Criteria

Based upon the recommendations of the NABP Task Force on Virtual Manufacturers and Virtual Wholesale Distributors, the Verified-Accredited Wholesale Distributor (VAWD) accreditation criteria have been revised.

All seven sections of the VAWD criteria have been updated and will:

  • Allow virtual manufacturers and wholesale distributors to qualify for VAWD accreditation;
  • Provide  a more pronounced  definition of responsible distribution practices needed to address the influx of applicants with indeterminate supply chains; and
  • Provide stronger assurance that drugs diverted from pharmacies and unlawful sources are prevented from entering into the supply chain.

The revised criteria apply immediately to new applications. Current applicants or facilities that have already received accreditation will be given time to review if and how the changes will affect their business practices. Additional, detailed information will soon be distributed to affected applicants and accredited facilities offline. Virtual manufacturer and wholesale distributor applicants will also receive more details soon. 

Click on the links below to learn about each criterion.

Licensure
Facility
Virtual Manufacturers and Wholesale Distributors
Personnel
Record Keeping
Authentication and Verification
Returned, Damaged, and Outdated Drugs
Policies and Procedures
History of Criteria Revisions

Licensure

Qualifying Wholesale Distributor shall provide information to verify that:

1.  The Wholesale Distributor is engaged in the “Wholesale Distribution” of prescription Drugs and Devices which, for the purpose of these criteria, means distribution of Prescription Drugs and Devices to persons other than a consumer or patient and includes the offer to sell; deliver; offer to deliver; give away; or transfer, whether by passage of title, physical movement, or both.

2.  The Wholesale Distributor that provides services within a State, whether the Wholesale Distributor is located within the State or outside of the State, is licensed or registered in good standing, or eligible to become licensed or registered, to engage in wholesale drug distribution in all applicable jurisdictions.

3.  The Wholesale Distributor complies with all applicable statutes and regulations governing Wholesale Distribution where licensed or registered, and complies with the more stringent law or regulation as determined by conflicts of law rules.

4.  If the Wholesale Distributor is involved in the Distribution of controlled substances, including product that has been identified as “listed chemicals” regulated under the Controlled Substances Act, it is duly registered with United States Drug Enforcement Administration (DEA) and the appropriate state controlled substance agency and in compliance with all  applicable laws and rules for the storage, handling, reporting, transport, shipment, and Distribution of controlled substances and such precursor products.

5.  The Wholesale Distributor maintains sufficient liability insurance coverage and secured monetary funds to ensure payment in the event damages, fines, costs, and the like are assessed against Wholesale Distributor.

6.  The Wholesale Distributor has a Person to serve as the Designated Representative for the Wholesale Distributor facility who is actively involved in and aware of the actual daily operation of the Wholesale Distributor that engages in the Distribution of Drugs and Devices and, if required, shall be licensed or registered with the board of pharmacy or appropriate state regulatory agency.

7.  The Wholesale Distributor does not engage in the Wholesale Distribution of Prescription Drugs that are purchased or received from Pharmacies or Practitioners, or from Wholesale Distributors that obtained them from Pharmacies or Practitioners. The Wholesale Distributor may receive Prescription Drugs returned from Pharmacies or Practitioners that were distributed by the Wholesale Distributor. A Wholesale Distributor that operates solely as a Reverse Distributor may receive Drugs from Pharmacies and Practitioners regardless of where obtained for destruction in accordance with applicable laws and regulations, or return to the manufacturer or agent authorized by the manufacturer to accept returns on the manufacturer’s behalf.

Facility

Qualifying Wholesale Distributor shall provide information to verify that:

1.  The facility at which Drugs and Devices are received, stored, warehoused, handled, held, offered, marketed, displayed, or transported from shall:

     a.  Be of suitable construction to ensure that all Drugs and Devices in the facility are maintained in accordance with Labeling of such Drugs and Devices, or in compliance with official compendium standards such as the United States Pharmacopeia – National Formulary (USP-NF);

     b.  Be of suitable size and construction to facilitate cleaning, maintenance, and proper Wholesale Distribution operations;

     c.  Have adequate storage areas to provide adequate lighting, ventilation, temperature, sanitation, humidity, space, equipment, and security conditions:

          i.  All Drugs and Devices shall be stored at appropriate temperatures and under appropriate conditions in accordance with requirements, if any, in the Labeling of such Drugs and Devices, or in accordance with requirements in the current edition of an official compendium such as the USP-NF;

          ii.  Documentation of facility assessments, such as temperature mapping, or alternative processes will be maintained by the Wholesale Distributor to demonstrate the ability to properly store Prescription Drugs in accordance with the Labeling of the drug or the official compendium;

          iii.  If no storage requirements are established for a Drug, the Drug may be held at “controlled” room temperature, as defined in an official compendium such as USP-NF, to help ensure that its identity, strength, quality, and purity are not adversely affected; and

          iv.  Appropriate electromechanical, or electronic temperature and humidity recording equipment and/or logs, shall be utilized to document proper storage of Drugs and Devices. Temperature and humidity monitoring and recording systems will operate continuously.

     d.  Have a quarantine area for storage of Drugs and Devices that are outdated, damaged, deteriorated, Misbranded, or Adulterated, Counterfeit, or suspected of being Counterfeit, otherwise unfit for Distribution, or that are in immediate or sealed secondary containers that have been opened;

     e.  Be maintained in a clean and orderly condition;

     f.  Be free from infestation of any kind; and

     g.  Not be a personal residence.

2.  Appropriate inventory controls are maintained in order to detect and document any theft, Counterfeiting, or diversion of Drugs or Devices.

3.  Controlled substance Drugs are isolated from non-controlled substance Drugs and stored in a secure area in accordance with DEA security requirements and standards.

4.  Adequate security for the facility has been provided for:

     a.  All facilities used for Wholesale Drug Distribution shall be secure from unauthorized entry;     

     b.  Access from outside the premises shall be kept to a minimum and be well controlled;    

     c.  The outside perimeter of the premises shall be well lighted;

     d.  Entry into areas where Drugs or Devices are held shall be limited to authorized personnel;

     e.  All facilities shall be equipped with an alarm system to detect entry after hours;

     f.  All facilities shall be equipped with a security system that will provide suitable protection against theft and diversion. When appropriate, the security system shall provide protection against theft or diversion that is facilitated or hidden by tampering with computers or electronic records; and

     g.  Verifying that all persons or entities who undertake, whether directly or by any other arrangement, to transport Prescription Drugs and Devices for compensation, hereafter referred to as “Common Carriers,” used by the Wholesale Distributor ensures security via a verifiable security system.

5.  Wholesale Distributor facilities co-located with another business shall maintain processes and systems for separating and securing all aspects of the operation. Co-location with another business authorized to purchase Prescription Drugs shall comply with state licensing requirements and the records of Wholesale Distribution must provide traceability with a clear audit trail that distinguishes all purchases and distributions of the Wholesale Distributor from any other entity.

Virtual Manufacturers and Wholesale Distributors

VAWD defines virtual manufacturers and wholesale distributors as applicants that sell a prescription drug or device, but never physically possess the product. Any VAWD applicant or accredited facility whose business model falls within this definition, in full or in part, must utilize a warehouse and physical distribution facility that is VAWD accredited.

Personnel

Qualifying Wholesale Distributor shall provide information to verify that:

1.  The Wholesale Distributor’s Designated Representative has not been enjoined, disciplined, fined, punished, or the like for violating any federal or state laws regulating Prescription Drugs or Devices.

2.  The Wholesale Distributor’s Designated Representative has not been found guilty, pled guilty, or pled nolo contendere to any criminal offense.

3.  The Wholesale Distributor’s Designated Representative has a sound financial history.

4.  The Wholesale Distributor’s Designated Representative:

     a.  Has a minimum of two years of verifiable full-time managerial or supervisory experience in a Pharmacy or Wholesale Distributor where the Designated Representative’s responsibilities included but were not limited to record keeping, storage, and shipment of Drugs or Devices;

     b.   Serves as the Designated Representative for only one Prescription Drug facility at any one time;

     c.  Is actively involved in and aware of the actual daily operations of the Wholesale Distributor;

     d.  Is employed full-time in a managerial position by the Wholesale Distributor;

     e.  Is physically present at the Wholesale Distributor during normal business hours, except for time periods when absent due to illness, family illness or death, scheduled vacation, or other authorized absence. In the authorized absence of the Designated Representative, personnel employed by the Wholesale Distributor with knowledge of the operation and appropriate education and/or experience to assume responsibility for the duties of the Designated Representative will be present; and 

     f.  Is aware of, and knowledgeable about, all policies and procedures pertaining to the operations of the Wholesale Distributor.

5.  All personnel actively engaged in or who directly supervise the operation and handling of Prescription Drugs or Devices, including owner(s) and/or chief executive officer, management, officers, and other key personnel, prior to their association, employment, or contracting and regularly thereafter have met the following qualifications:

     a.  Appropriate local and national criminal background checks; and

     b.  Initial and for cause toxicology screening; and

     c.  Appropriate education, experience, and training necessary to safely and lawfully engage in the Wholesale Distribution of Prescription Drugs and Devices;

6.  All personnel with access to Prescription Drugs, including owner(s) and/or chief executive officer(s), management, officers, and other key personnel, are subject to toxicology screening prior to their association, employment, or contracting and are subject to for cause and random toxicology screening as warranted.

7.  The Wholesale Distributor maintains and enforces policies and procedures requiring documentation of responsible persons and persons in charge, including such persons’ titles, duties, and qualifications.

8.  The Wholesale Distributor maintains and enforces policies and procedures that ensure the qualifications described in 5 and 6 above are documented and retained.

9.  Qualifying Wholesale Distributors shall provide information to verify that, prior to the initial Wholesale Distribution or acquisition of Prescription Drugs to or from any Wholesale Distributor, the distributing or acquiring Wholesale Distributor requires all Common Carriers contracted with or utilized by the Wholesale Distributor to require its employees whose responsibilities include the handling of Prescription Drugs to undergo criminal background checks, initial and random toxicology screening, and security training.

Record Keeping

Qualifying Wholesale Distributor shall provide information to verify that:

1.  The Wholesale Distributor is establishing and maintaining inventories and records of all transactions regarding the receipt and Distribution or other disposition of all Drugs and Devices. These records shall include:

     a.  Pedigrees for all Drugs that are distributed, if Wholesale Distributor is not an Authorized Distributor, or in accordance with state and federal law, if stricter;

     b.  Appropriate information and data to identify the source of the product and type of product being received or distributed; and

     c.  All records related to the Wholesale Distribution of Prescription Drugs, including but not limited to; invoices of purchase, packing slips, shipping records, and sales invoices will accurately reflect the name of the Wholesale Distributor as it appears on the facility’s license issued by the state in which the Wholesale Distributor is engaged in Wholesale Distribution. Wholesale Distributors to whom a license has been issued in the same name and at the same address as another licensee authorized to purchase Prescription Drugs must utilize a method to distinguish purchases and distributions that are specific to the Wholesale Distributor.

2.  Inventories and records shall be made available for inspection and photocopying by any authorized official of any state, federal, or local government agency for a period of three (3) years following their creation date, or as otherwise required by law.

3.  A Pedigree is provided for the Wholesale Distribution of Drugs at the time of the transaction to another Wholesale Distributor, unless otherwise required by law.

4.  A Pedigree is received and provided for all Prescription Drugs received or purchased outside of the Normal Distribution Channel or as required by state or federal law, if stricter. As used in these criteria, Normal Distribution Channel means the Wholesale Distributor is engaged in Wholesale Distribution of Prescription Drugs such that the chain of custody for a Prescription Drug goes from a Manufacturer of the Prescription Drug, the Manufacturer’s Co-Licensee, the Manufacturer’s Third-Party Logistics Provider, or the Manufacturer’s Exclusive Distributor to:

     a.  a Wholesale Distributor that is an Authorized Distributor of Record (ADR) including intracompany distribution of any product [between Wholesale Distributor members of an affiliated group (as defined in section 1504(a) of the Internal Revenue Code of 1986) who are ADRs], to a Pharmacy, to a patient, or other designated persons authorized by law to dispense or administer such Prescription Drug to a patient;    

     b.  a Wholesale Distributor that is an ADR including intracompany distribution of any product [between Wholesale Distributor members of an affiliated group (as defined in section 1504(a) of the Internal Revenue Code of 1986) who are ADRs], to a Chain Pharmacy Warehouse, to that Chain Pharmacy Warehouse’s intracompany Pharmacy, to a patient or other designated persons authorized by law to dispense or administer such Prescription Drug to a patient;

     c.  a Chain Pharmacy Warehouse, to that Chain Pharmacy Warehouse’s intracompany Pharmacy, to a patient or other designated persons authorized by law to dispense or administer such Prescription Drug to a patient; or

     d.  a Wholesale Distributor that is an ADR including intracompany distribution of any product [between Wholesale Distributor members of an affiliated group (as defined in section 1504(a) of the Internal Revenue Code of 1986) who are ADRs], to a Wholesale Distributor.

5.  Records described in this section are kept at the inspection site and readily available for inspection during the retention period. Records kept at a central location must be available for inspection within two working days of a request.

6.  An ongoing list of persons with whom the Wholesale Distributor conducts business is maintained.

7.  The Wholesale Distributor is establishing and maintaining a system for the mandatory reporting of Prescription Drug and Devices shortages or losses that exceeds a reasonable level established by like persons to the board of pharmacy or appropriate state regulatory agency and Food and Drug Administration (FDA) where it is known or suspected that diversion is occurring.

8.  The Wholesale Distributor has adequate processes in place for monitoring purchase activity of customers and identifying ordering patterns that identify potential diversion or criminal activity in accordance with state and federal law for controlled substances and “listed chemicals.” This requirement also applies to other Prescription Drugs known by the Wholesaler to be subject to diversion or criminal activity, such as non-controlled pain medication, lifestyle Drugs, short supply Drugs, and Drugs with a high potential for diversion.

9.  Drug and Device records, data, and documents are securely stored and access is restricted, and that policies and procedures have been implemented to protect the integrity of such records, data, and documents.

Authentication and Verification

Qualifying Wholesale Distributor shall maintain and enforce policies and procedures that:

1.  Ensure the integrity, legitimacy, and authenticity of Prescription Drug and Device purchase orders and/or requests.

2.  Establishes a process that ensures the verification of vendor and customer licenses using data from appropriate state and federal agencies, at least annually.

3.  Ensure the regular verification of the identity, legitimacy, and proper operation of entities seeking to sell or purchase Prescription Drug and Device products.

4.  Ensure Due Diligence is conducted on Prescription Drug suppliers not within the Normal Distribution Channel to determine that they are engaged in the lawful distribution of Prescription Drugs obtained from legitimate sources. This includes an understanding of the vendor’s sources of Prescription Drugs and assurance the vendor will provide Prescription Drugs obtained from lawful sources and not in violation of special purchasing contracts for own use or other restricted use.

5.  Ensure the assessment and authentication of Pedigrees and other accompanying documentation, such as invoices and shipping documents, to verify, back to the Manufacturer or Authorized Distributor of Record that received or purchased the Drug from the Manufacturer,that each transaction listed on a Pedigree or other documentation has occurred, identify suspicious transactions, and prevent the receipt of Prescription Drugs that have suspicious sources or transactions.

     a.  Suspicious sources and transactions include:      

          i.  A Wholesale Distributor located at the same address or having the same name as a Pharmacy or Practitioner, or other health care entity.   

          ii.  Transactions for Drugs that are bought and sold by several Wholesale Distributors, including those that occur within short time frames such as the same day.

          iii.  Intracompany transfers from a pharmacy to a Wholesale Distributor.

          iv.  Sales by Pharmacy to a Wholesale Distributor.

          v.  Sources that Wholesale Distribute Prescription Drugs in violation of contracts for “own use” or other restrictions limited by Group Purchasing Contracts or Federal Purchasing Programs.    

 b. Methods of Authentication include:

          i.  Receipt of an invoice (or shipping document) from the seller to the purchaser, which may have the prices redacted. Documentation requirements include at a minimum a copy of the invoice or shipping document. If this method is used to authenticate a Pedigree, the Wholesaler must review the document received for signs of tampering, incompleteness, or inconsistency with other invoices or shipping documents from that Manufacturer or Wholesaler, and must randomly verify the authenticity of the invoice or shipping document with the seller or shipping point reflected on that document using one of the methods in sub-subparagraph ii, iii, or iv below. Each wholesaler shall establish and adhere to policies and procedures for the random verification of the authenticity of the invoices or shipping documents according to statistically valid standards. 

          ii.  Telephone call to the seller. Documentation requirements include a signed statement by the person placing the telephone call identifying the person’s name and position title representing the seller who provides the information, the date the information was provided, and verification of the sales transaction between the parties, including verification of the date of the transaction and the quantity of Prescription Drugs involved in the transaction.

          iii.  E-mail communication with the seller. Documentation requirements include a copy of the e-mail that identifies the person’s name and position title representing the seller who provides the information, the date the information was provided, and verification of the sales transaction between the parties, including verification of the date of the transaction and the quantity of Prescription Drugs involved in the transaction.

          iv.  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). Documentation requirements include a written representation from the seller or independent person that the seller or independent person, as applicable, is responsible for the information included on the Web site and has adequate security on the information posted to prevent unauthorized tampering, manipulation, or modification of the information and a copy of the (dated) Web site page that confirms the sales transaction between the parties, including the date of the transaction and the quantity of Prescription Drugs involved in the transaction.

          v.  Receipt of a Pedigree in an electronic form digitally signed and electronically authenticated by an automated system that complies with the strictest state or federal regulation for self-authenticating Pedigrees.

6.  Ensure for cause authentications are conducted when the Verified-Accredited Wholesale Distributors (VAWD)-accredited Wholesale Distributor that purchases Drugs or Devices from another Wholesale Distributor has reason to believe, based on the totality of the facts and circumstances, that any Drug or Device purchased from the Wholesale Distributor is Counterfeit, suspected of being Counterfeit, Misbranded, or Adulterated. Examining factors shall include but are not limited to:

     a.  Date of purchase;

     b.  Lot number;

     c.  Sales invoice number; and

     d.  Contact information including name, address, telephone number, and e-mail address (if available) for the Wholesale Distributor that sold the Drug or Device for which Distribution is being Authenticated.

7.  Ensure that upon receipt, each shipping container shall be visually examined for identity and to determine if it may contain contaminated, Contraband, Counterfeit, suspected of being Counterfeit, or damaged Drugs or Devices, or Drugs or Devices that are otherwise unfit for Distribution. This examination shall be adequate to reveal container damage that would suggest possible contamination, Adulteration, Misbranding, Counterfeiting, suspicion of being Counterfeit, or other damage to the contents.

8.  Ensure that the Drugs or Devices found to be unacceptable under these criteria are quarantined from the rest of stock until it is determined that the Drugs and Devices are not outdated, damaged, deteriorated, Misbranded, Counterfeited, or Adulterated and they are further determined to be fit for human use.

9.  Ensure that each outgoing shipment shall be carefully inspected for identity of the Drugs or Devices and to ensure that there is no Delivery of Drugs or Devices that have been damaged in storage or held under improper conditions.

Returned, Damaged, and Outdated Drugs

Qualifying Wholesale Distributor shall maintain and enforce policies and procedures that:

1.  Ensure that any Drug or Device that is outdated, damaged, deteriorated, Misbranded, Counterfeited, suspected of being Counterfeited, Adulterated, or otherwise deemed unfit for human use shall be quarantined and physically separated from other Drugs and Devices until it is returned to either the Manufacturer or Wholesale Distributor from which it was acquired, or the destruction of the Drug or Device is authorized.

2.  Ensure that the disposition of Prescription Drugs sent for destruction is documented and proof of destruction, such as a Certificate of Destruction, is received and maintained by the Wholesale Distributor for inventory accountability,except when transferring drugs to the Manufacturer of that product or to a reverse distributor at the direction of the Manufacturer of that product.

3.  Ensure that when Drugs and Devices are Adulterated, Misbranded, Counterfeited, or suspected of being Counterfeit, notice of the Adulteration, Misbranding, Counterfeiting, or suspected Counterfeiting shall be provided to the board of pharmacy or appropriate state regulatory agency, FDA, and the Manufacturer or Wholesale Distributor from which they were acquired within three (3) business days. Any Drug or Device returned to a Manufacturer or Wholesale Distributor shall be kept under proper conditions during storage, handling, transport, and shipment, and documentation showing that proper conditions were maintained shall be provided to the Manufacturer or Wholesale Distributor to which the Drugs are returned.

4.  Ensure that when any Drug or Device whose immediate or sealed outer or secondary containers or Labeling are Adulterated, Misbranded, Counterfeited, or suspected of being Counterfeit, it shall be quarantined and physically separated from other Drugs or Devices until it is returned to either the Manufacturer or Wholesale Distributor from which it was acquired or destroyed. When the immediate or sealed outer or secondary containers or Labeling of any Drug or Device are Adulterated, Misbranded, Counterfeited, or suspected of being Counterfeit, notice of the Adulteration, Misbranding, Counterfeiting, or suspected Counterfeiting shall be provided to the board of pharmacy or appropriate state regulatory agency, FDA, and the Manufacturer or Wholesale Distributor from which it was acquired within three (3) business days.

5.  Ensure that when any Drug or Device that has been opened or used, but is not Adulterated, Misbranded, Counterfeited, or suspected of being Counterfeit, it shall be identified as such, and shall be quarantined and physically separated from other Drugs or Devices until it is returned to the Manufacturer or Wholesale Distributor from which acquired or it is destroyed.

6.  Ensure that if the conditions under which a Drug or Device has been returned cast doubt on the Drug’s or Device’s safety, identity, strength, quality, or purity, then the Drug or Device shall be destroyed, or returned to the supplier, unless examination, testing, or other investigation proves that the Drug or Device meets appropriate standards of safety, identity, strength, quality, and purity. In determining whether the conditions under which a Drug or Device has been returned cast doubt on the Drug’s or Device’s safety, identity, strength, quality, or purity, the Wholesale Drug Distributor shall consider, among other things, the conditions under which the Drug or Device has been held, stored, or shipped before or during its return and the condition of the Drug and its container, carton, or Labeling as a result of storage or shipping.

Policies and Procedures

Qualifying Wholesale Distributor shall maintain, enforce, and adhere to written policies and procedures, which shall be followed for:

1.  The receipt, security, storage, inventory, transport, and shipping and Distribution of Drugs, including policies and procedures for identifying, recording, and reporting losses or thefts, for correcting all errors and inaccuracies in inventories, and for ensuring the oldest approved stock of a Prescription Drug product is distributed first.

2.  Wholesale Distributors shall include in their written policies and procedures the following:

     a.  A procedure to be followed for handling recalls and written withdrawals of Drugs and Devices.

     b.  Any volunteer action by the Manufacturer to remove defective or potentially defective Drugs or Devices from the market; or

     c.  Any action undertaken to promote public health and safety by the replacement of existing merchandise with an improved product or new package design.

3.  To prepare for, protect against, and handle any crisis that affects the security or operation of any facility in the event of a strike, fire, flood, or other natural disaster, or other situations of local, state, or national emergency.

4.  To ensure that any outdated Drugs shall be segregated from other Drugs and either returned to the Manufacturer or destroyed in accordance with federal and state laws including all necessary documentation and the appropriate witnessing. This procedure shall provide for written documentation of the disposition of outdated Drugs. This documentation shall be maintained for three (3) years after disposition of the outdated Drugs.

5.  A procedure for disposing of and destroying containers, Labels, and packaging to ensure that the containers, Labels, and packaging cannot be used in Counterfeiting activities including all necessary documentation, maintained for a minimum of three (3) years, and the appropriate witnessing of the destruction of any Labels, packaging, Immediate Containers, or containers in accordance with all applicable federal and state requirements.

6.  A procedure for investigating discrepancies involving Counterfeit, suspected of being Counterfeit, Contraband, or suspected of being Contraband product in the inventory and reporting such discrepancies within three (3) business days to the board of pharmacy or appropriate state regulatory agency and appropriate federal agency.

7.  A procedure for reporting criminal or suspected criminal activities involving the inventory of Drug(s) and Device(s) to the board of pharmacy or appropriate state regulatory agency and appropriate federal agency within three (3) business days.

8.  A procedure for verifying security provisions of Common Carriers.

9.  A procedure for maintaining a Quality Improvement Program that monitors critical operations and tracks trends to improve processes.

History of Criteria Revisions

August 2006: VAWD Criteria updated to reflect amendments to the NABP Model Rules for the Licensure of Wholesale Distributors.

April 2009: VAWD Criteria updated to reflect amendments to the NABP Model Rules for the Licensure of Wholesale Distributors, addressing use of Common Carriers.

February 2013: VAWD Criteria updated pursuant to the recommendations of the Task Force on Virtual Manufacturers and Virtual Wholesale Distributors.