Missouri Board of Pharmacy Disciplining Those Who Violate Compounding Rules and Regulations

Missouri Board of Pharmacy appears to be aggressive against pharmacies and pharmacists who violate the rules relating to compounding drugs.  Here are a few examples:

Dennis L. Stockstill, #028884 – Richland, MO – August 22, 2011.
Probation for three (3) years. As pharmacist-in-charge, pharmacy
personnel compounded without proper licensure, equipment, or
environment; dispensed compounded substances with expired
ingredients and in batches that exceeded their beyond-use date;
maintained deficient compounding logs; misbranded and adulterated
compounded products; failed to issue a recall of misbranded
drugs; failed to supervise personnel to ensure compliance with
laws/regulations. Section 338.055.2(5), (6), (13), and (15), RSMo


Erin E. Thomas, #2005011039 – St Louis, MO – September 22,
2011. Probation for two (2) years to begin January 1, 2012. Use
of unlicensed facility to prepare sterile compounds; misbranded,
outdated, and inappropriately maintained drugs; compounded
commercially available products; dispensed sterile products without
documented prescriber authorization prior to end-product testing;
failed to validate beyond-use dates; compounded without a prescription.
Section 338.055.2(6) and (13), RSMo


Franck’s Compounding Pharmacy, #2005007704 – Ocala, FL
– September 9, 2011. Probation for three (3) years. Disciplinary
action in another state involving compounding of a solution with
incorrect measure of sodium selenite; operated without a license;
and improper labeling. Section 338.055.2(8), RSMo.

M D Pharmacy, Inc, #002337 – St Louis, MO – September 28, 2011.
Probation for three (3) years. Received drugs from non-wholesale,
unlicensed drug distributors; misbranding by overfilling stock
bottles; compounded prescriptions not logged; failed to maintain
hard copies of controlled substance prescriptions; failed to complete
 CII order forms; filled prescriptions for another pharmacy
without a Class J license; record keeping violations; drug security
violations; technician allowed to work and dispense without a
pharmacist on duty, and counsel patients; and allowed live animal
in pharmacy. Section 338.055.2(5), (6), (10), (13), and (15), RSMo.

Specialty Pharmacy of St Louis, LLC, #2003001140 – St Louis,
MO – September 22, 2011. Probation for three (3) years to begin
January 1, 2012. Compounded other than pursuant to individual
patient prescription; use of unlicensed facility to prepare sterile
compounds; misbranded, outdated, and inappropriately maintained
drugs; compounded commercially available products; dispensed
sterile products without documented prescriber authorization
prior to end-product testing; failed to validate beyond-use dates;
compounded without a prescription. Section 338.055.2(6) and
(13), RSMo

Lee E. Ori, #2000148445 – Des Peres, MO – September 22, 2011.
Probation for three (3) years to begin January 1, 2012. While
pharmacist-in-charge, compounded other than pursuant to an
individual patient prescription; use of unlicensed facility to prepare
sterile compounds; misbranded, outdated, and inappropriately
maintained drugs; compounded commercially available products;
dispensed sterile products without documented prescriber authorization
prior to end-product testing; failed to validate beyond-use
dates; compounded without a prescription. Section 338.055.2(6)
and (13), RSMo.

James A. Cordes, #028128 – Des Peres, MO – December 2, 2011.
Probation for two (2) years. As pharmacist-in-charge, misbranding,
compounded prescriptions not logged, prescriptions filled for
another pharmacy without a Class J permit, failure to keep complete
acquisition/purchase/distribution records, technician allowed to
work unsupervised and allowed to dispense prescriptions without
a pharmacist on duty, and failed to supervise personnel to ensure
compliance with laws/regulations. Section 338.055.2(5), (6), (13),
and (15). RSMo.

William R. Buntin, #027483 – Moberly, MO – June 10, 2012.
Suspended for three (3) months followed by probation for
five (5) years. While pharmacist-in-charge, violation of discipline
involving outdated drugs in pharmacy, incomplete
controlled substance inventory, failure to timely respond
to inspection compliance notice, compounding log and
product label did not contain active/therapeutic ingredients,
expired license displayed, sold pseudoephedrine products
without a current Methamphetamine Epidemic Self-Certification,
failed to maintain updated electronic record of
controlled substance shipments. Section 338.055.2(5), (6),
(13), and (15), RSMo


Buntins Pharmacy, #003884 – Moberly, MO – March 15,
2012. Probation for five (5) years. Violation of discipline
involving outdated drugs in pharmacy, controlled substance
not included in controlled substance inventory, failure to
timely respond to inspection compliance notice, compounding
log and product label did not contain active/therapeutic
ingredients for a compounded product, expired pharmacist
license displayed, sold pseudoephedrine products without
a current Methamphetamine Epidemic Self-Certification,
failed to maintain updated electronic record of controlled
substance shipments. Section 338.055.2(5), (6), (13), and
(15), RSMo

Pharmacy Solutions, Inc, #2002005329 – St Louis,  MO –
February 22, 2012. Probation for one (1) year. Compounding
without a prescription, unable to substantiate representations
regarding compounded products, compounded
commercially available products, compounding for office
stock, release of risk level 3 products prior to end-product
test completion, failure to investigate test results, failure to
validate beyond-use dates beyond 30 days, and compounded
with products restricted by Food and Drug Administration
(FDA). Section 338.055.2(5), (6), (13), (14), and (15),
RSMo