justicedao/ipfs_state_laws huggingface dataset:
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 and must comply with 503B manufacturing requirements of 21 USC 353 and is exempted from labeling and research requirements. (3) Class III. Repackagers or distributors of non-legend drugs will not be required to have a licensed pharmacist but is required to have competent supervisory personnel. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 History: BP 4-2015, f. & cert. ef. 7-1-15 1PB 2-1980, f. & ef. 4-3-80 Reverted to 1PB 8-1978, f. & ef. 10-17-78 1PB 2-1979(Temp), f. & ef. 10-3-79 1PB 8-1978, f. & ef. 10-17-78 1PB 6-1978(Temp), f. & ef. 7-1-78 1PB 33, f. 2-14-74, ef. 3-11-74 1PB 18, f. & ef. 10-14-64
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. Statutory/Other Authority: ORS 689 History: 1PB 2-1980, f. & ef. 4-3-80 Reverted to 1PB 33, f. 2-14-74, ef. 3-11-74 1PB 2-1979(Temp), f. & ef. 10-3-79 1PB 33, f. 2-14-74, ef. 3-11-74 1PB 18, f. & ef. 10-14-64
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. Statutory/Other Authority: ORS 689 History: 1PB 2-1980, f. & ef. 4-3-80 Reverted to 1PB 33, f. 2-14-74, ef. 3-11-74 1PB 2-1979(Temp), f. & ef. 10-3-79 1PB 33, f. 2-14-74, ef. 3-11-74 1PB 18, f. & ef. 10-14-64
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, 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 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; (b) Drug products which are used for experimentation or research purposes. (4) 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. Statutory/Other Authority: ORS 475 & 689.205 Statutes/Other Implemented: ORS 689.155 History: BP 4-2015, f. & cert. ef. 7-1-15 1PB 2-1981, f. & ef. 8-20-81
855-060-0029 Disposal of Drugs Drugs that are outdated, damaged, deteriorated, misbranded, adulterated, or illegitimate shall be quarantined and physically separated from other drugs until they are destroyed or returned to their supplier. Statutory/Other Authority: ORS 475.035, 689.155, 689.205, 689.305 & 689.315 Statutes/Other Implemented: ORS 689.155 History: BP 4-2015, f. & cert. ef. 7-1-15 PB 1-1992, f. & cert. ef. 1-31-92 1PB 2-1984, f. & ef. 3-7-84
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. Statutory/Other Authority: ORS 475.035 & 689.205 History: PB 1-1994, f. & cert. ef. 2-2-94 1PB 2-1980, f. & ef. 4-3-80
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. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 History: BP 4-2015, f. & cert. ef. 7-1-15 BP 5-2009, f. & cert. ef. 12-24-09 BP 2-2009(Temp), f. 6-22-09, cert. ef. 6-26-09 thru 12-23-09
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. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 History: BP 5-2009, f. & cert. ef. 12-24-09 BP 2-2009(Temp), f. 6-22-09, cert. ef. 6-26-09 thru 12-23-09
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. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 History: BP 8-2015, f. & cert. ef. 12-23-15 BP 5-2015(Temp), f. & cert. ef. 7-1-15 thru 12-27-15 BP 5-2009, f. & cert. ef. 12-24-09 BP 2-2009(Temp), f. 6-22-09, cert. ef. 6-26-09 thru 12-23-09
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. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 History: BP 4-2015, f. & cert. ef. 7-1-15 BP 5-2009, f. & cert. ef. 12-24-09 BP 2-2009(Temp), f. 6-22-09, cert. ef. 6-26-09 thru 12-23-09
855-065-0001 Application (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. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 History: BP 4-2015, f. & cert. ef. 7-1-15 BP 5-2009, f. & cert. ef. 12-24-09 BP 2-2009(Temp), f. 6-22-09, cert. ef. 6-26-09 thru 12-23-09 BP 12-2006, f. & cert. ef. 12-19-06 BP 4-2002, f. 6-27-02, cert. ef. 7-1-02 PB 1-1994, f. & cert. ef. 2-2-94 PB 3-1992, f. & cert. ef. 3-26-92 (and corrected 4-8-92) 1PB 2-1980, f. & ef. 4-3-80 1PB 2-1979(Temp), f. & ef. 10-3-79
855-065-0007 Minimum Qualifications 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. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 475.135, 689.155, 689.305, 689.315 & 689.405 History: BP 12-2006, f. & cert. ef. 12-19-06 PB 3-1992, f. & cert. ef. 3-26-92 (and corrected 4-8-92)
855-065-0009 Personnel 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. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.135, 689.305 & 689.315 History: BP 12-2006, f. & cert. ef. 12-19-06 PB 3-1992, f. & cert. ef. 3-26-92 (and corrected 4-8-92)
855-065-0012 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) An entry system that restricts access to areas where drugs are held, to authorized personnel. (b) An after-hours central alarm system 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. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 689.155 & ORS 689.305 History: BP 17-2022, amend filed 04/20/2022, effective 04/20/2022 BP 12-2006, f. & cert. ef. 12-19-06
855-070-0001 Definitions (1) Prophylactic means a drug, device or medical preparation intended for or having special utility in the prevention of a sexually transmitted disease, or in the prevention of conception. (2) Contraceptive means a drug, device or medical preparation intended for the prevention of conception. (3) Male condom means a prophylactic or contraceptive device in the form of a sheath which completely covers the penis with a closely fitting membrane. (4) Female condom means a prophylactic or contraceptive device in the form of an intravaginal pouch that consists of a sheath with a flexible ring on each end. Statutory/Other Authority: ORS 689.155 & 689.205 History: PB 1-1995, f. & cert. ef. 4-27-95
855-070-0005 Applications, Fees, and Licenses to Sell Prophylactics and Contraceptives (1) Every wholesaler or manufacturer of prophylactics or contraceptives who distributes in Oregon goods of the class specified in ORS 435.010 shall annually submit an application for a license issued by the Board of Pharmacy: (a) The application shall be made in writing on a form prepared by the Board and be accompanied by the fee listed in division 110; (b) One such application shall be submitted and license obtained for each location or separate address from which goods are distributed; (c) Licenses shall be issued upon receipt of the fee listed in division 110 and shall be in effect for one year from January 1 of each year. Licenses are not transferable; (d) Licenses shall be publicly or conspicuously displayed and the wholesaler or manufacturer to whom they are issued shall be open to inspection by the Board or other authorized persons designated by the Board; (e) Each application for a license shall include a list of all products or brands of prophylactics and contraceptives the applicant wishes to have approved for sale in the state. (2) Before any condom product can be distributed in Oregon, it must be approved by the Oregon Board of Pharmacy. Every manufacturer or wholesaler that intends to distribute either male or female condoms shall furnish to the Board the names of such products. (3) The Board may require proof to be furnished by the manufacturer or wholesaler that these products have received approval in accordance with the Federal Food, Drug and Cosmetic Act and regulations thereunder (Title 21 U.S.C. and CFR); (4) The requirements under the Federal Food, Drug and Cosmetic Act and regulations thereunder (Title 21 U.S.C. and CFR) relating to prophylactics and contraceptives are adopted by reference and made a part hereof. Statutory/Other Authority: ORS 689.205 Statutes/Other Implemented: ORS 435.010, 435.080, 435.100 & 689.155 History: BP 10-2006, f. and cert. ef. 12-19-06 PB 1-1995, f. & cert. ef. 4-27-95 PB 10-1987, f. & ef. 12-8-87 1PB 39, f. & ef. 1-8-76 1PB 36, f. 7-1-74, ef. 7-25-74 1PB 35(Temp), f. & ef. 3-26-74 1PB 32, f. 1-31-74, ef. 2-25-74 Reverted to 1PB 18, f. & ef. 10-14-64 1PB 29(Temp), f. & ef. 9-6-73 1PB 18, f. & ef. 10-14-64