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Oregon Bulletin

January 1, 2013

Board of Pharmacy, Chapter 855

Rule Caption: Amend Wholesaler and Fee Rules.

Adm. Order No.: BP 6-2012

Filed with Sec. of State: 12-13-2012

Certified to be Effective: 12-13-12

Notice Publication Date: 11-1-2012

Rules Amended: 855-065-0005, 855-110-0007

Subject: The rule amendments in division 65 amend the definition of Class II Wholesaler to include Oxygen USP and medical gases.

 The rule amendments in division 110 implement a licensing and delinquent fee for the registration and renewal of Supervising Physician Dispensing Outlets as required by 2012 Senate Bill 1565.

 Both rules expire by Temporary rule on December 16, 2012.

 The complete text of these rules is available on the Board’s website at: www.pharmacy.state.or.us.

Rules Coordinator: Karen MacLean—(971) 673-0001

855-065-0005

Definitions

(1) “Authenticate” means to verify that each transaction listed on the pedigree and other accompanying documentation has occurred and is accurately recorded.

(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) “Common Carrier” means an organization that is available to the public to transport a product or service using its facilities, or those of other carriers.

(8) “Contraband Drug” means a drug that is counterfeit, stolen, misbranded, obtained by fraud, or purchased by an entity for its own use and placed in commerce in violation of an own-use agreement for that drug.

(9) “Cooperative Pharmacy Warehouse” means a physical location for drugs that acts as a central warehouse and is owned, operated or affiliated with a group purchasing organization or pharmacy buying cooperative and distributes drugs exclusively to its members. To be considered part of the Normal Chain of Distribution as defined in section (16) of this rule, a Cooperative Pharmacy Warehouse must also be listed as an Authorized Distributor of Record for that manufacturer.

(10) “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.

(11) “Drop Shipment” means a drug transaction whereby the manufacturer, that manufacturer’s co-manufacturing partner, that manufacturer’s third-party logistics provider, or that manufacturer’s exclusive distributor delivers a drug directly to a chain pharmacy warehouse, a cooperative pharmacy warehouse, a pharmacy, or other person authorized to administer or dispense prescription drugs to a patient, but transfers title to the drug to a wholesale distributor. A drop shipment shall be considered as part of a normal chain of distribution as defined in section (16) of this rule.

(12) “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.

(13) “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.

(14) “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.

(15) “Manufacturer’s Exclusive Distributor” means an entity, including a manufacturer’s wholly owned distributor, that contracts with a manufacturer who is registered under Division 60 of this chapter of rules, to provide or coordinate warehousing, distribution, or other services on behalf of a manufacturer and takes title to that manufacturer’s drug, but does not have general responsibility to direct the drug’s sale or disposition. To be considered part of the Normal Chain of Distribution as defined in section (16) of this rule, a Manufacturer’s Exclusive Distributor must also be listed as an Authorized Distributor of Record for that manufacturer.

(16) “Normal Chain of Distribution” means a chain of distribution, including a drop-shipment, for a prescription drug that goes from: a manufacturer; a manufacturer’s co-manufacturing partner; a manufacturer’s exclusive distributor; or a manufacturer’s third-party logistics provider to:

(a) A pharmacy or a person authorized to administer or dispense a prescription drug to a patient; or

(b) A manufacturer’s authorized distributor of record, to a pharmacy or a person authorized to administer or dispense a prescription drug to a patient; or

(c) A manufacturer’s authorized distributor of record, to a chain pharmacy warehouse, to that chain pharmacy warehouse’s intra company pharmacy, to a patient or a person authorized to administer or dispense a prescription drug to a patient; or

(d) A chain pharmacy warehouse, to that chain pharmacy warehouse’s intra company pharmacy, to a patient or a person authorized to administer or dispense a prescription drug to a patient; or

(e) A manufacturer’s authorized distributor of record, to a specialty wholesaler, to a pharmacy or a person authorized to administer or dispense a prescription drug to a patient; or

(f) A manufacturer’s authorized distributor of record to a cooperative pharmacy warehouse, to a member of the affiliated group purchasing organization or pharmacy buying cooperative, to a patient or a person authorized to administer or dispense a prescription drug to a patient.

(17) “Pedigree” means a statement or record in a written or electronic form that accurately records each wholesale distribution of a prescription drug from the sale by a manufacturer through acquisition and sale by any wholesale distributor or repackager until final sale to a pharmacy or other person authorized to administer or dispense the drug. The pedigree must include, but not be limited to, the following information for each transaction:

(a) The source of the prescription drug, including the name and principal address of the seller;

(b) The proprietary and established name of the prescription drug, the National Drug Code number, the amount of the prescription drug, its dosage form and dosage strength, the date of the purchase, the sales invoice number or other unique shipping document number that identifies the transaction, container size, number of containers, expiration date, and lot number or control number of the prescription drug;

(c) The business name and address of each owner of the prescription drug and its shipping information, including the name and address of the facility of each person certifying delivery or receipt of the prescription drug.

(18) “Prescription Drug” means any drug required by law to be dispensed only by a prescription.

(19) “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.

(20) “Specialty Wholesale Distributor” means an entity that exclusively distributes a limited product line of drugs to a specific group of pharmacies or registered practitioners as approved in writing by the Board. To be considered part of the Normal Chain of Distribution as defined in section (16) of this rule, a Specialty Wholesale Distributor must also be listed as an Authorized Distributor of Record for that manufacturer.

(21) “Third-Party Logistics Provider” means an entity that contracts with a manufacturer who is registered under these rules to provide or coordinate warehousing, distribution, or other services on behalf of the manufacturer, but does not take title to the drug or have general responsibility to direct the sale or disposition of the drug. To be considered part of the Normal Chain of Distribution as defined in section (16) of this rule, a Third-Party Logistics Provider must also be listed as an Authorized Distributor of Record for that manufacturer.

(22) “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 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 for emergency medical reasons, including but not limited to 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 sale of a drug by a charitable organization described under 501(c)(3) of the Internal Revenue Code 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 retail pharmacy or chain pharmacy warehouse of expired, damaged, returned or recalled drugs to the original manufacturer, wholesale distributor, or to a third-party returns processor or reverse wholesaler, and the returns of saleable drugs to the original manufacturer or wholesaler.

(l) The transporting of a drug by common carrier where the common carrier does not take title to the drug and does not have responsibility to direct the drug’s sale or distribution.

(m) The sale, transfer, merger or consolidation of all or part of the business of a pharmacy from or with another pharmacy.

(n) 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.

(23) “Wholesale Distributor” means any entity engaged in the wholesale distribution of drugs, including any entity whose business name appears on any invoice or other type of shipping document indicating possession or title. 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; independent wholesale drug traders; third-party logistics providers; cooperative pharmacy warehouses; retail pharmacies that conduct wholesale distribution; and chain pharmacy warehouses that conduct wholesale distribution. To be considered part of the Normal Chain of Distribution as defined in section (16) of this rule, a Wholesale Distributor must also be listed as an Authorized Distributor of Record for that manufacturer.

(24) “Wholesaler” means any wholesale distributor:

(a) “Class I Wholesaler” means any person operating or maintaining a wholesale distribution center, wholesale business or any other business in which 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;

(b) “Class II 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)–(E) 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:

(A) Non-prescription drugs;

(B) 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;

(C) Prescription devices that do not contain a prescription drug;

(D) Drugs or devices possessed by a state or local government agency, or non-profit relief organization approved by the Board.

(E) Oxygen USP and medical gases.

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

855-110-0007

Fees for Registration, Renewal, and Reinspection of Drug Outlets

(1) County Health Clinic (including family planning clinics). Expires March 31 annually — $100. Delinquent renewal fee (postmarked after February 28) — $25.

(2) Drug Distribution Agent. Expires September 30 annually — $400. Delinquent renewal fee (postmarked after August 31) — $100.

(3) Drug Room (including correctional facility). Expires March 31 annually — $100. Delinquent renewal fee (postmarked after February 28) — $75.

(4) Manufacturer. Expires September 30 annually — $400. Delinquent renewal fee (postmarked after August 31) — $100.

(5) Medical Device, Equipment & Gas Class C. Expires January 31 annually — $50. Delinquent renewal fee (postmarked after December 31) — $25.

(6) Nonprescription Class A. Expires January 31 annually — $50. Delinquent renewal fee (postmarked after December 31) — $25.

(7) Nonprescription Class B. Expires January 31 annually — $50. Delinquent renewal fee (postmarked after December 31) — $25.

(8) Nonprescription Class D. Expires January 31 annually — $100. Delinquent renewal fee (postmarked after December 31) — $25.

(9) Prophylactic and/or Contraceptive Wholesaler and/or Manufacturer — $100. Expires December 31 annually.

(10) Re-inspection fee — $100. Applies to any re-inspection of a drug outlet occasioned to verify corrections of violations found in an initial inspection.

(11) Retail or Institutional Drug Outlet. Expires March 31 annually — $300. Delinquent renewal fee (postmarked after February 28) — $75.

(12) Wholesaler Class I, Expires September 30 annually — $400. Delinquent renewal fee (postmarked after August 31) — $100.

(13) Wholesaler Class II. Expires September 30 annually — $400. Delinquent renewal fee (postmarked after August 31) — $100.

(14) Remote Dispensing Machine/Facility. Expires March 31 annually — $100. Due by February 28 annually.

(15) Charitable Pharmacy. Expires March 31 annually — $75. Delinquent renewal fee (postmarked after February 28) — $25.

(16) Home Dialysis. Expires March 31 annually — $300. Delinquent renewal fee (postmarked after February 28) — $75.

(17) Supervising Physician Dispensing Outlet. Expires March 31 annually — $300. Delinquent renewal fee (postmarked after February 28) — $75.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.135, 689.774 & 2012 OL Ch. 34
Hist.: PB 1-1996, f. & cert. ef. 4-5-96; PB 1-1997, f. & cert. ef. 9-22-97; BP 3-1998, f. & cert. ef. 3-23-98; BP 2-2001(Temp), f. & cert. ef. 7-26-01 thru 1-22-02; BP 1-2002, f. & cert. ef. 1-8-02; BP 4-2002, f. 6-27-02, cert. ef. 7-1-02; BP 2-2005, f. 2-14-05, cert. ef. 3-1-05; 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 6-2010, f. & cert. ef. 6-29-10; BP 5-2011(Temp), f. 6-24-11, cert. ef. 7-1-11 thru 12-27-11; BP 8-2011, f. & cert. ef. 12-15-11; BP 5-2012(Temp), f. & cert. ef. 6-19-12 thru 12-16-12; BP 6-2012, f. & cert. ef. 12-13-12

Notes
1.) This online version of the OREGON BULLETIN is provided for convenience of reference and enhanced access. The official, record copy of this publication is contained in the original Administrative Orders and Rulemaking Notices filed with the Secretary of State, Archives Division. Discrepancies, if any, are satisfied in favor of the original versions. Use the OAR Revision Cumulative Index found in the Oregon Bulletin to access a numerical list of rulemaking actions after November 15, 2012.

2.) Copyright 2013 Oregon Secretary of State: Terms and Conditions of Use

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