OBNDD RULES AND REGULATIONS TITLE 475
475:10-1-1. Purpose
The rules of this Chapter specify the requirements to be met in order to obtain an OBN registration; list exceptions to obtaining such a registration; explain requirements for a scientific research registration; and exempts the Native American Church from registration for possession of peyote.
475:10-1-2. Time and method of payment of registration fees
Registration and re-registration fees shall be paid at the time when the application for registration or re-registration is submitted for filing.
[Source: Amended at 29 Ok Reg 1312, eff 6-25-12]
475:10-1-3. Exemption from registration or payment of fees
The Director may exempt from payment of a fee for registration or re-registration any agency of the United States, the State of Oklahoma, or any political subdivision or agency thereof, which is authorized to purchase controlled dangerous substances, to obtain such substances from official stocks, to dispense or administer such substances, to conduct scientific research, institutional instructional activities, or analytical laboratory activities with such substances or any combination thereof, in the course of official duties (e.g., city, county, state, or governmental institutions duly licensed by appropriate state agencies). A fee exemption must be requested at the time of application submission. If a fee exemption is not requested at the time of application submission, and payment is submitted with the application, no refund shall be given.
The Director may exempt from registration the following persons:
Any official, employee, or officer of any agency of the United States, State of Oklahoma, or political subdivision or agency thereof, who is authorized to purchase controlled dangerous substances, to obtain such substances from official stocks, to dispense or administer such substances, to conduct scientific research, institutional instructional activities, or analytical laboratory activities with such substances, to possess such substances or any combination thereof, in the course of his/her official duties or employment.
Such persons shall be deemed agents of their respective agencies, provided that their professional handling of controlled dangerous substances are confined to the agency of their specific place of official duties or employment [e.g., practitioners limited to practice with such official agency, pharmacies, or drug departments limited to dispensing of controlled dangerous substances to inpatients only of their respective institutions, registered nurses, and others as defined in 63 Okl.St.Ann.§ 2-302].
[Source: Amended at 12 Ok Reg 2835, eff 7-15-95; Amended at 29 Ok Reg 1312, eff 6-25-12]
475:10-1-4. Separate registration
Every person or entity who engages in, or who proposes to engage in, more than one group of independent activities shall obtain a separate registration for each group of activities, except as provided by this subsection. Any person or entity, when registered to engage in the group of activities described in each paragraph of this subsection, shall be authorized to engage in the coincident activities described in that subparagraph without obtaining a registration to engage in such coincident activities; provided that, unless specifically exempted, the registrant complies with
all requirements and duties prescribed by law for persons or entities registered to engage in such coincident activities.
A person or entity registered to manufacture any controlled dangerous substance or basic class of controlled dangerous substances shall be authorized to distribute that substance or class, but is not authorized to distribute any substance or class which the registrant is not registered to manufacture.
A person or entity registered to manufacture any controlled dangerous substance listed in Schedules I through V shall be authorized to conduct chemical analysis and preclinical research (including quality control analysis) with narcotic and non-narcotic controlled dangerous substances listed in those schedules which the registrant is authorized to manufacture.
A registrant authorized to conduct analytical laboratory activities with controlled dangerous substances shall be authorized to manufacture such substances for analytical or instructional purposes, to distribute such substances to other registrants authorized to conduct analytical laboratory activities, institutional instructional activities, or scientific research with such substances and to persons or entities exempted from registration provided such distribution is made in conformance with state law.
A person registered or authorized to conduct scientific research with controlled dangerous substances listed in Schedules I through V shall be authorized to conduct analytical laboratory activities with controlled dangerous substances listed in those schedules in which he/she is authorized to conduct scientific research, to manufacture such substances if and to the extent that such manufacturing is set forth in the protocol filed with the application for registration, to distribute such substances to other persons or entities registered or authorized to conduct analytical laboratory activities, institutional instructional activities, or scientific research with such substances, and to persons or entities exempted from registration provided such distribution is made in conformance with state law, and to conduct instructional activities with controlled dangerous substances.
Physicians, dentists, podiatrists, veterinarians, optometrists and other qualified persons who are authorized to carry on their respective activities under the laws of the State of Oklahoma and who are registered with the OBN to dispense, prescribe, and/or administer controlled dangerous substances shall be authorized to conduct instructional activities with those substances.
Trainers or handlers of a canine controlled dangerous substance detector who, in the ordinary course of their profession, desire to possess any controlled dangerous substance for training said canine.
A single registration to engage in any group of independent activities may include one or more controlled dangerous substances listed in the schedules authorized in that group of independent activities. A person registered to conduct scientific research with controlled dangerous substances listed in Schedule I may conduct scientific research with any substance listed in Schedule I for which the registrant has filed and had approved a scientific research protocol.
The following locations shall not be deemed to be principal places where controlled dangerous substances are manufactured, distributed, dispensed, and/or prescribed:
A warehouse where controlled dangerous substances are stored by or on behalf of a registered person, unless such substances are distributed directly from such warehouse to registered locations, other than the registered location from which the substances were delivered, or to persons.
An office used by agents of a registrant where sales of controlled dangerous substances are solicited, made, or supervised but which neither contain such substances (other than substances for display purposes or lawful distribution as samples only) nor serves as a distribution point for filling sales orders.
An office used by a practitioner (who is registered at another location) where controlled dangerous substances are prescribed but neither administered nor otherwise dispensed as a regular part of the professional practice of the practitioner at such office, and where no supplies of controlled dangerous substances are maintained.
[Source: Amended at 12 Ok Reg 2835, eff 7-15-95]
475:10-1-5. Exemptions of agents and employees
The following persons shall not be required to register and may lawfully possess controlled dangerous substances in the performance of their official duties under the provisions of the Act:
An agent, or employee thereof, of any registered manufacturer, distributor, dispenser and/or user for scientific purposes of any controlled dangerous substances if such agent is acting in the usual course of his/her business or employment.
An individual physician who is a resident or staff physician of a licensed or otherwise-authorized hospital shall not be required to register in order to administer, prescribe, or dispense controlled dangerous substances in the usual course of his/her professional practice, while acting within the scope of his/her employment in the hospital, provided that:
Such resident or staff physician is authorized to carry on the respective activities under the laws of the State of Oklahoma by their appropriate State of Oklahoma licensing board.
The hospital by whom he/she is employed has verified that the individual physician is so licensed by the appropriate State of Oklahoma licensing board.
Such administering, prescribing, and/or dispensing is confined solely to inpatients or outpatients of the hospital by which the individual physician is employed.
All prescriptions and records relating to controlled dangerous substances administered, dispensed, or prescribed to inpatients or outpatients shall reflect the designated specific internal hospital code number given to each resident or staff physician so authorized by the hospital pursuant to 475:25-1-18 and Title 21 Code of Federal Regulations, § 1301.22(C)(5) and (6).
Interns of teaching hospitals shall not be required to register and may administer, dispense, and/or prescribe controlled dangerous substances in accordance with paragraph
(2) of this Section, provided that:
All prescriptions issued by such interns for outpatients shall be countersigned by a physician licensed by the physician's appropriate State of Oklahoma licensing board and shall bear such physician's personal designated hospital code number.
Such intern is so authorized by the hospital and is acting only within the scope of his/her employment within the teaching hospital.
An individual physician, dentist, podiatrist, or veterinarian, as defined in 63 Okl.St.Ann. § 2-101, who is a resident or foreign-trained, whose practice is, for any reason, limited solely to federal, state, or local government institutions, shall dispense, administer and/or prescribe controlled dangerous substances under the authority of the license of the institutional hospital by whom he/she is employed in lieu of being registered himself/herself, provided that:
Such dispensing, administering, and/or prescribing is done in the usual course of his/her professional practice.
Such individual practitioner is authorized to carry on the respective activities under the laws of the State of Oklahoma by the appropriate State of Oklahoma licensing board.
The hospital or other institution by which he/she is employed has verified that the individual practitioner is so permitted to dispense, administer, and/or prescribe drugs within the jurisdiction.
Such individual practitioner is acting only within the scope of his/her employment in the hospital or institution.
Records relating to controlled dangerous substances that are prescribed by such residents, foreign-trained physicians, or physicians limited to federal, state, or local government institutions, shall be kept pursuant to Title 21 Code of Federal Regulations §1304.04 and 475:25-1-18.
An individual practitioner, as defined in (4) of this Section, who is limited solely to federal, state, or local government institutional practice, may obtain individual fee-exempt registration in the event that such institution by which he/she is employed does not maintain a hospital as defined by the appropriate State of Oklahoma licensing authority and the institution is not so registered with the OBN.
Such limited practitioners shall be required to maintain records of all controlled dangerous substances administered, dispensed, and prescribed by such practitioner.
Such limited practitioners shall be authorized to dispense, administer, and/or prescribe controlled dangerous substances in the course of their professional practice only within such institution as designated by their appropriate State of Oklahoma licensing boards.
Prior to being authorized to dispense, administer, and/or prescribe controlled dangerous substances at any new or additional location, such limited practitioners shall be required to report to the OBN each change of location or addition of institutional employment.
Such limited practitioners shall be held individually responsible for safeguards, record keeping, inventories, transferring, and disposing of controlled dangerous substances in accordance with this Chapter.
[Source: Amended at 29 Ok Reg 1312, eff 6-25-12]
475:10-1-6. Exempted persons engaging in private activities
If any person exempted by this Chapter also engages, or proposes to engage, as a private individual in any activities for which registration is required, such official shall obtain a registration for such private activities.
475:10-1-7. Exemption of law enforcement officials
The requirement of registration is waived for any officer or employee of any federal, state, or any political subdivision or agency thereof, who is engaged in the enforcement of federal, state or local law relating to controlled dangerous substances and is duly authorized to possess controlled dangerous substances in the course of his/her official duties, excluding law enforcement canine handlers/trainers; provided that law enforcement agencies maintaining analytical laboratories must obtain annual registration as otherwise provided in this Section.
Any exempted official may, when acting in the course of his/her official duties, possess any controlled dangerous substance and distribute any such substance to any other official who is also exempted by (a) of this Section and acting in the course of his/her official duties.
Any official engaged in drug education where possession of controlled dangerous substances is necessary shall obtain authorization for such possession from the Oklahoma State Bureau of Narcotics and Dangerous Drugs Control.
[Source: Amended at 12 Ok Reg 2835, eff 7-15-95]
475:10-1-8. Waiver of civil defense officials
The requirement of registration is waived for any official of a civil defense or disaster relief organization who, in the course of his/her official duties, is authorized to maintain and distribute controlled dangerous substances held for emergency use.
475:10-1-9. Application for registration pursuant to Title 63 Okl. St.Ann § 2-302
Any person or entity who is required to be registered and who is not so registered may apply for registration at any time unless otherwise provided in this Title. No person or entity required to be registered shall engage in any activity for which registration is required until the application for registration is granted and a Certificate of Registration is issued by the Director to such person or entity.
After any person or entity is first registered, the person or entity shall thereafter be required to be registered no later than the first day of November of each year.
Any person or entity who fails to register shall be in violation of the Uniform Controlled Dangerous Substances Act and subject to penalties as provided therein.
Applications for registration of new principal places of business and new personal registration requests received after July 1st of each year will, if accepted for registration, be registered for the forthcoming registration period and, therefore, will not be required to pay the registration fee for the remaining four (4) months of the registration period in which the application is made.
A thirty (30) day grace period from the registration expiration date may be given before a registration is inactivated.
[Source: Amended at 29 Ok Reg 1312, eff 6-25-12]
475:10-1-10. Application notices for registration and re-registration
Any person or entity required to be registered under Title 63 may register by contacting the OBN to obtain the registration application, downloading the registration application on the official OBN website, or applying on the official OBN website.
Any person or entity desiring to professionally handle controlled dangerous substances for the purpose of canine drug detector handling and/or training, manufacturing, distributing, conducting scientific research, or performing analytical laboratory activities of controlled dangerous substances listed in the Uniform Controlled Dangerous Substances Act, Schedules I through V, shall apply for registration as follows:
A canine drug detector handler/trainer or scientific researcher shall be registered with the OBN as an individual.
Applicants for scientific research, analytical laboratory activities, or institutional instructional activities shall attach one (1) copy of the proposed operational protocol to the application.
A detailed description, diagram, and/or photographs of all security measures proposed for the safe storage of all controlled dangerous substances shall be attached to the application.
Any person or entity licensed by the appropriate State of Oklahoma licensing authority who desires to professionally handle controlled dangerous substances in their practice of medicine, retail pharmacy, hospital, teaching institution, or institutional drug department shall apply for registration.
Registrants will be notified by renewal notice approximately ninety (90) days before the expiration date of October 31 of each year; if any registrant does not receive such notice within thirty (30) days prior to the expiration date of the registration, the registrant must give notice of such omission and request such notice either by personal contact with, or in writing to, the OBN. It shall be the registrant's responsibility to maintain a valid registration.
Each application shall include all information called for in the application, unless the item is not applicable, in which case this fact shall be indicated, and the application with comments shall be required to be returned to the OBN. The address of the registrant shall be the business address. A post office box will not be considered a sufficient business address. If the business address contains no physical street address, then a PO Box or route number may be listed, however, directions to the registrant's business location must be included with the application.
Each application, attachment, or other document filed as a part of any application shall be signed by the applicant or by an officer or official of the applicant. Those applications with questions left unanswered or without proper signature will not be accepted.
[Source: Amended at 12 Ok Reg 2835, eff 7-15-95; Amended at 24 Ok Reg 2736, eff 8-11-07;
Amended at 29 Ok Reg 1312, eff 6-25-12; Amended at 30 Ok Reg 544, eff 5-13-13]
475:10-1-11. Operational protocols
An operational protocol to conduct scientific research, analytical laboratory activities, or institutional instructional activities with controlled dangerous substances listed in Schedules I through V shall be in the following form and contain the following information where applicable:
Scientific research, analytical laboratory activities, or institutional instructional activities.
Name, business address, and if any, the Federal Drug Enforcement Administration (DEA) registration number.
Institutional affiliation, if any.
Qualifications, including an academic vita and an appropriate bibliography (listing publications).
Applicants shall be required affirmatively to establish (by documentation or suitable references or other appropriate means) their good moral character and high ethical professional standing.
Applicants for scientific research shall possess at least an earned bachelor's degree in natural science, medicine, or other appropriate field from institution(s) accredited by bodies recognized by the designated authority of the University of Oklahoma Health Sciences Center.
Applicants for scientific research proposing studies involving human subjects should minimally possess an earned doctorate in medicine or natural sciences or other appropriate field from accredited institution(s).
Applicants for analytical laboratory activities who propose studies involving chemical analysis or other chemical, physical, or biological scientific activities with Schedule I-V substances shall be required to have satisfactorily completed a minimum of thirty-two (32) semester hours, or the equivalent, of acceptable courses in chemistry, with one (1) or more accredited courses in analytical chemistry.
Institutional instructional activities or institutions of higher learning requesting registration of an agent of such institution shall be an institution accredited by the Oklahoma State Regents for Higher Education, or such agent of an institution shall be required to have satisfactorily completed a minimum of thirty-two (32) semester hours, or their equivalent, of acceptable courses in chemistry from an institution(s) accredited by bodies recognized by the United States Department of Education or the United States Department of Health and Human Services.
All said applicants shall further be required to document at least one
(1) year of recent suitable, professional experience for the activities to be undertaken for a Schedule I registration. This may consist of formal participation in established and recognized analytical laboratory analysis of controlled dangerous substances, research programs, institutional instructional activities, or other evidence of appropriate background approved by the Director (post-doctoral training, applicable laboratory experience, etc.).
Research project.
Title of project.
Statement of purpose.
Name of controlled dangerous substance or substances involved and the amount of each substance for use.
Description of the research to be conducted, including the number and species of research subjects, the dosage to be administered, the route and method of administration, and the duration of the project.
Location where the research will be conducted.
Statement of the security provisions for storing the controlled dangerous substances and for dispensing the controlled dangerous substances in order to prevent diversion.
If the researcher or investigator desires to manufacture any controlled dangerous substances listed in this part, a statement of the quantity to be manufactured and the sources of the chemicals to be used.
Authority.
Institutional approval.
Approval of Institutional Review Board.
Indication of an approval for new DEA registration number if additional registration is required by DEA.
Indication of an approved funded grant (number), if any.
Adequate environment and facilities. All said applicants shall be required to establish that they have access to and beneficial use of an institutional (or other) environment appropriate to the type of activities contemplated, and that they possess the necessary facilities (inclusive of proper laboratory facilities and equipment, etc.). This requirement shall be interpreted as requiring that overall environment, facilities, and equipment meet generally recognized standards for the activities proposed.
Confidentiality of research subjects.
Any registrant under the Uniform Controlled Dangerous Substances Act who intends to maintain the confidentiality of those persons who are the subjects of such research shall, pursuant to Title 63 Okl.St.Ann. § 2-106, upon registration or within a reasonable time thereafter, submit to the Director a separate request for each research project involving controlled dangerous substances, which shall contain the following:
The researcher's registration number with the OBN and/or DEA registration number(s) for that project.
The location of the research project.
A general description of the research or a copy of the research protocol as required in this Chapter.
A specific request to withhold the names and/or any identifying characteristics of the research subjects.
The reasons supporting the request.
Within thirty (30) days from the receipt of the request, the Director shall issue a letter, either granting confidentiality, requesting additional information, or denying confidentiality, in which case the reasons for the denial shall be included. A grant of confidentiality shall be limited solely to the specific research project indicated in the request.
Within thirty (30) days after the date of completion of the research project, the researcher shall so notify the Director.
[Source: Amended at 29 Ok Reg 1312, eff 6-25-12]
475:10-1-12. Filing of application
All applications for registration shall be submitted for filing with the OBN and shall be accompanied by the appropriate registration fee and any required attachments.
Any person or entity required to obtain more than one registration may submit all applications in one (1) package. Each application must be complete and should not refer to any accompanying application for required information.
475:10-1-13. Acceptance for filing
Applications submitted for filing are dated upon receipt. If found to be complete, the application will be accepted for filing. Applications failing to comply with the requirements of this Chapter will not generally be accepted for filing. A defective application will be returned to the applicant with a statement of the reason for not accepting the application for filing. A defective application shall be corrected and re-submitted for filing prior to acceptance of application.
Accepting an application for filing does not preclude any subsequent request for additional information and has no bearing on whether the application will be granted.
475:10-1-14. Additional information
The Director may require an applicant to submit such documents or written statements of fact relevant to the application as he/she deems necessary to determine whether the application should be granted. The failure of the applicant to provide such documents or statements within a reasonable time after being requested to do so shall be deemed to be a waiver by the applicant of an opportunity to present such documents or facts for consideration by the Director in granting or denying the application.
475:10-1-15. Amendments to and withdrawal of applications
An application may be amended or withdrawn without permission of the Director at any time before the date on which the applicant receives an order to show cause why the registration should not be denied, revoked or suspended pursuant to Title 63 Okl.St.Ann. § 2-305. An application may be amended with permission of the Director at any time where good cause is shown by the applicant or where the amendment is in the public interest.
After an application has been accepted for filing, the request by the applicant that it be returned or the failure of the applicant to respond to official correspondence regarding the application shall be deemed to be a withdrawal of the application.
[Source: Amended at 29 Ok Reg 1312, eff 6-25-12]
475:10-1-16. Inspection
The Director, his or her agents, as well as specifically designated or assigned state, county and municipal officers whose duty it is to enforce the laws of this State relating to controlled dangerous substances may inspect, or cause to be inspected, the establishment of an applicant or registrant pursuant to this Title and the provisions of Title 63 of the Oklahoma Statutes.
[Source: Amended at 29 Ok Reg 1312, eff 6-25-12]
475:10-1-17. Applications for scientific research in Schedule I substances
In the case of an application to conduct scientific research with controlled dangerous substances listed in Schedule I, the Director may process the application and protocol and forward a copy of each to an independent expert selected by the Director within seven (7) days after receipt. The independent expert shall promptly advise the Director concerning the qualification of the applicant.
An applicant whose protocol is defective shall be notified by the Director within seven (7) days after receipt of such protocol from the independent expert, and he/she shall be required to correct the existing defects before consideration shall be given to his/her submission.
After the independent expert finds that the applicant is qualified and competent and the protocol meritorious, the Director shall be notified. The Director shall issue a Certificate of Registration within ten (10) days after receipt of this notification unless he/she determines that the application should be denied pursuant to the Uniform Controlled Dangerous Substances Act or OAC 475.
If the independent expert finds that the protocol is not meritorious and/or the applicant is not qualified or competent, said designated authority shall notify the Director. The Director shall notify the applicant of said findings and his/her final decision, after which time the applicant may submit written request to the Director within thirty (30) days for a hearing to show cause why the application should not be denied.
[Source: Amended at 24 Ok Reg 2736, eff 8-11-07; Amended at 33 Ok Reg 1766, eff 9-11-16]
475:10-1-18. Certificate of registration form
The Certificate of Registration shall contain the name, business address, and registration number of the registrant, the schedules of controlled dangerous substances which the registrant is authorized to handle, any limitation or condition placed on the registration, and the expiration date of the registration. The registrant shall maintain the Certificate of Registration at the registered location and shall permit inspection of the Certificate by a peace officer or agency official in the enforcement of laws relating to controlled dangerous substances.
475:10-1-19. Surrender of certificate of registration
Upon the revocation, suspension, or retirement of the registrant's Certificate of Registration, the Director of the Oklahoma State Bureau of Narcotics and Dangerous Drugs Control shall require that the registrant immediately deliver the assigned Certificate of Registration to an officer of the Oklahoma State Bureau of Narcotics and Dangerous Drugs Control and shall further require the registrant to surrender, destroy, or provide the security deemed necessary by the Director for all stocks of controlled dangerous substances in control of the registrant.
In the event of limitation of a registrant's authority to handle controlled dangerous substances ordered by the Director or the authorized appropriate State of Oklahoma professional licensing board which may limit the registrant's professional services regarding controlled dangerous substances, the registrant shall be issued a new Certificate of Registration. No fee shall be required to be paid for the new Certificate of Registration.
[Source: Amended at 12 Ok Reg 2835, eff 7-15-95]
475:10-1-20. Modification of registration
Any registrant may apply to modify the registration to authorize the handling of additional controlled dangerous substances by submitting a letter of request to the Registration Division of the OBN. The letter shall contain the registrant's name, address, state and federal registration numbers as printed on the registrant's State of Oklahoma and Federal Certificates of Registration, the substances and/or schedules to be added to the registration, and shall be signed by the registrant. If the registrant is seeking to handle additional controlled dangerous substances listed in Schedule I of the Uniform Controlled Dangerous Substances Act for the purpose of analytical laboratory activities, scientific research, or institutional instructional activities, the registrant shall attach one (1) copy of the protocol describing each anticipated activity involved with the additional substances or, in the event of institutional instructional activities, a statement describing the nature, extent, and duration of such institutional instructional activity, as appropriate. No fee shall be required to be paid for the modification.
[Source: Amended at 29 Ok Reg 1312, eff 6-25-12]
475:10-1-21. Change of business address
The registrant shall notify the Registration Division of the Oklahoma State Bureau of Narcotics and Dangerous Drugs Control in writing, sent via U.S. certified mail, return receipt requested, or through the registrant's online account, within fourteen (14) calendar days of any change of their business (mailing or physical) address.
[Source: Amended at 29 Ok Reg 1312, eff 6-25-12]
475:10-1-22. Termination of registration
The registration of any person or entity shall terminate if and when such registrant dies, ceases legal existence, or discontinues business or professional practice including, but not limited to, full retirement. Any registrant who discontinues business or professional practice and/or no longer holds a valid Oklahoma license of the profession or occupation shall notify the Director within fourteen (14) calendar days of such fact.
[Source: Amended at 12 Ok Reg 2835, eff 7-15-95; Amended at 29 Ok Reg 1312, eff 6-25-12]
475:10-1-23. Special exempt persons -- Native American Church
The listing of mescaline as a controlled dangerous substance in Schedule I of the Uniform Controlled Dangerous Substances Act does not apply to the non-drug use of the peyote cactus in bona-fide religious ceremonies of the Native American Church, and members of the Native American Church so using the peyote cactus are exempt from registration with the Oklahoma State Bureau of Narcotics and Dangerous Drugs Control. Any person who produces peyote cactus for, or distributes the peyote cactus to, the Native American Church of the State of Oklahoma, however, is required to obtain registration annually as a distributor and to comply with all other requirements of the Uniform Controlled Dangerous Substances Act and OAC 475.
475:10-1-24. Ephedra/mahuang exemption
Products meeting the following criteria are exempt from application of Sections 2-210, 2-322, and 2-402 of the Uniform Controlled Dangerous Substances Act [O.S. Title 63, §§ 2-210, 2-322, 2-402]:
Dietary supplements containing naturally occurring ephedrine alkaloids, provided that all of the following conditions are met:
(A) the alkaloids are contained in an unadulterated naturally occurring organic material; and,
and,
(B) the product contains no hydrochloride or sulfate salts of ephedrine alkaloids;
(C) the product contains, per dosage unit or serving, not more than 25 milligrams of ephedrine alkaloids; and,
(D) the product is packaged with a prominent label securely affixed to each package that states the amount in milligrams of ephedrine alkaloids in a serving or dosage unit; the amount of food product or dietary supplement that constitutes a serving or dosage unit; the maximum recommended dosage unit of ephedrine alkaloids for a healthy adult; and that improper use of the product may be hazardous to a person's health; and,
(E) the product is labeled and marketed as "ephedra" or "mahuang" and not as "ephedrine." It shall be acceptable to include descriptions of the ephedra alkaloids such as "contains 25 mg. of naturally occurring ephedrine alkaloids." And,
In the course of selling, offering for sale, or otherwise distributing a product described in section 10-1-24 (A), a person shall not advertise or represent in any manner that the product causes euphoria, ecstasy, a "buzz", or "high", or an altered mental state, heightens sexual performance, or because it contains ephedrine alkaloids, increases muscle mass.
[Source: Added at 18 Ok Reg 2217, eff 6-11-01; Amended at 19 Ok Reg 1197, eff 5-13-02]
Title 475 - Oklahoma State Bureau of Narcotics and Dangerous Drugs Control Chapter 15 - Imminent Danger Suspension
475:15-1-1. Purpose
The rules of this Chapter govern the immediate suspension of a controlled dangerous substances registration pending the final outcome of an administrative proceeding.
[Source: Added at 12 Ok Reg 2839, eff 7-15-95]
475:15-1-2. Immediate suspension of registration
If the Director finds there is imminent danger to the public health or safety, he/she may immediately suspend any registration simultaneously with the institution of show cause proceedings.
Method. The registrant shall be notified of such suspension through an imminent danger letter signed by the Director.
Notice and surrender of controlled dangerous substances. The imminent danger letter shall be personally served on the registrant by an Agent of the Oklahoma State Bureau of Narcotics and Dangerous Drugs Control at which time the registrant shall be required to surrender to the Agent all controlled dangerous substances in his/her possession. In the event the registrant cannot be located by the Oklahoma State Bureau of Narcotics and Dangerous Drugs Control Agent, the Agent shall deliver the imminent danger letter to the address listed on the registrant's most current registration application on file with the Oklahoma State Bureau of Narcotics and Dangerous Drugs Control at which time the Agent shall take possession of all controlled dangerous substances located at such address.
Additional violations. Where there is a reasonable belief that a registrant has committed a new violation of OBN's rules or applicable law while serving a term of probation with OBN, the registrant's OBN registration may be immediately suspended until a hearing can be had, which shall be within fourteen (14) calendar days, unless otherwise agreed to by the parties.
[Source: Added at 12 Ok Reg 2839, eff 7-15-95; Amended at 29 Ok Reg 1317, eff 6-25-12]
475:15-1-3. Hearing following immediate suspension
A show cause hearing shall be held within fourteen (14) calendar days, unless waived by the parties, following the suspension of a registration suspended without a hearing.
[Source: Added at 12 Ok Reg 2839, eff 7-15-95; Amended at 29 Ok Reg 1317, eff 6-25-12]
475:20-1-1. Purpose
The rules of this Chapter mandate the security requirements for OBN registrants and other individuals in possession of controlled dangerous substances.
475:20-1-2. General security requirements
(a) All applicants and registrants shall provide effective controls and procedures to guard against theft and diversion of controlled dangerous substances. In order to determine whether a registrant has provided effective controls against diversion, the Director shall require adherence to the security requirements as set forth generally in the Uniform Controlled Dangerous Substances Act, and specifically by this Chapter, as standards for the physical security controls and operating procedures necessary to prevent diversion. Materials and construction which will provide a structural equivalent to the physical security controls set forth in 475:20-1-4 and 475:20-1-6 may be used in lieu of the materials and construction described in those Sections.
(b) Substantial compliance with the standards set forth in 475:20-1-3 through 475:20-1-7 may be deemed sufficient by the Director after evaluation of the overall security system and needs of the applicant or registrant. In evaluating the overall security system of a registrant or applicant, the Director may consider any of the following factors as he/she may deem relevant to the need for strict compliance with security requirements:
(1) The type of activity conducted (e.g., processing of bulk chemicals, preparing dosage forms, packaging, labeling, cooperative buying, etc.).
(2) The type and form of controlled dangerous substances handled (e.g., bulk liquids or dosage units, usable or non- usable powders).
(3) The quantity of controlled dangerous substances handled.
(4) The location of the premises and the relationship such location bears on security needs.
(5) The type of building construction comprising the facility and the general characteristics of the building(s).
(6) The type of vault, safe, and secure enclosures or other storage system (e.g., automatic storage and retrieval system) used.
(7) The type of closures on vaults, safes and secure enclosures.
(8) The adequacy of key control systems and/or combination lock control systems.
(9) The adequacy of electric detection and alarm systems, if any, including use of supervised transmittal lines and standby power sources.
(10) The extent of unsupervised public access to the facility, including the presence and characteristics of perimeter fencing, if any.
(11) The adequacy of supervision over employees having access to manufacturing and
storage areas.
(12) The procedures for handling business guests, visitors, maintenance personnel and non-employee service personnel.
(13) The availability of local police protection or of the registrant's or applicant's security personnel.
(14) The adequacy of the registrant's or applicant's system for monitoring the receipt, manufacture, distribution and disposition of controlled dangerous substances in its operations.
(c) When physical security controls become inadequate as a result of a controlled dangerous substance being transferred to a different schedule, or as a result of a non-controlled dangerous substance being listed on any schedule, or as a result of a significant increase in the quantity of controlled dangerous substances in the possession of the registrant during normal business operations, the physical security controls shall be expanded and extended accordingly. A registrant may adjust physical security controls within the requirements set forth in 475:20-1-3 through 475:20-1-7 when the need for such controls, as determined by the Director, decreases as a result of a controlled dangerous substance being transferred to a different schedule, or as a result of a controlled dangerous substance being moved from control, or as a result of a significant decrease in the quantity of controlled dangerous substances in the possession of the registrant during normal business operations.
(d) Any registrant or applicant desiring to determine whether a proposed security system substantially complies with, or is the structural equivalent of, the requirements set forth in 475:20- 1-3 through 475:20-1-7, may submit any plans, blueprints, sketches, or other materials regarding the proposed security system to the Oklahoma State Bureau of Narcotics and Dangerous Drugs Control.
475:20-1-3. Physical security controls for nonpractitioners; storage areas
Physical security controls for nonpractitioners and storage areas shall comply with Title 21 Code of Federal Regulations §1301.72, except physical security controls for medical marijuana retailers shall, at a minimum, meet the following requirements for each retail storage area:
(1) Each registered premise shall have a security alarm system which upon unauthorized entry shall transmit a signal directly to a central station protection agency or a local or state police agency, each having a legal duty to respond, or to a 24-hour control station operated by the registrant, or to such other source of protection as the Director may approve.
(2) All retail storage areas shall be equipped with self-closing, self-locking doors constructed of substantial material commensurate with the type of building construction, provided, however, a door which is kept closed and locked at all times when not in use and when in use is kept under direct observation of a responsible employee or agent of the registrant is permitted in lieu of a self-closing, self-locking door. Doors may be sliding or hinged. If door hinges are mounted on the outside, such hinges shall be sealed, welded or otherwise constructed to inhibit removal. Locking devices for such doors shall be either of the multiple-position combination, keyless entry, or key lock type and;
(A) In the case of key locks, shall require key control which limits access to a limited number of employees, or;
(B) In the case of multiple-position combination or keyless entry systems, the system shall be limited to a minimum number of employees and can be changed upon termination of employment of an employee having knowledge of the combination.
(3) The retail storage areas shall be accessible only to an absolute minimum number of authorized employees. When it is necessary for employee maintenance personnel, nonemployee maintenance personnel, business guests, or visitors to be present in or pass through a controlled dangerous substance storage area, the registrant shall provide for adequate observation of the area by an employee specifically authorized in writing.
475:20-1-4. Physical security controls for nonpractitioners; manufacturing areas
Physical security controls for nonpractitioners and manufacturing areas shall be in compliance with Title 21 Code of Federal Regulations §1301.73, except physical security controls for medical marijuana commercial growers, processors, packagers, and manufacturers shall, at a minimum, meet the following requirements:
All in-process medical marijuana shall be returned to the storage area at the termination of the process. If the process is not terminated at the end of a workday (except where a continuous process or other normal manufacturing operation should not be interrupted), the processing area or tanks, vessels, bins or bulk containers containing medical marijuana shall be securely locked, with adequate security for the area or building.
Each building shall require a security alarm system, that upon unauthorized entry, shall transmit a signal directly to a central station protection company, or local or state police agency that has a legal duty to respond, or a 24-hour control station operated by the registrant, or to such other source of protection as the Director may approve.
Each building shall be equipped with self-closing, self-locking doors constructed of substantial material commensurate with the type of building construction, provided, however, a door which is kept closed and locked at all times when not in use and when in use is kept under direct observation of a responsible employee or agent of the registrant is permitted in lieu of a self-closing, self-locking door. Doors may be sliding or hinged. If doors hinges are mounted on the outside, such hinges shall be sealed, welded or otherwise constructed to inhibit removal. Locking devices for such doors shall be either of the multiple-position combination, keyless entry, or key lock type and;
In the case of key locks, shall require key control which limits access to a limited number of employees, or;
In the case of multiple-position combination or keyless entry systems, the system shall be limited to a minimum number of employees and can be changed upon termination of employment of an employee having knowledge of the combination.
Any outdoor or greenhouse facilities shall provide adequate security measures for the area or building including the following:
The entire outdoor or greenhouse facility shall be surrounded by a fence and entry gates. Acceptable fencing shall be a metal chain link fence with a wire diameter at least nine (9) gauge or larger, or another similarly secure material or wood. The fence shall measure at least eight (8) feet from the ground to the top of the fence. The fence may be at least six (6) feet of acceptable fencing with a top guard of fencing wire with sharp edges or points, such as barbed wire, to enhance the overall height of the fence to the minimum of eight (8) feet. All support posts shall be steel and securely anchored.
All entry gates shall measure at least eight (8) feet from the ground to the top of the entry gate and shall be constructed of acceptable fencing. The entry gate may be at least six (6) feet of acceptable fencing with a top guard of fencing wire with sharp edges or points, such as barbed wire, to enhance the overall height of the entry gate to the minimum of eight (8) feet. All entry gates shall be kept closed and securely locked at all times when not in use and when in use shall be kept under direct observation of a responsible employee or agent of the registrant.
The fence and entry gates shall be in good repair and obscure the outdoor or greenhouse facility so that it is not easily viewed from outside the fence or entry gates.
The medical marijuana commercial growing, processing, packaging, and manufacturing areas shall be accessible only to an absolute minimum number of authorized employees. When it is necessary for employee maintenance personnel, nonemployee maintenance personnel, business guests, or visitors to be present in or pass through areas where controlled dangerous substances are present, the registrant shall provide for adequate observation of the area by an employee specifically authorized in writing.
A registrant may, in writing, request that the OBN waive one or more of the security requirements described in subsection (4) of this rule, by submitting on a form provided by the OBN a security waiver request for OBN approval. The OBN may in its discretion and on a case- by-case basis, approve the security waiver if it finds that the alternative safeguard proposed by the registrant meets the goals of the above security requirements. Approved security waivers expire at the same time as the underlying registration. The registrants request for a waiver shall include:
The specific portion(s) of subsection (4) that is requested to be waived;
The reason for the waiver; and,
A description of an alternative safeguard the registrant will implement in lieu of the requirement that is the subject of the waiver.