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-1.025 - Certification Authority and Digital Signatures for Self-Authenticating Electronic Pedigree

Current through Reg. 50, No. 138; July 16, 2024
(1) As used in this
				rule chapter the terms "certificate" and "Certification Authority" are as
				defined by section 668.003, F.S. (2005). The
				department will list on its website one or more companies authorized to serve
				as a Certification Authority to issue digital certificates to persons for
				purposes of certifying via a digital signature the accuracy and completeness of
				a pedigree paper for authentication purposes under sub-subparagraph
				61N-1.013(5)(d)
				1.f., F.A.C. The department recognizes that a Certification Authority listed on
				the department's website may revoke any digital certificate it has issued. In
				addition, the department recognizes that the certificate holder and the
				employer of the certificate holder may also seek revocation of a certificate,
				for example because of termination of the holder's employment or change of the
				holder's authority to sign a pedigree for the employing
				establishment.
(2) The department
				will list on its website a Certification Authority that requests in writing to
				the bureau that it be so listed, if the request demonstrates:
(a) The Certification Authority meets the
				requirements set forth in the Federal Government Bridge Certification Authority
				Certificate Policy (FBCA CP), of the federal General Services Administration
				for "medium assurance" certificates, or comparable requirements.
(b) The Certification Authority will issue
				two types of certificates the status of which is ascertainable within the
				digital signature. One type of certificate will indicate that the person to
				whom the digital signature is issued signs on behalf of a company that is
				lawfully permitted in Florida to engage in the unrestricted wholesale
				distribution of a prescription drug in or into Florida. The other type of
				certificate will indicate that the person to whom the digital signature is
				issued signs on behalf of a company that is not lawfully permitted in Florida
				but is lawfully permitted in its resident state to engage in the wholesale
				distribution of prescription drugs, or is licensed in Florida under a
				restricted distributor permit.
(c)
				The Certification Authority requires at a minimum the following written
				documentation prior to granting a digital certificate to the person requesting
				a digital signature to sign an electronic pedigree:
1. Authorization from the establishment for
				whom the person is requesting a digital certificate that that person may sign
				pedigree papers on the establishment's behalf,
2. A valid, unexpired identification document
				which bears a photograph of the person requesting a digital certificate such
				as:
a. A passport issued by the United States,
				an immigration document issued by the Federal Government, or any document
				issued by an agency of the Federal Government or the Armed Services of the
				United States,
b. A passport issued
				by a foreign government if the passport includes or is accompanied by a
				document proving that the alien is lawfully in the United States, or
c. A document issued by a state or political
				subdivision if the issuing state or political subdivision prohibits the
				issuance of the identification document to an alien who is unlawfully in the
				United States, and the state or political subdivision requires independent
				verification of the records offered by the person to prove identity when
				applying for the identification document.
3.
a. A
				copy of the state issued permit for the company's name and address for whom the
				person is requesting a digital certificate demonstrating authorization by the
				state of Florida to engage in the unrestricted wholesale distribution of
				prescription drugs in or into Florida, or
b. A copy of the state issued permit or
				license for the company's name and address for whom the person is requesting a
				digital certificate demonstrating authorization by the state in which the
				company resides to engage in the wholesale distribution of prescription drugs,
				or demonstrating authorization by the state of Florida to engage in the
				wholesale distribution of prescription drugs under a restricted distributor
				permit.
(d) The
				Certification Authority shall submit to the department a statement from an
				independent auditor confirming that the Certification Authority complies with
				the requirements of this rule and the applicable provisions of subparagraph
				61N-1.013(5)(d)
				1., F.A.C., so that a recipient of a pedigree signed with a digital signature
				issued by the Certification Authority can rely on the integrity of the digital
				signature.