MD. Health Occupations Code Ann. §  12-6C-10 (2021)
2021 Maryland Statutes|Health Occupations|Title 12 - Pharmacists and Pharmacies|Subtitle 6C - Wholesale Distributor Permitting and Prescription Drug Integrity Act|Section 12-6C-10 - Pedigree

    (a)    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.    (b)    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.    (c)    (1)    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.        (2)    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.    (d)    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.    (e)    The pedigree shall include:        (1)    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:            (i)    The name, address, telephone number, and if  available, electronic mail address, of each owner and each  wholesale distributor of the prescription drug;            (ii)    The name and address of each location from  which the prescription drug was shipped, if different from the  owner’s;            (iii)    Transaction dates; and            (iv)    Certification that each recipient has  authenticated the pedigree;        (2)    The name of the prescription drug;        (3)    The dosage form and strength of the prescription  drug;        (4)    The size of the container;        (5)    The number of containers;        (6)    The lot number and National Drug Code of the  prescription drug; and        (7)    The name of the manufacturer of the finished  dosage form.    (f)    Each pedigree for a prescription drug shall be:        (1)    Maintained by the purchaser and the wholesale  distributor for 3 years from the date of sale or transfer; and        (2)    Available for inspection or use within 5 business  days on request of the Board, the Board’s designee, or an  authorized law enforcement officer.