That an order disposing of the petition for variance and waiver filed by AmerisourceBergen Drug Corporation on October 3, 2013. The following is a summary of the agency’s disposition of the petition: The petitioner is seeking a variance and ...

 

DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION

Drugs, Devices and Cosmetics

The Department of Business and Professional Regulations, Division of Drugs, Devices and Cosmetics hereby gives notice:

That an order disposing of the petition for variance and waiver filed by AmerisourceBergen Drug Corporation on October 3, 2013.

The following is a summary of the agency’s disposition of the petition:

The petitioner is seeking a variance and waiver from the requirements of subparagraph 61N-1.012(3)(a)1., Florida Administrative Code. The Department published notice of the petition in the October 24, 2013, issue of the Florida Administrative Register, Volume 39, Number 208.

The Petitioner requests:

A.) A waiver from the requirement of subparagraph 61N-1.012(3)(a)1., that the pedigree paper include the full proprietary or generic name of the drug, and

B.) A variance permitting Petitioner to utilize the abbreviated name of each proprietary or generic drug, as supplied by the manufacturer, in combination with the drug’s unique NDC number.

Prior to November 27, 2013, the Department interpreted Section 499.012, Florida Statutes, as requiring the name of the prescription drug as it appears on the label to appear on the prescription drug pedigree.

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, Section 585(a), provides:

“SEC. 585. UNIFORM NATIONAL POLICY.

“(a) PRODUCT TRACING AND OTHER REQUIREMENTS.—Beginning on the date of enactment of the Drug Supply Chain Security Act, no State or political subdivision of a State may establish or continue in effect any requirements for tracing products through the distribution system (including any requirements with respect to statements of distribution history, transaction history, transaction information, or transaction statement of a product as such 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) or this subchapter (or regulations issued thereunder), or which are inconsistent with—

“(1) any waiver, exception, or exemption pursuant to section 581 or 582; or

“(2) any restrictions specified in section 582.

In light of the language in the federal statute pre-empting states’ laws regarding requirements for tracking and tracing prescription drug products through the distribution chain, including requirements for paper and electronic pedigrees, subparagraph 499.01212(2)(a)3., Florida Statutes, is preempted.

Section 120.542, Florida Statutes (2013), places the burden on Petitioner to demonstrate that the underlying purpose of the statute will be or has been achieved by some other means.

Petitioner has met the burden of demonstrating that the use of the abbreviated proprietary or generic name of prescription drugs in addition to the specific NDC number unique to such drug, on the electronic pedigrees, satisfies the safety concerns addressed by the existing subparagraph 61N-1.012(3)(a)1., F.A.C.

Petitioner has met the burden of demonstrating that substantial economic and technological hardship would result if the rule was strictly applied to Petitioner.

Granting the petition for variance/waiver would not remove the safety provisions of the Rule and would sufficiently protect the public.

Based on the foregoing, Petitioner’s request for a variance and waiver as set forth in paragraph A and B above, is granted.

Petitioner should note that effective January 1, 2015, manufacturers and wholesale distributors will begin using transaction history, transaction information, and transaction statements in the distribution of prescription drug product. “Transaction information” is defined in Section 581(26) of the DQSA, as including the proprietary or established name or names of the product.

A copy of the Order or additional information may be obtained by contacting: Dinah Green at The Division of Drugs, Devices and Cosmetics, 1940 N. Monroe Street, Suite 26A, Tallahassee, FL 32399-1047, [phone].