Florida Administrative Code › 61 - DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION › 61N - Drugs, Devices and Cosmetics › Chapter 61N-1 - REGULATIONS FOR DRUGS, DEVICES AND COSMETICS › Section 61N-1.030 - Product Tracking and Tracing - Wholesale Distributor Requirements

Current through Reg. 50, No. 138; July 16, 2024
The following tracking and tracing requirements shall apply
				  to wholesale distributors:
(1) PRODUCT
				TRACING.
(a) A wholesale distributor shall not
				accept ownership of a product unless the previous owner prior to, or at the
				time of, the transaction provides the transaction history, transaction
				information, and a transaction statement for the product, as applicable under
				this paragraph.
(b) A wholesale
				distributor that purchased a product directly from the manufacturer, the
				exclusive distributor of the manufacturer, or a repackager that purchased
				directly from the manufacturer, shall prior to, or at the time of, each
				transaction in which the wholesale distributor transfers ownership of a
				product, provide to the subsequent purchaser:
1. A transaction statement, which shall state
				that the wholesale distributor, or a member of the affiliate of the wholesale
				distributor, purchased the product directly from the manufacturer, the
				exclusive distributor of the manufacturer, or a repackager that purchased the
				product directly from the manufacturer; and,
2. The transaction history and transaction
				information.
3. If provided to a
				dispenser, the transaction history, transaction information, and transaction
				statement shall be on a single document in a paper or electronic
				format.
4. If provided to a
				wholesale distributor, the transaction history, transaction information, and
				transaction statement shall be through any combination of self-generated paper,
				electronic data, or manufacturer provided information on the product
				package.
5. The lot number of the
				product, the initial transaction date and the initial shipment date from the
				manufacturer are not required to be included in the transaction history and
				information for transactions falling under paragraph
				61N-1.030(1)(b),
				F.A.C.
(c) A wholesale
				distributor that did not purchase a product directly from the manufacturer, the
				exclusive distributor of the manufacturer, or a repackager that purchased
				directly from the manufacturer, shall prior to, or at the time of, each
				transaction or subsequent transaction, provide to the subsequent purchaser, a
				transaction statement, transaction history, and transaction information, in a
				paper or electronic format that complies with the requirements set forth in the
				departmental rules.
1. The transaction history
				supplied shall begin only with the wholesale distributor that purchased the
				product directly from the manufacturer, the exclusive distributor of the
				manufacturer or a repackager that purchased directly from the
				manufacturer.
2. The wholesale
				distributor that did not purchase directly from the manufacturer, the exclusive
				distributor of the manufacturer or a repackager that purchased directly from
				the manufacturer, shall inform the subsequent purchaser that the wholesale
				distributor received a direct purchase statement from a wholesale distributor
				that purchased the product directly from the manufacturer, the exclusive
				distributor of the manufacturer or a repackager that purchased directly from
				the manufacturer.
(d) A
				wholesale distributor shall capture the transaction information, including lot
				level information, transaction history, and transaction statement for each
				transaction described in this rule and maintain such information, history, and
				statement for not less than 6 years after the date of the transaction; and
				maintain the confidentiality of the transaction information, including any lot
				level information, transaction history, and transaction statement for a product
				and prohibit disclosure to any person other than state or federal officials,
				except to comply with the provisions of rules
				61N-1.028,
				61N-1.029,
				61N-1.030,
				61N-1.031 and
				61N-1.032,
				F.A.C.