SOUTH CAROLINA DEPARTMENT OF LABOR, LICENSING AND REGULATION
BEFORE THE STATE BOARD OF PHARMACY
In the Matter of:
Physician Specialty Compounding by
ORDER
Sunlake,
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 Physician
Specialty Compounding by Sunlake ("Applicant"). Applicant was duly noticed to appear
because all applicants of this type must appear before the Board or Nonresident Pharmacy
Committee; this Applicant was approved to come before the full Board in lieu of waiting for the
next available committee meeting. Ingrid Bendeck, Pharmacist-in-Charge, 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 ofRegulations, Reg. 99-43, as amended.
FINDINGS OF FACT
1. Applicant is located in Lutz, Florida.
2. Applicant submitted an application for a nonresident pharmacy permit, which application
was received on June 4, 2013 ("Application").
3. Applicant's proposed pharmacist-in-charge is Ingrid Bendeck ("PIC"). The PIC, is
licensed in Florida with license number 44687.
4. Applicant has been compounding since December 2007. Applicant also has a retail
pharmacy business. Applicant is interested in sending medications into South Carolina.
5. Applicant does business in Georgia, New York, New Jersey, and Alabama. Applicant
has sales people lined up for South Carolina.
6. Applicant has not shipped any products into South Carolina.
1 7. The Florida inspection report states that the inspector was unable to locate the quality and
-control policies and procedures, as well as the policies and procedures for controlled
compounding. The report also noted that there were expired medications on the shelf.
8. Applicant did not submit policies and procedures with the Application.
9. Applicant submitted the beyond use dates in her Application materials as the expiration
date ofthe active pharmaceutical ingredient.
10. Applicant complies with a technician ratio of 3: 1.
11. Applicant mostly compounds creams and ointments.
12. Applicant has not studied the standard operating procedures but does read the standard
operating procedures for the compounds prepared at the pharmacy.
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. Ifan
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. It is very concerning to the Board that the quality and control procedures
were not available onsite for the Florida Board's inspection. Additionally, the Board cannot
verify the procedures policies and procedures because they were not provided in the Application.
It is also concerning that the beyond use date is being calculated solely based on the active
pharmaceutical ingredient'S beyond use date; this date should be calculated based on all the
ingredients involved in the compound. Per United States Pharmacopeia 795 standards, beyond
use date should be calculated based on drug-specific and general stability documentation, as well
2 as the nature of the drug, its degradation mechanism, the container in which it is packaged, the
expected storage conditions, and the intended duration of the therapy when assigning a beyond
use date.
Based on all of the evidence and testimony as laid out in this Order, including the above
mentioned concerning factors, Applicant's Application is denied.
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.
No comments:
Post a Comment