WHOLESALE DRUG OUTLETS
(1) These rules (OAR 855-065-0001 to 855-065-0013) apply to any person, including any business entity, located in or outside Oregon that engages in the wholesale distribution of prescription or non-prescription drugs in Oregon except that a manufacturer that is registered under division 60 of this chapter of rules does not also need to register as a wholesale distributor under these rules if they only distribute their own products or those manufactured by a Co-Manufacturing Partner as defined in OAR 855-065-0005.
(2) Any person who is a Third-Party Logistics Provider as defined in division 62 or whose sole purpose is the marketing, brokering or arranging the distribution of drugs manufactured by a manufacturer must register as a Drug Distribution Agent in accordance with division 62 of this chapter of rules.
Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: 1PB 2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80; PB 3-1992, f. & cert. ef. 3-26-92 (and corrected 4-8-92); PB 1-1994, f. & cert. ef. 2-2-94; BP 4-2002, f. 6-27-02, cert. ef. 7-1-02; BP 12-2006, f. & cert. ef. 12-19-06; BP 2-2009(Temp), f. 6-22-09, cert. ef. 6-26-09 thru 12-23-09; BP 5-2009, f. & cert. ef. 12-24-09; BP 4-2015, f. & cert. ef. 7-1-15
(1) “Affiliate” means a business entity that has a relationship, or is an authorized trading partner, with a second business entity if, directly or indirectly:
(a) One business entity controls, or has the power to control, the other business entity; or
(b) A third party controls, or has the power to control, both of the business entities.
(2) "Authorized Distributor of Record" means a wholesale distributor with whom a manufacturer has established an ongoing relationship to distribute the manufacturer's prescription drug. An ongoing relationship is deemed to exist between such wholesale distributor and a manufacturer when the wholesale distributor, including any affiliated group of the wholesale distributor, as defined in Section 1504 of the Internal Revenue Code, complies with either or both of the following:
(a) The wholesale distributor has a written agreement currently in effect with the manufacturer evidencing such ongoing relationship; or
(b) The wholesale distributor is listed on the manufacturer's current list of authorized distributors of record, which is updated by the manufacturer no less than monthly.
(3) "Broker" means a person engaged in the marketing, offering, or contracting for wholesale distribution and sale of a drug into, within, or out of Oregon and who does not take physical possession of the brokered substance.
(4) "Chain Pharmacy Warehouse" means a physical location for drugs that acts as a central warehouse and performs intra company sales or transfers of drugs to a group of chain pharmacies that have the same common ownership and control.
(5) "Closed Door Pharmacy" means a pharmacy that provides pharmaceutical services to a defined and exclusive group of patients and is not open for dispensing to the general patient population and cannot be registered as a wholesale distributor.
(6) "Co-Manufacturing Partner" means a pharmaceutical manufacturer that has entered into an agreement with another pharmaceutical manufacturer to engage in a business activity or occupation related to the manufacture or distribution of a prescription drug.
(7) "Designated Representative" means an individual designated by each wholesale distributor registered by the Board who will serve as the primary contact person for the wholesale distributor with the Board and who is responsible for managing the company's operations at that registered location.
(8) "Drug Sample" means a unit of a drug that is intended to promote the sale of the drug, but which is not itself for sale.
(9) “Illegitimate Product” means a product for which credible evidence shows that the product is:
(a) Counterfeit, diverted, or stolen;
(b) Intentionally adulterated such that the product would result in serious adverse health consequences or death to humans;
(c) The subject of a fraudulent transaction; or
(d) Otherwise unfit for distribution such that the product would be reasonably likely to result in serious adverse health consequences or death.
(10) "Intra Company Transfer" means the transfer of any drug between a division, subsidiary, parent, and an affiliated or related company under the common ownership and control of a corporate entity.
(11) "Manufacturer" means anyone, including a manufacturer's co-manufacturing partner, who is engaged in manufacturing, preparing, propagating, compounding, processing, packaging, repackaging, or labeling of a drug, except when the process is part of a shared pharmacy service agreement as defined in OAR 855-006-0005.
(12) "Pedigree" for the purpose of this Division consists of:
(a) “Transaction History,” which means a statement in paper or electronic form, including the transaction information for each prior transaction going back to the manufacturer of the product.
(b) “Transaction Information,” which must include, but is not limited to:
(A) The proprietary or established name or names of the product;
(B) The strength and dosage form of the product;
(C) The National Drug Code number of the product;
(D) The container size;
(E) The number of containers;
(F) The lot number of the product;
(G) The date of the transaction;
(H) The date of the shipment, if more than 24 hours after the date of the transaction;
(I) The business name and address of the person from whom ownership is being transferred; and
(J) The business name and address of the person to whom ownership is being transferred.
(c) “Transaction Statement,” which is a statement, in paper or electronic form, that the entity transferring ownership in a transaction is compliant with Food and Drug Administration (FDA) regulations set forth by the Drug Quality and Security Act and includes but is not limited to:
(A) Confirmation that the entity is authorized or registered as required under the Drug Supply Chain Security Act;
(B) Acknowledgement that product is received from an authorized or registered entity, as required under the Drug Supply Chain Security Act;
(C) Confirmation of receipt of transaction information and of transaction statement from the prior owner of the product, as required under the Drug Supply Chain Security Act;
(D) Verification that a suspect or illegitimate product was not knowingly shipped;
(E) Confirmation that systems and processes are in place to comply with verification requirements under the Drug Supply Chain Security Act;
(F) Confirmation that false transaction information was not knowingly provided; and
(G) Confirmation that transaction history was not knowingly altered.
(13) "Prescription Drug" means any drug required by law to be dispensed only by a prescription.
(14) “Quarantine” means the storage or identification of a product, to prevent distribution or transfer of the product, in a physically separate area clearly identified for such use or through other procedures.
(15) "Repackage" means repackaging or otherwise changing the container, wrapper, or labeling to further the distribution of a prescription drug excluding that completed by the pharmacist responsible for dispensing the product to a patient.
(16) “Repackager” means a person who owns or operates an establishment that repacks and relabels a product or package for:
(a) Further sale; or
(b) Distribution without a further transaction.
(17) “Suspect Product” means a product for which there is reason to believe that such product is:
(a) Potentially counterfeit, diverted, or stolen;
(b) Potentially intentionally adulterated such that the product would result in serious adverse health consequences or death to humans;
(c) Potentially the subject of a fraudulent transaction; or
(d) Otherwise unfit for distribution such that the product would result in serious adverse health consequences or death.
(18) “Trading Partner” means:
(a) A manufacturer, repackager, wholesale distributor, or dispenser from whom a manufacturer, repackager, wholesale distributor, or dispenser accepts direct ownership of a product or to whom a manufacturer, repackager, wholesale distributor, or dispenser transfers direct ownership of a product; or
(b) A third-party logistics provider from whom a manufacturer, repackager, wholesale distributor, or dispenser accepts direct possession of a product or to whom a manufacturer, repackager, wholesale distributor, or dispenser transfers direct possession of a product.
(19) “Validate” means to verify that each transaction listed on the pedigree and other accompanying documentation has occurred and is accurately recorded.
(20) "Wholesale Distribution" means distribution of a drug to a person other than a consumer or patient, but does not include:
(a) Delivery by a retail pharmacy of a prescription drug to a patient or patient's agent pursuant to the lawful order of a licensed practitioner.
(b) The sale of minimal quantities of a prescription drug by retail or institutional pharmacies to licensed practitioners for office use.
(c) The sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug which may include:
(A) Emergency medical reasons;
(B) Drug or devices used during a federal or state declared emergency; or
(C) The transfer of a drug by a pharmacy to another pharmacy to alleviate a temporary shortage.
(d) Intra company transfer of drugs as defined in these rules.
(e) The lawful distribution of a drug sample by a manufacturer's or a distributor's representative.
(f) The distribution of a drug or an offer to distribute a drug by a charitable organization to a non-profit affiliate of the organization to the extent permitted by law.
(g) The purchase or acquisition of a drug by a hospital or other health care entity that is a member of a group purchasing organization, for the hospital's or health care entity's own use, from the group purchasing organization or from other hospitals or health care entities that are members of the organization or under common control.
(h) The transfer of a prescription drug between pharmacies pursuant to a shared pharmacy service agreement as defined in OAR 855-006-0005.
(i) The distribution by a manufacturer, as part of a prescription assistance program, of a drug intended for a specific patient, to a person authorized to prescribe, administer or dispense prescription drugs.
(j) The sale, purchase, or trade of blood and blood components intended for transfusion.
(k) Drug returns, when conducted in accordance with state and federal laws and regulations. A drug return includes the sale or transfer from a dispenser, retail pharmacy, or chain pharmacy warehouse of expired, damaged, returned or recalled drugs to the original manufacturer, wholesale distributor, or to a reverse wholesaler, and the returns of saleable drugs to the original manufacturer or wholesaler.
(l) The sale, transfer, merger or consolidation of all or part of the business of a pharmacy from or with another pharmacy.
(m) The distribution of drugs by a manufacturer registered under division 60 of this chapter of rules of its own products to a person other than a patient.
(21) "Wholesale Distributor" means any entity engaged in the wholesale distribution of drugs. The term "Wholesale Distributor" includes but is not limited to, own-label distributors; private-label distributors; warehouses, including manufacturers' and distributors' warehouses; drug wholesalers or distributors; retail pharmacies that conduct wholesale distribution; and chain pharmacy warehouses that conduct wholesale distribution.
(22) "Wholesaler" means any wholesale distributor:
(a) "Class I Wholesaler" for the purpose of these rules means any person operating or maintaining a wholesale distribution center, wholesale business or any other business in which prescription drugs, including controlled drugs, devices containing prescription drugs, medicinal chemicals, or poisons are sold, dispensed, stocked, exposed or offered for sale at wholesale to a pharmacy or other legally licensed drug outlets or persons and is required to comply with all pedigree requirements;
(b) "Class II Wholesaler" means any person operating or maintaining a wholesale distribution center, wholesale business or any other business in which any non-prescription drugs are stored, or offered for sale or distribution at wholesale to a drug outlet or practitioner legally authorized to resell, distribute, dispense or administer.
(c) “Class III Wholesaler” means any person operating or maintaining a wholesale distribution center, wholesale business or any other business in which any of the products in paragraphs (A)-(F) below are stored, or offered for sale or distribution at wholesale to a drug outlet or practitioner legally authorized to resell, distribute, dispense or administer and is exempted from Federal recordkeeping requirements:
(A) Drugs distributed exclusively for veterinary use. If any prescription drugs not intended for veterinary use are offered for sale, the wholesaler must register as a Class I wholesaler;
(B) Prescription devices that do not contain a prescription drug;
(C) Drugs or devices possessed by a state or local government agency, or non-profit relief organization approved by the Board;
(D) Oxygen USP and medical gases;
(E) Intravenous drugs; by which formulation, are intended for the replenishment of fluids, electrolytes or calories;
(F) Medical convenience kits which includes any non controlled drug product or biological product, assembled in kit form.
Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: 1PB 2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80; PB 3-1992, f. & cert. ef. 3-26-92 (and corrected 4-8-92); BP 12-2006, f. & cert. ef. 12-19-06; BP 2-2009(Temp), f. 6-22-09, cert. ef. 6-26-09 thru 12-23-09; BP 5-2009, f. & cert. ef. 12-24-09; BP 4-2012(Temp), f. & cert. ef. 6-19-12 thru 12-16-12; BP 6-2012, f. & cert. ef. 12-13-12; BP 4-2015, f. & cert. ef. 7-1-15
(1) Every wholesale distributor, wherever located, that engages in wholesale distribution into, out of, or within Oregon must be registered with the Board in accordance with the laws and regulations of Oregon before engaging in wholesale distribution of drugs. Every applicant for registration or renewal of registration must pay the appropriate fee in accordance with OAR 855-110-0007 and 855-110-0010. An applicant must register as a Class I Wholesaler or a Class II Wholesaler unless the applicant qualifies for registration as a Drug Distribution Agent under Division 62 of this chapter of rules.
(2) Application for registration must be on a form approved by the Board and must include, but not be limited to, the following information:
(a) The name, business address, social security number and federal tax identification number of each owner, officer, and stockholder owning more than 10 per cent of the stock of the company, unless the stock of the company is publicly traded;
(b) All trade or business names used by the applicant including any businesses outside Oregon;
(c) The names, addresses and telephone numbers of the designated representatives for all facilities used by the applicant that engage in wholesale distribution into, out of, or within Oregon;
(d) The normal business hours for the applicant; and
(e) Any disciplinary action taken by any state or federal authority against the applicant or any other wholesale distributor under common ownership or control, or any owner, principal or designated representative of the applicant, in connection with the drug laws or regulations of any state or the federal government.
(3) The Board may require a criminal history and financial background check of each principal, owner, officer and designated representative of the applicant prior to initial registration and prior to any renewal. Any such checks shall be at the applicant's expense.
(4) The Board may require a physical inspection of each facility prior to initial registration and prior to any renewal.
(5) Any wholesale distributor located outside the boundaries of Oregon, applying for registration or re-registration, as a Class I Wholesaler, must provide evidence of one of the following:
(a) A current license or registration as a wholesale distributor in a state that has a license or registration procedure approved by the Board that included a physical inspection within the past three years; or
(b) A current accreditation by a process approved by the Board such as The National Association of Boards of Pharmacy's Verified Accredited Wholesale Distributor (VAWD) program or other nationally recognized accreditation program or contract inspection service.
(6) Any wholesale distributor located inside the boundaries of Oregon, applying for registration or re-registration, as a Class I Wholesaler, must provide evidence of one of the following:
(a) A current accreditation by a process approved by the Board such as The National Association of Boards of Pharmacy's Verified Accredited Wholesale Distributor (VAWD) program or other nationally recognized accreditation program or contract inspection service; or
(b) That it is a small business as defined in ORS 183.310(10); and
(A) The applicant has no affiliation with any out-of-state pharmaceutical company; and
(B) All owners and principals of the applicant are Oregon residents; and
(C) No owner or principal, or close family member of an owner or principal, has a controlling or business interest in any other pharmaceutical company; and
(D) Neither the applicant, nor any of its owners or principals, has ever been found to be in violation of any drug law or regulation in this or any other state.
(7) In addition to the above registration requirements, an applicant for registration as a Class I wholesaler under this rule, that has not received VAWD accreditation, must provide evidence that it has obtained a bond or equivalent means of security of at least $100,000 that provides direct access to the Oregon Board of Pharmacy as a beneficiary to secure payment of any administrative penalties that may be imposed by the Board and any fees and costs that may be incurred by the Board and that:
(a) Are related to a registration held by the wholesale distributor; and
(b) Are authorized under Oregon law; and
(c) The wholesale distributor fails to pay less than thirty days after the penalties, fees, or costs become final.
(8) The Board may make a claim against a bond or security posted under section (7) of this rule within one year after the wholesale distributor's registration is no longer valid or sixty days after the conclusion of whichever occurs later:
(a) An administrative or legal proceeding before or on behalf of the Board that involves the wholesale distributor and results in penalties, fees or costs; or
(b) An appeal of such a proceeding.
(9) Where operations are conducted at more than one location by a single wholesale drug outlet, each such location that does business in Oregon must be registered by the Board.
(10) The registrant must notify the Board, within 15 days, of any substantial change to the information provided on the registration application. Substantial change shall include but not be limited to: change of ownership; change of business address; change of normal business hours; any disciplinary action taken or pending by any state or federal authority against the registrant, or any of its principals, owners, directors, officers, or designated representatives.
(11) The registration certificate is issued to a specific person and is non-transferable. Additions or deletions of an owner or partner shall be considered as a change of ownership.
(12) A new registration form is required for a change of ownership or location and must be submitted to the Board with the fees as specified in OAR 855-110-0007 within 15 days of the change.
(13) Upon written request, the Board may waive any of the requirements of this rule if a waiver will further public health or safety. A waiver granted under this section shall only be effective when it is issued in writing.
Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: BP 12-2006, f. & cert. ef. 12-19-06; BP 2-2009(Temp), f. 6-22-09, cert. ef. 6-26-09 thru 12-23-09; BP 5-2009, f. & cert. ef. 12-24-09
The Board may deny an application for an initial registration or renewal of registration as a wholesale distributor on any of the following grounds:
(1) The applicant has been found by the Board or by a court to have violated the pharmacy or drug laws or rules of this state or of any other state or of the federal government.
(2) The applicant has been convicted of any offence under federal, state, or local laws.
(3) The applicant has a history of non-compliance with state or federal rules or laws regulating the manufacture, distribution, or dispensing of drugs.
(4) The applicant has made a material misrepresentation to the Board in the course of applying for an initial or renewal of registration.
(5) Disciplinary action has been taken by the federal government or by any state, or local government regarding any license or registration currently or previously held by the applicant for the manufacture, distribution or dispensing of any drugs.
(6) The applicant has engaged in any conduct involving moral turpitude.
(7) The Board determines that granting the registration is not consistent with the public health or safety or is otherwise not in the public interest.
Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 475.135, 689.155, 689.305, 689.315 & 689.405
Hist.: PB 3-1992, f. & cert. ef. 3-26-92 (and corrected 4-8-92); BP 12-2006, f. & cert. ef. 12-19-06
As a part of the registration or re-registration application, an applicant for registration as a Class I Wholesaler must name a Designated Representative (DR) for each wholesale distributor registered under these rules. The DR must:
(1) Be employed in a full-time managerial position by the wholesale distributor and may not be listed as the DR for more than one registrant without the specific written authority of the Board.
(2) Have at least two years verifiable full-time managerial or supervisory experience in a pharmacy or with a wholesale distributor registered under these rules or with another state.
(3) Have verifiable experience in record keeping and storage of prescription drugs.
(4) Be actively involved in and aware of the daily operations of the wholesale distributor.
(5) Be knowledgeable about all policies and procedures of the wholesale distributor.
(6) Be physically present at the wholesale distributor during normal business hours, which must be posted to be visible to the public, except when absent due to emergency, authorized absence or legitimate business reason (as used in this rule, "normal business hours" means at least six hours between 6.00 am and 7.00 pm on at least five days between Monday and Saturday every week, excluding national and local holidays). Class I wholesalers located within Oregon must designate a replacement DR and notify the Board accordingly, when any absence of the DR exceeds 15 days.
(7) The DR must conduct a self-inspection of the facility by September 1 each year, and document the results of this self-inspection on Oregon Wholesaler Self-Inspection Form provided by the Board. The DR must certify in writing, under penalties of perjury, that the information recorded on the Oregon Wholesaler Self-Inspection Form is correct. This form must be retained for three years and must be made available to the Board within two days upon request.
(8) The DR must ensure that the wholesale drug outlet has policies and procedures in effect and implemented to ensure that the outlet employs adequate personnel with the education and experience necessary to engage in the wholesale distribution of drugs safely and lawfully.
Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155 & 689.315, 689.325
Hist.: PB 3-1992, f. & cert. ef. 3-26-92 (and corrected 4-8-92); BP 12-2006, f. & cert. ef. 12-19-06
Minimum Requirements for Record Keeping and Inventory Management
(1) A Wholesale distributor must establish and maintain inventories and records of all transactions regarding the receipt and distribution or other disposition of drugs. These records must comply with all federal drug laws and regulations unless exempted.
(2) Inventories and records required by this rule must be made available for inspection and copying by any authorized official of the Drug Enforcement Agency, the Food and Drug Administration, the Department of Agriculture, law enforcement agencies, and this Board.
(3) Inventories and records required under these rules must be maintained for a minimum of three years following disposition of the drugs.
(4) Records described in this section that are less than 13 months old must be kept at the inspection site or be immediately retrievable by computer or other electronic means, and must be immediately available for inspection. All other records required by this rule must be made available for inspection within three business days of a request.
(5) A wholesale distributor must establish, maintain, and adhere to written policies and procedures for the receipt, security, storage, inventory, transport, shipping and distribution of drugs, including policies and procedures for identifying, recording, and reporting any loss, theft, counterfeiting or diversion of any drug and for correcting all errors and inaccuracies in inventories. A wholesale distributor must include in its written policies and procedures the following:
(a) A procedure whereby the oldest approved stock of a drug is distributed first. The procedure may permit deviation from this requirement if such deviation is temporary and appropriate.
(b) A procedure to be followed for handling a recall or withdrawal of a drug. Such procedure must be adequate to deal with a recall or withdrawal 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 Board;
(B) Any voluntary action by the manufacturer to remove a defective or potentially defective drug from the market; or
(C) Any action undertaken to promote public health and safety by replacing an existing drug with an improved product or new package design.
(c) A procedure to prepare for, protect against, and handle any crisis that affects the security or operation of the facility in the event of strike, fire, flood, or other natural disaster, or other local, state, or national emergencies.
(d) A procedure to ensure that any outdated drug is segregated from other drugs and either returned to the manufacturer or destroyed. This procedure must provide for written documentation of the disposition of an outdated drug. This documentation must be maintained for three years after disposition of the outdated drug.
(e) Disposition and destruction of containers, labels, and packaging to ensure that the containers, labels, and packaging are not used in counterfeiting activities, including necessary documentation and witnessing in accordance with state and federal law.
(f) Investigation of discrepancies in the inventory involving counterfeit, suspected counterfeit, contraband, or suspected contraband drugs and reporting of discrepancies within three business days to the Board and any other appropriate state or federal agency.
(g) Reporting of criminal or suspected criminal activities involving the inventory of drugs to the Board within three business days.
(h) Conducting for cause authentication as required under section (7) of this rule.
(i) Procedures for accurately documenting the temperature and humidity conditions of the storage facility.
(6) A wholesale distributor must maintain and adhere to written policies and procedures for all incoming and outgoing product shipments, including but not limited to the following:
(a) Upon receipt, visual examination of each shipping container sufficient to identify the drugs in the container and to determine whether the drugs may be outdated, adulterated, misbranded, contaminated, contraband, counterfeit, damaged, or otherwise unfit for distribution.
(b) Upon receipt, review of records for accuracy and completeness, considering the:
(A) Total facts and circumstances surrounding each transaction involving the drugs; and
(B) Wholesale distributors involved.
(c) Quarantine of a drug considered to be outdated, adulterated, misbranded, contaminated, contraband, counterfeit, damaged, or otherwise unfit for distribution until:
(A) Examination and a determination is made that the drug is fit for distribution; or
(B) The drug is destroyed or returned to the manufacturer or wholesale distributor from which the drug was acquired.
(d) If the wholesale distributor identifies a suspect product, the wholesale distributor must quarantine the product and promptly conduct an investigation to determine whether the suspect product is illegitimate. If it is determined to be an illegitimate product the wholesale distributor must provide notice to the Board, the Food and Drug Administration, and the trading partners involved in the transaction, within 24 hours.
(e) If the immediate or sealed outer or secondary container or labeling of a drug is adulterated, misbranded, counterfeit, or suspected counterfeit, the wholesale distributor must:
(A) Quarantine the drug until the drug is destroyed or returned to the manufacturer or wholesale distributor from which the drug was acquired; and
(B) Provide notice of the adulteration, misbranding, counterfeiting, or suspected counterfeiting to the Board, the Food and Drug Administration, and the manufacturer or wholesale distributor from which the drug was acquired, within 24 hours.
(f) A drug that is not adulterated, misbranded, counterfeit, or suspected counterfeit, but has been opened or used, is identified as such and quarantined until the drug is destroyed or returned to the manufacturer or wholesale distributor from which the drug was acquired.
(g) A drug that will be returned to a manufacturer or wholesale distributor is stored, handled and transported under proper conditions before the return, and documentation showing that proper conditions were maintained must be provided to the manufacturer or wholesale distributor to which the drug is returned.
(h) Inspection of each outgoing shipment to verify the identity of each drug and to ensure that each drug has not been damaged in storage or held under improper conditions.
(i) Contraband, counterfeit, or suspected counterfeit drugs, other evidence of criminal activity, and accompanying documentation are retained until a disposition is authorized by the Board or the Food and Drug Administration.
(j) Any sealed outer or secondary shipping container or labeling, and accompanying documentation, for a drug that is suspected to be counterfeit or fraudulent, is retained until a disposition is authorized by the Board and the Food and Drug Administration.
(k) Operations comply with all state and federal laws, rules and regulations applicable to wholesale drug distribution.
(l) All confidential information is stored in an area with restricted access and in such a way as to protect the integrity and confidentiality of the information.
(7) A wholesale distributor must maintain pedigree records for a minimum of three years.
(8) If the wholesale distributor is involved in the distribution of controlled substances, the distributor must register with the Drug Enforcement Administration and the Board, and comply with all laws related to the storage, handling, transport, shipment, and distribution of controlled substances including, but not limited to, the isolation of controlled substances from non-controlled substances and storage of the controlled substances in a secure area in accordance with Drug Enforcement Administration security requirements and standards.
Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155, 689.315, 689.325 & 689.765
Hist.: 1PB 2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80; PB 3-1992, f. & cert. ef. 3-26-92 (and corrected 4-8-92); BP 12-2006, f. & cert. ef. 12-19-06; BP 4-2015, f. & cert. ef. 7-1-15
Storage of Drugs
(1) As a condition for receiving and retaining a wholesale distributor registration issued under these rules, an applicant must satisfy the Board that the applicant has and will continuously maintain acceptable storage and handling conditions and facilities standards for each facility at which drugs are received, stored, warehoused, handled, held, offered, marketed, or displayed, or from which drugs are transported, including:
(a) Suitable construction of the facility and appropriate monitoring equipment to ensure that drugs in the facility are maintained in accordance with labeling or in compliance with official compendium standards.
(b) Suitable size and construction to facilitate cleaning, maintenance, and proper wholesale distribution operations.
(c) Adequate storage areas to provide appropriate lighting, ventilation, temperature, sanitation, humidity, space, equipment, and security conditions.
(d) A quarantine area for the separate storage of drugs that are outdated, damaged, deteriorated, misbranded, adulterated, counterfeit, suspected counterfeit, otherwise unfit for distribution, or contained in immediate or sealed secondary containers that have been opened.
(e) Maintenance of the facility in a clean and orderly condition.
(f) Maintenance of the facility in a commercial, nonresidential building.
(g) Freedom of the facility from infestation by insects, rodents, birds or vermin of any kind.
(2) The facility must be equipped with appropriate manual, electromechanical, or electronic temperature and humidity recording equipment, devices, and logs to document proper storage of drugs.
(3) The facility must meet security standards including but not limited to:
(a) Access controls that restrict access to areas where drugs are held, to authorized personnel.
(b) An after hours central alarm or a comparable entry detection system.
(c) Adequate outside perimeter lighting.
(d) Safeguards against theft and diversion, including employee theft and theft or diversion facilitated or hidden by tampering with computers or electronic records.
Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155 & 689.305
Hist.: BP 12-2006, f. & cert. ef. 12-19-06
(1) The following practices are expressly prohibited:
(a) A wholesale distributor may not purchase drugs from a closed-door pharmacy.
(b) A wholesale distributor may not sell, distribute or transfer a drug to a person who is required by the laws and rules of Oregon to be registered with the Oregon Board of Pharmacy and who is not appropriately registered by the Board. Before furnishing a drug to any person not known to the wholesale distributor, the wholesale distributor must verify that the person is legally authorized to receive the drug.
(c) A wholesale distributor may not purchase any drug from a person who is required by the laws and rules of Oregon to be registered with the Oregon Board of Pharmacy and who is not appropriately registered by the Board. Before purchasing a drug from any person not known to the wholesale distributor, the wholesale distributor must verify that the person is legally authorized to sell the drug.
(d) A Class 1 Wholesaler who is classified as a "Specialty Wholesaler Distributor" as defined in OAR 855-065-005(20) may not:
(A) Sell, distribute or transfer a prescription drug to a pharmacy or to a practitioner who is licensed to prescribe the prescription drug, without providing a complete pedigree for the prescription drug, unless the prescription drug was purchased directly from the manufacturer or from the manufacturer's authorized distributor of record.
(B) Sell, distribute or transfer a prescription drug to a wholesale distributor, without providing a complete pedigree for the prescription drug.
(2) A wholesaler may not perform, cause the performance of, or aid the performance of any of the following:
(a) The manufacture, repackaging, sale, delivery, holding, or offering for sale of a drug that is adulterated, misbranded, counterfeit, suspected counterfeit, or is otherwise unfit for distribution.
(b) The adulteration, misbranding, or counterfeiting of a drug.
(c) The intentional receipt of a drug that is adulterated, misbranded, stolen, obtained by fraud or deceit, counterfeit, or suspected product, and the delivery or proffered delivery of the drug for pay or otherwise.
(d) The alteration, mutilation, destruction, obliteration, or removal of the whole or a part of the labeling of a drug or the commission of another act with respect to a drug that results in the drug being misbranded.
(e) The forging, counterfeiting, simulating, or falsely representing a drug using a mark, stamp, tag, label, or other identification device without the authorization of the manufacturer.
(f) The purchase or receipt of a drug from a person that is not registered to distribute drugs to the purchaser or recipient.
(g) The sale or transfer of a drug to a person that is not authorized under the law of the jurisdiction in which the person receives the drug, to purchase or receive drugs from the person selling or transferring the drug.
(h) The failure to maintain or provide records as required under these rules.
(i) Providing the Board, a representative of the Board, or a state or federal official with false or fraudulent records or making false or fraudulent statements regarding a matter related to these rules.
(j) Participating in the wholesale distribution of a drug that was:
(A) Purchased by a public or private hospital or other health care entity under the terms of an "own-use" contract; or
(B) Donated or supplied at a reduced price to a charitable organization; or
(C) Stolen or obtained by fraud or deceit; or
(D) Illegally imported into the USA.
(k) Obtaining or attempting to obtain a drug by fraud, deceit, misrepresentation, or engaging in fraud, deceit, or misrepresentation in the distribution of a drug.
(l) Failing to maintain required pedigree records.
(m) Receiving a prescription drug through wholesale distribution without receiving a required pedigree attested to as accurate and complete by the wholesale distributor.
(n) Distributing a drug that was previously dispensed by a retail pharmacy or a practitioner.
(o) Failing to report an act prohibited by any of the rules in OAR 855.065 to the appropriate state or federal authorities.
Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155, 689.305, 689.315 & 689.527
Hist.: BP 12-2006, f. & cert. ef. 12-19-06; BP 4-2015, f. & cert. ef. 7-1-15
State Archives • 800 Summer St. NE • Salem, OR 97310