Tuesday, September 3, 2013

Report from SC Board of Pharmacy Shows TX {partially) inspected Nuvision 2011. Nuvision also claims to have a third party who inspects them. Really?


SOUTH CAROLINA DEPARTMENT OF LABOR, LICENSING AND REGULATION

BEFORE THE BOARD OF PHARMACY

In the Matter of:
Nu Vision Phannacy,
FINAL ORDER
Applicant.
This matter came before the Board ofPhannacy("Board"), as  a result of the Nonresident
Permit  Subcommittee's  Recommendation.  Applicant  was  duly  noticed  to  appear  at  this
subcommittee meeting for an application hearing by letter.  The Applicant did not appear at the final
application hearing. .
Permit applications ofthis type are governed by S.C. Code Sections 40-43-86, 40-43-89, and
Reg. 99-43, as amended
----.
FINDINGS OF FACT
1. Applicant is located in Dallas, Texas. Applicant~s proposed phannacist-in-charge is Kristi
Kubosh.  She appeared on behalf ofthe Applicant.
2. Applicant applied on January 3,2012 for a nonresident phannacy permit.
3. Applicant  mostly  makes  nutrients  and  creams,  and  some  controlled  substances  with
testosterone injectables.  Applicant mostly does sterile compounding, with some non-sterile
compounding.  Applicant testified that the facility began sterile compounding in August or
September of2012.
4. Applicant last Texas inspection was in Apri12011 (partial inspection).  Applicant testified
that Texas does inspections approximately every 3 years.  Applicant is not sure why the last
inspection  was  partial.  In 2011,  the facility ,was  building  a  clean room  and  becoming
certified.
5. Applicant has a third-party that inspects the sterile facility.
6. Applicant has not shipped products or preparations into South Carolina previously.
7. Applicant markets at trade shows, and gets business through referrals.  Most ofApplicant's
preparations are specialty compounds.
I 8. Applicant is licensed in multiple other states.
9. Applicant has a 3: 1 ratio oftechnicians and phannacists.  The six technicians employed are
Texan certified.
CONCLUSIONS OF LAW
In an application hearingt
"(t)he applicant shall demonstrate to the satisfaction ofthe board
that the applicant meets all requirements for the issuance ofa license." S.C. Code Ann. §40.1-130
(1976, as amended). Thus
t
the burden ofproofin 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.
Pursuant to S.C. Code Ann. § 40-43-140, the Board may suspend, revoke, deny, or refuse to
renew the permit or impose disciplinary action authorized for violations ofthis chapter.
NOW,  THEREFORE,  BASED  ON  THE  RECOMMENDATION  OF  THE
SUBCOMMITTEE",IT..IS.ORDERED, A1)JUDGED,AND DECREED that:
The Applicant meets the qualifications as set out by law, and is approved for a non-resident
pharmacy permit, pending a successful inspection by the Texas Board ofPhannacy on the sterile
portion ofthe facility.
AND IT IS SO ORDERED.
South Carolina Board of Pharmacy
Date: March 29. 2013
found here http://www.llr.state.sc.us/POL/FinalOrders/Pharmacy/pdf/NuVision%20Pharmacy%203-2013.pdf

No comments: