Rule 44:58 DRUG CONTROL
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
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
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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