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Rule 44:58 DRUG CONTROL

ARTICLE 44:58

DRUG CONTROL

Chapter

44:58:01             Definitions.

44:58:02             Requirements of registration.

44:58:03             Applications for registration.

44:58:04             Action on applications.

44:58:05             Hearings.

44:58:06             Modification of registration.

44:58:07             Records, reports, and inventories.

44:58:08             Prescriptions.

44:58:09             Administrative procedures.

44:58:10             Security requirements.

44:58:11             Hypodermic control regulations, Repealed.

44:58:12             General provisions, Repealed.

44:58:13             Exempted Schedule III substances.


Rule 44:58:01 DEFINITIONS

CHAPTER 44:58:01

DEFINITIONS

Section

44:58:01:01        Definitions.


Rule 44:58:01:01 Definitions.

          44:58:01:01.  Definitions. Words defined in SDCL 34-20B-1 have the same meaning when used in this article. In addition, terms used in this article mean:

          (1)  "Act," the State Drugs and Substances Control Act, SDCL chapter 34-20B;

          (2)  "Controlled premises," places where records required under the act are kept or places where persons registered under the act or exempted from registration under the act may lawfully hold, manufacture, distribute, dispense, administer, or otherwise dispose of controlled substances;

          (3)  "Department," the state Department of Health;

          (4)  "Division," the Division of Health Systems Development and Regulation of the Department of Health;

          (5)  "Drug Enforcement Administration" or "DEA," the United States Department of Justice, Drug Enforcement Administration, or its successor agency;

          (6)  "Hearing," a hearing held pursuant to this article for the granting, denial, revocation, or suspension of a registration pursuant to §§ 44:58:04:02, 44:58:04:05, and 44:58:04:07 to 44:58:04:09, inclusive;

          (7)  "Individual practitioner," a physician, dentist, veterinarian, optometrist, nurse practitioner, nurse midwife, physician's assistant, or podiatrist licensed by the state of South Dakota or the United States to practice, who is registered or exempt from registration with the division to dispense, administer, or prescribe controlled substances in the course of practice;

          (8)  "Institutional practitioner," a hospital or other institutional employee who is licensed, registered, or otherwise permitted by the state of South Dakota or the United States, to dispense, distribute, or administer a controlled substance in the course of practice;

          (9)  "Long-term care facility (LTCF)," a nursing facility, retirement care, mental care, or other facility or institution which provides extended health care to residents;

          (10)  "Pharmacist," a pharmacist licensed by the state of South Dakota to dispense controlled substances or a pharmacist intern, authorized by the state, who is under the immediate and personal supervision of a pharmacist;

          (11)  "Prescription," an order for medication which is dispensed to or for an ultimate user;

          (12)  "Register" and "registration," the registration required and permitted by SDCL 34-20B-29 to 34-20B-37, inclusive;

          (13)  "Registrant," a person who is registered pursuant to SDCL 34-20B-29 to 34-20B-37, inclusive;

          (14)  "Research protocol," a detailed description of each research project being initiated; and

          (15)  "Secretary," the secretary of health or a person appointed by the secretary to act on the secretary's behalf.

          Source: 1 SDR 30, effective October 7, 1974; 6 SDR 93, effective July 1, 1980; 11 SDR 36, effective September 11, 1984; 21 SDR 14, effective August 4, 1994; 21 SDR 219, effective June 27, 1995; 25 SDR 48, effective October 1, 1998.

          General Authority:SDCL 34-20B-41.

          Law Implemented:SDCL 34-20B-10 to 34-20B-26, 34-20B-28 to 34-20B-37, 34-20B-41.


Rule 44:58:02 REQUIREMENTS OF REGISTRATION

CHAPTER 44:58:02

REQUIREMENTS OF REGISTRATION

Section

44:58:02:01 to 44:58:02:19    Repealed.

44:58:02:20                           Activities requiring separate registration.

44:58:02:21                           Activities covered by single registration.

44:58:02:22                           Waiver of registration.

44:58:02:23                           Compliancy requirements.


Rule 44:58:02:01 Repealed.

          44:58:02:01.  Persons required to register.Repealed.

          Source: 1 SDR 30, effective October 7, 1974; repealed, 6 SDR 93, effective July 1, 1980.


Rule 44:58:02:02 Repealed.

          44:58:02:02.  Activities deemed to be independent.Repealed.

          Source: 1 SDR 30, effective October 7, 1974; repealed, 6 SDR 93, effective July 1, 1980.


Rule 44:58:02:03 Repealed.

          44:58:02:03.  Separate registration required for each independent activity.Repealed.

          Source: 1 SDR 30, effective October 7, 1974; repealed, 6 SDR 93, effective July 1, 1980.


Rule 44:58:02:04 Repealed.

          44:58:02:04.  Manufacturers of basic class authorized to distribute.Repealed.

          Source: 1 SDR 30, effective October 7, 1974; repealed, 6 SDR 93, effective July 1, 1980.


Rule 44:58:02:05 Repealed.

          44:58:02:05.  Manufacturers of substances in Schedules II through IV authorized to analyze and research.Repealed.

          Source: 1 SDR 30, effective October 7, 1974; 6 SDR 93, repealed July 1, 1980.


Rule 44:58:02:06 Repealed.

          44:58:02:06.  Researchers of substances in Schedule I -- Limited manufacturing and research authorized.Repealed.

          Source: 1 SDR 30, effective October 7, 1974; repealed, 6 SDR 93, effective July 1, 1980.


Rule 44:58:02:07 Repealed.

          44:58:02:07.  Persons making chemical analysis -- Limited activities authorized.Repealed.

          Source: 1 SDR 30, effective October 7, 1974; repealed, 6 SDR 93, effective July 1, 1980.


Rule 44:58:02:08 Repealed.

          44:58:02:08.  Researchers of substances in Schedules II through IV -- Other activities authorized.Repealed.

          Source: 1 SDR 30, effective October 7, 1974; repealed, 6 SDR 93, effective July 1, 1980.


Rule 44:58:02:09 Repealed.

          44:58:02:09.  Persons dispensing or conducting research with substances in Schedules II through IV -- Authorized to conduct instructional activities.Repealed.

          Source: 1 SDR 30, effective October 7, 1974; repealed, 6 SDR 93, effective July 1, 1980.


Rule 44:58:02:10 Repealed.

          44:58:02:10.  Single registration for activity with more than one substance.Repealed.

          Source: 1 SDR 30, effective October 7, 1974; repealed, 6 SDR 93, effective July 1, 1980.


Rule 44:58:02:11 Repealed.

          44:58:02:11.  Separate registration required for separate locations.Repealed.

          Source: 1 SDR 30, effective October 7, 1974; repealed, 6 SDR 93, effective July 1, 1980.


Rule 44:58:02:12 Repealed.

          44:58:02:12.  Locations exempt from registration.Repealed.

          Source: 1 SDR 30, effective October 7, 1974; repealed, 6 SDR 93, effective July 1, 1980.


Rule 44:58:02:13 Repealed.

          44:58:02:13.  Agents and employees exempt from registration.Repealed.

          Source: 1 SDR 30, effective October 7, 1974; repealed, 6 SDR 93, effective July 1, 1980.


Rule 44:58:02:14 Repealed.

          44:58:02:14.  Affiliated practitioners exempt from registration.Repealed.

          Source: 1 SDR 30, effective October 7, 1974; repealed, 6 SDR 93, effective July 1, 1980.


Rule 44:58:02:15 Repealed.

          44:58:02:15.  Intern, resident, or foreign physician covered by employer's registration.Repealed.

          Source: 1 SDR 30, effective October 7, 1974; repealed, 6 SDR 93, effective July 1, 1980.


Rule 44:58:02:16 Repealed.

          44:58:02:16.  Law enforcement officials exempt from registration.Repealed.

          Source: 1 SDR 30, effective October 7, 1974; repealed, 6 SDR 93, effective July 1, 1980.


Rule 44:58:02:17 Repealed.

          44:58:02:17.  Law enforcement agency laboratories required to register -- Employees exempt.Repealed.

          Source: 1 SDR 30, effective October 7, 1974; repealed, 6 SDR 93, effective July 1, 1980.


Rule 44:58:02:18 Repealed.

          44:58:02:18.  Exemption of other federal individuals.Repealed.

          Source: 1 SDR 30, effective October 7, 1974; repealed, 6 SDR 93, effective July 1, 1980.


Rule 44:58:02:19 Repealed.

          44:58:02:19.  Exemption of employees of the division.Repealed.

          Source: 1 SDR 30, effective October 7, 1974; repealed, 6 SDR 93, effective July 1, 1980.


Rule 44:58:02:20 Activities requiring separate registration.

          44:58:02:20.  Activities requiring separate registration. Each of the following groups of activities is independent of the others and shall be conducted under separate registrations:

          (1)  Manufacturing and distributing controlled substances;

          (2)  Dispensing controlled substances listed in Schedule II through IV;

          (3)  Conducting research and instructional activities with controlled substances listed in Schedule II through IV;

          (4)  Conducting research and instructional activities with controlled substances listed in Schedule I; and

          (5)  Conducting chemical analysis of controlled substances listed in any schedule.

          Source: 6 SDR 93, effective July 1, 1980.

          General Authority:SDCL 34-20B-41.

          Law Implemented:SDCL 34-20B-29, 34-20B-41.


Rule 44:58:02:21 Activities covered by single registration.

          44:58:02:21.  Activities covered by single registration. Each of the following groups of activities may be conducted under a single registration:

          (1)  A person registered to manufacture controlled substances listed in Schedules II through IV is also authorized to conduct chemical analysis and research with controlled substances listed in the schedules which the person is authorized to manufacture;

          (2)  A practitioner registered to prescribe or dispense controlled substances listed in Schedules II through IV is also authorized to conduct instructional activities with those substances. The person is authorized to distribute up to five percent of those controlled substances to other persons registered to prescribe, dispense, or distribute controlled substances;

          (3)  A person registered or authorized to conduct research with controlled substances listed in Schedules II through IV is also authorized to conduct chemical analysis with substances listed in the schedules with which the person is authorized to conduct research; to manufacture the substances set forth in the statement filed with the person's application for registration; to distribute the substances to other persons registered or authorized to conduct chemical analysis, research or instructional activities with the substances; and to conduct instructional activities with controlled substances;

          (4)  A person registered to conduct research with controlled substances listed in Schedule I is also authorized to manufacture the substances set forth in the research protocol filed with the person's application for registration. The person is also authorized to distribute the substances to other persons registered to conduct research with Schedule I substances; and

          (5)  A person registered to conduct chemical analysis with controlled substances is also authorized to manufacture and import such substances for analytical or instructional purposes; to distribute such substances to other persons registered to conduct chemical analysis, research or instructional activities with the substances; and to conduct instructional activities with controlled substances.

          Source: 6 SDR 93, effective July 1, 1980.

          General Authority:SDCL 34-20B-41.

          Law Implemented:SDCL 34-20B-29, 34-20B-41.


Rule 44:58:02:22 Waiver of registration.

          44:58:02:22.  Waiver of registration. Registration is not required for the following persons in the circumstances described:

          (1)  An individual practitioner who is an agent of another practitioner registered to dispense controlled substances who, when acting in the usual course of employment, administers and dispenses but does not prescribe a controlled substance if permitted to do so by the jurisdiction in which the individual practices;

          (2)  An institutional practitioner who dispenses, administers, and prescribes controlled substances under the registration of the hospital or other institution by which the practitioner is employed, provided the following requirements are met:

               (a)  The dispensing, administering, or prescribing is done in the usual course of professional practice;

               (b)  The employing hospital or other institution authorizes the practitioner to dispense, administer, or prescribe under its registration and designates a specific method for identifying an individual so authorized; and

               (c)  A current list of the institutional practitioners is kept by the hospital or other institution and is made available to the public upon request for the purpose of verifying the authority of the prescribing institutional practitioner;

          (3)  An officer or employee of the United States Drug Enforcement Administration, United States Bureau of Customs, or the United States Food and Drug Administration or any other federal officer who is lawfully engaged in the enforcement of any federal law relating to controlled substances, drugs, or customs and is authorized to possess controlled substances while engaged in the course of official duties;

          (4)  An officer or employee of a state or a political subdivision or agency of a state, who is engaged in the enforcement of a state or local law relating to controlled substances and is authorized to possess controlled substances in the course of official duties, including the following:

               (a)  Possession of a controlled substance and distribution of the substance to another official who is also exempted by this section; and

               (b)  Procurement of a controlled substance in the course of an inspection pursuant to SDCL 34-20B-40 or in the course of a criminal investigation involving the person from whom the substance was procured;

          (5)  An official of the United States Army, Navy, Marine Corps, Air Force, Coast Guard, or Public Health Service who is authorized to prescribe, dispense, or administer, but not to procure or purchase, controlled substances in the course of official duties. Such officials shall follow the procedures set forth in chapter 44:58:08 regarding prescriptions, but shall state the branch of service or agency and use the official's service identification number in lieu of the required registration number;

          (6)  Law enforcement agency laboratory personnel when acting in the scope of their official duties under the registration of the laboratory by which they are employed. Laboratory activities do not include field or other preliminary chemical tests by officials exempted by this section; and

          (7)  An individual practitioner who holds a valid locum tenens certificate, as provided under SDCL 36-4-20.1 to 36-4-20.5, inclusive, who administers, dispenses, or prescribes controlled substances, provided the practitioner holds a valid DEA certificate and has filed an application for registration with the department.

          Source: 6 SDR 93, effective July 1, 1980; 11 SDR 36, effective September 11, 1984; 18 SDR 181, effective May 4, 1992; 21 SDR 219, effective June 27, 1995; 23 SDR 91, effective December 9, 1996.

          General Authority:SDCL 34-20B-41.

          Law Implemented:SDCL 34-20B-32.


Rule 44:58:02:23 Compliancy requirements.

          44:58:02:23.  Compliancy requirements. Each registrant shall comply with Title 21 Code of Federal Regulations (CFR) part 1300 to end as of April 2005.

 

          Source: 31 SDR 62, effective November 7, 2004; 32 SDR 128, effective January 30, 2006.

          General Authority: SDCL 34-20B-41.

          Law Implemented: SDCL 34-20B-41.

 

          Reference: Title 21 Code of Federal Regulations (CFR) 1300 to end. Copies may be obtained from the Superintendent of Documents, Attn: New Orders, P.O. Box 371954, Pittsburg, Pennsylvania 15250-7954. Phone: 1-866-512-1800. Cost: $22.

 


Rule 44:58:03 APPLICATIONS FOR REGISTRATION

CHAPTER 44:58:03

APPLICATIONS FOR REGISTRATION

Section

44:58:03:01                                Registration required -- Expiration date.

44:58:03:02                                Application forms -- Contents.

44:58:03:02.01                           Registration fee.

44:58:03:03                                Procedure for reregistration.

44:58:03:03.01 to 44:58:03:08    Repealed.

44:58:03:09                                Additional information -- Noncompliance with request.

44:58:03:10                                Repealed.


Rule 44:58:03:01 Registration required -- Expiration date.

          44:58:03:01.  Registration required -- Expiration date. A person required to register may not engage in any activity which requires registration until the registration is granted and a certificate is issued by the secretary. The expiration date of the registration coincides with the expiration date of the person's DEA registration.

          Source: 1 SDR 30, effective October 7, 1974; 6 SDR 93, effective July 1, 1980; 21 SDR 14, effective August 4, 1994; 21 SDR 219, effective June 27, 1995; 25 SDR 48, effective October 1, 1998.

          General Authority:SDCL 34-20B-41.

          Law Implemented:SDCL 34-20B-29.


Rule 44:58:03:02 Application forms -- Contents.

          44:58:03:02.  Application forms -- Contents. An application shall contain the person's name; signature; full address; professional license number; type of professional practice; a statement related to conviction of a felony under state or federal law; and a statement related to the denial, revocation, or surrender of a professional license or registration to handle controlled substances. Applications to conduct research and instructional activities with controlled substances as covered by subdivisions 44:58:02:20(3) and (4) shall include evidence of a valid DEA registration to conduct such research and a copy of the research protocol or a statement describing the instructional activities. Applications to manufacture controlled substances listed in Schedule II shall include evidence of a valid DEA registration to manufacture the substances.

          Source: 1 SDR 30, effective October 7, 1974; 6 SDR 93, effective July 1, 1980; 11 SDR 36, effective September 11, 1984; 25 SDR 48, effective October 1, 1998.

          General Authority:SDCL 34-20B-41.

          Law Implemented:SDCL 34-20B-29, 34-20B-35 to 34-20B-37, 34-20B-41.


Rule 44:58:03:02.01 Registration fee.

          44:58:03:02.01.  Registration fee. Each registrant shall pay a registration fee at the time of initial registration or at renewal of registration. Registration fees are non-refundable and may not be prorated. The registration fees are as follows:

 

          (1)  $150 for any dentist, medical doctor, optometrist, osteopathic doctor, pharmacy, veterinarian, or podiatrist;

          (2)  $150 for any nurse practitioner, nurse midwife, or physician assistant;

          (3)  $75 for any manufacturer, distributor, analytical lab, euthanasia, teaching institution, or researcher (including any drug detection dog trainer); and

          (4)  $75 for any locum tenens certificate.

 

          Source: 31 SDR 62, effective November 7, 2004; 35 SDR 305, effective July 1, 2009.

          General Authority: SDCL 34-20B-41.

          Law Implemented: SDCL 34-20B-41.

 


Rule 44:58:03:03 Procedure for reregistration.

          44:58:03:03.  Procedure for reregistration. A person registered under § 44:58:02:20 shall apply for reregistration in writing to the secretary not more than 60 days before the expiration date of the person's current registration.

          Source: 1 SDR 30, effective October 7, 1974; 6 SDR 93, effective July 1, 1980; 11 SDR 36, effective September 11, 1984; 21 SDR 14, effective August 4, 1994; 21 SDR 219, effective June 27, 1995.

          General Authority:SDCL 34-20B-41.

          Law Implemented:SDCL 34-20B-29.


Rule 44:58:03:03.01 Repealed.

          44:58:03:03.01.  Waiver of reregistration.Repealed.

          Source: 6 SDR 93, effective July 1, 1980; repealed, 21 SDR 219, effective June 27, 1995.


Rule 44:58:03:04 Repealed.

          44:58:03:04.  Federal registration must accompany applications for Schedules I and II.Repealed.

          Source: 1 SDR 30, effective October 7, 1974; repealed, 6 SDR 93, effective July 1, 1980.


Rule 44:58:03:05 Repealed.

          44:58:03:05.  Required information for applications.Repealed.

          Source: 1 SDR 30, effective October 7, 1974; repealed, 6 SDR 93, effective July 1, 1980.


Rule 44:58:03:06 Repealed.

          44:58:03:06.  Signatures on applications.Repealed.

          Source: 1 SDR 30, effective October 7, 1974; repealed, 6 SDR 93, effective July 1, 1980.


Rule 44:58:03:07 Repealed.

          44:58:03:07.  Filing of applications with director -- Joint filings.Repealed.

          Source: 1 SDR 30, effective October 7, 1974; repealed, 6 SDR 93, effective July 1, 1980.


Rule 44:58:03:08 Repealed.

          44:58:03:08.  Acceptance of filing -- Defective applications.Repealed.

          Source: 1 SDR 30, effective October 7, 1974; repealed, 6 SDR 93, effective July 1, 1980.


Rule 44:58:03:09 Additional information -- Noncompliance with request.

          44:58:03:09.  Additional information -- Noncompliance with request. The secretary may require an applicant to submit documents relevant to the application to determine if registration should be granted. The failure of the applicant to provide such documents within 15 days after the request is considered a waiver by the applicant of the opportunity to present such documents. Upon request, the secretary may extend the time for good cause.

          Source: 1 SDR 30, effective October 7, 1974; 6 SDR 93, effective July 1, 1980; 21 SDR 14, effective August 4, 1994; 21 SDR 219, effective June 27, 1995.

          General Authority:SDCL 34-20B-41.

          Law Implemented:SDCL 34-20B-29.


Rule 44:58:03:10 Repealed.

          44:58:03:10.  Amendments to and withdrawal of applications.Repealed.

          Source: 1 SDR 30, effective October 7, 1974; repealed, 6 SDR 93, effective July 1, 1980.


Rule 44:58:04 ACTION ON APPLICATIONS

CHAPTER 44:58:04

ACTION ON APPLICATIONS

Section

44:58:04:01                           Review of applications.

44:58:04:02                           Issuance of certificate of registration -- Denial of registration.

44:58:04:03                           Information contained on certificate.

44:58:04:04                           Location of the certificate.

44:58:04:05                           Suspension or revocation of registration.

44:58:04:06                           Repealed.

44:58:04:07                           Requirements of registrant upon service of notice of automatic suspension, revocation, or suspension.

44:58:04:08                           Limited revocations or suspensions.

44:58:04:09                           New certificate when limitation applied.

44:58:04:10 to 44:58:04:15    Repealed.

          Cross-Reference: Procedure and appellate procedure for revocation of licenses, SDCL 1-26-16 to 1-26-37.


Rule 44:58:04:01 Review of applications.

          44:58:04:01.  Review of applications. The secretary shall review the application for registration and other information regarding an applicant to determine that applicable standards are met.

          Source: 1 SDR 30, effective October 7, 1974; 6 SDR 93, effective July 1, 1980; 21 SDR 14, effective August 4, 1994; 21 SDR 219, effective June 27, 1995.

          General Authority:SDCL 34-20B-41.

          Law Implemented:SDCL 34-20B-29, 34-20B-35 to 34-20B-37, 34-20B-40.


Rule 44:58:04:02 Issuance of certificate of registration -- Denial of registration.

          44:58:04:02.  Issuance of certificate of registration -- Denial of registration. The secretary shall issue a certificate of registration after reviewing the application and finding the information in compliance with this chapter and SDCL 34-20B. The secretary shall issue an order when denying an application and, if requested by the applicant, hold a hearing on the application denial pursuant to SDCL 1-26.

          Source: 1 SDR 30, effective October 7, 1974; 6 SDR 93, effective July 1, 1980; 21 SDR 14, effective August 4, 1994; 21 SDR 219, effective June 27, 1995.

          General Authority:SDCL 34-20B-41.

          Law Implemented:SDCL 34-20B-29 to 34-20B-37.


Rule 44:58:04:03 Information contained on certificate.

          44:58:04:03.  Information contained on certificate. The certificate of registration shall contain the name, address, registration number of the registrant, any applicable federal registration numbers, the activity authorized by the registration, the schedules of controlled substances which the registrant is authorized to handle, and the expiration date of the registration.

          Source: 1 SDR 30, effective October 7, 1974; 6 SDR 93, effective July 1, 1980.

          General Authority:SDCL 34-20B-41.

          Law Implemented:SDCL 34-20B-29.


Rule 44:58:04:04 Location of the certificate.

          44:58:04:04.  Location of the certificate. The registrant shall conspicuously place the certificate at the registered location and shall permit inspection of the certificate and registered premises by any official of the division or other state or local agency engaged in enforcement of laws pertaining to controlled substances.

          Source: 1 SDR 30, effective October 7, 1974; 6 SDR 93, effective July 1, 1980; 21 SDR 219, effective June 27, 1995.

          General Authority:SDCL 34-20B-41.

          Law Implemented:SDCL 34-20B-29, 34-20B-40, 34-20B-41.


Rule 44:58:04:05 Suspension or revocation of registration.

          44:58:04:05.  Suspension or revocation of registration. The department may suspend or revoke any registration issued under the act as provided under SDCL 1-26.

          The reasons for suspension or revocation shall include  a finding that the registrant has done one or more of the following:

          (1)  Has furnished false or fraudulent information in an application filed under the act;

          (2)  Has been convicted of a felony under any state or federal law relating to a controlled substance;

          (3)  Has had a federal registration to manufacture, distribute, or dispense controlled substances suspended, revoked, or allowed to expire;

          (4)  Has been the subject of disciplinary action taken by the registrant's respective licensing board for substance abuse, misuse of controlled substances, or violation of state law related to prescribing or dispensing controlled substances; or

          (5)  Has violated the requirements of the act or this article.

          Source: 1 SDR 30, effective October 7, 1974; 6 SDR 93, effective July 1, 1980; 11 SDR 36, effective September 11, 1984; 18 SDR 181, effective May 4, 1992; 21 SDR 219, effective June 27, 1995.

          General Authority:SDCL 34-20B-41.

          Law Implemented:SDCL 34-20B-41.


Rule 44:58:04:06 Repealed.

          44:58:04:06.  Procedure prior to revoking or suspending registration.Repealed.

          Source: 1 SDR 30, effective October 7, 1974; repealed, 6 SDR 93, effective July 1, 1980.


Rule 44:58:04:07 Requirements of registrant upon service of notice of automatic suspension, revocation, or suspension.

          44:58:04:07.  Requirements of registrant upon service of notice of automatic suspension, revocation, or suspension. Upon service of the notice of automatic suspension, notice of revocation, or notice of suspension, the registrant shall immediately deliver the certificate of registration to the secretary. As instructed by the secretary, the registrant shall also deliver all controlled substances in the registrant's possession to the secretary or to authorized agents of the secretary or place all controlled substances in the registrant's possession under seal, with a complete inventory of items on hand, and store the items to preclude any further disposition of them without a court order until the time for taking an appeal has elapsed or until all appeals have been concluded.

          Source: 1 SDR 30, effective October 7, 1974; 6 SDR 93, effective July 1, 1980; 21 SDR 14, effective August 4, 1994; 21 SDR 219, effective June 27, 1995.

          General Authority:SDCL 34-20B-41.

          Law Implemented:SDCL 34-20B-41.

          Cross-Reference: Events causing automatic suspension of registration, § 44:58:06:02.


Rule 44:58:04:08 Limited revocations or suspensions.

          44:58:04:08.  Limited revocations or suspensions. The secretary may limit revocation or suspension of a registration to a particular schedule of controlled substance as circumstances indicate. Action required under § 44:58:04:05 is limited to the schedule or schedules revoked.

          Source: 1 SDR 30, effective October 7, 1974; 6 SDR 93, effective July 1, 1980; 21 SDR 14, effective August 4, 1994; 21 SDR 219, effective June 27, 1995.

          General Authority:SDCL 34-20B-41.

          Law Implemented:SDCL 34-20B-41.


Rule 44:58:04:09 New certificate when limitation applied.

          44:58:04:09.  New certificate when limitation applied. If revocation or suspension is limited to a particular schedule, the secretary shall issue the registrant a new certificate of registration for all substances not affected. The registrant shall deliver the old certificate of registration to the secretary.

          Source: 1 SDR 30, effective October 7, 1974; 6 SDR 93, effective July 1, 1980; 21 SDR 14, effective August 4, 1994; 21 SDR 219, effective June 27, 1995.

          General Authority:SDCL 34-20B-41.

          Law Implemented:SDCL 34-20B-41.


Rule 44:58:04:10 Repealed.

          44:58:04:10.  Suspension of registration authorized pending director's final order.Repealed.

          Source: 1 SDR 30, effective October 7, 1974; repealed, 6 SDR 93, effective July 1, 1980.


Rule 44:58:04:11 Repealed.

          44:58:04:11.  Actions required of registrant upon immediate suspension.Repealed.

          Source: 1 SDR 30, effective October 7, 1974; repealed, 6 SDR 93, effective July 1, 1980.


Rule 44:58:04:12 Repealed.

          44:58:04:12.  Effective time period of suspension.Repealed.

          Source: 1 SDR 30, effective October 7, 1974; repealed, 6 SDR 93, effective July 1, 1980.


Rule 44:58:04:13 Repealed.

          44:58:04:13.  Order to show cause required to revoke or suspend registration.Repealed.

          Source: 1 SDR 30, effective October 7, 1974; repealed, 6 SDR 93, effective July 1, 1980.


Rule 44:58:04:14 Repealed.

          44:58:04:14.  Request for hearing.Repealed.

          Source: 1 SDR 30, effective October 7, 1974; repealed, 6 SDR 93, effective July 1, 1980.


Rule 44:58:04:15 Repealed.

          44:58:04:15.  Director's agent may serve order to show cause.Repealed.

          Source: 1 SDR 30, effective October 7, 1974; repealed, 6 SDR 93, effective July 1, 1980.


Rule 44:58:05 HEARINGS

CHAPTER 44:58:05

HEARINGS

Section

44:58:05:01                           Conduct of hearings generally -- Not in lieu of criminal prosecutions.

44:58:05:02 to 44:58:05:10    Repealed.

          Cross-Reference: Hearing procedure, SDCL 1-26-16 to 1-26-29.


Rule 44:58:05:01 Conduct of hearings generally -- Not in lieu of criminal prosecutions.

          44:58:05:01.  Conduct of hearings generally -- Not in lieu of criminal prosecutions. Administrative hearings in contested cases shall be governed by the act, this article, and SDCL chapter 1-26.

          A hearing held for violation of this article is independent of, and not in lieu of, criminal prosecutions or other proceedings under the act or any other law of this state.

          Source: 1 SDR 30, effective October 7, 1974; 6 SDR 93, effective July 1, 1980.

          General Authority:SDCL 34-20B-41.

          Law Implemented:SDCL 34-20B-41, 1-26-27.

          Reference: Administrative Procedures Act, SDCL chapter 1-26.


Rule 44:58:05:02 Repealed.

          44:58:05:02.  Purpose of hearing -- Arguments not to be offered as evidence.Repealed.

          Source: 1 SDR 30, effective October 7, 1974; repealed, 6 SDR 93, effective July 1, 1980.


Rule 44:58:05:03 Repealed.

          44:58:05:03.  Waiver or modification of rules governing hearing procedure.Repealed.

          Source: 1 SDR 30, effective October 7, 1974; repealed, 6 SDR 93, effective July 1, 1980.


Rule 44:58:05:04 Repealed.

          44:58:05:04.  Time to make request for hearing.Repealed.

          Source: 1 SDR 30, effective October 7, 1974; repealed, 6 SDR 93, effective July 1, 1980.


Rule 44:58:05:05 Repealed.

          44:58:05:05.  Filing of written statement prior to hearing -- Inclusion in record.Repealed.

          Source: 1 SDR 30, effective October 7, 1974; repealed, 6 SDR 93, effective July 1, 1980.


Rule 44:58:05:06 Repealed.

          44:58:05:06.  Failure to request hearing -- Failure to appear.Repealed.

          Source: 1 SDR 30, effective October 7, 1974; repealed, 6 SDR 93, effective July 1, 1980.


Rule 44:58:05:07 Repealed.

          44:58:05:07.  Cancellation of hearing.Repealed.

          Source: 1 SDR 30, effective October 7, 1974; repealed, 6 SDR 93, effective July 1, 1980.


Rule 44:58:05:08 Repealed.

          44:58:05:08.  Time and place of hearing after waiver.Repealed.

          Source: 1 SDR 30, effective October 7, 1974; repealed, 6 SDR 93, effective July 1, 1980.


Rule 44:58:05:09 Repealed.

          44:58:05:09.  Final order -- Findings and conclusions -- Effective date -- Service.Repealed.

          Source: 1 SDR 30, effective October 7, 1974; repealed, 6 SDR 93, effective July 1, 1980.


Rule 44:58:05:10 Repealed.

          44:58:05:10.  Hearing officers' decisions final.Repealed.

          Source: 1 SDR 30, effective October 7, 1974; repealed, 6 SDR 93, effective July 1, 1980.


Rule 44:58:06 MODIFICATION OF REGISTRATION

CHAPTER 44:58:06

MODIFICATION OF REGISTRATION

Section

44:58:06:01        Applications for modification of registration -- Contents.

44:58:06:02        Events causing automatic suspension of registration.

44:58:06:02.01   Voluntary surrender and reinstatement of registration.

44:58:06:03        Secretary's consent required to transfer registration.


Rule 44:58:06:01 Applications for modification of registration -- Contents.

          44:58:06:01.  Applications for modification of registration -- Contents. A registrant may apply to modify a registration by submitting a revised application and a letter of request to the secretary. The letter shall contain all information required by §  44:58:03:02.

          Source: 1 SDR 30, effective October 7, 1974; 6 SDR 93, effective July 1, 1980; 21 SDR 14, effective August 4, 1994; 21 SDR 219, effective June 27, 1995.

          General Authority:SDCL 34-20B-41.

          Law Implemented:SDCL 34-20B-29, 34-20B-41.


Rule 44:58:06:02 Events causing automatic suspension of registration.

          44:58:06:02.  Events causing automatic suspension of registration. The registration of a person is automatically suspended if the person fails to maintain the person's professional license, fails to maintain DEA registration in South Dakota, discontinues professional practice within South Dakota, or changes name or address without notifying the secretary.

          Source: 1 SDR 30, effective October 7, 1974; 6 SDR 93, effective July 1, 1980; 21 SDR 14, effective August 4, 1994; 21 SDR 219, effective June 27, 1995.

          General Authority:SDCL 34-20B-41.

          Law Implemented:SDCL 34-20B-29, 34-20B-41.


Rule 44:58:06:02.01 Voluntary surrender and reinstatement of registration.

          44:58:06:02.01.  Voluntary surrender and reinstatement of registration. A registrant may voluntarily surrender the registration to prescribe controlled substances. If the surrender is made because the registrant is incapacitated, retires, or moves out of South Dakota, the registrant may apply for a new registration at any time.

          If the surrender is due to alleged failure to comply with the provisions of SDCL 34-20B or 22-42 or both, the following requirements apply:

          (1)  The surrender shall be for a specific length of time;

          (2)  The surrender statement shall specify the schedule or schedules which are involved;

          (3)  The registrant may not reapply for Schedule IV prescribing privileges until at least one-half of the specified time has passed;

          (4)  The registrant may not reapply for Schedule III prescribing privileges until at least five-eighths of the specified time has passed;

          (5)  The registrant may not reapply for Schedule II prescribing privileges until at least three-fourths of the specified time has passed;

          (6)  All applicants for reinstatement must be approved by the secretary;

          (7)  The applicant for reinstatement must demonstrate, through written or oral examination, a knowledge of the pharmacology and law related to the controlled substances for which the applicant is requesting prescribing privileges. The examination shall be prepared and given by at least three and no more than five health care professionals knowledgeable in the areas to be tested; and

          (8)  The final decision for reinstatement rests with the secretary.

          Source: 6 SDR 93, effective July 1, 1980; 11 SDR 36, effective September 11, 1984; 21 SDR 14, effective August 4, 1994; 21 SDR 219, effective June 27, 1995.

          General Authority:SDCL 34-20B-41.

          Law Implemented:SDCL 34-20B-29, 34-20B-41.


Rule 44:58:06:03 Secretary's consent required to transfer registration.

          44:58:06:03.  Secretary's consent required to transfer registration. A registration may not be transferred without written consent of the secretary. The method of transferring any existing stock of controlled substances must be indicated in a letter accompanying the certificate.

          Source: 1 SDR 30, effective October 7, 1974; 6 SDR 93, effective July 1, 1980; 21 SDR 14, effective August 4, 1994; 21 SDR 219, effective June 27, 1995.

          General Authority:SDCL 34-20B-41.

          Law Implemented:SDCL 34-20B-41.


Rule 44:58:07 RECORDS, REPORTS, AND INVENTORIES

CHAPTER 44:58:07

RECORDS, REPORTS, AND INVENTORIES

Section

44:58:07:01 and 44:58:07:02  Repealed.

44:58:07:03                                Inventory requirements.

44:58:07:04                                Acquisition, dispensing, and distribution records.

44:58:07:05                                Theft reports.

44:58:07:06 to 44:58:07:08         Repealed.

44:58:07:09                                Emergency supplies of controlled substances in long term care facilities.


Rule 44:58:07:01 Repealed.

          44:58:07:01.  Record, report, and inventory requirements generally.Repealed.

          Source: 1 SDR 30, effective October 7, 1974; repealed, 6 SDR 93, effective July 1, 1980.


Rule 44:58:07:02 Repealed.

          44:58:07:02.  Record, report, and inventory requirements specifically.Repealed.

          Source: 1 SDR 30, effective October 7, 1974; repealed, 6 SDR 93, effective July 1, 1980.


Rule 44:58:07:03 Inventory requirements.

          44:58:07:03.  Inventory requirements. Upon registration, a registrant shall make a written, typed, or printed inventory of all stocks of controlled substances. After the initial inventory is taken, the registrant shall take a new inventory of all stocks of controlled substances on hand at least every two years. The biennial inventory may be taken on any date which is within two years of the previous inventory date. The inventory shall contain the following:

          (1)  An exact count or measure of all Schedule I and II substances;

          (2)  An estimated count or measure of all Schedule III or IV substances; if a container holds more than 1,000 doses, the registrant shall make an accurate count; and

          (3)  The date, time of day (opening or closing of business), signature of the person taking the inventory, and signature of the registrant if not the same individual.

          Substances which are added to the list of controlled substances shall be inventoried on the date when the control takes effect and thereafter with the biennial inventory.

          Source: 6 SDR 93, effective July 1, 1980; 25 SDR 48, effective October 1, 1998.

          General Authority:SDCL 34-20B-41.

          Law Implemented:SDCL 34-20B-39, 34-20B-40.


Rule 44:58:07:04 Acquisition, dispensing, and distribution records.

          44:58:07:04.  Acquisition, dispensing, and distribution records. A dispenser shall maintain the records required to acquire, distribute, or dispense controlled substances in a readily retrievable manner. The following minimum standards shall be met:

          (1)  Acquisition of Schedule I and II substances will be verified through official order forms of the DEA;

          (2)  Acquisition of Schedule III and IV substances will be verified through invoices or other records;

          (3)  Dispensing of all controlled substances will be verified through prescriptions or other chronological records as follows:

               (a)  The records shall include the name and address of the patient (or species and name and address of the owner if the patient is an animal), the date, the controlled substance and dose, the quantity dispensed, and the name, address, and DEA number of the prescriber;

               (b)  A separate file shall be maintained for dispensed substances listed in Schedule II;

               (c)  Schedule III and IV records may be maintained in a separate file or marked with a red "C" at least one inch high and filed with the prescriptions for noncontrolled drugs. If the pharmacy uses an automated data processing system or electronic record keeping system for prescriptions which permits identification by prescription number and retrieval of original documents by prescriber's name, patient's name, controlled substance dispensed, and date filled, then the requirement to mark the hard copy prescription with a red "C" is waived; and

          (4)  Distribution of controlled substances to another registrant as provided under subdivision 44:58:02:21(1) shall be as follows:

               (a)  Distribution of Schedule I and II substances will be verified by the supplier's copy of the official DEA order form; and

               (b)  Distribution of Schedule III and IV substances will be verified by invoices.

          Source: 6 SDR 93, effective July 1, 1980; 11 SDR 36, effective September 11, 1984; 25 SDR 48, effective October 1, 1998.

          General Authority:SDCL 34-20B-41.

          Law Implemented:SDCL 34-20B-39, 34-20B-40.


Rule 44:58:07:05 Theft reports.

          44:58:07:05.  Theft reports. A registrant shall notify the division of the theft or loss of a controlled substance within 48 hours. The report shall include the names and quantities of drugs and the circumstances involved in the theft or loss.

          Source: 11 SDR 36, effective September 11, 1984; 21 SDR 219, effective June 27, 1995.

          General Authority:SDCL 34-20B-41.

          Law Implemented:SDCL 34-20B-39, 34-20B-40, 34-20B-44, 34-20B-48.


Rule 44:58:07:06 Repealed.

          44:58:07:06.  Emergency supplies.Repealed.

          Source: 25 SDR 48, effective October 1, 1998; repealed, 27 SDR 59, effective December 17, 2000.


Rule 44:58:07:07 Repealed.

          44:58:07:07.  Limits on Schedule II controlled substances.Repealed.

          Source: 25 SDR 48, effective October 1, 1998; repealed, 27 SDR 59, effective December 17, 2000.


Rule 44:58:07:08 Repealed.

          44:58:07:08.  Limits on Schedule III and IV controlled substances.Repealed.

          Source: 25 SDR 48, effective October 1, 1998; repealed, 27 SDR 59, effective December 17, 2000.


Rule 44:58:07:09 Emergency supplies of controlled substances in long term care facilities.

          44:58:07:09.  Emergency supplies of controlled substances in long term care facilities. Emergency supplies of controlled substances may be kept in long term care facilities under the following circumstances:

          (1)  The pharmacist supplying the controlled substances retains ownership and responsibility for the controlled substances, including a monthly physical inventory;

          (2)  The controlled substances are stored in a manner that allows only those individuals authorized to administer the controlled substance access to them;

          (3)  The controlled substances are stored in a sealed emergency box or in a separate locked cabinet, with a complete and accurate record kept of the controlled substances in the box or cabinet and their disposition;

          (4)  The facility notifies the pharmacist within 36 hours after the withdrawal of a Schedule II controlled substance and within 72 hours after the withdrawal of a Schedule III or IV controlled substance and the pharmacist replaces the controlled substance within 72 hours after notification; and

          (5)  No more than five different controlled substances are stored in the emergency box, which may contain no more than six doses of any Schedule II controlled substance, no more than six doses of any Schedule III or IV injectable controlled substance, and no more than 12 doses of any oral Schedule III or IV controlled substance.

          Source: 25 SDR 48, effective October 1, 1998.

          General Authority:SDCL 34-20B-41.

          Law Implemented:SDCL 34-20B-41.


Rule 44:58:08 PRESCRIPTIONS

CHAPTER 44:58:08

PRESCRIPTIONS

Section

44:58:08:01 and 44:58:08:02  Repealed.

44:58:08:03                                Prescription prohibited for general dispensing supply.

44:58:08:04                                Prescription prohibited for continuing dependence on drug.

44:58:08:05                                Manner of issuance of prescriptions.

44:58:08:06 to 44:58:08:09         Repealed.

44:58:08:09.01                           Dispensing controlled substances for maintenance purposes.

44:58:08:10 and 44:58:08:11  Repealed.

44:58:08:11.01                           Direct administering or dispensing of controlled substances.

44:58:08:12                                Repealed.

44:58:08:13                                Requirements for oral authorization of Schedule II substances in emergencies.

44:58:08:14 to 44:58:08:16         Repealed.

44:58:08:17                                Refilling of Schedule III and IV prescriptions -- Computerized information system authorized.

44:58:08:17.01                           Refilling of Schedule II prescriptions prohibited.

44:58:08:18                                Partial filling of prescriptions for Schedule II substances.

44:58:08:18.01                           Partial filling of prescriptions for Schedule II substances for nursing facility or terminally ill patients.

44:58:08:18.02                           Computerized system authorized for Schedule II prescription information for nursing facility or terminally ill patients.

44:58:08:18.03                           Facsimile transmission of Schedule II prescriptions.

44:58:08:19                                Repealed.

44:58:08:20                                Labeling of prescriptions for controlled substances.

44:58:08:21 and 44:58:08:22  Repealed.

44:58:08:23                                Dispensing placebo drugs.


Rule 44:58:08:01 Repealed.

          44:58:08:01.  Persons entitled to issue prescriptions.Repealed.

          Source: 1 SDR 30, effective October 7, 1974; repealed, 6 SDR 93, effective July 1, 1980.


Rule 44:58:08:02 Repealed.

          44:58:08:02.  Purpose of issuance of prescription.Repealed.

          Source: 1 SDR 30, effective October 7, 1974; repealed, 6 SDR 93, effective July 1, 1980.


Rule 44:58:08:03 Prescription prohibited for general dispensing supply.

          44:58:08:03.  Prescription prohibited for general dispensing supply. A prescription may not be issued by an individual practitioner to obtain controlled substances for general dispensing to patients.

          Source: 1 SDR 30, effective October 7, 1974; 6 SDR 93, effective July 1, 1980; 25 SDR 48, effective October 1, 1998.

          General Authority:SDCL 34-20B-41.

          Law Implemented:SDCL 34-20B-41.


Rule 44:58:08:04 Prescription prohibited for continuing dependence on drug.

          44:58:08:04.  Prescription prohibited for continuing dependence on drug. A prescription may not be issued for a controlled substance nor may a controlled substance be dispensed or administered to a drug dependent person for the purpose of continuing the person's dependency.

          Source: 1 SDR 30, effective October 7, 1974; 6 SDR 93, effective July 1, 1980.

          General Authority:SDCL 34-20B-41.

          Law Implemented:SDCL 34-20B-41.


Rule 44:58:08:05 Manner of issuance of prescriptions.

          44:58:08:05.  Manner of issuance of prescriptions. No practitioner may issue a prescription for a controlled substance for the practitioner's use. Prescriptions for controlled substances must be dated and signed on the day when issued and must bear the full name and address of the patient; the drug name, strength, dosage form, quantity prescribed, and directions for use; and the name, address, and registration number of the practitioner. A practitioner shall sign a prescription in the same manner as the practitioner would sign a legal document. If an oral order is not permitted, prescriptions must be written with ink, indelible pencil, or typewriter and must be manually signed by the practitioner. The prescriptions may be prepared by a secretary or agent for the signature of a practitioner, but the prescribing practitioner is responsible if the prescription does not conform in all essential respects to the law and this article. A liability rests upon the pharmacist who fills a prescription not prepared in the form prescribed in this article. Prescriptions for Schedule III and IV controlled substances may be transmitted directly from the individual practitioner to the pharmacy by facsimile equipment.

          Source: 1 SDR 30, effective October 7, 1974; 6 SDR 93, effective July 1, 1980; 18 SDR 181, effective May 4, 1992; 21 SDR 219, effective June 27, 1995; 25 SDR 48, effective October 1, 1998.

          General Authority:SDCL 34-20B-41.

          Law Implemented:SDCL 34-20B-41.


Rule 44:58:08:06 Repealed.

          44:58:08:06.  When hospital code number required in lieu of registration number.Repealed.

          Source: 1 SDR 30, effective October 7, 1974; repealed, 6 SDR 93, effective July 1, 1980.


Rule 44:58:08:07 Repealed.

          44:58:08:07.  When service identification number required in lieu of registration number.Repealed.

          Source: 1 SDR 30, effective October 7, 1974; repealed, 6 SDR 93, effective July 1, 1980.


Rule 44:58:08:08 Repealed.

          44:58:08:08.  Persons entitled to fill prescriptions.Repealed.

          Source: 1 SDR 30, effective October 7, 1974; repealed, 6 SDR 93, effective July 1, 1980.


Rule 44:58:08:09 Repealed.

          44:58:08:09.  Dispensing of narcotic drugs for narcotic rehabilitation program authorized.Repealed.

          Source: 1 SDR 30, effective October 7, 1974; repealed, 6 SDR 93, effective July 1, 1980.


Rule 44:58:08:09.01 Dispensing controlled substances for maintenance purposes.

          44:58:08:09.01.  Dispensing controlled substances for maintenance purposes. The administering or dispensing directly of a controlled substance listed in any schedule to a drug dependent person for the purpose of controlled withdrawal while in treatment in a drug treatment or rehabilitation program must be within the meaning of the term, "in the course of professional practice or research".

          Source: 6 SDR 93, effective July 1, 1980.

          General Authority:SDCL 34-20B-41.

          Law Implemented:SDCL 34-20B-41.


Rule 44:58:08:10 Repealed.

          44:58:08:10.  Dispensing of Schedule II substances by pharmacists.Repealed.

          Source: 1 SDR 30, effective October 7, 1974; repealed, 6 SDR 93, effective July 1, 1980.


Rule 44:58:08:11 Repealed.

          44:58:08:11.  Direct administering or dispensing of Schedule II substances by practitioner.Repealed.

          Source: 1 SDR 30, effective October 7, 1974; repealed, 6 SDR 93, effective July 1, 1980.


Rule 44:58:08:11.01 Direct administering or dispensing of controlled substances.

          44:58:08:11.01.  Direct administering or dispensing of controlled substances. An individual practitioner, in the course of professional practice only, may directly administer or dispense a controlled substance without a prescription to other persons. An individual practitioner or institutional practitioner may not order a controlled substance for direct administration or dispense a controlled substance, including any controlled substance sample, for the practitioner's use.

          Source: 6 SDR 93, effective July 1, 1980; 25 SDR 48, effective October 1, 1998.

          General Authority:SDCL 34-20B-41.

          Law Implemented:SDCL 34-20B-30, 34-20B-41.


Rule 44:58:08:12 Repealed.

          44:58:08:12.  Direct administering or dispensing of Schedule II substances by institutional practitioner.Repealed.

          Source: 1 SDR 30, effective October 7, 1974; repealed, 6 SDR 93, effective July 1, 1980.


Rule 44:58:08:13 Requirements for oral authorization of Schedule II substances in emergencies.

          44:58:08:13.  Requirements for oral authorization of Schedule II substances in emergencies. In an emergency situation, as defined in SDCL 22-42-2.2, a pharmacist may dispense a controlled substance listed in Schedule II upon receiving oral authorization of an individual practitioner, if:

          (1)  The quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period;

          (2)  The prescription is immediately reduced to writing by the pharmacist and contains all information required in § 44:58:08:05 except for the signature of the prescribing individual practitioner;

          (3)  The practitioner is not known to the pharmacist, the pharmacist must make a reasonable effort to determine that the oral authorization came from a registered individual practitioner by returning the prescriber's call using the phone number listed in the telephone directory or through other good faith efforts to assure the practitioner's identity; and

          (4)  Within seven days after authorizing an emergency oral prescription the individual practitioner shall supply the pharmacy with a written prescription for the emergency quantity prescribed. In addition to conforming to the requirements of § 44:58:08:05, the prescription shall have written on its face "Authorization for Emergency Dispensing," and the date of the oral order. Upon receipt, the dispensing pharmacist shall attach this prescription to the oral emergency prescription which had earlier been reduced to writing. If the emergency prescription is sent by mail, the carrier envelope must be postmarked within the seven days. The pharmacist shall notify the department if the prescribing practitioner fails to deliver a written prescription within seven days. Failure to notify the department voids the authority to dispense the controlled substance without a written prescription.

          Source: 1 SDR 30, effective October 6, 1974; 6 SDR 93, effective July 1, 1980; 25 SDR 48, effective October 1, 1998.

          General Authority:SDCL 34-20B-41.

          Law Implemented:SDCL 22-42-2.1, 22-42-2.2.


Rule 44:58:08:14 Repealed.

          44:58:08:14.  Dispensing of Schedule III and IV substances by pharmacists.Repealed.

          Source: 1 SDR 30, effective October 7, 1974; repealed, 6 SDR 93, effective July 1, 1980.


Rule 44:58:08:15 Repealed.

          44:58:08:15.  Direct administering or dispensing of Schedule III or IV substances by practitioner.Repealed.

          Source: 1 SDR 30, effective October 7, 1974; repealed, 6 SDR 93, effective July 1, 1980.


Rule 44:58:08:16 Repealed.

          44:58:08:16.  Direct administering or dispensing of Schedule III and IV substances by institutional practitioner.Repealed.

          Source: 1 SDR 30, effective October 7, 1974; repealed, 6 SDR 93, effective July 1, 1980.


Rule 44:58:08:17 Refilling of Schedule III and IV prescriptions -- Computerized information system authorized.

          44:58:08:17.  Refilling of Schedule III and IV prescriptions -- Computerized information system authorized. A prescription for a Schedule III or IV drug or substance may be refilled up to five times within a six-month period if the refills are authorized by the practitioner on the original prescription. Each refill dispensed shall be entered on the prescription or on a patient medication record which indicates the date, quantity dispensed, and initials or name of the dispensing pharmacist. If the pharmacist merely initials and dates the prescription, the pharmacist is assumed to have dispensed a refill for the full face amount of the prescription. Additional quantities of controlled substances listed in Schedule III or IV may only be authorized by a practitioner through issuance of a new prescription.

          As an alternative to the record procedures required by this section, an automated data processing system that complies with chapter 20:51:20 may be used for the storage and retrieval of refill information for prescription orders for controlled substances in Schedules III and IV.

          Source: 1 SDR 30, effective October 7, 1974; 6 SDR 93, effective July 1, 1980; 11 SDR 36, effective September 11, 1984; 18 SDR 181, effective May 4, 1992.

          General Authority:SDCL 34-20B-41.

          Law Implemented:SDCL 22-42-4.1, 22-42-4.2, 34-20B-41.

          Cross-Reference: Computer pharmacy, ch 20:51:20.


Rule 44:58:08:17.01 Refilling of Schedule II prescriptions prohibited.

          44:58:08:17.01.  Refilling of Schedule II prescriptions prohibited. No prescription for a Schedule II drug or substance may be refilled.

          Source: 11 SDR 36, effective September 11, 1984.

          General Authority:SDCL 34-20B-41.

          Law Implemented:SDCL 22-42-2.1, 22-42-2.2, 34-20B-41.


Rule 44:58:08:18 Partial filling of prescriptions for Schedule II substances.

          44:58:08:18.  Partial filling of prescriptions for Schedule II substances. A pharmacist may partially fill a prescription for a controlled substance listed in Schedule II, if unable to supply the full quantity called for in a written or emergency oral prescription, and a notation of the quantity supplied is made on the face of the prescription. The remaining portion of the prescription may be filled within 72 hours of the partial filling; however, if the remaining portion is not filled within the 72-hour period, the pharmacist shall notify the practitioner. No further quantity may be supplied beyond 72 hours without a new prescription.

          Source: 1 SDR 30, effective October 7, 1974; 6 SDR 93, effective July 1, 1980.

          General Authority:SDCL 34-20B-41.

          Law Implemented:SDCL 22-42-2.1, 22-42-2.2, 34-20B-41.


Rule 44:58:08:18.01 Partial filling of prescriptions for Schedule II substances for nursing facility or terminally ill patients.

          44:58:08:18.01.  Partial filling of prescriptions for Schedule II substances for nursing facility or terminally ill patients. Notwithstanding the provisions of § 44:58:08:18, a pharmacist may partially fill a prescription for a substance listed in Schedule II written for a patient in a nursing facility or for a patient with a medical diagnosis documenting a terminal illness. The pharmacist shall record on the prescription whether the patient is "terminally ill" or a "nursing facility patient." For each partial filling, the pharmacist shall record on the back of the prescription the date of the partial filling, the quantity dispensed, the remaining quantity authorized to be dispensed, and the identification of the dispensing pharmacist. Before any subsequent partial filling the pharmacist shall determine that the additional partial filling is necessary. The total quantity of the Schedule II controlled substance dispensed in all partial fillings may not exceed the total quantity prescribed. The prescription is valid for not more than 60 days from the date of issue unless it is terminated sooner by the discontinuance of medication.

          Source: 18 SDR 181, effective May 4, 1992; 21 SDR 219, effective June 27, 1995.

          General Authority:SDCL 34-20B-41.

          Law Implemented:SDCL 22-42-2.1, 22-42-2.2, 34-20B-41.


Rule 44:58:08:18.02 Computerized system authorized for Schedule II prescription information for nursing facility or terminally ill patients.

          44:58:08:18.02.  Computerized system authorized for Schedule II prescription information for nursing facility or terminally ill patients. Information pertaining to current Schedule II prescriptions for patients in a nursing facility or for patients with a medical diagnosis documenting a terminal illness may be maintained in an automated data processing system if the system has the capability to permit the following:

          (1)  Output, either display or printout, of the original prescription, number, date of issue, identification of the prescribing individual practitioner, identification of the patient, address of the nursing facility or hospital or the residence of the patient, identification of medication authorized (including dosage, form, strength, and quantity), a list of the partial fillings that have been dispensed under each prescription, and the information required in §44:58:08:18.01;

          (2)  Immediate updating of the prescription record each time a partial filling of the prescription is made; and

          (3)  Retrieval of partially filled Schedule II prescription information as required by chapter 20:51:20.

          Source: 18 SDR 181, effective May 4, 1992; 21 SDR 219, effective June 27, 1995.

          General Authority:SDCL 34-20B-41.

          Law Implemented:SDCL 34-20B-41.

          Cross-Reference: Computer pharmacy, ch 20:51:20.


Rule 44:58:08:18.03 Facsimile transmission of Schedule II prescriptions.

          44:58:08:18.03.  Facsimile transmission of Schedule II prescriptions. A written prescription for a Schedule II controlled substance may be transmitted from the individual prescribing practitioner to a pharmacy by facsimile equipment, if the original written, signed prescription is presented to the pharmacist for review prior to the actual dispensing of the controlled substance. The original prescription must be maintained as required in § 44:58:07:04.

          Schedule II controlled substance prescriptions intended for direct administration to a patient by parenteral, intravenous, subcutaneous, or intraspinal infusion may be transmitted by facsimile. The facsimile prescription serves as the original prescription and shall be maintained as required in § 44:58:07:04. Schedule II controlled substance prescriptions for residents of long-term care facilities or patients residing in a Medicare certified hospice may be transmitted directly from the prescribing practitioner to the pharmacy by facsimile equipment. The facsimile prescription serves as the original prescription and must be maintained as required in § 44:58:07:04. The facsimile prescription must be marked on the face with the notation "long term care resident" or "hospice patient."

          Source:  21 SDR 219, effective June 27, 1995; 25 SDR 48, effective October 1, 1998.

          General Authority:  SDCL 34-20B-41.

          Law Implemented:  SDCL 34-20B-41.


Rule 44:58:08:19 Repealed.

          44:58:08:19.  Partial filling of prescriptions for Schedule III and IV substances.Repealed.

          Source: 1 SDR 30, effective October 7, 1974; repealed, 6 SDR 93, effective July 1, 1980.


Rule 44:58:08:20 Labeling of prescriptions for controlled substances.

          44:58:08:20.  Labeling of prescriptions for controlled substances. The pharmacist filling any prescription for a controlled substance listed in Schedules II, III or IV shall attach to the container a label showing the date, the pharmacy name and address, the serial number of the prescription, the name of the patient, the name of the prescribing practitioner, directions for use and cautionary statements contained in the prescription or required by law. Controlled substances dispensed by an individual practitioner must be labeled with the name of the patient, the name of the practitioner, directions for use, the date, and any required cautionary statements.

          Source: 1 SDR 30, effective October 7, 1974; 6 SDR 93, effective July 1, 1980.

          General Authority:SDCL 34-20B-41.

          Law Implemented:SDCL 34-20B-41.


Rule 44:58:08:21 Repealed.

          44:58:08:21.  Filing of prescriptions required.Repealed.

          Source: 1 SDR 30, effective October 7, 1974; repealed, 6 SDR 93, effective July 1, 1980.


Rule 44:58:08:22 Repealed.

          44:58:08:22.  Dispensing of Schedule III and IV substances without prescription prohibited.Repealed.

          Source: 1 SDR 30, effective October 7, 1974; repealed, 6 SDR 93, effective July 1, 1980.


Rule 44:58:08:23 Dispensing placebo drugs.

          44:58:08:23.  Dispensing placebo drugs. The dispensing or prescribing of placebo or look-alike drugs by an individual practitioner is within the meaning of the term "in the course of professional practice or research".

          Source: 11 SDR 36, effective September 11, 1984.

          General Authority:SDCL 34-20B-41.

          Law Implemented:SDCL 22-42-16, 34-20B-41.


Rule 44:58:09 ADMINISTRATIVE PROCEDURES

CHAPTER 44:58:09

ADMINISTRATIVE PROCEDURES

Section

44:58:09:01        Permission to make inspections required of licensees.

44:58:09:02        Financial data excluded from inspection.

44:58:09:03        Inspection requirements.

44:58:09:04        Required contents of notice of inspection.


Rule 44:58:09:01 Permission to make inspections required of licensees.

          44:58:09:01.  Permission to make inspections required of licensees. As a privilege of receiving a registration under the act, each applicant must permit the secretary to enter controlled premises during regular business hours and conduct administrative inspections for the purposes of:

          (1)  Inspecting, copying, and verifying the records required to be kept under the act and this article;

          (2)  Inspecting all equipment, controlled substances, containers, and labeling found at the controlled premises relating to the act;

          (3)  Making a physical inventory of all controlled substances on hand at the premises;

          (4)  Collecting samples of controlled substances or precursors. If any samples are collected during an inspection, the inspector shall issue a receipt for the samples;

          (5)  Checking records and information on distribution of controlled substances as they relate to total distribution; and

          (6)  Except as provided in § 44:58:09:02, checking all other things appropriate for verification of the record referred to above or otherwise bearing on the act and this article.

          Source: 1 SDR 30, effective October 7, 1974; 6 SDR 93, effective July 1, 1980; 21 SDR 14, effective August 4, 1994; 21 SDR 219, effective June 27, 1995.

          General Authority:SDCL 34-20B-41.

          Law Implemented:SDCL 34-20B-39, 34-20B-40.


Rule 44:58:09:02 Financial data excluded from inspection.

          44:58:09:02.  Financial data excluded from inspection. Unless the owner, operator, or agent in charge of the controlled premises consents in writing, an inspection authorized by § 44:58:09:01 may not extend to financial, sales, or pricing data.

          Source: 1 SDR 30, effective October 7, 1974; 6 SDR 93, effective July 1, 1980; 21 SDR 219, effective June 27, 1995.

          General Authority:SDCL 34-20B-41.

          Law Implemented:SDCL 34-20B-40, 34-20B-44.


Rule 44:58:09:03 Inspection requirements.

          44:58:09:03.  Inspection requirements. A representative of the secretary, upon stating the purpose of the inspection and presenting credentials and written notice of inspection, may enter the premises and conduct inspections. Violation of the consent agreement is grounds for automatic revocation of any registration issued under the act.

          Source: 1 SDR 30, effective October 7, 1974; 6 SDR 93, effective July 1, 1980; 21 SDR 14, effective August 4, 1994; 21 SDR 219, effective June 27, 1995.

          General Authority:SDCL 34-20B-41.

          Law Implemented:SDCL 34-20B-40, 34-20B-44.


Rule 44:58:09:04 Required contents of notice of inspection.

          44:58:09:04.  Required contents of notice of inspection. The notice of inspection shall contain:

          (1)  The name and title of the owner, operator, or agent in charge of the controlled premises;

          (2)  The name of the controlled premises;

          (3)  The address of the controlled premises;

          (4)  The date and time;

          (5)  A statement that a notice of inspection is given; and

          (6)  The signature of the inspector.

          Source: 1 SDR 30, effective October 7, 1974; 6 SDR 93, effective July 1, 1980.

          General Authority:SDCL 34-20B-41.

          Law Implemented:SDCL 34-20B-40, 34-20B-41.


Rule 44:58:10 SECURITY REQUIREMENTS

CHAPTER 44:58:10

SECURITY REQUIREMENTS

Section

44:58:10:01        Security requirements of registrants.


Rule 44:58:10:01 Security requirements of registrants.

          44:58:10:01.  Security requirements of registrants. Controlled substances shall be stored in a securely locked, substantially constructed cabinet. However, substances listed in Schedules II through IV may be dispersed through the stock of noncontrolled substances in a manner to obstruct theft or diversion.

          Source: 1 SDR 30, effective October 7, 1974;  6SDR 93, effective July 1, 1980.

          General Authority:SDCL 34-20B-41.

          Law Implemented:SDCL 34-20B-41.


Rule 44:58:11 HYPODERMIC CONTROL REGULATIONS

CHAPTER 44:58:11

HYPODERMIC CONTROL REGULATIONS

(Repealed. 6 SDR 93, effective July 1, 1980)


Rule 44:58:12 GENERAL PROVISIONS

CHAPTER 44:58:12

GENERAL PROVISIONS

(Repealed. 6 SDR 93, effective July 1, 1980)


Rule 44:58:13 EXEMPTED SCHEDULE III SUBSTANCES

CHAPTER 44:58:13

EXEMPTED SCHEDULE III SUBSTANCES

Section

44:58:13:01        Exempted Schedule III substances.


Rule 44:58:13:01 Exempted Schedule III substances.

          44:58:13:01.  Exempted Schedule III substances. The following combinations of medicinal ingredients and Schedule III substances are exempt from control under the act or this article:

          (1)  Analgesic agents which are not controlled substances, combined with a barbiturate;

          (2)  Antiangina agents, combined with a barbiturate or meprobamate;

          (3)  Anticholinerigic agents, combined with a barbiturate, a benzodiazepine, or meprobamate;

          (4)  Antiasthmatic agents, combined with a barbiturate;

          (5)  Hormone replacement agents, combined with a benzodiazepine or meprobamate;

          (6)  Anabolic steroid and estrogen combinations; and

          (7)  Products that contain ephedrine in quantities at or less than:

               (a)  25 milligrams in combination with 400 milligrams of quaifenesin, packaged in blister packs of not more than two tablets per blister; and

               (b)  Five percent by weight in an anorectal preparation in combination with other active medicinal ingredients.

          Source: 6 SDR 93, effective July 1, 1980; 11 SDR 36, effective September 11, 1984; 21 SDR 14, effective August 4, 1994; 21 SDR 219, effective June 27, 1995; 23 SDR 195, effective May 26, 1997.

          General Authority:SDCL 34-20B-21, 34-20B-41.

          Law Implemented:SDCL 34-20B-21, 34-20B-41.


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