South Carolina Board of Pharmacy Order Dated August 15, 2013 Denying Non-Resident Pharmacy Permit to Concierge Compounding Pharmaceuticals

SOUTH CAROLINA DEPARTMENT OF LABOR, LICENSING AND REGULATION

BEFORE THE STATE BOARD OF PHARMACY

In the Matter of:
Concierge Compounding
ORDER
Pharmaceuticals,
Applicant.
This matter came before the State Board of Pharmacy ("Board") for hearing on June  19,
2013  as  a result of the non-resident pharmacy  permit application ("Application") of Concierge
Compounding  Pharmaceuticals (HApplicant").  Applicant was  duly  noticed to  appear  due  to  a
prior criminal  action.  Sally Chi a,  Pharmacist-in-Charge, and  Hootan Melamed, Permit Holder,
appeared on behalf of the Applicant.  Applications of this type are governed by S.C. Code Ann.
§§40-43-83, 40-43-86, 40-43-89 (1976,  as amended),  and South Carolina Code of Regulations,
Reg. 99-43, as amended.
FINDINGS OF FACT
1. Applicant is located in Henderson, Nevada.
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 Sally Chia ("PIC").  The PIC is licensed in
Nevada with license number 180l3.
4. Applicant  answered  "yes"  to  question, 2  on  the  Application,  related  to  a  criminal
prosecution.  In  1999,  Melamed  pled  guilty  to  a  felony  for  conspiracy  to  commit

securities fraud for a "pump and dump" scheme in the stock market.  This occurred while
he was a student in pharmacy schooL
5. Applicant garners interest in the  business  by traveling  to  trade shows.  Once Applicant
receives  some  business  in  a  certain  area,  Applicant  applies  in  the  appropriate  state.
1 Applicant is licensed in 15 states currently.
6. Approximately 80-90% of Applicant's business is out-of-state.
7. Applicant complies with a 3:1 technician to pharmacist ratio.
8. The Nevada Board does a separate compounding inspection on pharmacies.
9. Applicant  is  undergoing  the  Pharmacy  Compounding  Accreditation  Board  (PCAB)
accreditation process.
10. Regarding  adjustments  III  formulas,  Applicant  testified  that  they  write  down  any
adjustments  on  the  worksheets.  Now,  Applicant  is  printing  out  and  taping  any
adjustments on the worksheets.  Their new policy is to make adjustments in the formula.
The adjustments are not reflected in the materials as submitted to the Board.
11. Applicant does not think they have shipped products 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..,t-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 because
the Board does not believe Applicant has met the standards of pharmacy practice as required by
South Carolina law.  The Board has serious concerns regarding the accuracy and completeness of
the  compounded  formulas  provided  in  the  application.  Additionally,  in  the  materials  as
submitted to the Board, the formulas  are not adjusted and do  not definitively meet the standards
as required by South Carolina; as such, these omissions are not in compliance with the standards
for compounding set forth in S.C. Code Ann. §§ 40-43-86(CC) and 40-43-88.
2 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 ofthe Board
August 15,2013.