Michael J. Glazer, Ausley McMullen, Post office Box 391, 123 South Calhoun Street, Tallahassee, Florida 32301, on belhalf of H.D. Smith Wholesale Drug Company; The Petitioner is substantially affected by the statutes and rules cited in paragraphs ...

 

DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION

Drugs, Devices and Cosmetics

NOTICE IS HEREBY GIVEN that The Department of Business & Professional Regulation, Division of Drugs, Devices, and Cosmetics has issued an order disposing of the petition for declaratory statement filed by Michael J. Glazer, Ausley McMullen, Post Office Box 391, 123 South Calhoun Street, Tallahassee, Florida 32301, on behalf of H.D. Smith Wholesale Drug Company on June 24, 2014. The following is a summary of the agency’s disposition of the petition:

The Petitioner is substantially affected by the statutes and rules cited in paragraphs 11A-G above and has standing to seek a declaratory statement from the department. The Department is authorized to enforce the provisions of Chapter 499, Florida Statutes, and the administrative rules adopted pursuant to the statute. Prior to November 27, 2013, the provisions of Chapter 499, Florida Statutes and of the Florida Administrative Code cited in paragraphs 11A-G above, were interpreted by the Department to require a prescription drug pedigree to be provided by the wholesale distributor prior to or simultaneously with the distribution of a prescription drug; the pedigree had to include the information enumerated in the statute; the pedigree paper had to be authenticated in one or more of the ways set forth in Rule 61N-1.013(5)(d); electronic pedigrees had to be authenticated according to that rule; if a pedigree could not be authenticated, the prescription drugs had to be quarantined and the Department notified; returns of drugs from a pharmacy, health care entity or licensed health care practitioner that were the result of a mistake in ordering or shipment need not be included in a pedigree; returns not in that category had to be included in a pedigree and had to otherwise comply with paragraph 61N-1.012(3)(f), Florida Administrative Code. Effective November 27, 2013, the Drug Quality and Security Act (DQSA) was signed into law. The Act is comprised of Title I, the Compounding Quality Act, and Title II, the Drug Supply Chain Security Act. The DQSA Title II requires a uniform national system for tracking and tracing prescription drugs through the supply chain, and a uniform licensing system for prescription drug wholesale distributors, repackagers, and third party logistics providers. The Act applies to human finished dosage forms of prescription drugs only. The DQSA contains preemption language regarding tracking and tracing prescription drugs through the supply chain and regarding licensing of prescription drug manufacturers, wholesale distributors, and third party logistics providers. Currently, wholesale distributors are still required to obtain a permit from the Department to operate in this state, and to be in compliance with federal law. See, Sections 582-585, Drug Quality and Security Act. The preemption language in Section 585 of the Act as cited in paragraph 12 above, makes it clear that states may not establish or continue in effect any requirement for tracing products through the distribution system (including any requirement with respect to statements of distribution history, transaction history, transaction information, or transaction statement of a product as the product changes ownership in the supply chain, or verification, investigation, disposition, notification or recordkeeping relating to such systems, including paper or electronic pedigree systems or for tracking and tracing drugs throughout the distribution system) which are inconsistent with, more stringent than, or in addition to, any requirements applicable under section 503(e) (as amended by such Act). The Department has previously taken the position that the Florida pedigree requirements are preempted by the federal law. See, Declaratory Statement, In Re Petition for Declaratory Statement, Publix Supermarkets, Inc., Petitioner, Declaratory Statement Case Number DS2014-007. The DQSA does not have any specific references to or provisions requiring authentication. The Department takes the position that the Florida requirements for authentication are inconsistent with, more stringent than or in addition to the requirements in the amended federal law, and are preempted. With respect to returns, the provisions of the DQSA categorizes returns from dispensers and those from a wholesale distributor differently, and requires no transaction history, transaction statement, or transaction information for most returns. By contrast, the Florida provisions on returns require information to be included in a pedigree except in limited circumstances set forth in Florida Administrative Code paragraph 61N-1.012(3)(f). Because the provisions for returns under Florida law are inconsistent with, and more stringent than, the provisions in the DQSA, those provisions are preempted as well. The amended federal tracking and tracing requirements become effective January 1, 2015. The Department has previously taken the position that in the interim period before the effective date of the tracking and tracing requirements of the provisions of the DQSA, current federal minimum standards for wholesale distribution of prescription drugs, set forth in 21 C.F.R. §203, the Prescription Drug Marketing Act (PDMA), are applicable, and states may enforce those requirements of the PDMA. See, Declaratory Statement, In Re Petition for Declaratory Statement, Publix Supermarkets, Inc., Petitioner, Declaratory Statement Case Number DS2014-007. However, Petitioner asserts that it is an authorized distributor of record, and the PDMA, by its terms, does not address requirements for documenting the movement of prescription drugs for those in Petitioner’s status as an authorized distributor of record. In addition, the PDMA does not address returns of prescription drug product. It is not clear how Petitioner is to handle tracking and tracing requirements for distributions or returns in the interim period. While Petitioner implies that the grandfathering product provision of the DQSA operates retroactively to govern Petitioner’s distributions that occur prior to January 1, 2015, the Department cannot address the applicability of the DQSA provisions to Petitioner’s facts. However, as discussed above, the Department will not pursue administrative enforcement action against Petitioner if Petitioner does not comply with pedigree, authentication and returns requirements. Accordingly, applying the foregoing to Petitioner’s facts, Petitioner’s request for a declaratory statement is answered as follows: A. The Department will not pursue an administrative enforcement action against HDS if HDS does not comply with the pedigree and authentication requirements of Section 499.01212, Florida Statutes, and Rule 61N-1.013, Florida Administrative Code. B. The Department will not pursue an administrative enforcement action against HDS if HDS does not comply with the return requirements set forth in Florida Administrative Code Rule 61N-1.012. C. Nothing herein shall be construed as affecting or negating requirements of federal law for wholesale distribution of prescription drugs as such requirements apply to Petitioner.

A copy of the Order Disposing of the Petition for Declaratory Statement may be obtained by contacting: The Division of Drugs, Devices and Cosmetics, Dinah Greene, 1940 N. Monroe Street, Suite 26A, Tallahassee, FL 32399-1047.

Please refer all comments to: Reggie Dixon, Division Director, Division of Drugs, Devices and Cosmetics, 1940 N. Monroe Street, Suite 26A, Tallahassee, FL 32399-1047, website: http://interredesignalpha/dbpr/ddc/ddc_division_notices.html.