Md. Code Regs. 10.34.22.02

Current through Register Vol. 51, No. 25, December 13, 2024

Section 10.34.22.02 - Definitions

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.

Md. Code Regs. 10.34.22.02

Regulations .02 adopted effective March 28, 2005 (32:6 Md. R. 636)
Regulations .02 adopted effective April 7, 2008 (35:7 Md. R. 748)
Regulation .02B amended as an emergency provision effective June 18, 2009 (36:15 Md. R. 1163); amended permanently effective October 5, 2009 (36:20 Md. R. 1529)
Regulations .02, adopted effective 41:10 Md. R. 561, eff.7/1/2014