1.An aggrieved licensee may file a motion for rehearing in proper form, within 10 days, requesting reconsideration or a rehearing by the board or by the interlocutory hearing panel.
2.Grounds. The board or an interlocutory hearing panel may consider the motion for rehearing at the next regularly scheduled board meeting. The motion shall allege one or more of the following:
a.the board's decision was clearly contrary to the law or evidence;
b.newly discovered evidence not available at the time of the hearing which may be sufficient to reverse the board's decision;
c.issues not previously considered need to be examined; or
d.it is in the public interest to reconsider the issues and the evidence.
3.Time. The board or the hearing officer shall grant or deny the motion for rehearing within 30 days after its submission.
J.Judicial Review. An aggrieved licensee may appeal the board's decision to a court of competent jurisdiction within 30 days from the entry of the board order or the denial of the rehearing motion.
K.Cease and Desist Orders; Injunctive Relief
1.The board is empowered to issue an order to any person or facility engaged in any activity, conduct, or practice constituting a violation of the R.S. 40:972 et seq., or the regulations promulgated thereto, directing such person or facility to forthwith cease and desist from such activity, conduct, or practice.
2.If the person or facility to which the board directs a cease and desist order does not cease and desist the prohibited activity, conduct, or practice within the timeframe directed by said order, the board may seek, in any court of competent jurisdiction and proper venue, a writ of injunction enjoining such person or facility from engaging in such activity, conduct, or practice.
3.Upon proper showing of the board such person or facility has engaged in the prohibited activity, conduct, or practice, the court shall issue a temporary restraining order prohibiting the person or facility from engaging in the activity, conduct, or practices complained of, pending the hearing on a preliminary injunction, and in due course a permanent injunction shall be issued after a contradictory hearing, commanding the cessation of the finally determined unlawful activity, conduct, or practices identified in the complaint.
L.Reinstatement or Re-issuance of CDS License.
1.At any time after the suspension or revocation of a CDS license by the board, the board may reinstate the license, but only at an official meeting of the board, after written notice, and by vote of an affirmative majority of the members of the board present and voting. In the event a license is reinstated or reissued following previously applied sanctions relative to a violation of this Chapter, said reinstatement or re-issuance shall have affixed thereto an attachment or addendum, specifically setting forth any restrictions placed upon said reinstated or reissued license by the board.
2.In case of reinstatement, the reinstated licensee shall pay all applicable costs or fines, or both, and a reinstatement fee as provided for in the board’s fee schedule established pursuant to R.S. 37:1184 and 40:972.
M.Surrender of License
1.Any person or facility holding a valid CDS license which ceases to engage in activity requiring a CDS license shall surrender said license to the board upon termination of this activity.
2.Upon the surrender of said license, the person or facility shall forward all controlled substances and any unused order forms in his possession or under his control to the United State Drug Enforcement Administration as provided by federal laws and regulations.
3.In the event a person or facility surrenders his DEA Registration to the DEA, then the person or facility shall surrender his CDS license immediately to the board.
4.The acceptance of the voluntary surrender of a CDS license by the board shall result in the automatic suspension of the CDS license for an indefinite period of time.
AUTHORITY NOTE:Promulgated in accordance with R.S. 40:972.
HISTORICAL NOTE:Promulgated by the Department of Health and Hospitals, Board of Pharmacy, LR 34:2132 (October 2008).
Subchapter C.Security Requirements
A.A licensee shall provide effective controls and procedures to guard against theft or diversion of controlled substances. In evaluating the overall security system of a licensee or applicant, the board may consider any of the following factors:
1.the type of activity conducted (e.g., processing of bulk chemicals, preparing dosage forms, packaging, labeling, cooperative buying, etc.);
2.the type and form of controlled substances handled (e.g., bulk liquids or dosage units, usable powders or nonusable powders);
3.the quantity of controlled substances handled;
4.the physical location of the premises;
5.the type of building construction comprising the facility and the general characteristics of the building(s);
6.the type of vault, safe, and secure enclosures or other storage system(s) used;
7.the adequacy of key control systems, combination lock control systems, or both;
8.the adequacy of electric detection and alarm systems, if any, including use of supervised transmittal lines and standby power sources;
9.the extent of unsupervised public and visitor access to the facility including maintenance personnel and non-employee service personnel;
10.the adequacy of supervision of employee access;
11.local police protection or security personnel;
12.the adequacy for monitoring the receipt, manufacture, distribution, procurement, and disposition of controlled substances; and
13.the applicability of the security requirements contained in all federal, state, and local laws and regulations governing the management of waste.
Louisiana Register Vol. 34, No. 10 October 20, 2008