In this subtitle the following words have the meanings indicated. “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. “Authorized distributor of record” means a wholesale distributor with whom a manufacturer has established an ongoing relationship to distribute the manufacturer’s prescription drug. “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. “Co–licensed product” means a product of co–licensed partners. “Designated representative” means an individual who: Is designated by a wholesale distributor; Serves as the primary contact of the wholesale distributor with the Board; and Is actively involved in and aware of the daily operation of the wholesale distributor. “Drop shipment” means the sale of a prescription drug: To a wholesale distributor by: The manufacturer of the prescription drug; or The manufacturer’s co–licensed partner, third party logistics provider, or manufacturer’s exclusive distributor; and Through which: The wholesale distributor or a pharmacy warehouse takes title to but not physical possession of the prescription drug; 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 The pharmacy, pharmacy warehouse, or other authorized person receives delivery of the prescription drug directly from: The manufacturer; or The manufacturer’s third party logistics provider or the manufacturer’s exclusive distributor. “Facility” means a facility of a wholesale distributor where prescription drugs are stored, handled, repackaged, or offered for sale. “Intracompany sales” means 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 Transaction or transfer of a co–licensed product between co–licensed partners. “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. “Manufacturer’s exclusive distributor” means a person who: Contracts with a manufacturer to provide or coordinate warehousing, distribution, or other services on behalf of the manufacturer; and 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. “Normal distribution channel” means a chain of custody for a prescription drug that, directly or by drop shipment, goes: From: A manufacturer of the prescription drug; or The manufacturer’s co–licensed partner, third party logistics provider, or manufacturer’s exclusive distributor; and To: A pharmacy or other designated person authorized by law to dispense or administer the prescription drug to a patient; A wholesale distributor to a pharmacy or other designated person authorized by law to dispense or administer the prescription drug to a patient; 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; 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 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. “Ongoing relationship” means a relationship that exists between a wholesale distributor, including any affiliated group of the wholesale distributor, as defined in § 1504 of the Internal Revenue Code, and a manufacturer when the wholesale distributor: Has a written agreement currently in effect with the manufacturer evidencing the ongoing relationship; and Is listed on the manufacturer’s current list of authorized distributors of record. “Pedigree” means a document or electronic file containing information that records each wholesale distribution of a prescription drug. “Pharmacy warehouse” means a physical location for storage of prescription drugs that: Serves as a central warehouse; and Performs intracompany sales or transfers of the prescription drugs to a group of pharmacies that are under common ownership and control with the pharmacy warehouse. “Prescription device” means any device required by federal law or regulation to be dispensed only by a prescription. “Prescription drug” means any drug required by federal law or regulation to be dispensed only by a prescription. “Prescription drug” includes: A biological product; and Finished dosage forms and bulk drug substances subject to § 503(b) of the Federal Food, Drug, and Cosmetic Act. “Prescription drug” does not include blood and blood components intended for transfusion or biological products that are also medical devices. “Repackage” means to repackage or otherwise change the container, wrapper, or labeling of a prescription drug to further the distribution of the prescription drug. “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. “Repackager” means a person who repackages prescription drugs. “Third party logistics provider” means a person who: Contracts with a manufacturer to provide or coordinate warehousing, distribution, or other services on behalf of the manufacturer; but Does not take title to the prescription drug or have general responsibility to direct the prescription drug’s sale or disposition. “Wholesale distribution” means the distribution of prescription drugs or prescription devices to persons other than a consumer or patient. “Wholesale distribution” does not include: Intracompany sales; 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; The sale, purchase, distribution, trade, or transfer of a prescription drug or prescription device by the Department for public health purposes; The distribution of samples of a prescription drug by a manufacturer’s representative; Prescription drug returns conducted by a hospital, health care entity, or charitable institution in accordance with 21 C.F.R. § 203.23; The sale of minimal quantities of prescription drugs by retail pharmacies to licensed health care practitioners for office use; 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; 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; 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; 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 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. “Wholesale distributor” means a person that is engaged in the wholesale distribution of prescription drugs or prescription devices. “Wholesale distributor” includes: A manufacturer; A repackager; An own–label distributor; A private–label distributor; A jobber; A broker; A warehouse, including a manufacturer’s or distributor’s warehouse; A manufacturer’s exclusive distributor or an authorized distributor of record; A drug wholesaler or distributor; An independent wholesale drug trader; A third party logistics provider; A pharmacy that conducts wholesale distribution, if the wholesale distribution business accounts for more than 5% of the pharmacy’s annual sales; and A pharmacy warehouse that conducts wholesale distribution. “Wholesale distributor permit” means a permit issued by the Board under this subtitle to distribute prescription drugs or prescription devices into, out of, or within the State as a wholesale distributor.

This subtitle does not affect any person while distributing: Feed for livestock or poultry; Fertilizers; Fungicides; Insecticide; Land plaster; Lime; Seeds; Devices, drugs, or supplies of any kind for the treatment, care, or cure of farm animals; or Compounded nonsterile preparations or compounded sterile preparations provided in accordance with § 12–510 of this title to a licensed veterinarian who intends to dispense the compounded nonsterile preparations or compounded sterile preparations in accordance with § 2–313(c) of the Agriculture Article.

A wholesale distributor shall hold a permit issued by the Board before the wholesale distributor engages in wholesale distribution in the State. A manufacturer engaged in wholesale distribution shall hold a wholesale distributor permit issued under this subtitle. Notwithstanding paragraph (1) of this subsection, the information and qualification requirements for obtaining a permit under this subtitle, beyond that required by federal law, do not apply to: A manufacturer that distributes its own prescription drugs that are approved by the U.S. Food and Drug Administration; or A manufacturer that distributes its own prescription devices that are approved or authorized by the U.S. Food and Drug Administration. A manufacturer’s exclusive distributor and a third–party logistics provider shall hold a wholesale distributor permit issued under this subtitle. A wholesale distributor permit shall be displayed conspicuously in the place of business for which the permit is issued. A wholesale distributor permit is not transferable. Subject to any other restriction provided by law, a person may not purchase or obtain a prescription drug or prescription device unless the prescription drug or prescription device is purchased or obtained from a person who holds a wholesale distributor permit, a licensed pharmacist, or an authorized prescriber.

The Department may purchase and distribute prescription drugs and prescription devices for public health purposes. The Department shall adopt regulations, in consultation with the Board, to implement this section.

Notwithstanding any other provision of this subtitle, a wholesale distributor applicant or permit holder that prepares sterile drug products shall submit to the Board a report of an inspection conducted by the U.S. Food and Drug Administration or a Board designee: At the time of application; and On renewal. The inspection report required under subsection (a) of this section shall: Be conducted within 1 year before the date of application or renewal; and Demonstrate compliance with applicable federal good manufacturing practice standards. An applicant or permit holder is responsible for obtaining an inspection to meet the requirements of this section.

In this section the following words have the meanings indicated. “Accreditation organization” means a private entity that: Is recognized by the Board; and Conducts inspections and surveys of wholesale distributors based on nationally recognized and developed standards. “Deemed status” means a status under which a wholesale distributor may be exempt from initial and routine inspection requirements under this subtitle. The Board may only grant deemed status to a wholesale distributor that is: Currently accredited by an accreditation organization, wherever the wholesale distributor is located; or Located in a state that has requirements that: Are substantially equivalent to the requirements of this State; and Include pedigrees, routine inspections of wholesale distributors, operation of wholesale distributors in a commercial nonresidential facility, and security measures. The Board may issue a wholesale distributor permit by reciprocity to a wholesale distributor who holds a license or permit under the laws of another state if the Board determines that the requirements of that state are substantially equivalent to the requirements of this State. A wholesale distributor that receives a permit by reciprocity shall comply with the requirements of § 12–6C–05(e) and (f) of this subtitle. In addition to meeting the requirements under this subtitle, a wholesale distributor located out–of–state that is not eligible for reciprocity shall be accredited by an accreditation organization. The Board shall grant deemed status to a wholesale distributor that: Is currently accredited by an accreditation organization; or Has been granted reciprocity by the Board. The Board or its designee may inspect a wholesale distributor who is accredited or has been issued a permit by reciprocity to: Determine compliance with any permit requirement under this subtitle; or Investigate a complaint.

To apply for a wholesale distributor permit, an applicant shall: Pay to the Board an application fee set by the Board; and Submit an application to the Board on the form that the Board requires. The application shall include the following: The name, full business address, and telephone number of the applicant; All trade or business names used by the applicant; Addresses, telephone numbers, and the names of contact persons for the facility used by the applicant for the storage, handling, and distribution of prescription drugs; The type of business form under which the applicant operates, such as partnership, corporation, or sole proprietorship; The name of each owner and operator of the applicant, including: If an individual, the name of the individual; If a partnership, the name of the partnership and of each partner; If a corporation, the name of the corporation, the name and title of each corporate officer and director, and the state of incorporation; and If a sole proprietorship, the full name of the sole proprietor and the name of the sole proprietor’s business entity; A list of all licenses and permits issued to the applicant by any other state that authorizes the applicant to purchase or possess prescription drugs; For the designated representative and the immediate supervisor of the designated representative at the applicant’s place of business, the following: Name; Places of residence for the past 7 years; Date and place of birth; The name and address of each business where the individual was employed during the past 7 years, and the individual’s job title or office held at each business; A statement of whether, during the past 7 years, the individual has been the subject of any proceeding for the revocation of any professional or business license or any criminal violation and, if so, the nature and disposition of the proceeding; A statement of whether, during the past 7 years, the individual has been enjoined, either temporarily or permanently, by a court of competent jurisdiction from violating any federal or state law regulating the possession, control, or distribution of prescription drugs, together with details concerning the event; A description of any involvement, including any investments other than the ownership of stock in a publicly traded company or mutual fund, by the individual during the past 7 years with any business that manufactures, administers, prescribes, distributes, or stores prescription drugs, and any lawsuits in which the business was named as a party; A description of any misdemeanor or felony offense of which the individual, as an adult, was found guilty, regardless of whether adjudication of guilt was withheld or whether the individual pled guilty or nolo contendere; and If the individual indicates that a criminal conviction is under appeal and submits a copy of the notice of appeal, within 15 days after the disposition of the appeal, a copy of the final written order of disposition; and A photograph of the individual taken in the previous 180 days. The information required under subsection (b) of this section shall be provided under oath. The Board may not issue a wholesale distributor permit to an applicant unless the Board or its designee: If the applicant holds prescription drugs or devices, conducts a physical inspection of the applicant’s place of business, including any facility of the applicant; Finds that the place of business and facility, if any, meets the Board’s requirements; Determines that the designated representative of the applicant meets the following qualifications: Is at least 21 years of age; Has been employed full time for at least 3 years in a pharmacy or with a wholesale distributor in a capacity related to the dispensing and distribution of, and record keeping relating to, prescription drugs; Is employed by the applicant full time in a managerial level position; Is actively involved in and aware of the daily operation of the wholesale distributor; Is physically present, except for an authorized absence such as sick leave or vacation leave, at the facility of the applicant during regular business hours; Is serving as a designated representative for only one applicant at a time, or for two or more wholesale distributors who are located in the same facility and are members of an affiliated group, as defined in § 1504 of the Internal Revenue Code; Does not have any convictions for a violation of any federal, state, or local laws relating to wholesale or retail prescription drug distribution or distribution of controlled substances; and Does not have any convictions for a felony under federal, state, or local laws; and Determines that the immediate supervisor of the designated representative of the applicant meets the following qualifications: Is at least 21 years of age; Has been employed full time for at least 3 years in a pharmacy or with a wholesale distributor in a capacity related to the dispensing and distribution of, and record keeping relating to, prescription drugs; Is employed by the applicant full time in a managerial level position; Is actively involved in and aware of the daily operation of the wholesale distributor; Does not have any convictions for a violation of any federal, state, or local laws relating to wholesale or retail prescription drug distribution or distribution of controlled substances; and Does not have any convictions for a felony under federal, state, or local laws. The designated representative and the immediate supervisor of the designated representative of an applicant shall submit to a criminal history records check in accordance with § 12–6C–05.1 of this subtitle. In this subsection, “gross receipts” means gross receipts from sales of prescription drugs and devices in the State. This subsection does not apply to a pharmacy warehouse that is not engaged in wholesale distribution. An applicant for a wholesale distributor permit shall submit a surety bond or other equivalent means of security acceptable to the State, such as an irrevocable letter of credit or a deposit in a trust account or financial institution, payable to the State Board of Pharmacy to be deposited into an account established by the State under paragraph (7) of this subsection. The surety bond or other security shall be in the amount of: $100,000, if the annual gross receipts of the applicant for the previous tax year are $10,000,000 or more; or $50,000, if the annual gross receipts of the applicant for the previous tax year are less than $10,000,000. The Board may require by regulation documentation for the gross receipts of the wholesale distributor to qualify for a surety bond or other security in the amount of $50,000. The purpose of the surety bond is to secure payment of any fines or penalties imposed by the Board and any fees and costs incurred by the State relating to the permit that: Are authorized under State law; and Are not paid by the permit holder within 30 days after the fines, penalties, fees, or costs become final. The State may make a claim against the surety bond or other security until 2 years after the permit holder’s permit ceases to be valid. A single surety bond shall cover all facilities operated by the applicant in the State. The Board shall establish an account, separate from its other accounts, in which to deposit the applicant’s surety bond or other security. If a wholesale distributor distributes prescription drugs or prescription devices from more than one facility, the wholesale distributor shall obtain a permit for each facility. Within 30 days after the date the Board receives a completed application, including the results of all required criminal history records checks, the Board shall notify the applicant of the Board’s acceptance or rejection of the application.

In this subsection, “Central Repository” means the Criminal Justice Information System Central Repository of the Department of Public Safety and Correctional Services. This subsection applies to applicants located in the State. As part of an application to the Central Repository for a State and national criminal history records check, the designated representative and the immediate supervisor of the designated representative of an applicant shall submit to the Central Repository: A complete set of legible fingerprints taken in a format approved by the Director of the Central Repository and the Director of the Federal Bureau of Investigation; The fee authorized under § 10–221(b)(7) of the Criminal Procedure Article for access to Maryland criminal history records; and The mandatory processing fee required by the Federal Bureau of Investigation for a national criminal history records check. In accordance with §§ 10–201 through 10–229 of the Criminal Procedure Article, the Central Repository shall forward the criminal history records information of the designated representative and the immediate supervisor of the designated representative of an applicant to the Board and the applicant. Information obtained from the Central Repository under this subsection: Is confidential; May not be redisseminated; and May be used only for the permitting purpose authorized by this subtitle. The subject of a criminal history records check under this subsection may contest the contents of the criminal history records information issued by the Central Repository as provided in § 10–223 of the Criminal Procedure Article. If criminal history record information is reported to the Central Repository after the date of the initial criminal history records check, the Central Repository shall provide to the Board and the individual revised criminal history record information for the individual. This subsection applies to applicants located outside the State. The designated representative and the immediate supervisor of the designated representative of an applicant shall submit to a criminal history records check by the applicant’s state of residence, in accordance with the laws of the applicant’s state of residence. The criminal history records check shall consist of: A state criminal history records check for the applicant’s state of residence; and A national criminal history records check. The designated representative and the immediate supervisor of the designated representative of an applicant shall request the appropriate entity in the applicant’s state of residence to forward the results of the criminal history records check to the Board and the applicant. The Board shall ensure that information obtained under this subsection: Is kept confidential; Is not redisseminated; and Is used only for the permitting purpose authorized by this subtitle.

A wholesale distributor permit expires on May 31 after its effective date, unless the wholesale distributor permit is renewed for an additional 2–year term as provided in this section. Except as provided in paragraph (2) of this subsection, at least 1 month before a wholesale distributor permit expires, the Board shall send to the wholesale distributor permit holder a renewal notice by electronic means to the last known e–mail address of the permit holder. If requested by a wholesale distributor permit holder, the Board shall send to the permit holder a renewal notice by first–class mail to the last known address of the permit holder. If a renewal notice sent by electronic means under paragraph (1) of this subsection is returned to the Board as undeliverable, the Board shall send to the wholesale distributor permit holder a renewal notice by first–class mail to the last known address of the permit holder. A renewal notice sent under this subsection shall state: The date on which the current wholesale distributor permit expires; The date by which the renewal application must be received by the Board for the renewal to be issued and mailed before the current wholesale distributor permit expires; and The amount of the renewal fee. Before a wholesale distributor permit expires, a wholesale distributor permit holder periodically may renew it for an additional 2–year term, if the wholesale distributor permit holder: Otherwise is entitled to a wholesale distributor permit; Pays to the Board a renewal fee set by the Board; and Submits to the Board a renewal application on the form that the Board requires. The renewal application form shall set forth the information that the wholesale distributor provided under § 12–6C–05 of this subtitle. Within 30 days after receiving the form, the wholesale distributor shall identify and state under oath to the Board all changes or corrections to the information that was provided under § 12–6C–05 of this subtitle. The Board shall renew the wholesale distributor permit of a wholesale distributor permit holder who meets the requirements of this subtitle and any regulations adopted under this subtitle. If a wholesale distributor is located outside the State, the designated representative and immediate supervisor of the designated representative of the permit holder shall submit to a criminal history records check in accordance with § 12–6C–05.1 of this subtitle before the permit may be renewed. The Board may deny, suspend, or revoke the permit of a wholesale distributor if the Board determines that the wholesale distributor no longer qualifies for a permit.

The Board: Shall adopt regulations that require routine inspections of wholesale distributor facilities; and May adopt regulations establishing: Minimum requirements for the receipt, storage, and handling of prescription drugs or prescription devices, security precautions, quality control, record keeping, and procedures, policy, and responsibilities of personnel; and Education and experience requirements for personnel employed in positions responsible for carrying out the duties: Referenced in item (i) of this item; or Related to State permit requirements under this subtitle.

Information provided by a wholesale distributor or an applicant for a wholesale distributor permit under this subtitle may not be disclosed to any person or entity except a State licensing or permitting authority, State board, or government agency that needs the information for licensing, permitting, monitoring, or law enforcement purposes.

A wholesale distributor shall receive prescription drug returns or exchanges from a pharmacy or pharmacy warehouse according to the terms and conditions of the agreement between the wholesale distributor and the pharmacy or pharmacy warehouse. Returns of expired, damaged, recalled, or otherwise nonsaleable prescription drugs shall be distributed by the receiving wholesale distributor only to either the original manufacturer or a third party returns processor. Returns or exchanges of prescription drugs, saleable or otherwise, including any redistribution by a receiving wholesaler, are not subject to the pedigree requirements of § 12–6C–10 of this subtitle if they are exempt from the pedigree requirement of the U.S. Food and Drug Administration’s currently applicable Prescription Drug Marketing Act guidelines. Wholesale distributors and pharmacies shall be accountable for: Administering their returns process; and Ensuring that the returns process is secure and does not permit the entry of adulterated and counterfeit product. A wholesale distributor may supply prescription drugs only to a person authorized by law to dispense or receive prescription drugs. Except as provided in paragraph (2) of this subsection, a wholesale distributor may deliver prescription drugs only to: The premises listed on the recipient’s license or permit; or An authorized person or an agent of an authorized person at the premises of the wholesale distributor if: The identity and authorization of the person or agent is properly established; and This method of delivery is employed only to meet the immediate needs of a particular patient of the authorized person. Prescription drugs may be supplied to a hospital pharmacy receiving area if a pharmacist or authorized receiving personnel of the hospital pharmacy signs, at the time of delivery, a receipt showing the type and quantity of the prescription drug received. Any discrepancy between the type and quantity of the prescription drug indicated on the receipt and the type and quantity of the prescription drug received: Shall be reported to the delivering wholesale distributor by the next business day after the delivery to the hospital pharmacy receiving area; and May be reported to the Board for investigation. A wholesale distributor may not accept payment or allow the use of a person’s credit to establish an account for the purchase of prescription drugs from any person other than the owner of record, the chief executive officer, or the chief financial officer listed on the license or permit of a person legally authorized to receive prescription drugs. Any account established for the purchase of prescription drugs shall bear the name of the license or permit holder. A wholesale distributor may not operate out of a residence.

In this section the following words have the meanings indicated. “Covered entity” has the meaning stated in 42 U.S.C. § 256b(a)(4). “Package” has the meaning stated in 21 U.S.C. § 360eee(11). “340B drug” means a drug that: Is a covered outpatient drug under 42 U.S.C. § 256b; Has been subject to an offer for reduced prices by a 340B manufacturer under 42 U.S.C. § 256b(a)(1); and Is purchased by a covered entity. “340B drug” includes a drug that would have been purchased but for the limitation under subsection (c) of this section. “340B manufacturer” means a manufacturer, as defined in 42 U.S.C. § 1396r–8(k)(5), of covered outpatient drugs that has signed a pharmaceutical pricing agreement under 42 U.S.C. § 256b(a)(1). This section may not be construed to be: Less restrictive than any federal law that is applicable to a person regulated by this section; or In conflict with applicable federal and State laws and regulations. Except as provided in paragraph (2) of this subsection, a 340B manufacturer may not directly or indirectly deny, restrict, prohibit, discriminate against, or otherwise limit the acquisition of a 340B drug by, or delivery of a 340B drug to, a pharmacy that is under contract with or otherwise authorized by a covered entity to receive 340B drugs on behalf of the covered entity unless the receipt of 340B drugs is prohibited by the U.S. Department of Health and Human Services. A 340B manufacturer may limit the distribution of a 340B drug if the limitation is required under 21 U.S.C. § 355–1. A violation of subsection (c) of this section: Subject to paragraph (2) of this subsection, is an unfair, abusive, or deceptive trade practice within the meaning of Title 13 of the Commercial Law Article and is subject to the enforcement and penalty provisions contained in Title 13 of the Commercial Law Article; and If the alleged violation was committed by a person that is licensed or permitted by the Board, shall be investigated by the Board or the Consumer Protection Division of the Office of the Attorney General; or If the alleged violation was committed by a person that is not licensed or permitted by the Board, shall be investigated by the Consumer Protection Division of the Office of the Attorney General. As part of an investigation conducted under subparagraph (1)(i)2 of this paragraph, the Board or the Consumer Protection Division of the Office of the Attorney General may investigate an affiliate or a contractor of the 340B manufacturer, including a wholesaler or third–party logistics provider. In addition to the penalties under Title 13 of the Commercial Law Article, a civil fine may be assessed in the amount of $5,000 per violation of subsection (c) of this section. A violation of this section does not create a private right of action under § 13–408 of the Commercial Law Article. If a violation of subsection (c) of this section is committed by a person licensed or permitted by the Board, the Board may impose discipline, suspension, or revocation of the person’s license or permit. Each package of 340B drugs subject to a violation of subsection (c) of this section shall constitute a separate violation.

A person who is engaged in the wholesale distribution of a prescription drug that leaves, or has ever left, the normal distribution channel shall provide, before each wholesale distribution of the prescription drug, a pedigree to the person who receives the prescription drug. A retail pharmacy or pharmacy warehouse shall comply with the requirements of this section only if the pharmacy or pharmacy warehouse engages in the wholesale distribution of a prescription drug in the State. To be considered part of the normal distribution channel, a wholesale distributor, a manufacturer’s exclusive distributor, and a manufacturer’s third party logistics provider also must be an authorized distributor of record. Notwithstanding paragraph (1) of this subsection, a pharmacy warehouse that is not an authorized distributor of record shall be considered part of the normal distribution channel. Each person who engages in the wholesale distribution of a prescription drug, including repackagers but excluding the original manufacturer of the finished form of the prescription drug, who is provided a pedigree for the prescription drug and attempts to further distribute the prescription drug, shall authenticate, before any distribution of the prescription drug occurs, that each transaction listed on the pedigree has occurred. The pedigree shall include: All necessary identifying information relating to each sale in the chain of distribution of the prescription drug from the manufacturer or the manufacturer’s third party logistics provider, co–licensed partner, or manufacturer’s exclusive distributor, through acquisition and sale by any wholesale distributor or repackager, until final sale to a pharmacy or other person dispensing or administering the prescription drug, including: The name, address, telephone number, and if available, electronic mail address, of each owner and each wholesale distributor of the prescription drug; The name and address of each location from which the prescription drug was shipped, if different from the owner’s; Transaction dates; and Certification that each recipient has authenticated the pedigree; The name of the prescription drug; The dosage form and strength of the prescription drug; The size of the container; The number of containers; The lot number and National Drug Code of the prescription drug; and The name of the manufacturer of the finished dosage form. Each pedigree for a prescription drug shall be: Maintained by the purchaser and the wholesale distributor for 3 years from the date of sale or transfer; and Available for inspection or use within 5 business days on request of the Board, the Board’s designee, or an authorized law enforcement officer.

If a person knowingly violates any provision of this subtitle or any regulation adopted under this subtitle, the Board may impose a fine not to exceed $500,000. Before the Board imposes a fine, the Board shall consider the appropriateness of the fine in relation to: 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; and Any previous violations by the wholesale distributor. In addition to the penalty provided in subsection (a) of this section, the Board also may take disciplinary action against a permit holder who is convicted of or pleads guilty or nolo contendere to a violation of State, federal, or local drug laws.

On or before January 1, 2008, the Board shall adopt regulations to implement this subtitle.

On or before January 1, 2008, and on or before January 1 of each subsequent year, the Board shall report to the Governor and, in accordance with § 2–1257 of the State Government Article, to the General Assembly on the implementation of this subtitle.