Frequently Asked Questions for Pharmacists on Prescription Drug Wholesalers
Q: What federal law product tracing requirements apply to pharmacies?
A: The Drug Supply Chain Security Act (DSCSA) requires dispensers, which primarily include pharmacies, to comply with new requirements related to product tracing beginning July 1, 2015. Today FDA issued the DSCSA Implementation: Product Tracing Requirements for Dispensers–Compliance Policy Guidance. This document announces that FDA does not intend to take enforcement action against dispensers who, prior to November 1, 2015:
Under the DSCSA, a dispenser cannot accept ownership of certain human, finished prescription drugs unless the previous trading partner provides specific information (product tracing information) about those drugs. Additionally, dispensers must provide, capture and maintain the product tracing information associated with such drugs for all qualifying transactions they engage in.
However, FDA recognizes that some dispensers may need more time beyond the July 1st deadline to work with trading partners, to ensure they can properly receive, capture and maintain the product-tracing information required by law.
FDA posted a supporting webinar, “DSCSA Updates and Readiness Check: DSCSA Requirements for Dispensers and other Trading Partners,” and plans to host a series of stakeholder calls in the coming weeks.
Please check http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/default.htm to find the latest activities on the DSCSA.
Q: How can I find out whether a company is properly registered in North Carolina as a prescription drug wholesaler?
Prescription drug transfers between or among pharmacies that fall outside this limited, emergency exception are wholesale transactions would require a North Carolina wholesaler license. Note that the sale of excess stock to another pharmacy would be a wholesale activity.
Pharmacists should also be aware that transfers of prescription drugs between or among pharmacies must comply with the requirements of Title II of the federal Drug Quality and Security Act, also known as the Drug Supply Chain Security Act. More information is found here: http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/default.htm
Pharmacists should also be aware that any transfer of controlled substances between or among pharmacies requires compliance with all pertinent provisions of the federal Controlled Substances Act and associated regulations. Helpful guidance may be found in the Drug Enforcement Administration Pharmacist’s Manual, available here: http://www.deadiversion.usdoj.gov/pubs/manuals/pharm2/index.html
A: No. Board staff and North Carolina Department Agriculture and Consumer Services, Food & Drug Protection staff (the latter are responsible for wholesale prescription drug regulation in North Carolina) have received multiple inquiries regarding contacts from businesses that represent themselves as Internet-based marketplaces for independent pharmacies. The business model described is an on-line point of product exchange, allowing independent pharmacies to buy and sell t over-stocked prescription drug inventory and prescription drugs in short supply among themselves. Typically, such businesses suggest that, under FDA guidelines, a pharmacy may transfer up to 5% of its annual sales to another pharmacy without a wholesale license. Board staff and Food & Drug Protection staff view these models as inconsistent with both federal and state law governing wholesale prescription drug transactions (discussed above in the question “May a pharmacy transfer prescription drugs to another pharmacy?”) North Carolina General Statutes are consistent with applicable portions of the federal Food, Drug & Cosmetic Act with respect to limited transfers of prescription drugs between pharmacies for legitimate emergency medical reasons; transfers between retail pharmacies without a wholesale license simply for inventory management reasons are not allowed in North Carolina.
Board and Food & Drug Protection staff also are concerned that such business models are but another version of the “secondary” and “gray market” wholesaling. Staff has cautioned about this practice for years. See Item 2240 in the April 2012 Newsletter here: http://www.ncbop.org/Newsletters%5CApr2012.pdf.
See also this website notification from February 2014: