Wednesday, May 7, 2014

SC Department of Labor, Licensing, and Regulation May 2014 Newsletter (Pharmacy) inlcudes update on DQSA and Common Violations on Pharmacy Inspections

Update on DQSA



The president signed the Drug Quality and Security Act (DQSA) into

law on November 27, 2013. At this time, the South Carolina Department

of Labor, Licensing, & Regulation – Board of Pharmacy has not issued

any opinions. However, the Board has been tracking this legislation

since its introduction and is thoughtfully considering its application in

relation to South Carolina pharmacy law.

Board representatives participated in the Inter-Governmental Working

Meeting on Oversight of Compounding Pharmacies at Food and

Drug Administration (FDA) in Silver Spring, MD, in March 2014. The

Board is gathering information and will be analyzing how this legislation

affects the practice of pharmacy in South Carolina. This will include the

consideration of a memorandum of agreement between South Carolina

and FDA. Please look on the Board’s website for upcoming meeting

dates of the Board’s Compounding Committee where the legislation

will be discussed. The work of the Compounding Committee will be

presented to the full Board

Common Violations on Pharmacy Inspections
 
 
 
♦ Expired drugs in active stock. §40-43-86(A)(16)(c)

♦ Unlabeled drugs in active stock. §40-43-86(A)(16)(c)

♦ Out of range refrigerator/freezer temperatures. §40-43-86(A)



(16)(d)
 
♦ All supplies and equipment required for administration of



influenza vaccine per state protocol must be in stock. Refer to
 
Appendix B of the protocol. §40-43-190
 
♦ Incomplete repackaging and automated counting device logs.



§40-43-86(I)(1)(b)
 
♦ Incomplete compounding logs and formulas. §40-43-86(CC)(6)

♦ Required documentation on prescription transfers. §40-43-



86(G



quoted from here


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