Saturday, September 21, 2013

South Carolina Board of Pharmacy Order dated August 15, 2013 Denying Advantage Pharmacy, LLC Non-Resident Pharmacy Permit


SOUTH CAROLINA DEPARTMENT OF LABOR, LICENSING AND REGULATION

BEFORE THE STATE BOARD OF PHARMACY

In the Matter of:
Advantage Pharmacy, LLC.
ORDER
Applicant.
This matter came before the State Board of Pharmacy ("Board") for hearing on June  19
20,  2013  as  a  result  of the  non-resident  pharmacy  permit  application  ("Application")  of
Advantage Pharmacy, LLC ("Applicant").  Applicant was duly  noticed to appear due to  a prior
disciplinary  action.  Jason May,  Pharmacist-in-Charge,  and Doyle Beach,  Owner,  appeared on
behalf of the Applicant.  Applications of this type are governed by S.C. Code Ann.  §§40-43-86,
40-43-89 (1976, as amended), and South Carolina Code ofRegulations, Reg.  99-43, as amended.
FINDINGS OF FACT
1. Applicant is located in Hattiesburg, Mississippi.
2. Applicant submitted an application for a nonresident pharmacy permit, which application
was received on February 21,2013 ("Application").
3. Applicant's proposed pharmacist-in-charge is Jason May ("PIC").  The PIC is licensed in
Mississippi with license number E-09433.
4. Applicant's disciplinary matter occurred before Mr. May was the PIC of the facility.  In
20101
a  pharmacy  technician diverted  controlled substances.  The  pharmacy technician

who diverted was one ofthe first employees hired by the non-pharmacist owners, and the
owners trusted the employee.  She diverted 500 count bottles of Lortab from the facility.
The pharmacy technician had access to the pharmacy software and changed the counts, so
the diversion was difficult to uncover, and appeared perfect on inspection.
5. The  State  board  (in  Mississippi)  inspected  the  pharmacy  and  placed  the  permit  on
1 probation for a period of 2 years, and Applicant paid a fine.
6. Applicant is licensed in 19 states.
7. Applicant's  primary  business  is  nonsterile,  transdermal  and  wound  care.  Applicant  is
trying to work with ear, nose and throat  physician (ENTs) to get into the market to make
a fgedication to deliver antibiotics directly to the sinuses.  Applicant also makes scar care.
Applicant also does small scale testosterone products.
8. Applicant  would  look  to  perform  marketing  through  a  local  sales  force  and  forming
relationships with providers.
9. Applicant  was  questioned  regarding  records  and  the  Pharmacist's  Compounding  Log
submitted as part of the application materials; specifically the log records from February
7.  The Board was confused by the records.

1O.  Applicant does not intend to ship sterile products into South Carolina.

11. Applicant complies with a 2: 1 technician ratio in Mississippi.
12. Applicant is not currently shipping into South Carolina.
CONCLUSIONS OF LAW
In  an  application  hearing,  "(t)he  applicant  shall  demonstrate  to  the  satisfaction  of the
board that the applicant meets all requirements for the issuance of a license." S.C. Code Ann.  §
40-1-130  (1976,  as  amended).  Thus,  the  burden  of proof in  an  application  for  licensure  or
certification is on the Applicant to provide full, complete, and accurate responses to all questions
on the application and to demonstrate that he or she is qualified for the license sought.
After careful consideration, the Board determined that approval of the permit should be
denied based on testimony.  Under the Pharmacy Practice Act, specifically in S.C. Code Ann.  §
40-43-83(H),  it  states  "The  Board  of Pharmacy  may  deny  or refuse to renew  a  permit  if it
determines that the granting or renewing of such permit would not be in the public interest.  If an
application  is  refused,  the  board shall  notifY  the  applicant  in  writing  of its  decision  and  the
reasons for its decision."  Here, the Board finds that it would not be in the public interest due to
the inconsistencies and errors in the compounding log.  Some logs submitted in the application
were  also  incomplete.  The Board must rely on the materials submitted by the Applicant when
determining  whether  or not a  pharmacy  meets  the standards  as required  by the  Board.  When
questioned on the record, the Board did not feel  the inconsistencies were sufficiently explained
2 or compensated for;  furthermore,  these  inconsistencies  and  errors would  not be  in  compliance
with the standards for compounding set forth in S.C. Code Ann. §§  40-43-86(CC) and 40-43-88.
THEREFORE, IT IS ORDERED that Applicant's Application is DENIED.
AND IT IS SO ORDERED.
SOUTH CAROLINA DEPARTMENT OF
LABOR, LICENSING &  REGULATION
STATE BOARD OF PHARMACY
DDISON LIVINGSTON, R.PH. Pharm.D
airman of the Board
August 15,2013