Kentucky Statutes 315.406 – Prescription drug pedigree for drugs leaving normal distribution channel — Administrative regulations
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(1) (a) As of the date specified by an administrative regulation promulgated by the board pursuant to KRS Chapter 13A, each person or entity engaged in the wholesale distribution of prescription drugs that leave or that have ever left the normal distribution channel shall, prior to the distribution of the prescription drug, provide a pedigree to the person receiving the prescription drug.
(b) A retail pharmacy or a pharmacy warehouse shall comply with paragraph (a) of this subsection only if it engages in wholesale distribution of prescription drugs.
(2) The board shall specify the requirements for the contents and maintenance of a pedigree that are consistent with the federal requirements.
(3) The board shall promulgate an administrative regulation pursuant to KRS Chapter
13A to implement the provisions of this section no later than one hundred eighty
(180) days after July 15, 2008.
Effective: July 15, 2008
History: Created 2008 Ky. Acts ch. 124, sec. 6, effective July 15, 2008.
(b) A retail pharmacy or a pharmacy warehouse shall comply with paragraph (a) of this subsection only if it engages in wholesale distribution of prescription drugs.
Terms Used In Kentucky Statutes 315.406
- Board: means the Kentucky Board of Pharmacy. See Kentucky Statutes 315.010
- Drug: means any of the following:
(a) Articles recognized as drugs or drug products in any official compendium or supplement thereto. See Kentucky Statutes 315.010 - Federal: refers to the United States. See Kentucky Statutes 446.010
- Pharmacy: means every place where:
(a) Drugs are dispensed under the direction of a pharmacist. See Kentucky Statutes 315.010 - Prescription drug: means a drug which:
(a) Under federal law is required to be labeled with either of the following statements:
1. See Kentucky Statutes 315.010
(2) The board shall specify the requirements for the contents and maintenance of a pedigree that are consistent with the federal requirements.
(3) The board shall promulgate an administrative regulation pursuant to KRS Chapter
13A to implement the provisions of this section no later than one hundred eighty
(180) days after July 15, 2008.
Effective: July 15, 2008
History: Created 2008 Ky. Acts ch. 124, sec. 6, effective July 15, 2008.