reglab/statecodes huggingface dataset:
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 8 - Prohibitions and Discipline › Section 1760 - Disciplinary Guidelines

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
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.
1. New section
				  filed 7-1-97; operative 7-1-97 pursuant to Government Code section
				  11343.4(d)
				  (Register 97, No. 27). For prior history, see Register 83, No.
				  13.
2. Amendment of section and NOTE filed 10-3-2001; operative
				  11-2-2001 (Register 2001, No. 40).
3. Change without regulatory
				  effect adding article 8 heading filed 9-11-2002 pursuant to section
				  100, title 1, California Code of
				  Regulations (Register 2002, No. 37).
4. Repealer and new article
				  heading filed 9-7-2005; operative 10-7-2005 (Register 2005, No.
				  36).
5. Amendment of first paragraph filed 4-27-2009; operative
				  5-27-2009 (Register 2009, No. 18).
6. Amendment of "Disciplinary
				  Guidelines" (incorporated by reference) and amendment of section and NOTE filed
				  1-17-2018; operative 4-1-2018 (Register 2018, No.
				  3).
Note: 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
					 and
					 4300-
					 4313,
					 Business and Professions Code; and Sections
					 11400.20
					 and
					 11425.50(e),
					 Government Code.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 8 - Prohibitions and Discipline › Section 1761 - Erroneous or Uncertain Prescriptions

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(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.
1. Amendment
				  filed 2-22-80; effective thirtieth day thereafter (Register 80, No.
				  8).
2. Amendment filed 3-12-85; effective thirtieth day thereafter
				  (Register 85, No. 12).
3. Change without regulatory effect amending
				  NOTE filed 9-11-2002 pursuant to section
				  100, title 1, California Code of
				  Regulations (Register 2002, No. 37).
Note: Authority cited: Section
					 4005,
					 Business and Professions Code. Reference: Section
					 4005,
					 Business and Professions Code; and Section
					 11153,
					 Health and Safety Code.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 8 - Prohibitions and Discipline › Section 1762 - Unprofessional Conduct Defined

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
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.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 8 - Prohibitions and Discipline › Section 1763 - Coded Prescriptions. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. Repealer
				  filed 3-22-83; effective thirtieth day thereafter (Register 83, No.
				  13).
Note: Authority cited: Sections
					 4036
					 and
					 4350.5,
					 Business and Professions Code. Reference: Sections
					 4036
					 and
					 4350.5,
					 Business and Professions Code.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 8 - Prohibitions and Discipline › Section 1764 - Unauthorized Disclosure of Prescriptions

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
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.
1. Amendment
				  filed 2-19-85; effective thirtieth day thereafter (Register 85, No.
				  8).
2. Change without regulatory effect amending NOTE filed
				  9-11-2002 pursuant to section
				  100, title 1, California Code of
				  Regulations (Register 2002, No. 37).
Note: Authority cited: Section
					 4005,
					 Business and Professions Code. Reference: Sections
					 4040
					 and
					 4301,
					 Business and Professions Code.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 8 - Prohibitions and Discipline › Section 1765 - Commissions, Gratuities, and Rebates

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) 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 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.
1. Repealer of
				  former Section
				  1765, and renumbering and
				  amendment of former Section
				  1765.5 to Section
				  1765 filed 3-22-83; effective
				  thirtieth day thereafter (Register 83, No. 13). For prior history, see
				  Registers 68, No. 21, and 62, No. 9.
2. Repealer of subsection (b)
				  filed 7-10-85; effective thirtieth day thereafter (Register 85, No.
				  28).
3. Change without regulatory effect amending NOTE filed
				  9-11-2002 pursuant to section
				  100, title 1, California Code of
				  Regulations (Register 2002, No. 37).
Note: Authority cited: Section
					 4005,
					 Business and Professions Code. Reference: Sections
					 650
					 and
					 4301,
					 Business and Professions Code.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 8 - Prohibitions and Discipline › Section 1765.5 - Consultant Pharmaceutical Services. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. New section
				  filed 4-13-79; effective thirtieth day thereafter (Register 79, No.
				  15).
2. Renumbering and amendment to Section
				  1765 filed 3-22-83; effective
				  thirtieth day thereafter (Register 83, No. 13).
Note: Authority cited: Section
					 4008,
					 Business and Professions Code. Reference: Section
					 650,
					 Business and Professions Code.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 8 - Prohibitions and Discipline › Section 1766 - False or Misleading Advertising

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
No pharmacist or permit holder shall violate Section
				  17500
				  of the Business and Professions Code.
1. Amendment
				  filed 2-19-85; effective thirtieth day thereafter (Register 85, No.
				  8).
2. Change without regulatory effect amending NOTE filed
				  9-11-2002 pursuant to section
				  100, title 1, California Code of
				  Regulations (Register 2002, No. 37).
Note: Authority cited: Section
					 4005,
					 Business and Professions Code. Reference: Sections
					 651,
					 4301
					 and
					 17500,
					 Business and Professions Code.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 8 - Prohibitions and Discipline › Section 1767 - Substandard Drugs. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. Repealer
				  filed 3-22-83; effective thirtieth day thereafter (Register 83, No.
				  13).
Note: Authority cited: Sections
					 4008,
					 4008.1,
					 4008.2,
					 4008.3,
					 and
					 4009,
					 Business and Professions Code. Reference: Section
					 4240,
					 Business and Professions Code.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 8 - Prohibitions and Discipline › Section 1768 - Denial of Application-Reapplication

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(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.
1. New section
				  filed 4-30-97; operative 5-30-97 (Register 97, No. 18). For prior history, see
				  Register 83, No. 13.
Note: Authority cited: Section
					 4005,
					 Business and Professions Code. Reference: Sections
					 480,
					 486
					 and
					 489,
					 Business and Professions Code.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 8 - Prohibitions and Discipline › Section 1769 - Criteria for Rehabilitation

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) Examination of applicant by medical
				professionals to assess competency.
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 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) Denial
				of a license.
(1) When considering the denial
				of a facility or personal license under Section
				480
				of the Business and Professions Code on the grounds that the applicant has been
				convicted of a crime, the board will consider whether the applicant made a
				showing of rehabilitation if the applicant completed the criminal sentence at
				issue without a violation of parole or probation. In making this determination,
				the board will consider the following criteria:
(A) The nature and gravity of the
				crime(s).
(B) The length(s) of the
				applicable parole or probation period(s).
(C) The extent to which the applicable parole
				or probation period was shortened or lengthened, and the reason(s) the period
				was modified.
(D) The terms or
				conditions of parole or probation and the extent to which they bear on the
				applicant's rehabilitation.
(E) The
				extent to which the terms or conditions of parole or probation were modified,
				and the reason(s) for modification.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 8 - Prohibitions and Discipline › Section 1770 - Substantial Relationship Criteria

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) For the purpose of denial, suspension, or
				revocation of a personal or facility license pursuant to Section
				141 or Division 1.5 (commencing
				with Section
				475) of the Business and
				Professions Code, a crime, professional misconduct, or act shall be considered
				substantially related to the qualifications, functions or duties of the
				practice, profession, or occupation that may be performed under the license
				type sought or held if to a substantial degree it evidences present or
				potential unfitness of an applicant or licensee to perform the functions
				authorized by the license in a manner consistent with the public health,
				safety, or welfare.
(b) In making
				the substantial relationship determination required under subdivision (a) for a
				crime, the board will consider the following criteria:
(1) The nature and gravity of the
				offense;
(2) The number of years
				elapsed since the date of the offense; and
(3) The nature and duties of the practice,
				profession, or occupation that may be performed under the license type sought
				or held.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 8 - Prohibitions and Discipline › Section 1771 - Posting of Notice of Suspension

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
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.
1. New section
				  filed 8-3-79; effective thirtieth day thereafter (Register 79, No.
				  31).
2. Change without regulatory effect amending NOTE filed
				  9-11-2002 pursuant to section
				  100, title 1, California Code of
				  Regulations (Register 2002, No. 37).
Note: Authority cited: Section
					 4005,
					 Business and Professions Code. Reference: Section
					 4005,
					 Business and Professions Code.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 8 - Prohibitions and Discipline › Section 1772 - Disciplinary Condition of Suspension

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
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.
1. New section
				  8-3 -
				  79; effective thirtieth day
				  thereafter (Register 79, No. 31).
2. Amendment filed 3-22-83;
				  effective thirtieth day thereafter (Register 83, No. 13).
3. Change
				  without regulatory effect amending NOTE filed 9-11-2002 pursuant to section
				  100, title 1, California Code of
				  Regulations (Register 2002, No. 37).
Note: Authority cited: Section
					 4005,
					 Business and Professions Code. Reference: Section
					 4300,
					 Business and Professions Code.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 8 - Prohibitions and Discipline › Section 1773 - Disciplinary Conditions of Probation of Pharmacist

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(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.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 8 - Prohibitions and Discipline › Section 1774 - Disciplinary Conditions of Probation of Permit

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(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.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 9 - Citations and Fines › Section 1775 - Issuing Citations

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(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.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 9 - Citations and Fines › Section 1775.1 - Amount of Fines

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(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 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.
1. New section
				  filed 9-11-2003; operative 10-11-2003 (Register 2003, No. 37). For prior
				  history, see Register 2001, No. 25.
Note: 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.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 9 - Citations and Fines › Section 1775.15 - Executive Officer, Citations. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. New section
				  filed 6-22-2001; operative 7-22-2001 (Register 2001, No. 25).
2.
				  Repealer filed 9-11-2003; operative 10-11-2003 (Register 2003, No.
				  37).
Note: Authority cited: Sections
					 125.9,
					 148
					 and
					 4005,
					 Business and Professions Code. Reference: Sections
					 125.9
					 and
					 148,
					 Business and Professions Code.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 9 - Citations and Fines › Section 1775.2 - Factors Considered

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
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.
(h) The number
				of violations found in the investigation.
1. New section
				  filed 5-31-95; operative 6-30-95 (Register 95, No. 22).
2. Amendment
				  of first three paragraphs, new subsection (h) and amendment of NOTE filed
				  6-22-2001; operative 7-22-2001 (Register 2001, No. 25).
3. Amendment
				  of section heading, section and NOTE filed 9-11-2003; operative 10-11-2003
				  (Register 2003, No. 37).
Note: 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.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 9 - Citations and Fines › Section 1775.3 - Compliance with Orders of Abatement

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(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.
1. New section
				  filed 5-31-95; operative 6-30-95 (Register 95, No. 22).
2. Change
				  without regulatory effect amending NOTE filed 9-11-2002 pursuant to section
				  100, title 1, California Code of
				  Regulations (Register 2002, No. 37).
3. Amendment filed 9-11-2003;
				  operative 10-11-2003 (Register 2003, No. 37).
Note: Authority cited: Sections
					 125.9,
					 148
					 and
					 4005,
					 Business and Professions Code. Reference: Sections
					 125.9
					 and
					 148,
					 Business and Professions Code.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 9.1 - Prescription Drug Take-Back Services › Section 1776 - Prescription Drug Take-Back Services: Authorization

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
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.
1. New article
				  9.1 (sections
				  1776-1776.6) and section filed
				  6-6-2017; operative 6-6-2017 pursuant to Government Code section
				  11343.4(b)(3)
				  (Register 2017, No. 23).
Note: 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.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 9.1 - Prescription Drug Take-Back Services › Section 1776.1 - Pharmacies

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(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.
(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.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 9.1 - Prescription Drug Take-Back Services › Section 1776.2 - Pharmacies Offering Mail Back Envelope or Package Services

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(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.
1. New section
				  filed 6-6-2017; operative 6-6-2017 pursuant to Government Code section
				  11343.4(b)(3)
				  (Register 2017, No. 23).
Note: 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.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 9.1 - Prescription Drug Take-Back Services › Section 1776.3 - Collection Receptacles in Pharmacies

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(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 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.
(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.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 9.1 - Prescription Drug Take-Back Services › Section 1776.4 - Drug Take-Back Services in Skilled Nursing Facilities

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
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:
(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.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 9.1 - Prescription Drug Take-Back Services › Section 1776.5 - Reverse Distributors

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(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 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.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 9.1 - Prescription Drug Take-Back Services › Section 1776.6 - Record Keeping Requirements for Board Licensees Providing Drug Take-Back Services

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
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
				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).
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 9.6 - Citation and Fine - Patient Privacy Violations [Repealed] › Section 1777 - Authority to Issue Citations. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Note: Authority cited: Section
					 4005,
					 Business and Professions Code; and Section
					 56.36, Civil
					 Code. Reference: Section
					 56.36, Civil
					 Code; and Section
					 4301,
					 Business and Professions Code.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 9.6 - Citation and Fine - Patient Privacy Violations [Repealed] › Section 1777.1 - Amount of Fines for Violations by Pharmacists. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Note: Authority cited: Section
					 4005,
					 Business and Professions Code; and Section
					 56.36, Civil
					 Code. Reference: Section
					 56.36, Civil
					 Code; and Section
					 4301,
					 Business and Professions Code.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 9.6 - Citation and Fine - Patient Privacy Violations [Repealed] › Section 1777.2 - Amount of Fines for Violations by Non-Professional Licensees. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Note: Authority cited: Section
					 4005,
					 Business and Professions Code; and Section
					 56.36, Civil
					 Code. Reference: Section
					 56.36, Civil
					 Code; and Section
					 4301,
					 Business and Professions Code.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 9.6 - Citation and Fine - Patient Privacy Violations [Repealed] › Section 1777.3 - Factors Considered in Assessing Fines. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Note: Authority cited: Section
					 4005,
					 Business and Professions Code; and Section
					 56.36, Civil
					 Code. Reference: Section
					 56.36, Civil
					 Code; and Section
					 4301,
					 Business and Professions Code.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 9.6 - Citation and Fine - Patient Privacy Violations [Repealed] › Section 1777.4 - Compliance With Orders of Abatement. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Note: Authority cited: Section
					 4005,
					 Business and Professions Code; and Section
					 56.36, Civil
					 Code. Reference: Section
					 56.36, Civil
					 Code; and Sections
					 125.9
					 and
					 4301,
					 Business and Professions Code.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 9.6 - Citation and Fine - Patient Privacy Violations [Repealed] › Section 1777.5 - Contested Citations. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Note: Authority cited: Section
					 4005,
					 Business and Professions Code; and Section
					 56.36, Civil
					 Code. Reference: Section
					 56.36, Civil
					 Code; and Section
					 4301,
					 Business and Professions Code.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 9.8 - Citation and Fine - Internet Dispensing Violations [Repealed] › Section 1778 - Authority to Issue Citations. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Note: Authority cited: Section
					 4005,
					 Business and Professions Code. Reference: Section
					 4067,
					 Business and Professions Code.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 9.8 - Citation and Fine - Internet Dispensing Violations [Repealed] › Section 1778.1 - Factors Considered in Assessing Fines. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Note: Authority cited: Section
					 4005,
					 Business and Professions Code. Reference: Section
					 4067,
					 Business and Professions Code.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 9.8 - Citation and Fine - Internet Dispensing Violations [Repealed] › Section 1778.2 - Compliance With Orders of Abatement. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Note: Authority cited: Section
					 4005,
					 Business and Professions Code. Reference: Sections
					 125.9
					 and
					 4067,
					 Business and Professions Code.
California Code of Regulations › Title 16 - Professional and Vocational Regulations › Division 17 - California State Board of Pharmacy › Article 9.8 - Citation and Fine - Internet Dispensing Violations [Repealed] › Section 1778.3 - Contested Citations. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Note: Authority cited: Section
					 4005,
					 Business and Professions Code. Reference: Section
					 4067,
					 Business and Professions Code.