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BOARD OF PHARMACY
DIVISION 62
DRUG DISTRIBUTION AGENT
855-062-0003
Application
(1) The following persons must register
as a Drug Distribution Agent under this Division of rules:
(a) A broker;
(b) An import broker;
(c) An agent for a foreign manufacturer
who is registered with the Food and Drug Administration (FDA);
(d) Sales and marketing office
for a drug;
(e) A Drug Order Contractor;
(f) A Third-Party Logistics
Provider; and
(g) A person registered with
the FDA as the holder of a New Drug Application (NDA) or an Abbreviated New Drug
Application (ANDA) that contracts with a third-party for the manufacture of a drug
but does not take physical possession of the drug, does not have its name on the
label and is not accountable to the FDA for the purity and integrity of the drug.
(2) Any person who would otherwise
be required to register as a Wholesaler under Division 65 of this Chapter of rules
but who does not at any time have possession of a drug intended for distribution
must register as a Drug Distribution Agent under this Division of rules.
(3) A person whose sole purpose
is the marketing, brokering or arranging the initial distribution of drugs manufactured
by a registered manufacturer, but does not take physical possession of a product
must register as a Drug Distribution Agent.
Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: 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
855-062-0005
Definitions
(1) "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 drug.
(2) "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.
(3) "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.
(4)"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.
(5) “Drug”: In
this Division of rules, the term “drug” shall mean any drug and any
prescription device as these terms are defined in ORS 689.005.
(6) “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.
(7) “Manufacturer”
means any person, including a manufacturer's co-manufacturing partner, that is engaged
in the manufacture of a drug, is responsible or otherwise accountable to the Food
and Drug Administration (FDA) for the manufacture of the drug, or is the private
label manufacturer or distributor of product bearing its NDC number that is intended
for sale, distribution, dispensing or administration in Oregon, and who holds one
or more of the following registrations or licenses with the FDA:
(a) A New Drug Application number
(NDA);
(b) An Abbreviated New Drug
application number (ANDA);
(c) A Labeler Code number (LC)
or National Drug Code Number (NDC);
(d) An FDA Central File Number
(CFN);
(e) An FDA Establishment Identifier
number (FEI);
(f) A Biologic License Application
(BLA);
(g) An Outsourcing Facility.
(8) “Manufacture”
means the preparation, propagation, compounding, or processing of a drug or device
intended for human or animal use. Manufacture includes repackaging or otherwise
changing the container, wrapper, or labeling of any drug package in furtherance
of the distribution of the drug from the original place of manufacture to the person
who makes final delivery or sale to the ultimate consumer or user, except when the
process is part of a shared pharmacy service agreement as defined in OAR 855-006-0005.
(9)"Pedigree" for the purpose
of this Division consists of:
(a) “Transaction History”
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”
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”
is a statement, in paper or electronic form, that the entity transferring ownership
in a transaction is compliant with 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.
(10) “Person” means
individual, corporation, partnership, association, joint-stock company, business
trust or unincorporated organization.
(11) “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
to humans.
(12) “Third-Party Logistics
Provider” means an entity that provides or coordinates warehousing, or other
logistics services of a product in interstate commerce on behalf of a manufacturer,
wholesale distributor, or dispenser of a product, but does not take ownership of
the product, and not have responsibility to direct the sale or disposition of the
product.
Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: 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
855-062-0020
Registration
(1) Any person engaged in any part of the process of manufacture or wholesale distribution of a drug into, out of, or within Oregon must be registered with the Board. A person must register as either:
(a) A manufacturer under Division 60 of this chapter of rules; or
(b) A wholesaler under Division 65 of this chapter of rules; or
(c) A Drug Distribution Agent under this division of rules.
(2) A person that is required to register as a Drug Distribution Agent must be registered before commencing business in Oregon and before any drug for which they provide a manufacturing, marketing or distribution service, may be sold, distributed, dispensed or administered in Oregon.
(3) A person that is required to register as a Drug Distribution Agent must apply for registration on a form provided by the Board and must provide information required by the Board that shall include but is not limited to:
(a) The name, business address, social security number or 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) Every trade or business name used by the applicant;
(c) Any disciplinary action taken by any state or federal authority against the applicant or any other 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.
(4) An applicant for renewal must complete the form provided by the Board and submit it to the Board with the appropriate fee by August 31 annually.
(5) An applicant that provides a manufacturing or distribution service in respect of a controlled substance as defined in Division 80 of this chapter of rules must also complete and submit the Controlled Substance registration form provided by the Board, with the appropriate fee.
(6) The Board may require a criminal history and financial background check of each principal, owner or officer of the applicant prior to initial registration and prior to any renewal unless the applicant is publicly traded. Any such checks shall be at the applicant's expense.
(7) The Board may require a physical inspection of each facility prior to initial registration and prior to any renewal.
(8) Each separate business entity and each location that does business in Oregon must be separately registered by the Board.
(9) 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 is not limited to:
(a) Change of ownership;
(b) Change of business address;
(c) Any disciplinary action taken or pending by any state or federal authority against the registrant, or any of its principals, owners, directors, officers.
(10) The registration certificate is issued to a specific person and is non-transferable. Any addition or deletion of an owner or partner constitutes a change of ownership.
(11) The Board may waive any requirement of this rule if, in the Board's judgment, a waiver will further public health or safety. A waiver granted under this section shall only be effective when issued in writing.
Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: 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
855-062-0030
Minimum Qualifications
The Board may deny an application for registration or renewal of registration as a Drug Distribution Agent 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 a history of non-compliance with state or federal rules or laws regulating the manufacture, distribution, or dispensing of drugs;
(3) The applicant has made a material misrepresentation to the Board in the course of applying for an initial or renewal of registration;
(4) 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;
(5) The applicant has engaged in any conduct involving moral turpitude;
(6) 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 689.155
Hist.: 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
855-062-0040
Record Keeping
(1) A Drug Distribution Agent must establish
and maintain records regarding the distribution or other disposition of a drug.
(a) If a Drug Distribution Agent
distributes product to a wholesaler or pharmacy, the record must contain, but is
not limited to the following:
(A) The source of the drug,
including the name and physical address of the seller or transferor and any broker
or other person involved in the transaction, the address of the location from which
the drug was shipped and the address of the location to which the drug was shipped;
(B) The name, dose and quantity
of the drug distributed;
(C) The date of distribution
or other disposition of the drug.
(b) If a Drug Distribution Agent
distributes product to another Drug Distribution Agent, the pedigree must be maintained
and provided to the recipient of the distribution.
(2) 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, authorized law enforcement agencies, and this Board.
(3) Records required under these
rules must be maintained for three years.
(4) Records required under these
rules that are less than 13 months old must be kept at the address of record or
be immediately retrievable by computer or other electronic means, and must be immediately
available for inspection. All other records required by these rules must be made
available for inspection within three business days of a request.
Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: 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 5-2015(Temp), f. & cert. ef. 7-1-15 thru 12-27-15
855-062-0050
Prohibited Practices
(1) The following practices are expressly
prohibited:
(a) A Drug Distribution Agent
may not participate in the purchase of a drug from a closed-door pharmacy;
(b) A Drug Distribution Agent
may not participate in any way in the sale, distribution or transfer of a drug to
a person who is required by the laws and rules of Oregon to be registered with the
Board and who is not appropriately registered. Before authorizing or facilitating
the distribution of a drug, a Drug Distribution Agent must verify that the person
supplying or receiving the drug is appropriately registered with the Board.
(2) A Drug Distribution Agent
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 receipt of a drug that
is adulterated, misbranded, stolen, obtained by fraud or deceit, counterfeit, or
suspected counterfeit, 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;
(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) Facilitating the distribution
or attempting to facilitate the distribution of a drug by fraud, deceit, or misrepresentation;
(l) Facilitating the distribution
of a drug that was previously dispensed by a retail pharmacy or a practitioner;
(m) Failing to report an act
prohibited by any of the rules in OAR Chapter 855 to the appropriate state or federal
authorities.
Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155
Hist.: 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
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contained in the Administrative Order filed at the Archives Division,
800 Summer St. NE, Salem, Oregon 97310. Any discrepancies with the
published version are satisfied in favor of the Administrative Order.
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