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 10.34.22.02 - Definitions

Current through Register Vol. 51, No. 14, July 12, 2024
A. In this chapter,
				  the following terms have the meanings indicated.
B. Terms Defined.
(1) ANDA" means an Abbreviated New Drug
				  Application number and contains data that, when submitted to the U.S. Food and
				  Drug Administration's (FDA) Center for Drug Evaluation and Research, Office of
				  Generic Drugs, provides for the review and ultimate approval of a generic drug
				  product.
(1-1) "Authenticate" means to affirmatively verify, before
					 any wholesale distribution of a prescription drug occurs, that each transaction
					 listed on the pedigree for the prescription drug has occurred.
(2) "Authorized distributor of
				  record" means a wholesale distributor with whom a manufacturer has established
				  an ongoing relationship to distribute the manufacturer's prescription
				  drug.
(3) "Blood" means whole blood
				  collected from a single donor and processed either for transfusion or further
				  manufacturing.
(4) "Blood
				  component" means that part of blood separated by physical or mechanical
				  means.
(5) "Board" means the State
				  Board of Pharmacy.
(5-2) "Central repository" means the Criminal Justice
					 Information System Central Repository of the Department of Public Safety and
					 Correctional Services
(5-1)
				  "Cease to operate" means the date on which the last prescription
				  drug or prescription device is distributed by the permit holder.
(6) "Co-licensed partner" means a person in a
				  relationship in which two or more persons have the right to engage in the
				  manufacturing or marketing of a prescription drug, consistent with the U.S.
				  Food and Drug Administration's implementation of the Federal Prescription Drug
				  Marketing Act.
(7) "DEA" means the
				  U. S. Drug Enforcement Administration.
(8) "Designated representative" means an
				  individual who:
(a) Is designated by the
				  wholesale distributor;
(b) Serves
				  as the primary contact of the wholesale distributor with the Board;
				  and
(c) Is actively involved in,
				  and aware of, the daily operation of the wholesale distributor.
(8-1) "Designee" means a Board contracted or Board
					 recognized entity.
(9) "Drop shipment" means the sale of a
				  prescription drug:
(a) To a wholesale
				  distributor by:
(i) The manufacturer of the
				  prescription drug; or
(ii) The
				  manufacturer's co-licensed partner, third-party logistics provider, or
				  manufacturer's exclusive distributor; and
(b) Through which:
(i) The wholesale distributor or a pharmacy
				  warehouse takes title to, but not physical possession of, the prescription
				  drug;
(ii) The wholesale
				  distributor invoices the pharmacy, pharmacy warehouse, or other person
				  authorized by law to dispense or administer the prescription drug to a patient;
				  and
(iii) The pharmacy, pharmacy
				  warehouse, or other authorized person receives delivery of the prescription
				  drug directly from the manufacturer, the manufacturer's third-party logistics
				  provider, or the manufacturer's exclusive distributor.
(10) "FDA" means the U. S. Food
				  and Drug Administration.
(11)
				  "Gross receipts" means gross receipts from sales of prescription drugs and
				  devices in the State.
(12) Health
				  Care Entity.
(a) "Health care entity" means a
				  person that provides diagnostic, medical, surgical, or dental treatment, or
				  chronic or rehabilitative care.
(b)
				  "Health care entity" does not include a community pharmacy or a wholesale
				  distributor.
(c) "Health care
				  entity" may not simultaneously be a health care entity and a community pharmacy
				  or wholesale distributor.
(12-1) "Intracompany sales" means a:
(a) Transaction or transfer of prescription
				  drugs between a division, subsidiary, parent, or affiliated or related company
				  under common ownership and control of a corporate entity, other than a
				  transaction or transfer of prescription drugs from a pharmacy to a wholesale
				  distributor; or
(b) Transaction or
				  transfer of a co-licensed product between co-licensed partners.
(13) "Manufacturer"
				  means a person licensed or approved by the U.S. Food and Drug Administration to
				  engage in the manufacture of prescription drugs or prescription devices,
				  consistent with the definition of "Manufacturer" under the U.S. Food and Drug
				  Administration's regulations and guidelines implementing the Prescription Drug
				  Marketing Act.
(14) "Manufacturer's
				  exclusive distributor" means a person who:
(a)
				  Contracts with a manufacturer to provide or coordinate warehousing,
				  distribution, or other services on behalf of the manufacturer; and
(b) Takes title to the manufacturer's
				  prescription drug, but does not have general responsibility to direct the sale
				  or disposition of the manufacturer's prescription drug.
(14-1) "NDA" means a New Drug Application number assigned
					 by the FDA for drugs formally proposed to the FDA as a new pharmaceutical for
					 sale and marketing in the U.S.
(15) "Normal distribution channel" means a
				  chain of custody for a prescription drug that, directly or by drop shipment,
				  goes:
(a) From:
(i) A manufacturer of the prescription drug;
				  or
(ii) The manufacturer's
				  co-licensed partner, third-party logistics provider, or manufacturer's
				  exclusive distributor; and
(b) To:
(i)
				  A pharmacy or other designated person authorized by law to dispense or
				  administer the prescription drug to a patient;
(ii) A wholesale distributor to a pharmacy or
				  other designated person authorized by law to dispense or administer the
				  prescription drug to a patient;
(iii) A wholesale distributor to a pharmacy
				  warehouse to the pharmacy warehouse's intracompany pharmacy or other designated
				  person authorized by law to dispense or administer the prescription drug to a
				  patient;
(iv) A pharmacy warehouse
				  to the pharmacy warehouse's intracompany pharmacy, or other designated person
				  authorized by law to dispense or administer the prescription drug to a patient;
				  or
(v) An authorized distributor of
				  record to another authorized distributor of record solely for distribution to
				  an office-based health care practitioner authorized by law to dispense or
				  administer the prescription drug to a patient.
(16) "Pedigree" means a document or
				  electronic file containing information that records each wholesale distribution
				  of a prescription drug.
(16-1) "Pharmacy" means a pharmacy that has been issued a:
(a) Waiver pharmacy permit in
				  accordance with COMAR 10.34.17; or
(b) Full service pharmacy permit
(17) "Prescription device" means
				  any device required by federal law or regulation to be dispensed only by a
				  prescription.
(18) Prescription
				  Drug.
(a) "Prescription drug" means any drug
				  required by federal law or regulation to be dispensed only by a
				  prescription.
(b) "Prescription
				  drug" includes:
(i) A biological product;
				  and
(ii) Finished dosage forms and
				  bulk drug substances subject to § 503(b) of the Federal Food, Drug and
				  Cosmetic Act.
(c)
				  "Prescription drug" does not include blood and blood components intended for
				  transfusion or biological products that are also medical devices.
(18-1) "Reinstatement" means renewal of a wholesale
					 distributor permit after the permit has expired.
(18-2) "Renewal" means renewing a wholesale distributor
					 permit before the date of expiration.
(19) Repackage.
(a) "Repackage" means to repackage or
				  otherwise change the container, wrapper, or labeling of a prescription drug to
				  further the distribution of the prescription drug.
(b) "Repackage" does not include changes to a
				  container, wrapper, or labeling of a prescription drug completed by the
				  pharmacist responsible for dispensing the prescription drug to a
				  patient.
(20)
				  "Repackager" means a person who repackages prescription drugs.
(21) "Third-party logistics provider" means a
				  person who:
(a) Contracts with a manufacturer
				  to provide or coordinate warehousing, distribution, or other services on behalf
				  of the manufacturer; and
(b) Does
				  not take title to the prescription drug, or have general responsibility to
				  direct the prescription drug's sale or disposition.
(21-1) "UDI" means a Unique Device Identification number
					 that is created through a globally accepted device identification and coding
					 standard that allows the unambiguous identification of a specific medical
					 device.
(21-2) Virtual Manufacturer.
(a) "Virtual Manufacturer" means an entity
				  that engages in the manufacture of drug or device products for which it:
(i) Owns the NDA or ANDA number, if a
				  prescription drug;
(ii) Owns the
				  UDI number, as available, for a prescription device;
(iii) Contracts with a contract manufacturing
				  organization for the physical manufacture of the drug or device product;
(iv) Is not involved in the
				  physical manufacture of the drug or device product; and
(v) At no time takes physical possession of,
				  or stores, the drug or device product.
(b) "Virtual Manufacturer" may include
				  entities that are identified as a broker, own-label distributor, sponsor
				  manufacturer, private-label manufacturer, or contract manufacturer.
(22) Wholesale
				  Distribution.
(a) "Wholesale distribution"
				  means the distribution of prescription drugs or prescription devices to persons
				  other than a consumer or patient.
(b) "Wholesale distribution" does not
				  include:
(i) Intracompany sales;
(ii) The sale, purchase, distribution, trade,
				  or transfer of a prescription drug or an offer to sell, purchase, distribute,
				  trade, or transfer a prescription drug for emergency medical reasons which
				  include transfers of prescription drugs or devices by a retail pharmacy to
				  another retail pharmacy to alleviate a temporary shortage;
(iii) The distribution of samples of a
				  prescription drug by a manufacturer's representative;
(iv) Prescription drug returns conducted by a
				  hospital, health care entity, or charitable institution in accordance with
				  21 CFR §
														203.23, as amended;
(v) The sale of minimal quantities of
				  prescription drugs by retail pharmacies to licensed health care practitioners
				  for office use;
(vi) The sale,
				  purchase, or trade of a prescription drug, an offer to sell, purchase, or trade
				  a prescription drug, or the dispensing of a prescription drug in accordance
				  with a prescription;
(vii) The
				  sale, transfer, merger, or consolidation of all or part of the business of a
				  pharmacy to or with another pharmacy, whether accomplished as a purchase and
				  sale of stock or business assets;
(viii) The sale, purchase, distribution,
				  trade, or transfer of a prescription drug from one authorized distributor of
				  record to one additional authorized distributor of record, if the manufacturer
				  has stated in writing to the receiving authorized distributor of record that
				  the manufacturer is unable to supply the prescription drug, and the supplying
				  authorized distributor of record states in writing that the prescription drug
				  being supplied had until that time been exclusively in the normal distribution
				  channel;
(ix) The delivery of, or
				  offer to deliver, a prescription drug by a common carrier solely in the common
				  carrier's usual course of business of transporting prescription drugs, if the
				  common carrier does not store, warehouse, or take legal ownership of the
				  prescription drug; or
(x) The sale
				  or transfer from a pharmacy or pharmacy warehouse of expired, damaged,
				  returned, or recalled prescription drugs to the original wholesale distributor,
				  the original manufacturer, or a third-party returns processor.
(23) Wholesale
				  Distributor.
(a) "Wholesale distributor"
				  means a person that is engaged in the wholesale distribution of prescription
				  drugs or prescription devices.
(b)
				  "Wholesale distributor" includes:
(i) A
				  manufacturer;
(ii) A
				  repackager;
(iii) An own-label
				  distributor;
(iv) A private-label
				  distributor;
(v) A
				  jobber;
(vi) A broker;
(vii) A warehouse, including a manufacturer's
				  or distributor's warehouse;
(viii)
				  A manufacturer's exclusive distributor, or an authorized distributor of
				  record;
(ix) A drug wholesaler or
				  distributor;
(x) An independent
				  wholesale drug trader;
(xi) A
				  third-party logistics provider;
(xii) A pharmacy that conducts wholesale
				  distribution, if the wholesale distribution business accounts for more than 5
				  percent of the pharmacy's annual sales; and
(xiii) A pharmacy warehouse that conducts
				  wholesale distribution.