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The Oregon Administrative Rules contain OARs filed through September 15, 2014
 
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BOARD OF PHARMACY

 

DIVISION 60

PHARMACEUTICAL MANUFACTURERS

 855-060-0001

Application

No place of manufacturing, wholesaling or repackaging of drugs or medicines, as defined in ORS 689.005(20), (35), and (36) shall be conducted or operated until it has been registered by the State Board of Pharmacy, except that compounding or repackaging, as a part of a Shared Pharmacy Services agreement as defined in OAR 855-006-0005(20), does not constitute manufacturing. Manufacturing registration expires September 30th annually:

(1) All applications for registration of a new or relocated manufacturer shall be accompanied by the required fees as set forth in 855-110-0007(3).

(2) Application shall specify the location of the manufacturer premises. 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 person 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 subsection (2)(a), (b), and (c) of this rule.

(4) A change of ownership or location requires a new application, fee and registration within 15 days.

(5) 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.

(6) The registration cannot be prorated.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155, 689.305, 689.315 & 689.325
Hist.: 1PB 2-1980, f. & ef. 4-3-80; PB 1-1994, f. & cert. ef. 2-2-94; Administrative correction 5-23-00; BP 1-2002, f. & cert. ef. 1-8-02; BP 12-2006, f. & cert. ef. 12-19-06

855-060-0004

Registration

(1) Any person that manufactures, or contracts for the manufacture of a drug or prescription device that is intended for sale, distribution, dispensing or administration in Oregon must register with the Oregon Board of Pharmacy.

(2) Any person that holds one or more of the following registrations with the Federal Food and Drug Administration (FDA) must register as a Manufacturer.

(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).

(3) A person that is registered with the FDA as a repackager must register as a Manufacturer.

(4) A person whose sole purpose is the marketing, brokering or arranging the initial distribution of drugs manufactured by a manufacturer, but does not take physical possession of a product must register as a Drug Distribution Agent under OAR 855-062-0005.

(5) A person who is registered with the FDA as the Agent for a foreign manufacturer must register as a Drug Distribution Agent under OAR 855-062-0005.

(6) An applicant for a new or renewal of registration must provide all information specified on the form provided by the Board, and pay the fee as specified in OAR 855-110-0007. The applicant must also provide any additional information requested by the Board. An application that does not contain all required information is incomplete and will not be processed.

(7) The registration is non-transferable. Addition or deletion of an owner shall be considered as a change of ownership except where the registrant is a publicly held corporation. A new application for registration and payment of a new registration fee is required when a registrant changes ownership or location. This new application must be submitted to the Board at least 15 days prior to the change.

(8) A person who compounds a drug that is distributed in Oregon not based on a patient specific prescription must register with the Board as a Manufacturer, unless done so pursuant to a Shared Pharmacy Services agreement, as defined in OAR 855-006-0005, between two in-state entities.

Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155 & 689.305
Hist.: BP 9-2011, f. 12-30-11, cert. ef. 1-1-12; BP 1-2013(Temp), f. 3-6-13, cert. ef. 3-7-13 thru 9-3-13; BP 5-2013, f. & cert. ef. 8-29-13

855-060-0005

General Provisions and Minimum Standards

In order to qualify for a manufacturing registration, the applicant shall meet certain minimum standards:

(1) Organization: The physical plant of the manufacturer shall be properly organized with adequate facilities and qualified personnel to operate the same under the direction of a technically trained or professionally competent supervisor:

(a) The production supervisor in charge shall be responsible to the proper administrative authority of the manufacturer for the developing, supervising, and coordinating of all the activities of the manufacturing plant so far as production techniques are involved;

(b) Departmentalization shall follow good administrative procedure integrated with the administration of the manufacturing firm in general;

(c) The organizational structure of the manufacturing operation may vary depending upon the size and character of the particular products manufactured. (It is not the intent of the minimum standard requirements set out in the rules herein provided to cast all manufacturers in the same mold, although it is their intent to assure the establishment of fundamental principles which will enable competent production with sufficient freedom to supply the demand for adequate pharmaceutical products.)

(2) Policies: The production supervisor in charge, with approval of the director or other proper administrative or executive authority of the manufacturer, shall initiate and develop rules and regulations pertaining to the manufacturing procedures of the firm or producer. Such policies and procedures established by rule and regulation shall conform with techniques currently practiced in the other pharmaceutical industries of a similar kind. (The spirit of the minimum standard requirements for licensees is one of helpful cooperation.)

(3) Personnel: The production supervisor in charge shall be a person adequately trained in the specialized functions required for manufacturing of pharmaceutical products and may be required to submit properly attested documents of proof of formal education qualifying him for this position. He shall have such assistants as the volume of work in the plant may dictate. The personnel shall also include such additional technically trained persons as the activities of the manufacturer may require to supply pharmaceutical service of the highest quality. The adequacy of the personnel will be determined by the size and scope of the manufacturing operation.

(4) Facilities: Adequate pharmaceutical and administrative facilities shall be provided including particularly:

(a) Essential manufacturing equipment to process properly the products to be manufactured;

(b) An adequate, up-to-date library for information concerning drugs and pharmaceutical products;

(c) Refrigeration for storage of thermolabile products;

(d) Adequate floor space;

(e) Sanitary facilities, lighting, ventilation, and plant safety as prescribed by the Workers Compensation Department, the Occupational Safety and Health Division.

(5) Products Control: Pharmaceutical manufacturing operations require facilities for chemical, physical and usually biological and bacteriological testing. The extent of laboratory facilities required for products control depends upon the products to be manufactured, the specifications and standards they are required to meet, and the raw materials involved in their production. If the manufacturing process is not large enough to justify the maintenance of a products control staff, the manufacturer's samples or products shall be sent to a competent laboratory for control checking of the manufactured product.

(6) Manufacturing of drug substances shall be separated from manufacturing of food substances.

Stat. Auth.: ORS 689
Stats. Implemented:
Hist.: 1PB 18, f. & ef. 10-14-64; 1PB 23, f. 2-14-74, ef. 3-11-74; 1PB 2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80

855-060-0010

Sanitation and Plant Safety

(1) The manufacturing plant, its equipment and facilities, shall be maintained in a clean and orderly condition.

(2) The physical facilities of the manufacturing plant, shall be maintained so as to conform with the laws of this state and the rules and regulations of the Workers Compensation Department, the Occupational Safety and Health Division, relating to sanitation and safety. (The provisions of this section shall be applicable to storerooms, toilets, washrooms, basements, and all other portions of the plant wherein business is conducted.)

(3) Toilet and washroom accommodations shall be maintained separately and distinct from the manufacturing facilities. The doors to toilet and washroom accommodations shall at all times remain closed, except as a means of ingress or egress.

(4) The walls, ceilings, windows, and floors of the manufacturing plant shall be clean and maintained in good repair.

(5) The manufacturing plant shall be well lighted, ventilated, and kept free of obnoxious odors.

(6) No waste materials shall be permitted to collect upon the floors, counters, or other portions of the manufacturing plant. Waste receptacles shall be placed in convenient places for disposal of waste materials.

(7) No merchandise shall be stored in toilets or washrooms or be permitted to stand or to be stored or placed in any portion of the manufacturing plant except in a storeroom. Storerooms shall be maintained at a cool temperature, shall be dry and ventilated, free from rodents, insects, obnoxious odors, and shall be equipped with adequate lighting facilities. Merchandise shall be arranged in an orderly manner.

(8) The plumbing of the manufacturing plant shall be maintained in good repair.

(9) Equipment and materials necessary for processing or producing items to be manufactured shall be maintained in an orderly and clean condition. All instruments and equipment shall be thoroughly cleansed following use.

Stat. Auth.: ORS 689
Stats. Implemented:
Hist.: 1PB 18, f. & ef. 10-14-64; 1PB 33, f. 2-14-74, ef. 3-11-74; 1PB 2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80

855-060-0015

Classification of Manufacturers

(1) Class I. A Class I manufacturer is required to employ an Oregon licensed pharmacist or a person approved by the Board who by experience and education possesses the necessary qualifications to supervise manufacturing procedures for United States Pharmacopeia, National Formulary, Accepted Dental Remedies products and including the manufacture of other internal medicines, controlled substances, dangerous external preparations, injectables, products requiring the prescription legend, poisons, and pure (U.S.P. and N.F. chemicals).

(2) Class II. A Class II manufacturer is required to employ personnel with a Bachelor of Science degree or equivalent, but not necessarily a licensed pharmacist to supervise manufacturing procedures, which are limited to non-toxic external preparations intended for preventative medication including antiseptics, germicides, detergents, or other agents intended for use in sanitation and not regulated by some other state agency.

(3) Class III. Repackagers or distributors of non-legend drugs will not be required to have a licensed pharmacist in charge, but will be required to have competent supervisory personnel.

Stat. Auth.: ORS 689
Stats. Implemented:
Hist.: 1PB 18, f. & ef. 10-14-64; 1PB 33, f. 2-14-74, ef. 3-11-74; 1PB 6-1978(Temp), f. & ef. 7-1-78; 1PB 8-1978, f. & ef. 10-17-78; 1PB 2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80

855-060-0020

Qualifications of Manufacturing and Wholesaling Personnel

(1) Only qualified personnel shall be employed to manufacture products.

(2) No drugs or medical supplies shall be manufactured in this state except under the personal supervision of a licensed pharmacist, chemist, or other person qualified by scientific or technical training or experience to perform such duties of supervision, as may be necessary, to protect the public health and safety. The manufacture of drugs and medicines shall be limited to persons having the necessary professional and/or technical qualifications and such persons may be required to submit properly attested documents of proof of formal education qualifying them for these positions.

Stat. Auth.: ORS 689
Stats. Implemented:
Hist.: 1PB 18, f. & ef. 10-14-64; 1PB 33, f. 2-14-74, ef. 3-11-74; 1PB 2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80

855-060-0025

Labeling

(1) All stocks and materials, as well as products produced, shall be labeled and conform to the strength and purity as required by law.

(2) A sample label of each product manufactured shall be supplied to the State Board of Pharmacy upon request.

Stat. Auth.: ORS 689
Stats. Implemented:
Hist.: 1PB 18, f. & ef. 10-14-64; 1PB 33, f. 2-14-74, ef. 3-11-74; 1PB 2-1979(Temp), f. & ef. 10-3-79; 1PB 2-1980, f. & ef. 4-3-80

855-060-0027

Identification of Prescription Drugs

(1) All prescription drug products in tablet or capsule form intended for oral administration will be required to be specifically identified. These drug products, when sold or distributed in Oregon after January 1, 1983, must be marked by the manufacturer with a code imprint identifying the drug product and the manufacturer or distributor of the drug product.

(2) "Code imprint" means an individual symbol, number, company name, words, letters, marking, National Drug Code, or any combination thereof, identifying the drug product and the manufacturer or distributor of the drug product.

(3) Exceptions to the requirement are:

(a) Drug products purchased by a pharmacy, pharmacist, or licensed wholesaler prior to January 1, 1983, and held for resale;

(b) Drug products which are manufactured by or upon the order of a practitioner licensed by law to prescribe or administer drugs and which are to be used solely by the patient for whom prescribed;

(c) Drug products which are used for experimentation or research purposes;

(d) The Board of Pharmacy, upon application of a manufacturer or distributor, may also exempt a particular drug product from the requirements of this regulation on the grounds that imprinting is not feasible because of such drug product's size, texture, or other unique characteristics.

Stat. Auth.: ORS 475 & ORS 689
Stats. Implemented:
Hist.: 1PB 2-1981, f. & ef. 8-20-81

855-060-0029

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.

Stat. Auth.: ORS 475.035, 689.155, 689.205, 689.305 & 689.315
Stats. Implemented:
Hist.: 1PB 2-1984, f. & ef. 3-7-84; PB 1-1992, f. & cert. ef. 1-31-92

855-060-0035

Registration of Mobile Manufacturers

(1) A mobile manufacturer means a manufacturer who manufactures within a vehicle equipped to provide unit dose packaging and repackage capabilities operated by a currently licensed pharmacist in this state.

(2) Stock medication for packaging and repacking will be furnished by the purchaser and shall exclude controlled substances.

(3) The vehicle shall be secure against pilferage, maintained and operated in accordance with good manufacturing practices standards in this division.

(4) All unit dose packages must be labeled in conformity with ORS 689.005.

(5) Records shall be maintained of all package operations of receipt and disposition of drugs.

(6) The building in which this vehicle is stored shall be its permanent address and shall maintain security of vehicle.

(7) Vehicle shall be registered annually; registration shall expire annually on July 1, of each year.

(8) Applicant must show to the Board that he will be actively in charge of equipment in this vehicle at all times it is in operation.

(9) If so required, the vehicle shall be registered with the federal Food and Drug Administration.

(10) The vehicle shall not display insignia or device to indicate that drugs are stored within or represent it as a pharmacy.

Stat. Auth.: ORS 475.035 & 689.205
Stats. Implemented:
Hist.: 1PB 2-1980, f. & ef. 4-3-80; PB 1-1994, f. & cert. ef. 2-2-94

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