4729-9-28 Licensure as a virtual wholesale distributor/broker.

 

 

 

4729-9-28                    Licensure as a Virtual Wholesale Distributor/Broker.

 

 

 

(A)"Virtual  Wholesale  Distributor/Broker"  means  any  person  engaged  in  wholesale distribution of dangerous drugs in or into Ohio which:

 

(1)Has title but does not take physical possession of dangerous drugs;

 

(2)Shall be licensed by the state board of pharmacy as a wholesale distributor pursuant to section 4729.52 of the Revised Code with a virtual wholesale distributor/broker classification; and

 

(3)Shall be registered as a business entity with the appropriate state or local authority(s) and must operate out of a location that is zoned for commercial use and not out of a residence or personal dwelling.

 

(B)The following information shall be required on a form supplied by the state board of pharmacy from each person making application for a license as a wholesale distributor of dangerous drugs with a virtual wholesale distributor/broker classification:

 

(1)The name, full business address (not a post office box), and telephone number;

 

(2)All trade or business names used by the licensee, any trade or business names under which licensee was previously or is presently licensed;

 

(3)Addresses, telephone numbers, and the full names of contact persons for all facilities used by the licensee for the storage, handling, and distribution of dangerous drugs;

 

(4)The  type  of  ownership  or  operation  (i.e.,  sole  proprietorship,  partnership, corporation, or government agency);

 

(5) The full name(s) of the owner and/or operator of the licensee, including:

 

(a) If a sole proprietorship, the full name of the sole proprietor, and the name of the business entity;

 

(b) If a partnership, the full name of each partner, and the name of the partnership;

 

(c) If a corporation, the full name and title of each corporate officer and director, the corporate names, the name of the state of incorporation, the corporation number, and a copy of the corporation papers;

 

(d)If a government agency, the name of the agency, and the full name of each officer and director of the agency.

 

(6) A copy of any existing licensure the entity has from the state in which it is

 

 

located or a letter from a state entity where it is located that indicates that the state does not license such entities;

(7) A copy of any federal licensure or registration, including a drug enforcement agency registration if distributing controlled substances;

(8) If the entity making application for a wholesale distributor of dangerous drugs license with a virtual wholesale distributor/broker classification is located outside the boundaries of the state of Ohio, part of the licensing process shall be an inquiry to the licensing authority of the state in which that entity is located. This inquiry will determine whether the entity possesses a current and valid license to distribute dangerous drugs in that state and the experience the licensing authority has had with the entity. If a state does not license Virtual Wholesale Distributor/Brokers as defined in paragraph (A) of this rule, the facility must maintain Verified-Accredited Wholesale Distributors (VAWD) accreditation from the National Association of Boards of Pharmacy.

(9) Pursuant to division (A)(1) of section 4729.53 of the Revised Code, a new wholesale distributor of dangerous drug license with a virtual wholesale distributor/broker classification will not be issued until the owner(s), the officers (if incorporated) or agency directors (if a government agency) of the wholesale operation submit fingerprints to the Ohio bureau of criminal identification and investigation (BCI&I) for a criminal records check. If there is a change in officers, owners or agency directors, all new officers, owners or agency directors shall submit to a criminal records check. The criminal records check shall consist of both a BCI&I criminal records check and a federal bureau of investigations records check (FBI). The results of the criminal records check must be sent directly to the Ohio state board of pharmacy from BCI&I. To be considered valid, the criminal records check must have been performed within the past twelve months. After the board receives the results of all of the required criminal records checks the license process will proceed. The owner(s) or officers may submit electronic fingerprint impressions pursuant to rule 4729-5-12 of the Administrative Code, or, if located outside of Ohio, they may submit ink fingerprint impressions as instructed on a form provided by the board.

(10) Any additional information as the state board of pharmacy may require.

(C) Prior to the end of the licensing period, a renewal application requesting such information as the state board of pharmacy may require will be sent to the attention of the responsible person. Such a renewal application shall be completed and returned with the applicable fee on or before the established deadline. As part of the renewal application, a person meeting the definition of a virtual wholesaler/broker that was licensed by the board as a wholesale distributor of dangerous drugs prior to the effective date of this rule shall demonstrate compliance with the requirements in paragraph (B)(8) of this rule. Failure to do so may result in a refusal by the board

to renew the license.

(D) Virtual Wholesale Distributors/Brokers shall establish and maintain inventories and records of all transactions regarding the receipt and distribution or other disposition of dangerous drugs.

(1) These records shall include but not be limited to the following information:

(a) The source of the drugs, including the all of the following:

(i) name and principle address of the seller or transferor;

(ii) the address of the location from which the drugs were shipped; and

(iii) verification that the seller or transferor is appropriately licensed to sell or transfer dangerous drugs at wholesale.

(b) The identity and quantity of the drugs received and distributed or disposed of.

(c) The dates of receipt and distribution of the drugs.

(d)A system of records and procedures shall be maintained which prevent the sale or other distribution of dangerous drugs to any person not authorized by division (B) of section 4729.51 of the Revised Code.

(e) A system shall be designed and operated to disclose orders for controlled substances and other dangerous drugs subject to abuse. Reports, generated by the system, shall be furnished to the state board of pharmacy within three working days of receipt of a request from the board. The reports shall include the name and address of the purchaser, date of purchases, product trade name, national drug code (NDC) number, size of package, and quantity purchased.

(2) Inventories and records shall be made available for inspection and photocopying by properly identified and authorized state board of pharmacy designated agents, federal, state, or local law enforcement agency officials for a period of three years following disposition of the drugs.

(3) Records described in this rule that are kept at the inspection site or that can be immediately retrieved by computer or other electronic means shall be readily available for authorized inspection during the retention period.

(a) Records kept at a central location apart from the inspection site and not electronically retrievable shall be made available for inspection within two working days of a request by properly identified and authorized state board of pharmacy designated agents, federal, state, or local law

enforcement agency officials.

(b) Virtual wholesale distributors/brokers intending to maintain records, described in this rule, at a location other than the place licensed by the state board of pharmacy must obtain approval from the board.

(E) The virtual wholesale distributors/broker shall inform the state board of pharmacy of suspicious orders for controlled substances and other dangerous drugs subject to abuse, immediately upon discovery. Suspicious orders are those which, in relation to the wholesaler's records as a whole, are of unusual size, unusual frequency, or deviate substantially from established buying patterns.

(F) Virtual wholesale distributors/brokers shall establish, maintain, and adhere to written policies and procedures which shall be followed for the receipt, security, storage, inventory, and distribution of dangerous drugs, including policies and procedures for identifying, recording, and reporting losses or thefts, and for correcting all errors and inaccuracies in inventories. At a minimum, virtual wholesale distributors/brokers shall include in their written policies and procedures the following:

(1) A procedure whereby the oldest approved stock of a dangerous drug product is distributed first. The procedure may permit deviation from this requirement, if such deviation is temporary and appropriate.

(2) A procedure to be followed for handling recalls and withdrawals of dangerous drugs. Such procedure shall address recalls and withdrawals due to:

(a) Any action initiated at the request of the food and drug administration or other federal, state, or local law enforcement or other government agency, including the state board of pharmacy;

(b) Any  voluntary  action  by  the  manufacturer  to  remove  defective  or potentially defective drugs from the market;

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

(3) A procedure to ensure that virtual wholesale distributors/brokers prepare for, protect against, and handle any crisis that affects security or operation of any facility in the event of strike, fire, flood, or other natural disaster, or other situations of local, state, or national emergency.

(4) A procedure to ensure that any adulterated dangerous drugs shall be segregated from other drugs and either returned to the manufacturer or destroyed. This procedure shall provide for written documentation of the disposition of outdated dangerous drugs.

(5) This documentation shall be maintained for three years after disposition of the outdated drugs.

(G) Wholesale distributors of dangerous drugs shall establish and maintain accurate and current lists of officers, directors, managers, and other persons in charge of wholesale drug distribution, storage, and handling, including a description of their duties and a summary of their qualifications.

(H) Personnel employed in the wholesale distribution of dangerous drugs shall be required to have appropriate education and/or experience to assume responsibility for positions related to compliance with the licensing regulations.

(I) Wholesale drug distributors shall operate in compliance with applicable federal, state, and local laws and regulations.

(1) Virtual wholesale distributors/brokers shall permit properly identified and authorized state board of pharmacy designated agents, federal, state, and local law enforcement officials to enter and inspect their premises and delivery vehicles, and to audit their records and written operating procedures at reasonable times and in a reasonable manner, to the extent authorized by law.

(2) Any virtual wholesale distributor/broker making a wholesale sale of a controlled substance shall be required to possess a license as a wholesale distributor of dangerous drugs with a virtual wholesale distributor/broker classification and a license as a wholesaler or manufacturer of controlled substances, except that a licensed terminal distributor of dangerous drugs may make an occasional sale of a controlled substance pursuant to rule 4729-9-10 of the Administrative Code.

(J) Virtual wholesale distributors/brokers shall be subject to the provisions of any applicable federal, state, or local laws or regulations that relate to dangerous drug salvaging or reprocessing.

(K) The state board of pharmacy shall be notified within thirty days of any new facilities, work or storage areas to be constructed or utilized for dangerous drugs or of any changes in operation of the registrant being used or implemented.

(L) The virtual wholesale distributors/brokers shall comply with Title II of the Drug Quality and Security Act (9/3/2015).

(M) Virtual wholesale distributors/brokers shall submit wholesale sale information to the board of pharmacy in accordance with Chapter 4729-37 of the Administrative Code.

Effective:	04/01/2016
Five Year Review (FYR) Dates:	04/01/2021
CERTIFIED ELECTRONICALLY
Certification
02/12/2016
Date
Promulgated Under:	119.03
Statutory Authority:	3719.28, 4729.26
Rule Amplifies:	3719.03, 4729.53