Md. Code Regs. 10.34.22.05

Current through Register Vol. 51, No. 22, November 1, 2024

Section 10.34.22.05 - Violations and Penalties

A. After a hearing held under Health Occupations Article, §12-601, Annotated Code of Maryland, the Board may deny, suspend, revoke, or place on probation a permit holder, reprimand a permit holder, or impose a fine if the permit holder:

(1) Is convicted of, or pleads guilty or nolo contendere to, violations of federal, State, or local drug or device laws or regulations;

(2) Is convicted of, or pleads guilty or nolo contendere to, a felony or to a crime involving moral turpitude, whether or not any appeal or other proceeding is pending to have the conviction or plea set aside;

(3) Commits any of the following acts:

(a) Obtains or attempts to obtain a permit by:

(i) Providing false information to the Board; or

(ii) Other fraudulent or deceptive means;

(b) Fails to:

(i) Establish or maintain inventories, records, or written policies and procedures as required by Regulation .07 of this chapter;

(ii) Register with the Maryland Division of Drug Control, and with the U.S. Drug Enforcement Agency, as required by Regulation .07D of this chapter; or

(iii) Permit the Board, the Maryland Division of Drug Control, the U.S. Drug Enforcement Agency, or other authorized federal, State, or local law enforcement officials showing proper identification, to enter, inspect, copy records, or audit as required by Regulation .07D of this chapter;

(c) Willfully makes or maintains false inventories or records;

(d) Violates a provision of, or regulation promulgated under, Health Occupations Article, Title 12, Annotated Code of Maryland;

(e) Manufactures, repackages, sells, delivers, or holds or offers for sale any prescription drug or device that is adulterated, misbranded, counterfeit, suspected of being counterfeit, or has otherwise been rendered unfit for distribution or wholesale distribution;

(f) Adulterates, misbrands, or counterfeits prescription drugs or devices;

(g) Receives prescription drugs or devices that are adulterated, misbranded, stolen, obtained by fraud or deceit, counterfeit, or suspected of being counterfeit, or delivers or proffers delivery of such prescription drug or device for pay or otherwise;

(h) Alters, mutilates, destroys, obliterates, or removes the whole or any part of the product labeling of a prescription drug or device, or commits any other act with respect to a prescription drug or device that results in the prescription drug or device being misbranded;

(i) Forges, counterfeits, simulates, or falsely represents prescription drugs or devices without the authority of the manufacturer, or uses any mark, stamp, tag, label, or other identification device without the authorization of the manufacturer;

(j) Purchases or receives a prescription drug or device from a person who is not licensed to wholesale distribute prescription drugs or devices to that purchaser or recipient;

(k) Sells or transfers a prescription drug or device to a person who is not legally authorized to receive a prescription drug or device;

(l) Provides the Board, its representatives, or federal or State officials with false or fraudulent records, or makes false or fraudulent statements regarding any matter within the provisions of these regulations;

(m) Wholesale distributes prescription drugs or devices that were:

(i) Purchased by a public or private hospital, or other health care entity;

(ii) Donated or supplied at a reduced price to a charitable organization;

(iii) Stolen or obtained by fraud or deceit; or

(iv) Donated to a drop-off site or repository under the Prescription Drug Repository Program set forth in Health-General Article, Title 15, Subtitle 6, Annotated Code of Maryland;

(n) Fails to obtain a license, or operates without a valid license when a license is required;

(o) Obtains, or attempts to obtain, a prescription drug or device by fraud, deceit, misrepresentation, or engages in misrepresentation or fraud in the distribution or wholesale distribution of a prescription drug or device;

(p) Distributes a prescription drug or device to a consumer or patient ;

(q) Fails to obtain, authenticate, or pass on a pedigree when required under these regulations;

(r) Receives a prescription drug pursuant to a wholesale distribution without first receiving a pedigree, when required, that was attested to as accurate and complete by the wholesale distributor;

(s) Distributes or wholesale distributes a prescription drug or device that was previously dispensed by a pharmacy or distributed by a practitioner;

(t) Fails to report prohibited acts as listed in these regulations;

(u) Fails to exercise due diligence as provided in Regulation .08 of this chapter;

(v) Otherwise conducts the wholesale distribution of prescription drugs or devices in a manner not in accordance with the law;

(w) Accepts payment or credit for the sale of prescription drugs in violation of Health Occupations Article, § 12-6 C-09(d), Annotated Code of Maryland; or

(x) If the requirements of Health Occupations Article, § 12-6 C-09(a), Annotated Code of Maryland, are applicable and are not met, the purchasing or otherwise receiving a prescription drug from a pharmacy; or

(4) Is disciplined by a licensing or disciplinary authority of any state or country, or disciplined by a court of any state or country, for an act that would constitute a ground for Board action against a wholesale distributor permit holder under §A or B of this regulation.

B. Acts prohibited under this regulation do not include a prescription drug manufacturer, or agent of a prescription drug manufacturer, obtaining or attempting to obtain a prescription drug for the sole purpose of testing the prescription drug for authenticity.

Md. Code Regs. 10.34.22.05

Regulations .05 adopted effective March 28, 2005 (32:6 Md. R. 636)
Regulations .05 adopted effective April 7, 2008 (35:7 Md. R. 748)
Regulations .05, adopted effective 41:10 Md. R. 561, eff.7/1/2014