General Pedigree Questions

Which prescription drugs are subject to the pedigree requirements?

Prescription drugs subject to pedigree requirements include all prescription drugs labeled for human use, including brand-named prescription drugs, generic prescription drugs, and some medical devices that contain a prescription drug. An example of a medical device is a convenience kit; the U.S. Food and Drug Administration (FDA) has treated any prescription drug component in such a kit as a drug, and Florida is, therefore, following the FDA’s direction.

The only exceptions are for medical gases, veterinary prescription drugs, and any drug distributed under a limited veterinary prescription drug wholesale permit labeled for human use but sold to a veterinarian for animal use.

Who must provide a pedigree?

Anyone, including a repackager, who is engaged in the wholesale distribution of a prescription drug from, within, or into the state of Florida, must provide a pedigree, with two exceptions:

• The manufacturer of a prescription drug. A “manufacturer” includes the actual manufacturer; the NDA/ANDA holder, even though a contract manufacturer is used; and the distribution point for the manufacturer, whether the distribution point is owned by the manufacturer or is a contracted third party logistics provider for the manufacturer. If a manufacturer also engages in the wholesale distribution of any prescription drug that it did not manufacture, then a pedigree must be provided to the recipient of the drug; or

• A member of an affiliated group that distributes a prescription drug to a member warehouse or retail pharmacy. The affiliated group must be composed of at least 50 retail pharmacies, warehouses, or repackagers.

To whom must the pedigree be provided?

A pedigree must be provided to every person who receives a prescription drug from a wholesale distributor or repackager, including: a manufacturer; a repackager; a pharmacy; a medical practitioner authorized to purchase or possess the prescription drug; a person in Florida holding an exemption for authorized research, teaching, or testing; a hospital pharmacy; or anyone other than the patient.

Are end users required to pass a pedigree for prescription drugs that are returned to the wholesale distributor?

A pedigree is not required upon the return of a prescription drug to the wholesale supplier, or when the drug is adulterated or otherwise unusable and is transferred to a licensed reverse distributor or destruction facility. Please see 64F-12.012(3)(f), Florida Administrative Code (F.A.C.), for complete details of the return requirements for prescription drugs.

May I wholesale distribute a prescription drug, if the prescription drug is received prior to the pedigree?

No. Except for drop shipment transactions, a pedigree must be received prior to or contemporaneously with the receipt of prescription drugs (see section 499.005(29), F.S.).

What does “authenticating” a pedigree mean and how do I do it?

“Authenticate” means to affirmatively verify, before the distribution of a legend drug, that each transaction listed on the pedigree has occurred (see section 499.003(4), F.S.). In addition, section 499.0121(4)(d), F.S. requires:

Upon receipt, a wholesaler must review records required under this section for the acquisition of prescription drugs for accuracy and completeness, considering the total facts and circumstances surrounding the transactions and the wholesale distributors involved. This includes authenticating each transaction listed on a pedigree, as defined in Section 499.001(31), F.S.

Rule 64F-12.013(5)(d), F.A.C., sets out the following methods for authentication. Please see the rule in its entirety for full documentation requirements.

• Receipt of an invoice (or shipping document) from the seller to the purchaser, which may have the prices redacted;

• Telephone call to the seller;

• Email communication with the seller;

• Verification of the transaction per a web-based system established by the seller or an independent person that is secure from intentional or unintentional tampering or manipulation to conceal an accurate and complete history of the prescription drug transaction(s);

• Receipt of a legible and unaltered copy of a previous transaction's pedigree that has been signed under oath at the time of the previous transaction to support the transaction to which the pedigree relates; or

• Receipt of a pedigree in an electronic form from an automated system that was successfully opened and decrypted by an automated system.

Who must authenticate a pedigree and did it change during the 2006 legislative session?

A wholesale distributor or repackager must authenticate the information on the pedigree; a pharmacy, practitioner, or hospital is not subject to this requirement. The authentication requirement was not changed during the 2006 legislative session.

What do I do if I cannot authenticate the pedigree?

At a minimum, a wholesale distributor should not accept the prescription drug for which an accurate and completed pedigree has not been received; this prescription drug is deemed adulterated by law. Although currently there is no requirement under the law to notify the department, we encourage you to notify us if the information on the pedigree cannot be authenticated and the “problem” does not appear to be a simple typographical or similar error.

What is the definition of “wholesale distribution?”

“Wholesale distribution” means the distribution of a prescription drug to a person, other than a consumer or patient, with certain limited exceptions enumerated in section 499.012(1), F.S., and Rule 64F-12.001(2)(cc), F.A.C. “Wholesale distribution” does not include the act of dispensing or administering a prescription drug to a patient.

“Distribution” is further defined in section 499.003(15), F.S. as “to sell; offer to sell; give away; transfer, whether by passage of title, physical movement, or other; deliver; or offer to deliver.” This means that a wholesale distribution includes both the sales part of the transaction as well as the physical movement of the prescription drug.

Is a pedigree required for the distribution of an active pharmaceutical ingredient (API) by a wholesale distributor or repackager?

Yes. API’s are prescription drugs by definition. Both wholesale distributors and repackagers must provide a pedigree when distributing an API.

Are there any exceptions or special provisions if I am an authorized distributor of record?

No. As of July 1, 2006, the concept of authorized distributor of record is no longer applicable.

Direct Purchase Pedigree Questions

What is the new form of pedigree created by HB 371, and when may it be used?

The additional form of pedigree created by HB 371 (“direct purchase”) consists of the following items:

• The statement “This wholesale distributor purchased the specific unit of the prescription drug directly from the manufacturer”;

• The manufacturers’ national drug code identifier and the name and address of the wholesale distributor and the purchaser of the prescription drug;

• The name of the prescription drug as it appears on the label; and

• The quantity, dosage form and strength of the prescription drug

Please note that the wholesale distributor must also maintain and make available to the department, upon request, the point of origin of the prescription drugs, including intracompany transfers; the date of the shipment from the manufacturer to the wholesale distributor; the lot numbers of such drugs; and the invoice numbers from the manufacturer.

The direct purchase pedigree may only be used where a wholesale distributor purchases and receives a specific unit of a prescription drug directly from the manufacturer of the prescription drug and distributes the prescription drug directly, or through an intracompany transfer, to a chain pharmacy warehouse or an end user. “Chain pharmacy warehouse” means a wholesale distributor permitted pursuant to section 499.01, F.S., that maintains a physical location for prescription drugs that functions solely as a central warehouse to perform intracompany transfers of such drugs to a member of its affiliated group as described in section 499.0121(6)(h)1., F.S.

How does the department define “intracompany” as used in section 499.003(31)(b)2.?

The term “intracompany” will be defined by rule, but is currently interpreted by the department to mean the distribution of prescription drugs between two establishments wholly owned by the same business entity.

How does the department define “point of origin” as used in section 499.003(31)(b)2.b.?

The term “point of origin” will be defined by rule, but is currently interpreted by the department to mean the location or locations from which the manufacturer transferred title and possession of the specific unit of the prescription drug.

Who is an “end user”?

An “end user” is a person authorized by law to purchase and receive prescription drugs for the purpose of administering or dispensing the drug, as defined in section 465.003, F.S.

May a retail pharmacy wholesale distributor use the direct purchase pedigree to distribute a prescription drug to an end user?

A retail pharmacy wholesale distributor may use this statement only when the retail pharmacy wholesale distributor purchases the specific unit of the prescription drug directly from the manufacturer and distributes the prescription drug directly to an end user; otherwise, a full pedigree must be used.

May a drug repackager provide a direct purchase pedigree?

This will depend on the repackager’s operation.

YES, if a drug repackager purchases finished and fully labeled prescription drugs directly from the prescription drug manufacturer for placement in a convenience kit, provided that the drug repackager does not change the immediate container or label of the specific unit of the finished and fully labeled prescription drug received from the manufacturer. The department treats as a drug repackager the maker of a combination medical device containing any prescription drug component, as long as the FDA requires that such component comply with federal prescription drug regulations.

NO, if a drug repackager changes the specific unit of a prescription drug purchased directly from the manufacturer must. Examples of operations required to provide a full pedigree are:

• Companies that repackage bulk prescription drugs (APIs); and

• Companies that alter a packaging component that may have direct contact with the prescription drug (e.g., repackaging from bottles of 500 dosage units to bottles of 30 dosage units.).
  How do I handle existing prescription drug inventory on July 1, 2006 that was not accompanied by a pedigree?

The Department is in the process of promulgating rules regarding this subject. However, under the department’s current interpretation, all existing inventory in commerce prior to July 1, 2006 may be distributed under pre-July 1, 2006 laws and rules if the wholesale distributor provides the department a list of such inventory by July 17, 2006 by disk, hard copy, or e-mail with file attached. Please mark inventory information “Trade Secret.”

Please mail, fax, or electronically mail inventory information to:

Rebecca Poston, Executive Director
Florida Board of Pharmacy, and
Drugs, Devices and Cosmetics Program
4052 Bald Cypress Way Bin C#04
Tallahassee, Fl 32399-3255
Fax: (850) 413-6982
E-Mail: Rebecca_Poston@doh.state.fl.us
Drop Shipment Questions

How do we handle drop shipments?

House Bill 371 specifically authorized the receipt of a prescription drug without first receiving a pedigree for “drop shipment” transactions. A drop shipment transaction is defined as the wholesale distributor taking title to, but not possession of, a prescription drug and the prescription drug's manufacturer shipping the prescription drug directly to an end user or to a member of an affiliated group, with the exception of a repackager.

The prescription drug manufacturer, wholesale distributor, and the end user or member of an affiliated group each have specific obligations in a drop shipment transaction:

• The manufacturer must provide, and the end user or member of an affiliated group must acquire, a shipping document within 14 days after the receipt of the prescription drug. The shipping document must contain the following information:

  • The name and address of the manufacturer, including the point of origin of the shipment, and the names and addresses of the wholesale distributor and the purchaser;

  • The name of the prescription drug as it appears on the label; and

  • The quantity, dosage form, and strength of the prescription drug.

• The wholesale distributor must provide an invoice and a sworn statement to the recipient of the prescription drug within 14 days after receiving a shipment notification from the manufacturer. The sworn statement is: "This wholesale distributor purchased the specific unit of the prescription drug listed on the invoice directly from the manufacturer, and the specific unit of prescription drug was shipped by the manufacturer directly to a person authorized by law to administer or dispense the legend drug, as defined in s. 465.003, Florida Statutes, or a member of an affiliated group, as described in s. 499.0121(6)(h), Florida Statutes, with the exception of a repackager.” The invoice must contain a unique cross-reference to the manufacturer’s shipping document. In addition, the wholesale distributor must also maintain and make available to the department, upon request, the lot number if not contained in the shipping document acquired by the recipient.

What is the penalty for failure to provide the required documentation in a drop ship transaction?

It is a third degree felony for the failure of the manufacturer to provide the shipping document; the recipient to acquire the shipping document; or the wholesale distributor to provide the invoice and sworn statement.

Miscellaneous Questions

Can we use a website to provide the pedigree to our pharmacy customers?

Yes. A wholesale distributor may serve as a repository of a customer’s pedigree if the wholesale distributor specifies on the customer’s invoice or other distribution document the method for immediately accessing all pedigrees associated with each prescription drug. Please refer to Rule 64F-12.012(3)(a)2., F.A.C. for the entire rule language.

Will there be additional information and / or rules to implement Florida’s pedigree requirements?

Yes. Please visit www.doh.state.fl.us/pharmacy/drugs for the latest information.