OPERATION OF NONPRESCRIPTION AND MEDICAL DEVICE,
EQUIPMENT AND GAS (MDEG) OUTLETS
(1) All applications for registration of a new or relocated proprietary drug outlet shall be accompanied by the required fees as set forth in 855-110-0007.
(2) Application shall specify the location of the proprietary drug outlet. When the applicant is not the owner of the business, the application shall indicate the owner and the applicant's affiliation with the owner:
(a) If the owner is a partnership or other multiple owner, the names of the partners or persons holding the five largest interests shall be indicated on the application.
(b) If the owner is a corporation, the name filed shall be the same as filed with the Corporation Commissioner. The name of the corporation, the names of the corporation officers and the names of the stockholders who own the five largest interests shall be indicated on the application.
(c) Upon request by the Board, the applicant shall furnish such information as required by the Board regarding the partners, stockholders, or other persons not named in the application.
(3) All registration renewal applications shall be accompanied by the annual fee and contain the same information required in subsections (2)(a), (b) and (c) of this rule.
(4) If the annual registration fee referred to in section (1) of this rule is not paid by January 31 of the current year, a delinquent fee as set forth in OAR 855-110-0007 shall be included with the application for registration renewal.
(5) A change of ownership or location requires a new application, fee and registration within 15 days of the change .
(6) The registration certificate is issued to a person or firm and is non-transferable. Additions or deletions of a partner/partners shall be considered as a change of ownership.
(7) The registration fee cannot be prorated.
(8) No nonprescription drug or medical gas authorized to be sold at retail under this registration shall be sold, given away, or otherwise disposed of until application has been approved and a certificate of registration issued. There shall be four types of drug outlet registrations:
(a) Class A shall be for all outlets except those that own more than one vending machine distributing more than six nonprescription drugs.
(b) Class B shall be for all outlets except those that own more than one vending machine distributing six or less nonprescription drugs.
(c) Class C shall be for all outlets distributing medicinal gases.
(d) Class D shall be for all outlets with more than one vending machine distributing nonprescription drugs.
(e) Class E shall be for any nonprofit, tax exempt, food distribution facility that distributes food products and nonprescription drugs at no cost, other than nominal delivery charges, to charitable organizations including regional food banks, for distribution at no cost to individuals. This registration, which shall be issued at no cost to the registrant, expires on January 31st annually.
Explanation: The intention of this section is that an owner of a single vending machine that contains over-the-counter medications can register as either a Class A or Class B outlet based on the number of medications in the machine. The owner of more than one vending machine that contains over-the-counter medications shall register as a Class D outlet and inform the Board of their locations. Class E registration is intended for the Oregon Food Bank and other regional food banks located in Oregon.
(9) If there is more than one drug outlet under the same roof and each outlet is independently operated by different owners, a separate registration shall be obtained for each outlet.
(10) In case of loss of the certificate of registration, the Board may require a sworn statement before a notary public to be filed in the Board office before duplicate certificates of registration can be issued.
(11) Each vending machine that contains nonprescription drugs must have an obvious and legible statement on the machine that identifies the owner of the machine, advises the customer to check the expiration date of the product before using, and lists the phone number for the Board of Pharmacy.
(12) A Class D nonprescription drug outlet shall keep the Board informed in writing of the current location of all of its vending machines.
(13) Notwithstanding the requirements of this rule and the other rules in this Division, upon written request the Board may waive any of the requirements of this rule or the other rules in this Division if a waiver will further public health and safety. A waiver granted under this section shall only be effective when it is issued in writing.
Stat. Auth.: ORS 689.155 & 689.205
Stats. Implemented: ORS 475.035, 689.135 & 689.305
Hist.: 1PB 2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80; PB 1-1992, f. & cert. ef. 1-31-92; PB 1-1996, f. & cert. ef. 4-5-96; PB 1-1997, f. & cert. ef. 9-22-97; BP 2-2008, f. & cert. ef. 2-20-08
Sales by drug outlets except itinerant vendors shall be made only from the premises at the location registered by the Board.
Hist:. 1PB 2-1981, f. & ef. 8-20-81; PB 1-1992, f. & cert. ef. 1-31-92; PB 1-1996, f. & cert. ef. 4-5-96
Minimum Standards for Nonprescription and Medical Gas Drug Outlets
(1) Drug outlets shall have floor space and shelving to insure that drugs are stocked and stored in sanitary, well-lighted areas. Where applicable, temperature, ventilation and moisture controls shall be employed.
(2) Expiration dates on drug outlet drugs shall be the responsibility of each drug outlet to insure products are in date.
(3) There shall be no advertisements of any kind by a drug outlet using the following or similar terms: "drug store", "pharmacy", "apothecary".
Stat. Auth.: ORS 475.035 & ORS 689.205
Stats. Implemented: ORS 689.305 & ORS 689.325
Hist.: 1PB 2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80; PB 1-1992, f. & cert. ef. 1-31-92; PB 1-1996, f. & cert. ef. 4-5-96
Change of Business Name, Closure
(1) Any change of business name of a drug outlet must be reported to the Board within 15 days by filing a new application for which no fee is required. New certificates of registration will be issued at the next regular renewal period.
(2) Any closure of a drug outlet shall be reported to the Board within 15 days.
Sales of Non-Prescription Drugs
Registered nonprescription drug outlets may sell or donate non-prescription drugs in the original and unbroken packages only, properly labeled according to state and federal law, in conformity with rules of the Board. A nonprescription drug outlet shall not purchase or receive nonprescription drugs from a source not registered with the Board.
Stat. Auth.: ORS 475.035 & 689.205
Stats. Implemented: ORS 689.135, 689.305 689.315
Hist.: 1PB 2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80; PB 1-1992, f. & cert. ef. 1-31-92; PB 1-1996, f. & cert. ef. 4-5-96; BP 2-2008, f. & cert. ef. 2-20-08
Disposal of Drugs
Drugs that are outdated, damaged, deteriorated, misbranded, or adulterated shall be quarantined and physically separated from other drugs until they are destroyed or returned to their supplier.
Seasonal Nonprescription Drug Outlets
(1) Seasonal nonprescription drug outlets are defined as those outlets who either by location or weather are restricted to a seasonal demand for services.
(2) Seasonal nonprescription drug outlets shall be exempt from delinquent fees for nonprescription registration if renewals are paid no later than June 1 of current year.
Stat. Auth.: ORS 475.035 & ORS 689.205
Stats. Implemented: ORS 689.325
Hist.: 1PB 1-1981(Temp), f. & ef. 4-1-81; 1PB 2-1981, f. & ef. 8-20-81; PB 1-1992, f. & cert. ef. 1-31-92; PB 1-1996, f. & cert. ef. 4-5-96
Medical Device, Equipment and Gas (MDEG) Outlet (Class C)
(1) Medical Device, Equipment and Gas (MDEG) Outlets may sell:
(a) Nonprescription drugs;
(b) Specific drugs and materials that require the order or prescription of a practitioner:
(A) USP Oxygen,
(B) USP Sodium Chloride Irrigation,
(C) USP Sodium Chloride Injection,
(D) Sterile water for irrigation,
(E) Urological catheters, and
(F) Respiratory devices
(2) Medicinal Gas Drug Outlets shall distribute medicinal Nitrous Oxide only to practitioners or institutional drug outlets.
(3) Record keeping: All records of receipt and distribution of medical devices, equipment, and gas must be maintained for a minimum of three years and must be readily retrievable.
Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.305
Hist.: PB 1-1992, f. & cert. ef. 1-31-92; PB 1-1996, f. & cert. ef. 4-5-96; BP 1-2002, f. & cert. ef. 1-8-02
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