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Pharmacist FAQs

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:

1. accept ownership of certain human, finished prescription drugs without receiving the transaction information, transaction history, and a transaction statement (product tracing information) prior to or at the time of a transaction, as required by section 582(d)(1)(A)(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act); or

2. do not capture and maintain the product tracing information, as required by section 582(d)(1)(A)(iii) of the FD&C Act.

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.

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Q: How can I find out whether a company is properly registered in North Carolina as a prescription drug wholesaler?

A: The Department of Agriculture maintains a searchable, on-line database of prescription drug wholesalers licensed in North Carolina. The database is available here: http://www.ncagr.com/aspzine/fd/fdpd/search.asp


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Q: May a pharmacy transfer prescription drugs to another pharmacy?

A: North Carolina Wholesale Prescription Drug Distributors Laws provides an exemption to allow limited transfers between or among pharmacies only under very specific circumstances in N.C.G.S. 106-145.2(10)(e): "The sale, purchase, or trade of a prescription drug or an offer to sell, purchase or trade a prescription drug for emergency medical reasons. Emergency medical reasons include transfers of prescription drugs by a retail pharmacy to another retail pharmacy to alleviate a temporary shortage when the gross dollar value of the transfer does not exceed 5% of the total prescription drug sales revenue of either the transferor or transferee pharmacy during a 12 consecutive month period."

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


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Q: I have been approached by a business that says it can broker sales of prescription drugs among pharmacies.  Is this business model allowed under North Carolina law?

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:

FRIDAY, FEBRUARY 21, 2014

CAUTION TO NORTH CAROLINA PHARMACIES CONCERNING “SECONDARY” WHOLESALER SOLICITATIONS FOR SHORTAGE DRUGS.  Board of Pharmacy staff and staff of the Food and Drug Safety Division of the North Carolina Department of Agriculture has been made aware that at least one “secondary” wholesaler is soliciting pharmacies to purchase “shortage” drugs from a primary wholesaler and then resell them to the “secondary” wholesaler.  There are several important issues that pharmacies should keep in mind:

(1) Any sales of this sort are wholesale prescription drug transactions.  Any pharmacy engaged in such transactions that is not also a currently licensed prescription drug wholesaler would be in violation of North Carolina law.

(2) The “secondary” wholesaler has suggested that a pharmacy may engage in such transactions without being a wholesaler under a “5% rule” allowing sales to relieve shortages; any such suggestion is false.  North Carolina law provides a limited mechanism whereby one pharmacy may, in an emergency situation, transfer a small amount of prescription drugs to another pharmacy to help that pharmacy through an emergency.  North Carolina law does not provide a mechanism for a pharmacy to sell any amount of a prescription drug to a wholesaler for subsequent distribution to other pharmacies or wholesalers.  More information may be found here:  http://www.ncbop.org/faqs/Pharmacist/faq_Wholesalers.htm

(3) As most pharmacists are aware, Congress recently passed the Drug Quality and Security Act.  Title II of that act, governing drug supply chain security, sets forth many federal law requirements for prescription drug wholesalers.  Provisions of this statute are being rolled out gradually, but any pharmacy contemplating becoming a prescription drug wholesaler must be aware of these stringent requirements and prepared to meet them. 

(4) The issue of “gray market” wholesaling of shortage prescription drugs is one that North Carolina authorities have worked closely with federal officials to monitor and address.  A Congressional investigation into these practices, and their often significant threat to the public health and safety, was conducted last year.  More information may be found here:  http://democrats.oversight.house.gov/investigation-of-the-gray-market/


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Q: How do I apply for a drug wholesaler's license in North Carolina?

A: Drug wholesale licenses are handled by the NC Department of Agriculture's Food & Drug Protection Division. Please visit http://www.ncagr.gov/fooddrug/index.htm for information.


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