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California Pharmacy Law: Prescription Requirements and Disciplinary Actions, Study notes of Pharmacy

Various sections of the California Health and Safety Code and California Code of Regulations related to the prescription and possession of controlled substances. It also includes instances of disciplinary actions taken against pharmacists and pharmacies for violations of these regulations.

Typology: Study notes

2021/2022

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KAMALA
D.
HARRIS
Attorney General
of
California
MARC
D.
GREENBAUM
Supervising Deputy Attorney General
ZACHARYT. FANSELOW
Deputy Attorney General
State
Bar
No. 274129
300 So. Spring Street, Suite 1702
Los Angeles,
CA
90013
Telephone: (213) 897-2562
Facsimile: (213) 897-2804
Attorneys
for
Complainant
BEFORETHE
BOARD OF PHARMACY
DEPARTMENT OF CONSUMER AFFAffiS
STATE OF CALIFORNIA
In the Matter
of
the Accusation Against:
KERR'S PHARMACY,
12142 Santa Monica Blvd.
Los Angeles,
CA
90025
HARRY PETERS, Pharmacist-In-Charge
Original Permit No.
PHY
35423,
HARRY PETERS
12142 Santa Monica Blvd
Los Angeles, CA 90025
Original Pharmacist License No. RPH 28331,
and
JOHN WILLIAM SHAFER
151 Venttll'a Way
Chatsworth,
CA
91311
Original Pharmacist License No. RPH 36106
Respondents.
Case Nos. 4998 and 5106
ACCUSATION
Complainant alleges:
PARTIES
I. Virginia Herold ("Complainant") brings this Accusation solely in her official capacity
as the Executive Officer
ofthe
Board
of
Pharmacy, Department
of
Consumer Affairs.
I
Accusation
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KAMALA Attorney General D. HARRIS of California MARC D. GREENBAUM Supervising Deputy Attorney General ZACHARYT. FANSELOW Deputy Attorney General State300 So. Spring Street, Suite 1702 Bar No. 274129 Los Angeles,Telephone: (213) 897-2562 CA 90013 Attorneys^ Facsimile: for^ (213) 897-2804 Complainant

BOARD OF PHARMACY^ BEFORETHE DEPARTMENT OF CONSUMER AFFAffiS STATE OF CALIFORNIA

In the Matter of the Accusation Against: KERR'S PHARMACY, Los Angeles,^ 12142 Santa Monica Blvd. CA 90025 HARRY PETERS, Pharmacist-In-Charge Original Permit No. PHY 35423, HARRY PETERS 12142 Santa Monica Blvd Los Angeles, CA 90025 Original Pharmacist License No. RPH 28331,

and

JOHN WILLIAM SHAFER

Chatsworth,^ 151 Venttll'a Way CA 91311 Original Pharmacist License No. RPH 36106 Respondents.

Case Nos. 4998 and 5106

ACCUSATION

Complainant alleges: PARTIES I. Virginia Herold ("Complainant") brings this Accusation solely in her official capacity as the Executive Officer ofthe Board of Pharmacy, Department of Consumer Affairs. I

2. On or about February 24, 1989, the Board of Pharmacy issued Original Permit No.

PHY 35423 to Kerr's Pharmacy, Harry Peters, Pharmacist-In-Charge ("Respondent Pharmacy"). The Original Permit was in full force and effect at all times relevant to the charges brought herein and will expire on February I, 2015, unless renewed.

  1. On or about July 31, 1973, the Board of Pharmacy issued Original Pharmacist License No. RPH 28331 to Harry Peters ("Respondent Peters"). The Original Pharmacist License was in full force and effect at all times relevant to the charges brought herein and will expire on April30, 2016, unless renewed.
  2. On or about December 19, 1980, the Board of Pharmacy issued Original Pharmacist License Number RPH 36106 to John William Shafer ("Respondent Shafer"). The Pharmacist License was in full force and effect at all times relevant to the charges brought herein and will expire on February 28, 2015, unless renewed. JURISDICTION
  3. This Accusation is brought before the Board of Pharmacy, Department of Consumer Affairs ("Board"), under the authority of the following laws. All section references are to the Business and Professions Code unless otherwise indicated.
  4. Section 4300 provides, in pertinent part, that every license issued by the Board is subject to discipline, including suspension or revocation.
  5. Section 4300.1 states: "The expiration, cancellation, forfeiture, or suspension of a board-issued license by operation oflaw or by order or decision of the board or a court oflaw, the placement of a license on a retired status, or the voluntary surrender of a license by a licensee shall not deprive the board of jurisdiction to commence or proceed with any investigation of, or action or disciplinary proceeding against, the licensee or to render a decision suspending or revoking the license." STATUTORY PROVISIONS
  6. Section 4022 states: "Dangerous drug" or "dangerous device" means any drug or device unsafe for self-use in humans or animals, and includes the following: 2
  1. Section 4113, subdivision (c), states: "The pharmacist-in-charge shall be responsible for a pharmacy's compliance with all state and federal laws and regulations pertaining to the practice of pharmacy."
  2. Section 4301 states: "The board shall take action against any holder of a liceose who is guilty of unprofessional conduct or whose license has been procured by fraud or misrepresentation or issued by mistake. Unprofessional conduct shall include, but is not limited to, any of the following:

"(b) Incompetence. "(c) Gross negligence.

"(f) The commission of any act involving moral turpitude, dishonesty, fraud, deceit, or com1ption, whether the act is committed in the course of relations as a licensee or otherwise, and whether the act is a felony or misdemeanor or not.

"(i) Except as otherwise authorized by law, knowingly selling, fhrnishing, giving away, or administering, or offering to sell, furnish, give away, or administer, any controlled substance to an addict. "(j) The violation of any of the statutes of this state, of any other state, or of the United States regulating controlled substances and dangerous drugs.

"(o) Violating or attempting to violate, directly or indirectly, or assisting in or abetting the violation of or conspiring to violate any provision or term of this chapter or of the applicable federal and state laws and regulations governing pharmacy, including regulations established by the board or by any other state or federal regulatory agency."

  1. Section 4342, subdivision (a), states: "The board may institute any action or actions as may be provided by law and that, in its discretion, are necessary, to prevent the sale of pharmaceutical preparations and drugs that do not 4

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conform to the standard and tests as to quality and strength, provided in the latest edition of the

United States Pharmacopoeia or the National Formulary, or that violate any provision of the

Sherman Food, Drug and Cosmetic Law (Part 5 (commencing with Section 109875 ofDivision

104 of the Health and Safety Code)."

15. Health and Safety Code section 11170 states: "No person shall prescribe, administer,

or fhrnish a controlled substance for himself"

16. Health and Safety Code section 11217 states, in pertinent part:

"Except as provided in Section 11223, no person shall treat an addict for addiction to a

narcotic drug except in one of the following:

"(a) An institution approved by the State Department ofHealth Care Services, and where

the patient is at all times kept under restraint and control.

"(b) A city or c01mty jail.

"(c) A state prison.

"(d) A facility designated by a c01mty and approved by the State Department of Health Care

Services pursuant to Division 5 (commencing with Section 5000) of the Welfare and Institutions

Code.

"(e) A state hospital.

"(f) A county hospital.

"(g) A facility licensed by the State Department of Health Care Services pursuant to Division

10.5 (commencing with Section 11750).

"(h) A facility as defined in subdivision (a) or (b) of Section 1250 and Section 1250.3."

17. Health and Safety Code section 11350, subdivision (a), states:

"Except as otherwise provided in this division, every person who possesses (I) any

controlled substance specified in subdivision (b) or (c), or paragraph (I) of subdivision (f) of

Section 11054, specified in paragraph (14), (15), or (20) of subdivision (d) of Section II 054, or

specified in subdivision (b) or (c) of Section 11055, or specified in subdivision (h) of Section

II 056, or (2) any controlled substance classified in Schedule III, IV, or V which is a narcotic drug,

unless upon the written prescription of a physician, dentist, podiatrist, or veterinarian licensed to

  1. Code of Federal Regulations, title 21, section 1304.11 states, in pertinent part: "(a) General requirements. Each inventory shall contain a complete and accurate record of all controlled substances on hand on the date the inventory is taken, and shall be maintained in written, typewritten, or printed form at the registered location. An inventory taken by use of an oral recording device must be promptly transcribed. Controlled substances shall be deemed to be "on hand" if they are in the possession of or under the control of the registrant, including substances returned by a customer, ordered by a customer but not yet invoiced, stored in a warehouse on behalf of the registrant, and substances in the possession of employees of the registrant and intended for distribution as complimentary samples. A separate inventory shall be made for each registered location and each independent activity registered, except as provided in paragraph (e)(4) of this section. In the event controlled substances in the possession or under the .control of the registrant are stored at a location for which he/she is not registered, the substances shall be included in the inventory of the registered location to which they are subject to control or to which the person possessing the substance is responsible. The inventory may be taken either as of opening of business or as of the close of business on the inventory date and it shall be indicated on the inventory.

"(c) Biennial inventory date. After the initial inventory is taken, the registrant shall take a new inventory of all stocks of controlled substances on hand at least every two years. The biennial inventory may be taken on any date which is within two years of the previous biennial inventory date." COST RECOVERY

22. Section 125.3 states, in pertinent part, that the Board may request the administrative

law judge to direct a licentiate fmmd to have committed a violation or violations of the licensing act to pay a sum not to exceed the reasonable costs of the investigation and enforcement of the case. I I I I I I 7

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FIRST CAUSE FOR DISCIPLINE

(Unprofessional Conduct)

23. Respondent Shafer is subject to disciplinary action under section 4301, subdivision (f),

for unprofessional conduct, in that Respondent Shafer admittedly took controlled substances from Respondent Pharmacy without a prescription. The circumstances are as follows: a. On or about Apri130, 2013, officers from the Ventura County Sheriff's Department searched the home of Respondent Shafer. Officers found a large supply of prescription medication during their search and some of the controlled substances· featured labels from Respondent Pharmacy. Examples of controlled substances found at Respondent Shafer's home include: Fentanyl Patches, Meprobamate, Hydrocodone/APAP, Desoxyo, Preludin, Qualude, Tylenol with Codeine, Diethylprodin, Phenobarbital, Temazepam, Zolpidem, Flurazepam, Propoxyphene/APAP, Alprazolam, Chloral Hydrate, Lorazepam, Tranxene and Marijuana. Examples of non controlled dangerous drugs fmmd were: Lisinopril, Cimetidine, Naltrexone and Levoxyl. b. During an interview with Ventura County Sheriff's Department officers, Respondent Shafer stated that, while he was working at Respondent Pharmacy, he became friendly with AS., the care taker of a terminal cancer patient. Respondent Shafer stated that he suspected that AS. was using illegal drugs and after discussing AS.' use of controlled substances, Respondent Shafer offered to let her stay at his home and help her detox from heroin. While AS. was stayiog at his home, Respondent Shafer provided her with controlled substances he had stored in his home to allegedly assist her detoxification. c. During the interview with Ventura County Sheriff's Department officers, Respondent Shafer admitted that he took hydrocodone pills from Respondent Pharmacy to keep at his home for his own consumption. Respondent Shafer stated that he took the hydrocodone recreationally and analogized it to drinking beer. d. On or about May 13, 2013, during an interview with a Board inspector, Respondent Shafer admitted that he had taken some expired zolpidcm I Omg tablets and a dozen ibuprofen 600 mg tablets from Respondent Pharmacy.

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authorized treatment facility. The conduct is described in additional detail in paragraph 23, subparagraphs (a) and (b), which is hereby incorporated by reference as though set forth fully. SIXTH CAUSE FOR DISCIPLINE (Diversion of Controlled Substances from Respondent Pharmacy by Employee)

  1. Respondent Pharmacy and Respondent Peters are subject to disciplinary action under section 4113, subdivision (c), and California Code of Regulations, title 16, section 1709.1, subdivision (a), for the possession and diversion of controlled substances from Respondent

Pharmacy by employee Respondent Shafer in violation of section 4301, subdivisions G) and ( o), in

conjunction with section 4060 and Health and Safety Code section 1'1350, subdivision (a). The circumstances are as follows: a. On^ or^ about^ May^ 13, 2013, an inspector for the Board interviewed Respondent Peters. Respondent Peters stated that Respondent Shafer has worked for him since the 1980's, that he knew Respondent Shafer used marijuana and that Respondent Shafer also used other prescription drugs. Respondent Peters fi1rther admitted that he knew Respondent Shafer kept large quantities of controlled substances at his horne and described Respondent Shafer as a "hoarder." b. The conduct is described in additional detail in paragraph 23, subparagraphs (a) through (d) inclusive, which is hereby incorporated by reference as though set forth fully. SEVENTH CAUSE FOR DISCIPLINE (Failure to Inventory Controlled Substances)

  1. Respondent Pharmacy and Respondent Peters are subject to disciplinary action under section 4301, subdivision (o), in that Respondent Pharmacy and Respondent Peters violated Code of Federal Regulations, title 21, section 1304.11, by failing to inventory all controlled substances in stock at least every two years as required by the Drug Enforcement Administration ("DBA") Controlled Substances Inventory. The circumstances are as follows: a. On^ or^ about^ May^ 13, 2013, during^ an^ inspection^ of^ Respondent Pharmacy,^ an inspector for the Board asked Respondent Peters for the pharmacy's bi-annual inventory.

Respondent Peters gave the Board inspector an inventory dated May I, 2013, but admitted that

the inventory was incomplete. 10

b. During the Board's inspection on or about May 13, 2013, the Board inspector also asked to review Respondent Pharmacy's prior bi-ammal inventory. Respondent Peters provided an inventory dated March 31, 2011. However, the March 31, 2011, inventory only listed schedule II narcotics and did not contain any inventory for schedule III through schedule V narcotics. Respondent Peters admitted that the pharmacy did not complete an inventory for schedule III through schedule V drugs in 2011. EIGHTH CAUSE FOR DISCIPLINE (Drugs Lacking Quality or Strength)

  1. Respondent Pharmacy and Respondent Peters are subject to disciplinary action under section 4342 for the willfiil sale of drugs lacking quality or strength. The circumstances are as follows:

a. On or about May 13, 2013, during an inspection of Respondent Pharmacy, an

inspector for the Board found numerous expired medications kept for sale throughout the pharmacy's shelves. NINTH CAUSE FOR DISCIPLINE (Failure to Maintain Dangerous Drugs in a Safe and Secure Manner)

  1. Respondent Pharmacy is subject to disciplinary action lmder section 4301, subdivision ( o ), in that Respondent Pharmacy violated California Code of Regulations, title 16, section 1714, subdivision (b), for failing to maintain its dangerous drugs in a safe and secure manner. During the Board's inspection on or about May 13, 2013, the Board requested records of drug purchases and disposition. A review of Respondent Pharmacy's DEA inventory,^1 purchase orders, disposition records, and drugs on the pharmacy's shelves identified the following variances: a. Over one hundred unaccmmted for tablets of Acetaminophen/Codeine 300/30 mg. b. Over five hundred unaccounted for tablets of Alprazolarn 0.5 mg. c. Over fifty unaccounted for tablets of Diazepam 2mg.

d. Over five hm1dred linaccmmted for tablets of Oxycodonc/AP AP 5/325.

(^1) Only Schedule II controlled substances had been inventoried as detailed in paragraph 19.

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ELEVENTH CAUSE FOR DISCIPLINE

(Incompetence and/or Gross Negligence)

  1. Respondent Pharmacy and Respondent Peters are subject to disciplinary action under section 4301, subdivisions (b) and/or (c), in that Respondent Pharmacy and Respondent Peters' failure to identity and record the number of dangerous drugs stored at Respondent Pharmacy, as well as Respondent Pharmacy and Respondent Peters' failure to properly maintain and secure those drugs, amounts to incompetence and/or gross negligence. The conduct and specific dangerous drug variances, numbering in the thousands, are described in paragraph 31, subparagraphs (a) through (u) inclusive, and paragraph 32, which are hereby incorporated by reference as though set forth fully. TWELFTH CAUSE FOR DISCIPLINE (Failure to Keep the Pharmacy in a Clean and Orderly Condition)
  2. Respondent Pharmacy and Respondent Peters are subject to disciplinary action under section 4301, subdivision (o), in that Respondent Pharmacy and Respondent Peters violated California Code of Regulations, title 16, section 1714, subdivision (c), by failing to keep the pharmacy in a clean and orderly condition. The circumstances are as follows: a. On or about May 13, 2013, during an inspection of Respondent Pharmacy, an inspector for the Board found that the pharmacy's drug shelves, drawers and cabinets were extremely dirty, with a thick layer of dust and grim throughout the pharmacy storage areas. In addition, the sink in the bathroom did not have running water. DISCIPLINARY CONSIDERATIONS
  3. To determine the degree of discipline, if any, to be imposed on Respondent Pharmacy and Respondent Peters, Complainant alleges the following: a. On^ or about November 25, 1991, the California State Board^ of^ Pharmacy brought a disciplinary action against Respondent Peters and Respondent Pharmacy entitled In the Matter of the Accusation Against Harry Peters, Kerr's Pharmacy, Board Case No. AC 1988 1581. On or about June I 0, 1994, a stipulation became effective whereby Respondent Peters' Original License Certificate No. PG028331 was placed on probation for three years and Respondent Pharmacy's 13

Original Permit No. ZB018241 was placed on probation for three years. That decision is now

final and is incorporated by reference as ifset forth fully.

  1. To determine the degree of discipline, if any, to be imposed on Respondent John William Shafer, Complainant alleges the following: a. On or about December 21, 1984, the California State Board of Pharmacy brought a disciplinary action against Respondent Shafer entitled In the Matter of the Accusation Against The Pharmacy; John Shcifer; Richard Foster; Amos Cranford, Board Case No. 1222. On or about December 6, 1985, the Board adopted the Administrative Law Judge's Proposed Decision suspending Respondent Shafer's license for one year. The suspension was stayed and Respondent Shafer was placed on probation for one year. That decision is now final and is incorporated by

reference as ifset forth fully.

PRAYER WHEREFORE, Complainant requests that a hearing be held on the matters herein alleged, and that following the hearing, the Board of Pharmacy issue a decision:

  1. Revoking or suspending Pharmacy Permit Number PHY 35423, issued to Kerr's Pharmacy, Harry Peters, Pharmacist-In-Charge;
  2. Revoking or suspending Phmmacist License Number RPH 28331, issued to Harry Peters;
  3. Revoking or suspending Pharmacist License Number RPH 36106, issued to John William Shafer;
  4. Ordering Harry Peters, Harry Peters and John William Shafer to pay the Board of Pharmacy the reasonable costs of the investigation and enforcement of this case, pursuant to Business and Professions Code section 125.3; and, I I I I I I I I I I I I I I I 14