1) Prescription drugs that are outdated, damaged,
deteriorated, misbranded or adulterated shall be placed in a
quarantine area and physically separated from other drugs until
they are destroyed or returned to their supplier.
(2) Any prescription drugs whose immediate or sealed outer or
sealed secondary containers have been opened or used shall be
identified as such, and shall be placed in a quarantine area and
physically separated from other prescription drugs until they are
either destroyed or returned to the supplier.
(3) If the conditions under which a prescription drug has been
returned cast doubt on the drug's safety, identity, strength,
quality or purity, the drug shall be destroyed or returned to the
supplier unless testing or other investigation proves that the drug
meets the standards set forth in the latest edition of the United
States Pharmacopeia.
(f) Policies and procedures must be written and made available
upon request by the board.
(1) Each wholesaler and third-party logistics provider shall
establish, maintain, and adhere to written policies and
procedures, which shall be followed for the receipt, security,
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storage, inventory and distribution of prescription drugs,
including policies and procedures for identifying, recording, and
reporting losses or thefts, for correcting all errors and
inaccuracies in inventories, and for maintaining records to
document proper storage.
(2) The records required by paragraph (1) shall be in accordance
with Title 21, Code of Federal Regulations, Section 205.50(g).
These records shall be maintained for three years after
disposition of the drugs.
(3) Each wholesaler and third-party logistics provider shall
establish and maintain lists of officers, directors, managers and
other persons in charge of drug distribution, storage and
handling, including a description of their duties and a summary of
their qualifications.
(4) Each wholesaler and third-party logistics provider shall
provide adequate training and experience to assure compliance
with licensing requirements by all personnel.
(g) The board shall require an applicant for a licensed premise or
for renewal of that license to certify under penalty of perjury that
it meets the requirements of this section at the time of licensure
or renewal.
Authority cited: Section 4005, Business and Professions Code.
Reference: Sections 4025, 4043, 4045, 4051, 4053, 4053.1, 4054,
4059, 4120, 4160, 4161, 4161.5, 4304, and 4342 of the Business
and Professions Code; Sections 109985 and 111280 of the Health
and Safety Code; Section 321 of Title 21, U.S. Code; and Section
205.50 of Title 21, Code of Federal Regulations.
1780.1. Minimum Standards for Veterinary Food-Animal Drug
Retailers.
In addition to the minimum standards required of wholesalers
by section 1780, the following standards shall apply to veterinary
food-animal drug retailers.
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(a) Drugs dispensed by a veterinary food-animal drug retailer
pursuant to a veterinarian's prescription to a veterinarian's client
are for use on food-producing animals.
(b) Repackaged within the meaning of Business and Professions
Code section 4041 means that a veterinary food-animal drug
retailer may break down case lots of dangerous drugs as
described in 4022(a), legend drugs or extra label use drugs, so
long as the seals on the individual containers are not broken.
Veterinary food-animal drug retailers shall not open a container
and count out or measure out any quantity of a dangerous,
legend or extra label use drug.
(c) Dangerous drugs, legend drugs or extra label use drugs
returned to a veterinary food-animal drug retailer from a client
shall be treated as damaged or outdated prescription drugs and
stored in the quarantine area specified in section 1780(e)(1).
Returned drugs may not be returned to stock, or dispensed,
distributed or resold.
(d) A pharmacist or person issued a permit under Business and
Professions Code section 4053 (hereafter called a vet retailer
designated representative) may dispense drugs for use on food-
producing animals on the basis of a written, electronically
transmitted or oral order received from a licensed veterinarian.
Only a pharmacist or the vet retailer designated representative
may receive an oral order for a veterinary food-animal drug from
the veterinarian. A written copy of the oral prescription shall be
sent or electronically transmitted to the prescribing veterinarian
within 72 hours.
(e) When a vet retailer designated representative dispenses a
prescription for controlled substances, the labels of the
containers shall be countersigned by the prescribing veterinarian
before being provided to the client.
(f) Whenever a vet retailer designated representative dispenses
to the same client for use on the same production class of food-
animals, dangerous drugs, legend drugs or extra label use drugs
prescribed by multiple veterinarians, the vet retailer designated
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representative shall contact the prescribing veterinarians for
authorization before dispensing any drugs.
(g) Refilling a veterinarian's prescription
(1) A veterinary food-animal drug retailer may refill a
prescription only if the initial prescription is issued indicating that
a specific number of refills are authorized. If no refills are
indicated on the initial prescription, no refills may be dispensed.
Instead, a new prescription is needed from the veterinarian.
(2) A veterinary food-animal drug retailer may not refill a
veterinarian's prescription order six months after the issuance
date of the initial order. Records of any refills shall be retained by
the veterinary food-animal drug retailer for three years.
(h) Labels affixed to a veterinary food-animal drug dispensed
pursuant to Business and Professions Code section 4041 shall
contain the:
(1) Active ingredients or the generic names(s) of the drug
(2) Manufacturer of the drug
(3) Strength of the drug dispensed
(4) Quantity of the drug dispensed
(5) Name of the client
(6) Species of food-producing animals for which the drug is
prescribed
(7) Condition for which the drug is prescribed
(8) Directions for use
(9) Withdrawal time
(10) Cautionary statements, if any
(11) Name of the veterinarian prescriber
(12) Date dispensed
(13) Name and address of the veterinary food-animal drug
retailer
(14) Prescription number or another means of identifying the
prescription, and if an order is filled in multiple containers, a
sequential numbering system to provide a means to identify
multiple units if shipped to the same client from the same
prescription (container 1 of 6, container 2 of 6, etc.)
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(15) Manufacturer's expiration date
(i) A record of shipment or an expanded invoice shall be
included in the client's shipment, and shall include the names of
the drugs, quantity shipped, manufacturer's name and lot
number, date of shipment and the name of the pharmacist or vet
retailer designated representative who is responsible for the
distribution. Copies of the records shall be distributed to the
prescribing veterinarian and retained by the veterinary food-
animal drug retailer for three years.
(j) If a retailer is unable at any one time to fill the full quantity of
drugs prescribed, the retailer may partially ship a portion so long
as the full quantity is shipped within 30 days. When partially
filling a veterinarian's prescription, a pharmacist or vet retailer
designated representative must note on the written prescription
for each date the drugs are shipped: the quantity shipped, the
date shipped, and number of containers shipped, and if multiple
containers are dispensed at one time, each container must be
sequentially numbered (e.g., 1 of 6 containers),. If a retailer is
unable to dispense the full quantity prescribed within 30 days, a
new veterinarian's prescription is required to dispense the
remainder of the drugs originally prescribed.
(k) Upon delivery of the drugs, the supplier or his or her agent
shall obtain the signature of the client or the client's agent on the
invoice with notations of any discrepancies, corrections or
damage.
(l) If a person, on the basis of whose qualifications a certificate
of exemption has been granted under Business and Professions
Code Section 4053 (the vet retailer designated representative),
leaves the employ of a veterinary food-animal drug retailer, the
retailer shall immediately return the certificate of exemption to
the board.
(m) Training of Vet Retailer Designated representative:
(1) A course of training that meets the requirements of section
4053(b)(4) shall include at least 240 hours of theoretical and
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practical instruction, provided that at least 40 hours are
theoretical instruction stressing:
(A) Knowledge and understanding of the importance and
obligations relative to drug use on food-animals and residue
hazards to consumers.
(B) Knowledge and understanding of state and federal law
regarding dispensing of drugs, including those prescribed by a
veterinarian.
(C) Knowledge and understanding of prescription terminology,
abbreviations, dosages and format, particularly for drugs
prescribed by a veterinarian.
(D) Understanding of cautionary statements and withdrawal
times.
(E) Knowledge and understanding of information contained in
package inserts.
(2) As an alternative to the training program specified in
paragraph (1), other training programs that satisfy the training
requirements of 4053 include fulfillment of one of the following:
(A) Possessing a registration as a registered veterinary
technician with the California Veterinary Medical Board.
(B) Being eligible to take the State Board of Pharmacy's
pharmacist licensure exam or the Veterinary Medical Board's
veterinarian licensure examination.
(C) Having worked at least 1,500 hours within the last three
years at a veterinary food-animal drug retailer's premises
working under the direct supervision of a vet retailer designated
representative. The specific knowledge, skills and abilities listed
in sections 1780.1(m)(1)(A-E) shall be learned as part of the 1500
hours of work experience. A vet retailer designated
representative who vouches for the qualifying experience earned
by an applicant for registration must do so under penalty of
perjury.
Authority cited: Sections 4005 and 4197, Business and
Professions Code. Reference: Sections 4040, 4041, 4053, 4059,
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4063, 4070, 4081, 4196, 4197, 4198 and 4199, Business and
Professions Code.
1781. Pharmacist or Designated Representative on Premises
and In Control.
(a) A registered pharmacist, or a designated representative
certified in accordance with Section 4053 of the Business and
Professions Code, shall be present and in control of a
manufacturer's or wholesaler's licensed premises during the
conduct of business.
(b) A designated representative-3PL, qualified in accordance
with Section 4053.1 of the Business and Professions Code, shall
be present and in control of a third-party logistics provider’s
licensed premises during the conduct of business.
Authority cited: Section 4005, Business and Professions Code.
Reference: Sections 4022.5, 4022.7, 4053, 4053.1, 4160, and
4161, Business and Professions Code.
1782. Reporting Sales of Drugs Subject to Abuse.
Each manufacturer, wholesaler, and third-party logistics
provider shall report to the Board or its designee, up to twelve
(12) times a year, all sales of dangerous drugs subject to abuse as
designated by the Board for reporting, in excess of amounts to be
determined by the Board from time to time. Reports shall be
made within thirty (30) days of the request in the form specified
by the Board.
Authority cited: Section 4005, Business and Professions Code.
Reference: Sections 4081, 4164, 4165, and 4332, Business and
Professions Code.
1783. Manufacturer, Wholesaler, or Third-Party Logistics
Provider Furnishing Drugs and Devices.
(a) A manufacturer, wholesaler, or third-party logistics provider
shall furnish dangerous drugs or devices only to an authorized
person; prior to furnishing dangerous drugs and devices to a
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