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Steven W. Schierholt, Esq. John R.

Kasich
Executive Director Governor

STATE OF
BOARD OF PHARMACY

NOTICE OF OPPORTUNITY FOR HEARING


PROPOSAL TO DENY APPLICATION
FOR TERMINAL DISTRIBUTOR OF DANGEROUS DRUGS LICENSE

IN THE MATTER OF: Case No. 2018-1098

Hartley Medical Center Pharmacy, Inc. PENDING License No. 02-2855450


Amy Phan Trinh, R.Ph
-THIS IS A RED INK STAMP-
113 W. Victoria Street I certify this to be a true and exact copy of
Long Beach, CA 90808 the original document on Me vat the
:SBoard
Otik
October 4, 2018
Sieven W. ., Executive Dir.
Dear Ms. Amy Phan Trinh and William A. Stuart: Date: /
-MUST HAVE SEAL TO BE OFFICIAL-
You are hereby notified, in accordance with the provisions of Section 119.07 of the Ohio Revised Code the State
of Ohio Board of Pharmacy (Board) proposes to deny your application(s) for license as a Terminal Distributor of
Dangerous Drugs (TDDD) under authority of Section 4729.57.

JURISDICTION

1. Pursuant to Section 4729.57 of the Ohio Revised Code (ORC) and the rules adopted thereunder, the
Board has the authority to suspend, revoke, or refuse to grant or renew any license issued pursuant to
Section 4729.55 of the ORC to practice as a TDDD in the state of Ohio. Additionally, Section 4729.57 of
the Revised Code grants the Board the authority to impose a monetary penalty or forfeiture not to
exceed in severity any fine designated under the Revised Code for a similar offense or $1,000 if the acts
committed have not been classified as an offense by the ORC.

2. On or about November 17, 2017, Amy Phan Trinh signed as the Responsible Person and William A. Stuart
signed as the applicant on an application for a TDDD License on behalf of Hartley Medical Center
Pharmacy, Inc. (HMCP).

ALLEGATIONS

1. Between June 29, 2015, and July 8, 2015, HMCP was inspected by the United States Food and Drug
Administration (FDA) and received observations of non-compliance on a Form 483. On April 21, 2016,
the FDA sent HMCP a warning letter regarding this inspection. The letter stated that your compounding
is below the required standards. It stated as follows:

a. You were compounding as a 503B without proper registration.

b. You were compounding under insanitary conditions.

77 South High Street, 17th Floor, Columbus, Ohio 43215

T: (614) 466.4143 I F: (614) 752.4836 I contact@pharmacy.ohio.gov I www.pharmacy.ohio.gov


The FDA sent a "Close Out Letter" on September 26, 2017 stating that HMCP had adequately addressed
the violations contained in the warning letter from April 21, 2016.

2. On or about November 16, 2016, the National Association of Boards of Pharmacy (NABP) completed a
Verified Pharmacy Program (VPP) inspection of Hartley Medical Center Pharmacy. The findings were as
follow:

a. Stock solutions prepared using bulk APIs are deemed medium-risk after quarantine
when they should be categorized as high-risk.

b. Stock solutions are not being discarded after 6 hours once punctured, but are instead
being treated as multi-dose vials and being kept for up to 28 days after puncture, and

c. Prescriptions prepared using stock solution are deemed medium-risk after quarantine
when they should be categorized as high-risk.

d. Humidity monitoring not being performed in drug storage area.

e. Cleaning of ISO 5 PEC is only being performed with sterile disinfectant and sterile 70%
isopropyl alcohol (IPA), but not sterile water.

f. Failed gloved fingertip tests are not subjected to testing to identify the organism down
to the genus level.

g. Pharmacy personnel do not utilize a nail cleaner when completing hand hygiene prior
to beginning sterile compounding.

h. Smoke testing was last conducted May, 2015, and is not regularly performed during
certification testing.

i. Pass-through was not included as a location in surface sampling program.

j. Compounding did not cease after the detection of highly pathogenic microorganisms
(in this case, mold) by any means including viable air/surface sampling, media fills,
gloved fingertip testing, failed sterility tests, etc.

k. Validation is not being conducted on routine surface/air sampling procedures.

I. Patient specific label may not reflect identification of compounding technician or


verifying pharmacist.

3. Between March 20, 2017 and March 24, 2017, Hartley Medical Center Pharmacy was inspected by the
FDA. Two observations of non-compliance were reported. They were:

a. The repeater pump used to dispense drug stock is wheeled from the ISO 7 anteroom to the ISO
6 clean room when needed and then returned.

Hartley Medical Center Case No. 2018-1098 2


b. Emergency exit double doors from ISO 6 clean room were sealed with tape. The tape had been
worn or was not fully maintaining the seal in some areas, thus possibly compromising the
integrity of the ISO 6 space.

Corrective action was taken by HMCP and the FDA took no further action.

4. On or about February 26, 2018, the California Board of Pharmacy completed and inspection of Hartley
Medical Center Pharmacy. The findings were as follow:

a. Pharmacy assigns a 180 day beyond use date to hydromorphone and morphine
solutions prepared from non-sterile ingredients without performing a method
suitability test for stability study.

b. Action level for fungal growth in ISO areas do not meet USP 797 recommendations.

5. In your application for licensure as a TDDD submitted on November 20, 2017, you answered "yes" to
legal question 11f, which asks:

"has the applicant ever been the subject of an investigation or disciplinary action by the Drug
Enforcement Administration or appropriate issuing body of any state or jurisdiction that resulted
in the surrender, suspension, revocation or probation of the applicant's license or registration?"

You also answered "yes" to question 11g, which asks:

"has the applicant ever been the subject of a disciplinary action by the Drug Enforcement
Administration or appropriate issuing body of any state or jurisdiction that was based in whole
or in part, on the applicant's prescribing, dispensing, diverting, administering, storing, personally
furnishing, compounding, supplying or selling a controlled substance or other dangerous drug
(i.e. prescription drug), or is such action pending?"

From 2010 through 2018, Hartley Medical Center Pharmacy has been disciplined in (7) separate
instances by (5) different state professional licensing boards. They are:

a. May, 2010 Colorado Board of Pharmacy order issued for your failure to comply with data
submission requirement of Colorado's prescription drug monitoring program, and/or;

b. October, 2010 California Board of Pharmacy citation issued for your use of expired ingredients
to compound medications and a compounded product's labeled expiration date exceeding the
expiration date of ingredients used in the compound, and/or;

c. December, 2015 Hawaii Board of Pharmacy settlement agreement and order for you not
reporting disciplinary action in another state, as well as failure to report disciplinary action by
another state, and/or;

d. June, 2016 Colorado Board of Pharmacy order for your conduct in relation to the compounding
of BLT cream listed in the 2010 California Board of Pharmacy citation, as well as for failure to
report this action to the Colorado Board of Pharmacy, and/or;

Hartley Medical Center Case No. 2018-1098 3


e. December, 2016 Alabama Board of Pharmacy final order for the revocation of your non-resident
pharmacy permit issued by the Alabama Board due to compounding issues brought to light by
the FDA during their inspection from June 29, 2015 to July 8, 2015, and the National Association
of Boards of Pharmacy (NABP) during their Verified Pharmacy Program (VPP) inspection from
November 16, 2016 to November 17, 2016, and/or;

f. September, 2017 Alabama Board of Pharmacy Amendment of December, 2016 order, your non-
resident pharmacy permit was suspended with immediate revision of the suspension to
probation, and/or;

g. March, 2018 Colorado Board of Pharmacy letter of admonition your disciplinary action in
Alabama in 2016-2017 and the failure to notify the Colorado Board of Pharmacy within (30) days
of the action being taken.

POTENTIAL VIOLATIONS OF LAW

1. Such conduct as set forth in paragraphs (1), (2), (3) and (4) of the Allegations Section, if proven, constitutes
a violation of each of the following divisions of Section 4729.57 of the Ohio Revised Code (ORC), each
violation punishable by a maximum penalty of $1,000:

a. Violating any rule of the board, ORC Section 4729.57(A)(2); and/or

b. Violating any provision of this chapter, ORC Section 4729.57(A)(3); and/or

c. Except as provided in section 4729.89 of the Revised Code, violating any provision of the "Federal
Food, Drug, and Cosmetic Act," 52 Stat. 1040 (1938), 21 U.S.C.A. 301, or Chapter 3715. of the
Revised Code, ORC Section 4729.57(A)(4); and/or

d. Violating any provision of the federal drug abuse control laws or Chapter 2925. or 3719. of the
Revised Code, ORC Section 4729.57(A)(5); and/or

e. Ceasing to satisfy the qualifications of a TDDD set forth in section 4729.55 of the Revised Code,
ORC Section 4729.57(A)(7).

2. Such conduct as set forth in paragraphs (1), (2), (3) and (4) of the Allegations Section, if proven, constitutes
a violation of each of the following divisions of Section 4729.55 of the ORC, TDDD license requirements:

a. Adequate safeguards are assured that the applicant will carry on the business of a terminal
distributor of dangerous drugs in a manner that allows pharmacists and pharmacy interns
employed by the terminal distributor to practice pharmacy in a safe and effective manner, ORC
4729.55(D); and/or

b. If the applicant, or any agent or employee of the applicant, has been found guilty of violating
section 4729.51 of the Revised Code, the "Federal Food, Drug, and Cosmetic Act," 52 Stat. 1040
(1938), 21 U.S.C.A. 301, the federal drug abuse control laws, Chapter 2925., 3715., 3719., or 4729.
of the Revised Code, or any rule of the board, adequate safeguards are assured to prevent the
recurrence of the violation, ORC 4729.55(E).

Hartley Medical Center Case No. 2018-1098 4


3. Such conduct as set forth in paragraphs (1), (2), (3) and (4) of the Allegations Section, if proven, each
constitutes a violation of the following sections of Rule 4729-16-03(B) of the Ohio Administrative Code
(OAC), drugs compounded in a pharmacy, each punishable by a maximum penalty of $1,000: For all sterile
compounded drug products, the pharmacy shall comply with the United States pharmacopeia chapter
<797>, USP 38 - NF 33, or any official supplement thereto (9/10/2015), OAC Rule 4729-16-03(B).

4. Such conduct as set forth in paragraphs (1)(a) of the Allegations Section, if proven, constitutes a violation
of section of Rule 4729-16-03(C) of the OAC, drugs compounded in a pharmacy, punishable by a maximum
penalty of $1,000: compliance with section 503A of the Federal Food, Drug, and Cosmetic Act
(11/27/2013).

5. Such conduct as set forth in paragraphs (1), (2), (3) and (4) of the Allegations Section, if proven, each
constitutes a violation of the following sections of Rule 4729-16-03(F) of the OAC, drugs compounded in
a pharmacy, each punishable by a maximum penalty of $1,000: In order to compound drug products, a
pharmacy shall meet the minimum standards for a pharmacy pursuant to rule 4729-9-02 of the OAC.

6. Such conduct as set forth in paragraphs (1), (2), (3) and (4) of the Allegations Section, if proven, each
constitutes a violation of the following section of Rule 4729-16-03(H)(2) of the OAC, drugs compounded
in a pharmacy, each punishable by a maximum penalty of $1,000: For all compounded drug products, the
pharmacist shall be responsible for: the proper maintenance, cleanliness, and use of all equipment used
in compounding.

7. Such conduct as set forth in paragraphs (1), (2), (3) and (4) of the Allegations Section, if proven, each
constitutes a violation of the following sections of Rule 4729-5-11 of the OAC, Responsible person, each
punishable by a maximum penalty of $1,000:

a. The responsible person shall be responsible for the practice of the profession of pharmacy,
including, but not limited to, the supervision and control of dangerous drugs as required in division
(B) of section 4729.55 of the Revised Code, adequate safeguards as required in division (C) of
section 4729.55 of the Revised Code, security and control of dangerous drugs as required in
rule 4729-9-11 of the Administrative Code and maintaining all drug records otherwise required,
OAC Rule 4729-5-11(A)(2); and/or

b. The person to whom the terminal distributor of dangerous drugs license has been issued and all
pharmacists on duty are responsible for compliance with all state and federal laws, regulations,
and rules governing the distribution of drugs and the practice of pharmacy, OAC Rule 4729-5-
11(A)(3).

8. Such conduct, as set forth in paragraphs (1), (2), (3) and (4) of the Allegations Section, if proven, each
constitutes a violation of the following sections of Rule 4729-16-12 of the OAC, each punishable by a
maximum penalty of $1,000:

a. For all sterile compounded products, the pharmacy shall comply with the United States
pharmacopeia chapter <797>, USP 38 - NF 33, or any official supplement thereto (9/10/2015),
OAC 4729-16-12(C); and/or

Hartley Medical Center Case No. 2018-1098 5


b. A pharmacy shall follow the compounding requirements pursuant to rules 4729-16-03 and 4729-
16-06 of the Administrative Code, current professional compounding standards, and all applicable
federal and state laws, rules, and regulations, OAC 4729-16-12(L).

9. Such conduct as set forth in paragraph (5) of the Allegations Section, if proven, each constitutes a violation
of the following sections of Rule 4729-9-19(A) of the OAC, each violation punishable by a maximum
penalty of $1,000:

a. Is not of good moral character and habits, OAC Rule 4729-9-19(A)(4); and/or

b. Has been disciplined by any professional licensing board, OAC Rule 4729-9-19(A)(7).

10. Such conduct as set forth in paragraph (5) of the Allegations Section, if proven, each constitutes a violation
of the following sections of Rule 4729-9-19(6)(3) of the OAC, each violation punishable by a maximum
penalty of $1,000, knowingly employing a person who:

a. Is not of good moral character and habits, OAC Rule 4729-9-19(B)(3)(f); and/or

b. Has been disciplined by any professional licensing board, OAC Rule 4729-9-19(B)(3)(i).

YOU ARE FURTHER NOTIFIED, in accordance with the provisions of Chapters 119. and 4729. of the Ohio Revised
Code, that you are entitled to a hearing before the State of Ohio Board of Pharmacy, if you request such a hearing
within thirty 30 days of the date of the mailing of this notice.

IF YOU DESIRE A HEARING, such request shall either be mailed to the State of Ohio Board of Pharmacy, Attn: Legal,
77 South High Street, 17th Floor, Columbus, Ohio 43215-6126 or an e-mail request may be sent to
legal@pharmacy.ohio.gov (please note faxes will not be accepted). YOUR REQUEST MUST BE MUST BE
RECEIVED ON OR PRIOR TO THE 30TH DAY FOLLOWING THE MAILING DATE OF THIS NOTICE. You may appear at
such hearing in person, by your attorney, or by such other representative as is permitted to practice before the
agency, or you may present your position, arguments or contentions in writing; and, at this hearing, you may also
present evidence and examine any witnesses appearing for and against you. If you are a corporation, you must
be represented at the hearing by an attorney licensed to practice in the state of Ohio.

YOU ARE FURTHER ADVISED that if there is no request for such a hearing received by the Board on or prior to
the 30th day following the mailing of this notice, the State of Ohio Board of Pharmacy, upon consideration of
the aforementioned allegations against you, may take action without such a hearing.

If you have questions regarding the Chapter 119. Administrative Hearing process, please e-mail your questions
to legal@pharmacy.ohio.gov or call the Board office at 614-466-4143 and ask for the legal department.

BY ORDER OF THE STATE BOARD OF PHARMACY

Steven W. Schierholt, Esq., Executive Director

Hartley Medical Center Case No. 2018-1098 6


SWS/jak/k11

CMRRR: 9414 7118 9956 0700 0435 07

cc: John D. Kendzior, Esq., via email:1Kendzior@reedsmith.com

Hartley Medical Center Case No. 2018-1098 7


James Lindon Attorney, Ph.D.
35104 Saddle Creek
Avon, Ohio 44011-4907

Provided to you as a courtesy

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