This Web-based Law Books Guide (“Guide”) is intended to provide an overview of the statutory and regulatory framework of the 50 states, the District of Columbia, Puerto Rico and Guam, with respect to wholesale drug distribution licensing and pedigree requirements. Each section of the Guide examines the requirements of one of these jurisdictions as set forth by state law and overseen by the state or territory agency responsible for oversight of wholesale drug distribution. Although the federal Prescription Drug Marketing Act (PDMA) and the United States Food & Drug Administration’s (FDA) implementing regulations thereunder apply in all such jurisdictions, this Guide is intended to focus solely on state and other non-federal requirements.
This Guide is designed to serve as a convenient reference for HDMA members regarding state regulation of the distribution of prescription and, in certain cases, non-prescription pharmaceutical products in the U.S. Although every attempt has been made to ensure that this Guide is accurate, it is not intended to be a comprehensive collection and interpretation of all laws and regulations applicable to the wholesale drug distribution industry at any level. Rather, it is by necessity based on the authors’ selection of materials and interpretation of legal requirements and policies. The statutory and regulatory requirements and policies included in this Guide, as well as the interpretation thereof, change over time.
THE GUIDE IS NOT INTENDED TO PROVIDE LEGAL OR REGULATORY ADVICE, and certain matters are beyond its scope. Specific decisions should be based on a review of the law, including relevant statutes, regulations (including rulemaking preambles where applicable) and other agency documents, such as binding or non-binding guidance materials, with the specific assistance and legal advice of your independent legal counsel and regulatory advisors.
Although this Guide includes links providing direct access to other Internet sites, HDMA takes no responsibility for the content or information contained on those other sites, and does not exert any editorial or other control over those other sites. HDMA is providing information and services on the Internet as a benefit to its members in furtherance of HDMA’s not-for-profit and tax-exempt status. HDMA makes no representations about the suitability of this information and these services for any purpose.
The names, trademarks, service marks and logos of HDMA appearing on this Web site may not be used in any advertising or publicity, or otherwise to indicate HDMA’s sponsorship of or affiliation with any product or service, without HDMA’s prior express written permission.
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