| (ii) available for inspection and photocopying not later than the second business day after the date a request is submitted by the department or a peace officer in this state. (G) Verification procedures. (i) Each transaction listed on the pedigree must be affirmatively authenticated prior to any wholesale distribution of a prescription drug. (ii) A person who is engaged in the wholesale distribution of a prescription drug, and who is in possession of a pedigree for a prescription drug shall certify, using the following methods, that each transaction listed on the pedigree has occurred. (I) Invoice confirmation. Receipt of an invoice (or shipping document) from the seller to the purchaser, which may have the prices redacted. Documentation requirements include at a minimum a copy of the invoice or shipping document. If this method is used to authenticate a pedigree, the wholesaler shall review the document received for signs of tampering, incompleteness, or inconsistency with other invoices or shipping documents from that manufacturer or wholesaler, and shall randomly verify the authenticity of the invoice or shipping document with the seller or shipping point reflected on that document using one of the methods in the subsections below. Each wholesaler shall establish policies and procedures for the random verification of the authenticity of the invoices or shipping documents according to statistically sound standards. Each wholesaler shall establish policies and procedures for verification with those wholesalers in the distribution chain with which the wholesaler performing the authentication does not have an established prescription drug vendor relationship. (II) Telephonic confirmation. Documentation requirements include a signed statement by the person placing the telephone call identifying the person's name and position title representing the seller who provides the information, the date the information was provided, and verification of the sales transaction between the parties, including verification of the date of the transaction and the quantity of prescription drugs involved in the transaction. (III) Electronic mail confirmation. Documentation requirements include a copy of the e-mail that identifies the person's name and position title representing the seller who provides the information, the date the information was provided, and verification of the sales transaction between the parties, including verification of the date of the transaction and quantity of prescription drugs involved in the transaction. (IV) Electronic web-based confirmation. Verification of the transaction per a web-based system established by the seller or an independent person that is secure from intentional or unintentional tampering or manipulation to conceal an accurate and complete history of the prescription drug transaction(s). Documentation requirements include a written representation from the seller or independent person that the seller or independent person, as applicable, is responsible for the information included on the website and has adequate security on the information posted to prevent unauthorized tampering, manipulation, or modification of the information and a copy of the dated website page that confirms the sales transaction between the parties, including the date of the transaction and quantity of prescription drugs involved in the transaction. (V) Notarized copy confirmation. Receipt of a legible and unaltered copy of a previous transaction's pedigree paper that had been signed under oath at the time of the previous transaction to support the transaction to which the pedigree paper relates. If this method is used to authenticate a pedigree, the wholesaler shall review the document received for signs of tampering, incompleteness, or inconsistency, and shall randomly verify the authenticity of pedigrees using one of the methods in the this subparagraph. Each wholesaler shall establish policies and procedures for the random verification of the authenticity of these copies of pedigree according to statistically sound standards. (VI) Exclusive purchasing. A wholesale distributor may use a written agreement between the wholesale distributor and an authorized distributor of record that requires that all prescription drugs distributed to the wholesale distributor by the authorized distributor of record must be purchased by the authorized distributor of record from the manufacturer. If this method is used to authenticate a pedigree, the wholesale distributor shall establish policies and procedures for the random verification of the authenticity of the pedigrees that disclose the authorized distributor of record purchased the prescription drug from the manufacturer according to statistically sound standards. (VII) Other methods. Any other method approved by the department. (4) Premises. Prescription drugs distributed by a manufacturer or wholesale distributor may be delivered only to the premises listed on the license, except as listed in paragraph (5) of this subsection. A manufacturer or wholesale distributor may distribute prescription drugs to an authorized person or agent of that person at the premises of the manufacturer or wholesale distributor if: (A) the identity and authorization of the recipient is properly established; and (B) delivery is made only to meet the immediate needs of a particular patient of the authorized person. (5) Delivery to hospital pharmacies. Prescription drugs may be distributed to a hospital pharmacy receiving area if a pharmacist or an authorized receiving person signs, at the time of delivery, a receipt showing the type and quantity of the prescription drug received. Any discrepancy between the receipt and the type and quantity of the prescription drug actually received shall be reported to the delivering manufacturer or wholesale distributor not later than the next business day after the date of delivery to the pharmacy receiving area. (g) Prescription drug labeling. Prescription drugs sold by wholesale distributors shall meet the labeling requirements of the Act and those adopted in §229.420(a) of this title. (h) Prescription drugs that are combination products. Any prescription drug that is a combination product as described in §229.424(c) of this title (relating to Licensure Requirements) is also subject to the applicable requirements in Subchapter X of this chapter (relating to Licensing of Device Distributors and Manufacturers). (i) Prescription drugs that are also cosmetics. Any prescription drug that is also a cosmetic or component thereof is also subject to the applicable requirements of Subchapter D of this chapter (relating to Regulation of Cosmetics). (j) Nonprescription drugs. Nonprescription drugs offered for sale by wholesale distributors of prescription drugs shall be in compliance with the applicable requirements of Subchapter O of this chapter (relating to Licensing of Wholesale Distributors of Nonprescription Drugs--Including Good Manufacturing Practices). |
