SELECT FROM THE FOLLOWING:

Why should wholesalers use PedigreeSecure.com?
How can PedigreeSecure.com help my company comply with the PDMA?
Is PedigreeSecure.com a law enforcement agency?
What kind of standards does PedigreeSecure.com uphold?
What information is required to become a member of PedigreeSecure.com?
What is PedigreeSecure.com's verification process?
Does PedigreeSecure.com assist unauthorized distributors or secondary wholesalers?
What is the PedigreeSecure.com Due Diligence Investigation Process?
What is PedigreeSecure.com's policy on restricted access and use of pedigree information?

Why Should Wholesalers Use PedigreeSecure.com?

The Prescription Drug Marketing Act of 1987 [hereinafter the PDMA], was signed into law on April 22, 1988. The PDMA amends the Federal Drug and Cosmetic Act [21 USC 353, et seq.]. The PDMA [Public Law 100-293, 100th Congress] was enacted after Congressional investigations and resulting findings that concluded that the existing pharmaceutical drugs distribution system was ineffective.

The PDMA came into being because Congress concluded that American consumers cannot purchase prescription drugs with the certainty that the products are safe and effective. Lawmakers furthermore found that the integrity of the distribution system was insufficient to prevent the introduction and eventual retail sale of substandard, ineffective or counterfeit drugs. They reasoned that new laws were necessary because there was an unacceptable risk that counterfeit, adulterated, misbranded, subpotent, or expired drugs were being sold to the American public.

Most relevant to the services provided by PedigreeSecure.com, Congress realized that a wholesale drug diversion submarket had developed, that prevented effective control over, or even routine knowledge of, the true sources of drugs. Essentially, the law now mandates that unauthorized wholesale distributors (also known as secondary distributors) must provide purchasers with a statement (a “Pedigree”) that records each distribution of a drug including its initial purchase from an authorized wholesaler.

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How Can PedigreeSecure.com help my company comply with the PDMA?

PedigreeSecure.com has developed a unique electronic data storage system designed to facilitate both buyers and sellers’ ability to ascertain the Pedigree trail for purchases of pharmaceutical products. We take on your burden of having to track pedigree statements: we verify a Pedigree’s accuracy by conducting our own independent due diligence investigation of the sources listed on a wholesale distributor’s pedigree. In an effort to assist you with regulatory compliance, we have designed a compliance management system that archives and indexes fax-generated reports. We take the worry out of wondering whether or not you are in compliance with the PDMA by keeping all of the information in a safely stored database that’s only a “click away” and readily accessible for your retrieval. This is how we can assist you and our industry:

• PedigreeSecure.com’s process helps to eliminate inaccurate pedigrees that can result in the distribution of possibly tainted products.
• PedigreeSecure.com assists the industry in its efforts to prevent tainted products from entering the supply chain without being traced.
• PedigreeSecure.com assists the industry in providing pedigree verification on all electronically stored pedigrees that are accessible only by your company or by Federal, State, local regulators.
• PedigreeSecure.com assists the industry in reducing the transfer of inaccurate pedigrees
• PedigreeSecure.com is committed to assisting its clients in complying with the PDMA efforts, geared toward the industry’s goal of ensuring that products that enter the supply chain are verifiable and safe for distribution.
  

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Is PedigreeSecure.com a law enforcement agency?

PedigreeSecure.com is NOT a law enforcement agency. It is a private corporation that is providing a compliance management solution for the pharmaceutical industry. We are not an arm of law enforcement, and are not required to automatically report any Pedigree inconsistencies, or irregularities to any branch of law enforcement. Nonetheless, our services are available to you, and we’ll gladly send proof of your pedigrees to law enforcement on your behalf, should you request us to do so.

PedigreeSecure.com’s services are restricted. We service only secondary or unauthorized wholesale distribution markets. If you seek advice concerning distributions of drug samples, sales or purchases of coupons, or sales or purchases with regard to any public or private hospital, or other health care entity, please exit this site immediately, and read the PDMA for the proscriptions against those activities [see sections 4 and 5 of the PDMA, in particular].

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What kind of standards does PedigreeSecure.com uphold?

PedigreeSecure.com promises to uphold the highest standards of conduct in performing its services. Here’s what we promise:

• PedigreeSecure.com will provide and maintain Pedigree confirmation services of the highest standard and integrity.
• PedigreeSecure.com will take responsibility for the work that it does in researching the pedigree of its registrants.
• PedigreeSecure.com will be sure to exhaust its resources to find accurate information to ensure that it does not cause danger to any person’s or company’s reputation.
• PedigreeSecure.com will avoid, where possible, any and all conflicts of interest between itself, its clients, and those concerned with the ultimate use of the goods or services concerned.
• PedgreeSecure.com will not misrepresent the verification service they provide, or the status of the companies that it has verified.
• PedigreeSecure.com will act with fairness.
  

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What information is required to become a member of PedigreeSecure.com?

In order to benefit from our service, each applicant must officially register to join the website. The registration process requires providing the following:

• Official company name.
• Company Address
• Company Telephone Number
• Company Fax Number
• A copy of the company’s pharmaceutical license, with the company’s registration ID
  Number affixed in the upper right hand corner of the fax copy.
• Payment of the required registration fee
• Principle Domestic Business authorization statement signed and delivered via fax (see #?
  Below for more information).
  

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What is PedigreeSecure.com's verification process?

How it works:

Records Search Process: Your Validation Number

PedigreeSecure.com Confirmation Statement

Pedigree will ensure that the Pedigree history for each sales item provided is accurate. It will confirm the accuracy of the pedigree statement, by affirming that for each sale a pedigree statement is traceable to the entities listed on the statement. Pedigree will investigate each pedigree, to ensure that each sale listed on the pedigree is traceable to an “authorized distributor” or “manufacturer” as required by the PDMA.

The PDMA Verification Process Applies to Unauthorized Distributors

Authorized Distributors or Primary Distributors cannot Use this Service

The PDMA requires full disclosure on all pedigree statements to distributors who are not considered “Authorized Distributors.” Authorized distributors are distributors of prescription drugs who primarily buy them from manufacturers. Authorized Distributors are generally understood to be “primary wholesale distributors” or “primary wholesalers.” A company is considered an authorized distributor if it has an on-going relationship with manufacturers due to their established purchasing patterns.

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Does PedigreeSecure.com assist unauthorized distributors or secondary wholesalers?

Generally speaking, a secondary wholesale distributor (or unauthorized wholesaler) is a distributor of prescription drugs who primarily buys them from other wholesale distributors, rather than directly from a manufacturer. The industry does recognize, however, that some secondary wholesale distributors do purchase drugs directly from a manufacturer, and that some primary or authorized distributors purchase prescription drugs from secondary wholesale distributors.

PedigreeSecure.com is only able to verify pedigree-listed sources for products that are distributed within the secondary market, and only those pedigrees that are received by members of this service. Distribution of products in the secondary market that have chosen not use PedigreeSecure.com cannot be verified and are not within the responsibility of pedigree confirmation by PedigreeSecure.com.

The process outlined below relates to the unauthorized wholesale distributor, who is required to identify each sale of a drug (including the date of the sale) before its sale to any other unauthorized distributor.

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What is the PedigreeSecure.com Due Diligence Investigation Process?

Here is the big picture: PedigreeSecure.com will contact each distributor listed on the pedigree statement to verify the accuracy of the information listed on the pedigree. PedigreeSecure.com will create a validation log of each source that was contacted to ascertain the Pedigree trail. Each log will be date and time stamped and kept on file.

Here are the details:

For Pharmaceutical Drug Sellers

Records Search Process: Your Validation Number

Your pedigree records will be accessible to you, simply by logging onto PedigreeSecure.com’s website using your secure username and password. After logging onto the site, you will be able to access your Pedigree records.

Each individual Pedigree that you submit for registration will be identified by its sales invoice number which you will provide on your pedigree statement. PedigreeSecure.com will create a corresponding Confirmation Number to facilitate pedigree searches. In the event that you wish to conduct a search in the future, you have the option of using either your invoice number (which is displayed on the Pedigree statement) or the validation number (which is provided by PedigreeSecure.com) to ascertain the status of the pedigree you seek to confirm. In addition, after logging on, you have the option of hitting the "search all" tab, and you will be able to display the entire list of your pedigrees that were received and stored by PedigreeSecure.com on your behalf.

The Confirmation number will be proof positive of receipt of the pedigree. Once a pedigree search is requested, and a Pedigree is searched, the results will be displayed immediately on the PedigreeSecure.com website.

For Pharmaceutical Drug Buyers

At no charge, buyers of pharmaceutical products can obtain information regarding the status of a seller’s pedigree by registering on the Pedigree website. However, the buyer’s access to information will be restricted to receiving an official PedigreeSecure.com confirmation of whether or not the seller’s Pedigree has been verified. When a source is “Confirmed,” that means that all of the sources listed on pedigrees have been contacted by PedigreeSecure.com and verified as confirmed and accurate to the best of our knowledge. The official confirmation is available for print and should be stored with the invoice for an official reminder that After registering, the buyer can download and print an official PedigreeSecure.com Confirmation approval number for the requested pedigree. PedigreeSecure.com will electronically store the pedigree that is associated with that invoice although it will be available for immediate viewing and copying by Federal, State, Local regulators with drug enforcement authority.

To reiterate: The buyer simply enters the company name of the seller, as well as the invoice number and/or validation number issued to the seller for that specific sale. Upon entering the information, the Buyer will receive an immediate on-screen message stating one of the following:

Confirmed: “The “Invoice number ### from “company name” has been Confirmed."

Unconfirmed: “PedigreeSecure.com cannot confirm the pedigree of [name of company].”

Pedigrees that are not confirmed will NOT be validated and the seller will be notified immediately that accurate information must be provided. Un-confirmed pedigrees will be returned immediately to the seller, giving the seller an opportunity to return an updated corrected pedigree for re-confirmation. Buyers will be informed that the revised information will be delivered, within a promised period of time. Otherwise, the buyer will be contacted and informed by PedigreeSecure.com that it cannot verify and confirm the seller’s pedigree.

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What is PedigreeSecure.com's policy on restricted access and use of pedigree information?

The PedigreeSecure.com Process is designed to be an electronic data interchange where the information that is submitted is stored electronically, then verified and made available to the member and Federal, State, Local regulators with drug enforcement authority). This is accomplished without the risk of disseminating a seller’s business secrets, trade, or other proprietary information except on the client’s demand (or when demanded by law enforcement authorities).

PedigreeSecure.com will ensure that the requested pedigree information is only disclosed to pedigree “providers” (any company providing a pedigree for the sale of a product), and authorized representatives of Federal, State, and local agencies with drug law enforcement responsibilities. The purpose of our service is to help alleviate the seller’s fear of having to disclose its business or commercial sources to a buyer which, oftentimes, encourages a seller not to divulge accurate information. This may result in incomplete pedigrees.

PedigreeSecure.com does NOT guarantee the efficacy of any pharmaceutical product listed in the Pedigree. PedigreeSecure.com only states whether or not the pedigree sources listed are verified and confirmed as accurate. Counterfeit products can still enter the supply chain at the manufacturer or authorized distributor level as there is no current legal requirement under law for those entities to provide a pedigree statement.

PedigreeSecure.com is only able to verify pedigree-listed sources for products that are distributed within the secondary market, and only those pedigrees that are received by members of this service. Distribution of products in the secondary market that have chosen not to use PedigreeSecure.com cannot be verified and are not within the responsibility of pedigree confirmation by PedigreeSecure.com.

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