OTC Medical Device Distributor Accreditation Criteria

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• Returned, Damaged, and Outdated Drugs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

The following criteria apply to any entity engaged in the distribution of diagnostic OTC medical devices that may be delivered by a pharmacy pursuant to a prescription.

Licensure

Qualifying over-the-counter (OTC) device distributors of diagnostic OTC medical devices shall provide information to verify that:

1. The OTC medical device distributor is engaged in the distribution of OTC medical devices which, for the purpose of these criteria, means distribution of an OTC medical device to someone other than a consumer or patient.
2. The OTC medical device distributor that provides services within a state, whether the OTC medical device distributor is located within the state or outside the state, is licensed or registered in good standing, or eligible to become licensed or registered, as required, in OTC medical device distribution in all applicable jurisdictions.
3. The OTC medical device 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. The OTC medical device 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 the OTC medical device distributor.
5. The OTC medical device distributor purchased the OTC medical device from the manufacturer or a distributor who purchased the OTC medical device from the manufacturer; thereby, preventing the receipt of diverted OTC devices to include, but not limited to, OTC devices originally sold to pharmacies, OTC medical devices dispensed to patients, and restricted use OTC devices.

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Facility

Qualifying OTC medical device distributors shall provide information to verify that:

1. The facility at which OTC medical devices are received, stored, warehoused, handled, held, offered, marketed, displayed, or transported from shall:
   1. Be of suitable construction to ensure that all OTC medical devices in the facility are maintained in accordance with the labeling of such OTC devices or in compliance with official compendium standards such as the United States Pharmacopeia – National Formulary (USP-NF)
   2. Be of suitable size and construction to facilitate cleaning, maintenance, and proper OTC medical device distribution operations
   3. Have adequate storage areas to provide adequate lighting, ventilation, temperature, sanitation, humidity, space, equipment, and security conditions:
      1. 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 the requirements in the current edition of an official compendium such as the USP-NF;
      2. Documentation of facility assessments, such as temperature mapping, or alternative processes will be maintained by the OTC medical device distributor to demonstrate the ability to properly store OTC medical devices in accordance with the labeling of the OTC medical device or the official compendium;
      3. If no storage requirements are established for an OTC medical device, the OTC medical devices 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
      4. Appropriate electromechanical, or electronic temperature and humidity recording equipment and/or logs, shall be utilized to document proper storage of OTC medical devices. Temperature and humidity monitoring and recording systems will operate continuously.
   4. Have a quarantine area for storage of OTC medical devices that are outdated, damaged, deteriorated, misbranded, adulterated, counterfeit or suspected of being counterfeit, otherwise unfit for distribution, or that are in immediate or sealed secondary containers that have been opened.
   5. Be maintained in a clean and orderly condition;
   6. Be free from infestation of any kind; and
   7. Not be a personal residence.
2. Appropriate inventory controls are maintained in order to detect and document any theft, counterfeiting, or diversion of OTC medical devices.
3. Adequate security for the facility has been provided for:
   1. All facilities used for OTC medical device distribution shall be secure from unauthorized entry;
   2. Access from outside the premises shall be kept to a minimum and be well controlled;
   3. The outside perimeter of the premises shall be well lighted;
   4. Entry into areas where OTC medical devices are held shall be limited to authorized personnel;
   5. All facilities shall be equipped with an alarm system to detect entry after hours;
   6. 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
   7. Verifying that all persons or entities who undertake, whether directly or by any other arrangement, to transport OTC medical devices on behalf of, the OTC medical device distributor ensures security via a verifiable security and delivery system.
4. OTC device 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 OTC medical devices shall comply with federal and state licensing requirements and the records of OTC medical device distribution must provide a clear audit trail that distinguishes all purchases and distributions of the OTC medical device distributor from any other entity.

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Virtual Manufacturers and OTC Medical Device Distributors

The OTC Medical Device Distributor Accreditation program defines virtual manufacturers and OTC medical device distributors as applicants that distribute an OTC medical device but never physically possess the product. Any OTC Medical Device Distributor Accreditation 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 OTC Medical Device Distributor accredited.

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Personnel

Qualifying OTC medical device distributor shall provide information to verify that:

1. The OTC medical device distributor, its officers, or its management, have not been enjoined, disciplined, fined, punished, or the like for violating any federal or state laws regulating drugs or devices.
2. The OTC medical device distributor, its officers, or its management have not been found guilty, pled guilty, or pled nolo contendere to any criminal offense.
3. The OTC medical device distributor’s facility manager has a sound financial history.
4. The OTC medical device distributor’s facility manager:
   1. Has a minimum of one year of verifiable full-time managerial or supervisory experience in wholesale distribution where the facility manager’s responsibilities included, but were not limited to, record keeping, storage, and shipment of drugs or devices;
   2. Serves as the facility manager for only one OTC medical device facility at any one time;
   3. Is actively involved in and aware of the actual daily operations of the OTC medical device distributor;
   4. Is employed full-time in a managerial position by the OTC medical device distributor;
   5. Is physically present at the OTC medical device distributor during normal business hours, except for time periods when absent due to illness, family illness or death, scheduled vacation, or another authorized absence. In the authorized absence of the facility manager, personnel employed by the OTC distributor with knowledge of the operation and appropriate education and/or experience to assume responsibility for the duties of the facility manager will be present; and
   6. Is aware of, and knowledgeable about, all policies and procedures pertaining to the operations of the OTC medical device distributor.
5. All personnel actively engaged in or who directly supervise the operation and handling of OTC medical devices, including the 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:
   1. Appropriate local and national criminal background checks; and
   2. Initial and for-cause toxicology screening; and
   3. Appropriate education, experience, and training necessary to safely and lawfully engage in the wholesale distribution of OTC medical devices;
6. The OTC medical device distributor maintains and enforces policies and procedures requiring documentation of responsible persons and persons in charge, including such persons’ titles, duties, and qualifications.
7. The OTC medical device distributor maintains and enforces policies and procedures that ensure the qualifications described in 5 above are documented and retained.
8. Qualifying OTC medical device distributors shall provide information to verify that, prior to the initial wholesale distribution or acquisition of OTC medical devices to or from any OTC medical device distributor, the distributing or acquiring OTC medical device distributor requires all delivery service providers contracted with or utilized by the OTC medical device distributor to require its employees whose responsibilities include the handling of OTC medical devices to undergo criminal background checks, initial and random toxicology screenings, and security training.

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Record Keeping

Qualifying OTC medical device distributors shall provide information to verify that:

1. The OTC medical device distributor is maintaining inventories and records regarding the receipt and distribution or other disposition of all OTC medical devices. These records shall include:
   1. Appropriate information and data to identify the source of the device and type of device being received or distributed; and
   2. All records related to the wholesale distribution of OTC medical devices, including but not limited to, invoices of purchase, packing slips, shipping records, and sales invoices, will accurately reflect the name of the OTC medical device distributor as it appears on the facility’s state license, as required, and the name under which the facility is seeking accreditation. Wholesale distributors to whom a license has been issued in the same name and at the same address as another licensee authorized to purchase OTC medical devices must utilize a method to distinguish purchases and distributions that are specific to the OTC medical device 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. 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.
4. An ongoing list of persons with whom the OTC medical device distributor conducts business is maintained.
5. The OTC medical device distributor shall establish and maintain a system for reporting:
   1. To the board of pharmacy and FDA device shortages or losses where theft or diversion is suspected.
      Instances of counterfeit, suspected of being counterfeit, contraband, or suspected of being contraband OTC medical devices 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.
   2. The OTC medical device distributor has adequate processes in place for monitoring the purchase activity of customers and identifying ordering patterns that identify potential diversion or criminal activity. This requirement also applies to other OTC medical devices known by the wholesaler to be subject to diversion or criminal activity, such as diabetic testing supplies.
6. OTC medical 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.

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Authentication and Verification

Qualifying OTC medical device distributors shall maintain and enforce policies and procedures that:

1. Ensure the integrity, legitimacy, and authenticity of OTC medical device purchase orders and/or requests.
2. Establish 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 OTC devices.
4. Ensure OTC medical device suppliers are engaged in the distribution of lawful products obtained from legitimate sources. This includes an understanding of the vendor’s sources of OTC medical devices and assurance the vendor will provide OTC medical devices obtained from lawful sources.
5. 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 OTC devices, or OTC medical 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, previously dispensed, or other damage to the contents.
6. Ensure that the OTC medical devices found to be unacceptable under these criteria are quarantined from the rest of stock until it is determined that the OTC medical devices are not outdated, damaged, deteriorated, misbranded, counterfeited, or adulterated and they are further determined to be fit for human use. This includes the reporting to appropriate authorities.
7. Ensure that each outgoing shipment shall be carefully inspected for identity of the OTC medical devices and to ensure that there is no delivery of OTC medical devices that have been damaged in storage or held under improper conditions.

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Returned, Damaged, and Outdated Drugs

Qualifying OTC medical device distributors shall maintain and enforce policies and procedures that:

1. Ensure that any OTC medical device that is outdated, damaged, deteriorated, misbranded, counterfeited, suspected of being counterfeited, adulterated, or otherwise deemed unfit for human use be quarantined and physically separated from other OTC medical devices until it is returned to either the manufacturer or wholesale distributor from which it was acquired, or the destruction of the OTC medical device is authorized.
2. Ensure that the disposition of OTC medical devices sent for destruction is documented and proof of destruction, such as a certificate of destruction, is received and maintained by the OTC medical device distributor for inventory accountability, except when transferring OTC medical devices to the manufacturer of that product or to a reverse distributor at the direction of the manufacturer of that product.
3. Ensure that when OTC medical 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 OTC medical 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 OTC medical device distributor to which the OTC medical devices are returned.
4. Ensure that when any OTC medical 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 OTC medical devices until it is returned to either the manufacturer or OTC medical device distributor from which it was acquired or destroyed. When the immediate or sealed outer or secondary containers or labeling of any drug or OTC medical 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, or as otherwise required by law.
5. Ensure that when any OTC medical 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 OTC medical 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 OTC medical device has been returned cast doubt on the OTC medical device’s safety, identity, strength, quality, or purity, then the OTC medical device shall be destroyed, or returned to the supplier, unless examination, testing, or other investigation proves that the OTC medical device meets appropriate standards of safety, identity, strength, quality, and purity. In determining whether the conditions under which an OTC medical device has been returned cast doubt on the drug’s or device’s safety, identity, strength, quality, or purity, the OTC medical device distributor shall consider, among other things, the conditions under which the OTC medical device has been held, stored, or shipped before or during its return and the condition of the OTC medical device and its container, carton, or labeling as a result of storage or shipping.

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Policies and Procedures

Qualifying OTC medical device distributors shall maintain, enforce, and adhere to written policies and procedures, which shall be followed for:

1. The receipt, security, storage, inventory, transport, shipping, and distribution of OTC medical devices, including policies and procedures for identifying, recording, and reporting losses or thefts or for correcting all errors and inaccuracies in inventories, and for ensuring the oldest approved stock of a OTC medical device is distributed first.
2. OTC medical device distributors shall include in their written policies and procedures the following:
   1. A procedure to be followed for handling recalls and written withdrawals of OTC medical devices.
   2. Any volunteer action by the manufacturer to remove defective or potentially defective OTC medical devices from the market; or
   3. 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 OTC medical devices shall be segregated from other OTC medical devices 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 OTC medical devices. 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:
   1. Counterfeit, suspected of being counterfeit, contraband or OTC medical devices 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 OTC medical devices to the board of pharmacy or appropriate state regulatory agency and appropriate federal agency within three (3) business days, or sooner if required by law.
8. A procedure for verifying security provisions of delivery service providers.
9. A procedure for maintaining a quality improvement program that monitors critical operations and tracks trends to improve processes.
10. A procedure for monitoring and reporting suspicious offers for OTC medical devices including unsolicited sales offers to the board of pharmacy or appropriate state regulatory agency and appropriate federal agency within three (3) business days, or sooner if required by law.

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