Henry Schein 2012 Annual Report Download - page 49
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Operating and Security Standards
At the federal level, the Federal Food, Drug, and Cosmetic Act, or FDC Act, requires certain wholesalers to
provide a drug pedigree for each wholesale distribution of prescription drugs, which includes an identifying
statement that records the chain of ownership of a prescription drug. Currently, the United States Food and Drug
Administration, in exercise of its enforcement discretion, requires these wholesalers to maintain drug pedigrees that
include transaction dates, names and addresses regarding transactions going back to either the manufacturer or the
last authorized distributor of record that handled the drugs. The United States Food and Drug Administration, or
FDA, has continued to develop its policies regarding the integrity of the supply chain, such as by issuing a Final
Guidance in 2010 regarding standardized numerical identification for prescription drug packages, and by issuing a
proposed rule in 2012 for a unique medical device identification system.
Many states have implemented or are considering similar drug pedigree laws and regulations. There have been
increasing efforts by various levels of government, including state departments of health, state boards of pharmacy
and comparable agencies, to regulate the pharmaceutical distribution system in order to prevent the introduction of
counterfeit, adulterated or mislabeled pharmaceuticals into the distribution system. A number of states, including
Florida, have already implemented pedigree requirements, including drug tracking requirements, which are
intended to protect the integrity of the pharmaceutical distribution system. California has enacted a statute that,
beginning in 2015, will require manufacturers to identify each package of a prescription pharmaceutical with a
standard, machine-readable unique numerical identifier, and will require manufacturers and distributors to
participate in an electronic track-and-trace system and provide or receive an electronic pedigree for each transaction
in the drug distribution chain. The law will take effect on a staggered basis, commencing on January 1, 2015 for
pharmaceutical manufacturers, and July 1, 2016 for pharmaceutical wholesalers and repackagers. Other states have
passed or are reviewing similar requirements. Bills have been proposed in Congress that would impose similar
requirements at the federal level.
The Combat Methamphetamine Enhancement Act of 2010, which became effective in April 2011, requires
retail sellers of products containing certain chemicals, such as pseudoephedrine, to self-certify to the Drug
Enforcement Administration (“DEA”) that they understand and agree to comply with the laws and regulations
regarding such sales. The law also prohibits distributors from selling these products to retailers who are not
registered with the DEA or who have not self-certified compliance with the laws and regulations. Various states
also impose restrictions on the sale of certain products containing pseudoephedrine and other chemicals. The
Secure and Responsible Drug Disposal Act of 2010, signed by President Obama in October 2010, is intended to
allow patients to deliver unused controlled substances to designated entities to more easily and safely dispose of
controlled substances while reducing the chance of diversion. The law authorizes the DEA to promulgate
regulations to allow, but not require, designated entities to receive unused controlled substances.
Regulated Software; Electronic Health Records
The FDA has become increasingly active in addressing the regulation of computer software intended for use in
health care settings, and has been developing policies on regulating clinical decision support tools as medical
devices. Certain of our businesses involve the development and sale of software and related products to support
physician and dental practice management, and it is possible that the FDA could determine that one or more of our
products is a medical device, which could subject us or one or more of our businesses to substantial additional
requirements with respect to these products.