Tennessee Board of Pharmacy Approves 5 Million Dollar Civil Penalty from NECC and Former PIC

Board Approved Five Million Dollar Civil

Penalty from NECC and Former PIC

Nearly two years ago on October 15, 2012, after several

Tennessee patient illnesses and deaths were reported in conjunction

with sterile products compounded by an out-of-state

pharmacy, a consent order was executed for the voluntary

surrender of the Tennessee pharmacy license held by the New

England Compounding Center (NECC), located at 697 Waverly

Street, Framingham, MA. Also, Barry James Cadden, former

pharmacist-in-charge (PIC) and part owner of NECC, agreed

to the surrender of his Tennessee pharmacist license, which

was accepted and completed by the Board on October 23, 2012.

During the May 12, 2014 meeting, William West, legal counsel

for respondents Paul D. Moore, Chapter 11 Trustee of the Estate

of New England Compounding Pharmacy, Inc, dba New England

Compounding Pharmacy, Inc, and Cadden, agreed to a $5 million

civil penalty levied by the Tennessee Board of Pharmacy

on behalf of itself and the Division of Health Related Boards.

(Under the terms of the consent order, all victims’ claims

are to be settled before any assessments are collected by the

Board.) The civil penalty assessments included violations for

the following statutes and Board rules.

Tennessee Code Annotated:

♦♦63-1-134(a) Penalty for violation of statute, rule or order --

Recovery. (“. . . authorized by any board, commission or

agency attached to the division of health related boards,

each respective board, commission or agency may assess

a civil penalty against such person in an amount not to

exceed one thousand dollars ($1,000) for each separate

violation of a statute, rule. . .”)

♦♦63-10-305. Power of board to suspend, revoke, or refuse

to issue licenses -- Civil penalties.

♦♦63-1-144. Payment of costs of investigation and

prosecution.

Tennessee Board of Pharmacy Rules:

♦♦1140-01-08 Application for Pharmacy Practice Site,

Manufacturer and Wholesaler/Distributor Licenses.

♦♦1140-03-.08 Repackaging.

♦♦1140-03-.03 Medical and Prescription Orders.

♦♦1140-03-.14(8). Pharmacist-In-Charge. (Board notification

of termination of business)

♦♦1140-03-.14(14) Pharmacist-In-Charge. (PIC shall report

prescription order that caused serious personal injury or

death)

♦♦1140-03-.06 Labeling Requirements.

♦♦1140-07-.06 Labeling.

Upon this agreement, Cadden and the bankruptcy court agreed

that “Any and all licenses granted by the Board to NECC or Mr.

Cadden shall be deemed to be irrevocably voluntarily surrendered;

. . .” as stated in the executed consent order.
quoted from here