Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.22 - Licensing of Wholesale Prescription Drug or Device Distributors › Section 10.34.22.05 - Violations and Penalties

Current through Register Vol. 51, No. 14, July 12, 2024
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.