April 2004              return to newsletter contents page

Distributors Facing Pedigree Laws in Growing Number of States

On June 3, 2003 Florida Governor Jeb Bush signed the Prescription Drug Protection Act or Pedigree Paper law. Many provisions of the act became effective July 1, 2003, with other portions being phased in as of January 1, 2004 and full pedigree requirements effective July 1, 2006.

These regulations include requirements for pedigree paperwork to be issued with the sale of prescription drugs when the supplier is not the manufacturer or an authorized distributor of record. Pedigree paperwork is also required for each transaction that includes a “Specified Drug.”  Currently pedigree

 requirements affect shipments to wholesale distributors only, the target date for full implementation is July 1, 2006.

What do you mean by pedigree papers?

A pedigree paper is the written history identifying each of the previous sales of a prescription (Rx) drug, including lot number.

What is an authorized distributor of record?

Florida law defines “authorized distributor of record” as those distributors with whom a manufacturer has established an ongoing relationship to distribute the manufacturer’s products.

When you receive any products from the specified drug list (see attachment) and/or (Rx) drugs from a secondary wholesaler (non-authorized distributor of record) you MUST obtain pedigree paperwork in order to receive the shipment. You must also review the paperwork for completeness and accuracy. The pedigree paperwork must contain the following detailed information:

• Name of the prescription or controlled drug (proprietary or generic)

• Name of Manufacturer or Distributor listed on the product label

• Dosage Form (tablets, vials, capsules, etc.)

• Strength

• Container Size

• Quantity by Lot Number

• Name and Address of each previous owner of the prescription drug back to the manufacturer

• Name and Address of each location from which the drug was shipped if different from the owner’s

• Transaction Dates

*Note: This information may be on a separate form or contained within the body of a packing list.

When are Pedigree Papers required?

• All (Rx) / controlled drugs on the “Specified Drug” list, must have pedigree paperwork regardless if the supplier is an Authorized Distributor of Record.

• All (Rx) / controlled drugs from distributors other than Cardinal Health or AmerisourceBergen require pedigree paperwork in all cases.

When are Pedigree papers not required?

• Pedigree papers are NOT required when the (Rx) / controlled drug is coming from the manufacturer. However, it is important to note that proper lot numbers and expiration dates are present.

• Non-specified (Rx) / controlled drugs received from Cardinal Health or AmerisourceBergen do not require pedigree paperwork. AmerisourceBergen and Cardinal Health are recognized as authorized distributors of record.

Receiving Process

Once a product has been determined to be a (Rx) / controlled drug:

• Identify its origin to determine whether pedigree information is required

• If required, ensure all pedigree information is present (see bullets on page 1)

• Ensure the product quantity is received by appropriate lot number and date.

• Retain record for 3 years

Note: Authorized personnel handle controlled drugs in the drug cage. Records for these transactions are maintained there.

If a product does not meet the requirements of the pedigree checklist, the item should be placed into Exception status with notations that one or more criteria have not been met.

Production / Shipping process

At the packing stage, a cover page is printed automatically (see attachment) and is stapled on top of the packing paperwork. This pedigree statement must include the following:

• Name of prescription or controlled drug (proprietary or generic)

• Name of manufacturer or distributor listed on the product label

• Dosage form (tablets, vials, capsules)

• Strength

• Container size

• Quantity by lot number

• Name and address of each previous owner of the prescription drug back to the manufacturer.

• Name and address of each location from which the drug was shipped if different from the owner’s.

• Transaction dates (date we received the item). Must be signed by the appropriate Designated Representative (or another Designated Representative in his/her absence). The signature is followed by “Designated Representative FDOH” (Florida Department of Health).

Currently the bolded items above must be added manually. The original Pedigree Information Sheet is shipped with the order. A copy of this sheet must be kept on file for a period of 3 years.

Record Retention

Pedigree paperwork must be segregated and maintained for a period of 3 years.

For updates and announcements go to: www.doh.state.fl.us/pharmacy/drugs and click on “what’s hot”

Other States Adopting Pedigree Laws

In addition to Florida’s Pedigree Law, other states are implementing or close to implementing similar laws including: Washington, Oregon, California, Nevada, Idaho, Utah, Arizona, New Mexico, Colorado, Oklahoma, and Texas.