This chapter establishes standards for the imposition of disciplinary sanctions, monetary penalties, and civil fines for violations of Health Occupations Article, Title 12, Annotated Code of Maryland. In this chapter, the following terms have the meanings indicated. Terms Defined. “Act” means Health Occupations Article, Title 12, Annotated Code of Maryland. “Board” means the State Board of Pharmacy. “Civil fine” means a fine assessed by the Board against a person for practicing without an active license, pharmacy permit, registration, or wholesale distributor permit. “License” means, unless the context requires otherwise, a license issued by the Board to practice pharmacy. “Penalty” means monetary penalty. “Pharmacy permit” means a permit issued by the Board to establish and operate a pharmacy. “Registration” means, unless the context requires otherwise, a registration issued by the Board to practice pharmacy as a registered pharmacy intern under the direct supervision of a licensed pharmacist or perform delegated pharmacy acts as a registered pharmacy technician under the direct supervision of a licensed pharmacist. “Sanction” means a disciplinary action reprimanding, restricting, suspending, or revoking a license, pharmacy permit, registration, or wholesale distributor permit. “Wholesale distributor permit” means a permit issued by the Board to establish and operate a wholesale distributor as defined in the Health Occupations Article, §12-6C-01(v), Annotated Code of Maryland. After a hearing pursuant to Health Occupations Article, §12-315, 12-601, 12-6B-09, or 12-6D-11, Annotated Code of Maryland, the Board may impose a penalty against a pharmacy technician, pharmacy intern, pharmacist, or wholesale distributor permit holder pursuant to Health Occupations Article, §12-314, 12-6B-10, 12-6C-11, or 12-6D-12, Annotated Code of Maryland, instead of or in addition to: Reprimanding the registrant, licensee, or wholesale distributor permit holder; Placing the registrant, licensee, or wholesale distributor permit holder on probation; Suspending a registration, license, or wholesale distributor permit; or Revoking a registration, license, or wholesale distributor permit. After a hearing pursuant to Health Occupations Article, §12-411, Annotated Code of Maryland, the Board may impose a penalty against a pharmacy permit holder pursuant to Health Occupations Article, §12-410, Annotated Code of Maryland: Instead of or in addition to suspending the pharmacy permit; or In addition to revoking the pharmacy permit. Notwithstanding the guidelines set forth in this chapter, in order to resolve a pending disciplinary action, the Board and the registrant, licensee, pharmacy permit holder, or wholesale distributor permit holder may agree to a surrender of a registration, license, pharmacy permit, or wholesale distributor permit or a consent order with terms, sanction, and penalty agreed to by the Board and the registrant, licensee, pharmacy permit holder, or wholesale distributor permit holder. Nothing in this chapter prohibits the Board from staying any period of nonactive suspension. Subject to the provisions of this chapter, the Board may impose the following sanctions and, if appropriate, penalties for violations of the Act and its regulations according to the minimum and maximum sanctions and penalties set forth in the following categories: If a registrant is found in violation of more than one category enumerated in this regulation, the category or categories containing the highest maximum sanction and penalty shall control. A departure from the guidelines set forth in this regulation, on its own, is not grounds for any hearing or appeal of a Board action. Subject to the provisions of this chapter, the Board may impose the following sanctions and, if appropriate, penalties for violations of the Act and its regulations according to the minimum and maximum sanctions and penalties set forth in the following categories: If a licensee is found in violation of more than one category enumerated in this regulation, the category or categories containing the highest maximum sanction and penalty shall control. A departure from the guidelines set forth in this regulation, on its own, is not grounds for any hearing or appeal of a Board action. The Board may not consider a petition for reinstatement of a license that has been revoked until at least 5 years have passed from the date of revocation. Subject to the provisions of this chapter, the Board may impose the following sanctions and, if appropriate, penalties for violations of the Act and its regulations according to the minimum and maximum sanctions and penalties set forth in the following categories: If a registrant is found in violation of more than one category enumerated in this regulation, the category or categories containing the highest maximum sanction and penalty shall control. A departure from the guidelines set forth in this regulation, on its own, is not grounds for any hearing or appeal of a Board action. The Board may not consider a petition for reinstatement of a registration that has been revoked until at least 5 years have passed from the date of revocation. Subject to the provisions of this chapter, the Board may impose the following sanctions and, if appropriate, penalties for violations of the Act and its regulations according to the minimum and maximum sanctions and penalties set forth in the following categories: If a pharmacy permit holder is found in violation of more than one category enumerated in this regulation, the category or categories containing the highest maximum sanction and penalty shall control. A departure from the guidelines set forth in this regulation, on its own, is not grounds for any hearing or appeal of a Board action. The Board may not consider a petition for reinstatement of a pharmacy permit that has been revoked until at least 5 years have passed from the date of revocation. Subject to the provisions of this chapter, the Board may impose the following sanctions and, if appropriate, penalties for violations of the Act and its regulations according to the minimum and maximum sanctions and penalties set forth in the following categories: If a wholesale distributor permit holder is found in violation of more than one category enumerated in this regulation, the category or categories containing the highest maximum sanction and penalty shall control. A departure from the guidelines set forth in this regulation, on its own, is not grounds for any hearing or appeal of a Board action. The Board may not consider a petition for reinstatement of a wholesale distributor permit that has been revoked until at least 5 years have passed from the date of revocation. Depending upon the facts and circumstances of each case, and to the extent that they apply, the Board may consider the following mitigating and aggravating factors in determining whether the sanction in a particular case should fall outside the range of sanctions established by the guidelines. These factors may include, but are not limited to, the following: Mitigating Factors: The licensee’s, registrant’s, or permit holder’s lack of a prior disciplinary record; The licensee, registrant, or permit holder self-reported the violation to the Board; The licensee’s, registrant’s, or permit holder’s full and voluntary admission of misconduct to the Board and cooperation during Board proceedings; The licensee, registrant, or permit holder implemented remedial measures to correct or mitigate harm arising from the misconduct; The licensee, registrant, or permit holder made a timely good-faith effort to make restitution or to rectify the consequences of the misconduct; Evidence of rehabilitation or rehabilitative potential; Absence of premeditation to commit the misconduct; Absence of potential harm to public or adverse impact; and The licensee’s, registrant’s, or permit holder’s conduct was an isolated incident and not likely to recur; and Aggravating Factors: The licensee, registrant, or permit holder has a previous criminal or administrative disciplinary history; The violation was committed deliberately or with gross negligence or recklessness; The violation had the potential for, or caused, serious patient harm; The violation was part of a pattern of detrimental conduct; The licensee, registrant, or permit holder was motivated to perform the violation for financial gain; The vulnerability of the patient or customer; The licensee, registrant, or permit holder attempted to hide error or misconduct from patients or others; Previous attempts at rehabilitation of the licensee, registrant, or permit holder were unsuccessful; and The licensee, registrant, or permit holder committed the violation under the guise of treatment. The existence of one or more of these factors does not impose on the Board or an Administrative Law Judge any requirement to articulate its reasoning for not exercising its discretion to impose a sanction outside of the range of sanctions set forth in this chapter. Nothing in this regulation requires the Board or an Administrative Law Judge to make findings of fact with respect to any of these factors. Practicing on an Expired License. The Board may assess a civil fine against a pharmacist who practices on an expired license in the amount of $1,000 per month of practice past the expiration date of the license, up to a maximum fine of $50,000. Working on an Expired Registration. The Board may assess a civil fine against a pharmacy technician or pharmacy intern who works on an expired registration in the amount of $25 per month of practice past the expiration date of the registration, up to a maximum fine of $250. Operating a Pharmacy on an Expired Permit. The Board may assess a civil fine against a permit holder that operates a pharmacy on an expired permit in the amount of $5,000 per month of operation past the expiration date of the permit, up to a maximum fine of $50,000. Practicing or Operating Without a License, Registration, or Pharmacy Permit. The Board may assess a civil fine of no less than $5,000 and no more than $50,000 against: An individual who practices pharmacy without a license; or An individual or entity that operates a pharmacy without a permit. The Board may assess a civil fine of no less than $250 and no more than $50,000 against an individual who works as an unregistered pharmacy technician or unregistered pharmacy intern. Factors in determining the amount of a fine include, but are not limited to, the following: The extent to which the individual or entity derived any financial benefit from the unauthorized practice or operation; The willfulness of the unauthorized practice or operation; Actual or potential public harm caused by the unauthorized practice or operation; and The length of time in which the individual or entity engaged in the unauthorized practice or operation. Operating on an Expired Wholesale Distributor Permit. The Board may assess a civil fine against a permit holder that operates on an expired wholesale distributor permit in the following amount: A maximum of $10,000 per month of operation past the expiration date of the permit, if the annual gross receipts in Maryland of the permit holder for the previous tax year were less than $10,000,000, up to a maximum fine of $500,000; or A maximum of $25,000 per month of operation past the expiration date of the permit, if the annual gross receipts in Maryland of the permit holder for the previous tax year were $10,000,000 or more, up to a maximum fine of $500,000. Practicing Without a License. The Board may assess a civil fine of no less than $10,000 and no more than $500,000 against an individual or entity that operates a wholesale distributor without a license. Factors in determining the amount of a fine include, but are not limited to, the following: The size of the wholesale distributor; The gravity of the violation for which the fine is to be imposed; The good faith of the wholesale distributor; Any previous violations by the wholesale distributor; Actual or potential public harm caused by the unauthorized operation; and The length of time in which the entity engaged in the unauthorized operation. A licensee, registrant, or permit holder shall pay to the Board a penalty imposed under this chapter within 30 days of the date the Board's order is issued, unless the Board's order specifies otherwise. Filing an appeal under State Government Article, §10-222, Annotated Code of Maryland, or Health Occupations Article, §12-316, 12-412, or 12-601, Annotated Code of Maryland, does not automatically stay payment of a penalty imposed by the Board pursuant to this chapter. If a licensee, registrant, or permit holder fails to pay, in whole or in part, a penalty imposed by the Board pursuant to this chapter, the Board may not restore, reinstate, or renew a license, registration, or permit until the penalty has been paid in full. In its discretion, the Board may refer cases of delinquent payment to the Central Collection Unit of the Department of Budget and Management to institute and maintain proceedings to ensure prompt payment. Deposit of Monies. The Board shall pay monies collected pursuant to this chapter, except for civil fines collected under Regulation .09 of this chapter, into the State's General Fund. Civil Fines. The Board shall pay civil fines collected under Regulation .09 of this chapter into the State Board of Pharmacy Fund, in accordance with Health Occupations Article, §12-707(e)(2), Annotated Code of Maryland. The Board shall pay civil fines collected under Regulation .10 of this chapter into the State’s General Fund. Health Occupations Article, §§1-606, 12-313, 12-314, 12-409, 12-410, 12-601, 12-6B-09, 12-6B-10, 12-6C-11, 12-6D-11, 12-6D-12, and 12-707, Annotated Code of Maryland Effective date: June 4, 1984 (11:11 Md. R. 962) Regulation .01 amended effective January 20, 2003 (30:1 Md. R. 25); January 28, 2008 (35:2 Md. R. 127) Regulation .02 amended effective January 28, 2008 (35:2 Md. R. 127) Regulation .03 amended effective February 19, 1990 (17:3 Md. R. 299); January 20, 2003 (30:1 Md. R. 25) Regulation .03A amended effective January 28, 2008 (35:2 Md. R. 127) Regulation .04 amended effective January 20, 2003 (30:1 Md. R. 25) Regulation .04-1 adopted effective January 28, 2008 (35:2 Md. R. 127) Regulation .05 amended effective January 20, 2003 (30:1 Md. R. 25) Regulation .06 amended effective January 28, 2008 (35:2 Md. R. 127) Regulation .06C, D amended and .06E, F adopted effective January 20, 2003 (30:1 Md. R. 25) Regulation .07B amended effective February 19, 1990 (17:3 Md. R. 299) Regulation .07B, D amended effective January 20, 2003 (30:1 Md. R. 25) Regulation .07C amended effective January 28, 2008 (35:2 Md. R. 127) Regulations .01—.07 repealed and new Regulations .01—.11 adopted effective December 24, 2012 (39:25 Md. R. 1613) Regulation .02B amended effective July 1, 2015 (42:7 Md. R. 569) Regulation .03A amended effective July 1, 2015 (42:7 Md. R. 569) Regulation .04A amended effective July 1, 2015 (42:7 Md. R. 569) Regulation .04-1 adopted effective July 1, 2015 (42:7 Md. R. 569) Regulation .09B, D amended effective July 1, 2015 (42:7 Md. R. 569)