reglab/statecodes huggingface dataset:
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 100 - Purpose and Scope; Definitions, Information, Payment of Fees, Certain Exemptions, Separate Registrations, Out-of-State Dispensing of Prescriptions › Section 61-4.100.111 - Exemption of Law Enforcement Officials

Current through Register Vol. 48, No. 6, June 28, 2024
(a) The requirement of registration is waived
				for the following persons in the circumstances described in this section:
(1) Any official or employee of the DEA, U.S.
				Department of Justice, any officer of the U.S. Bureau of Customs, any officer
				or employee of the United States Food and Drug Administration, and any other
				federal officer who is lawfully engaged in the law enforcement of any federal
				law relating to controlled substances, drugs or customs, and is duly authorized
				to possess controlled substances in the course of his or her official duties;
				and
(2) Any officer or employee of
				any state, or any political subdivision or agency thereof, who is engaged in
				the enforcement of any state or local law relating to controlled substances and
				is duly authorized to possess controlled substances in the course of his or her
				official duties.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 100 - Purpose and Scope; Definitions, Information, Payment of Fees, Certain Exemptions, Separate Registrations, Out-of-State Dispensing of Prescriptions › Section 61-4.100.112 - Exemption of Civil Defense Officials

Current through Register Vol. 48, No. 6, June 28, 2024
(a) The requirement of registration is waived
				for any official of a civil defense or disaster relief organization who, in the
				course of his or her official duties, is authorized to:
(1) Maintain, and distribute for such
				maintenance, controlled substances held for emergency use; or
(2) Procure controlled substances for the
				purpose of maintaining supplies for emergency use, provided that all of such
				procurement is from the U.S. General Services Administration and in accordance
				with the rules of the U.S. Office of Emergency Preparedness.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 100 - Purpose and Scope; Definitions, Information, Payment of Fees, Certain Exemptions, Separate Registrations, Out-of-State Dispensing of Prescriptions › Section 61-4.100.113 - Registration Regarding Ocean Vessels and Aircrafts

Current through Register Vol. 48, No. 6, June 28, 2024
Registration of masters of ocean vessels and aircraft or the
				  medical officers thereof shall be deemed sufficient if they are properly
				  registered with the U.S. Department of Justice, DEA.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 100 - Purpose and Scope; Definitions, Information, Payment of Fees, Certain Exemptions, Separate Registrations, Out-of-State Dispensing of Prescriptions › Section 61-4.100.114 - Dispensing of Out-of-State Prescriptions and Orders

Current through Register Vol. 48, No. 6, June 28, 2024
(a) Prescriptions or orders for controlled
				substances from out-of-state practitioners may be filled in good faith by
				dispensers provided:
(1) The dispenser knows
				the recipient; or requires proper ID and notes such on the
				prescription;
(2) The dispenser
				makes a good faith inquiry concerning whether the order or prescription is
				legitimate;
(3) The prescription or
				order meets all of the requirements of this regulation and the Act, including
				whether the order or prescription is for legitimate medical purposes, and is
				within the regular course of practice of the practitioner;
(4) The practitioner who issued the
				prescription would ordinarily be entitled to issue prescriptions under SC law
				(i.e., physicians, dentists, veterinarians, and podiatrists are authorized to
				issue prescriptions; chiropractors, psychologists, etc. are not authorized to
				prescribe drugs); and
(5) The
				prescribing practitioner holds a valid individual Federal [D.E.A.] controlled
				substance registration number in the state, district, or territory of origin of
				the prescription, or is exempt from such registration requirement under the
				provisions of Federal Regulation Regulation 21 CFR §1301.24.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 200 - Application for Registration › Section 61-4.200.201 - Time for Application for Registration; Expiration Date

Current through Register Vol. 48, No. 6, June 28, 2024
(a) Any person who is required to be
				registered and who is not so registered may apply for registration at any time.
				No person required to be registered shall engage in any activity for which
				registration is required until the application for registration is granted and
				a Certificate of Registration is issued by the Bureau Director to such
				person.
(b) Any person who is
				registered may apply to be reregistered not more than 60 days before the
				expiration date of his or her registration.
(c) Fees for registration for a physician
				shall be from October 2nd of the year until October 1st of the succeeding year.
				Fees for registration for any other person required to be registered shall be
				from April 2nd of the year until April 1st of the succeeding year. In the event
				any physician shall become registered subsequent to October 1st of any year,
				the entire registration fee shall be due and no pro-rata of fees will be
				allowed. In the event any other person required to be registered shall become
				registered subsequent to April 1st of any year, the entire registration fee
				shall be due and no pro-rata of fees will be allowed.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 200 - Application for Registration › Section 61-4.200.202 - Application Forms; Content; Signature

Current through Register Vol. 48, No. 6, June 28, 2024
(a) If the person is required to be
				registered, and is not so registered and is applying for registration;
(1) As a practitioner, pharmacy, mid-level
				practitioner, animal control, animal shelter, health clinic, EMS, rescue squad,
				or hospice, he or she shall apply on the applicable DHEC form or its electronic
				equivalent;
(2) As a narcotic
				treatment program, he or she shall apply on the applicable DHEC form or its
				electronic equivalent;
(3) As a
				distributor, canine unit, researcher, exporter, importer, broker, analytical or
				forensic laboratory, manufacturer or hospital, he or she shall apply on the
				applicable DHEC form or its electronic equivalent.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 200 - Application for Registration › Section 61-4.200.203 - Research Protocols

Current through Register Vol. 48, No. 6, June 28, 2024
(a)
				Applicants for "Researcher" registration in Schedule I shall submit a research
				protocol containing all the information required for Federal Schedule I
				research protocol set forth under 21 CFR §1301.32.
(b) Practitioners registered with DHEC
				desiring to perform incidental research on or with controlled substances under
				the provisions of S.C. Code Ann. §
									44-53-300(c)
				are not required to furnish the formal protocol (except for narcotic substances
				as is required under Federal law), but shall instead provide a written summary
				of the proposed research, including the scope, the substance to be utilized,
				the number of research subjects (and their identity if protection from
				prosecution is desired), the duration of the research and the estimated usage
				of the controlled substance. Insofar as is practical, the dispensing of the
				controlled substance utilized in a valid research project shall be performed by
				the researcher or a particular dispenser or small group of dispensers in order
				to maintain adequate control. While not imperative to DHEC, notice of any
				participating dispensaries or pharmacies should be made to the Bureau of Drug
				Control in order that inadvertent and unnecessary investigations of normally
				unusual dispensing practices may be avoided.
(c) DHEC may require additional information
				or updating of protocols from time to time, but not more often than annually,
				unless a major change or deviation from previously submitted protocols or
				summaries is discovered. It is the responsibility of the person conducting the
				research project to notify to Department prior to any change in a
				protocol.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 200 - Application for Registration › Section 61-4.200.204 - Additional Information

Current through Register Vol. 48, No. 6, June 28, 2024
The Bureau Director may request an applicant to submit such
				  documents or written statements of fact relevant to the application as he or
				  she deems necessary to determine whether the application should be granted. The
				  failure of the applicant to provide such documents or statements within a
				  reasonable time after having been requested to do so shall be deemed to be a
				  waiver by the applicant of an opportunity to present such documents or facts
				  for consideration by the Bureau Director in granting or denying the
				  application.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 200 - Application for Registration › Section 61-4.200.205 - Amendments to and Withdrawal of Applications

Current through Register Vol. 48, No. 6, June 28, 2024
(a) An application may be amended or
				withdrawn without permission of the Bureau Director at any time before the date
				on which the applicant receives an order to show cause pursuant to §309 or
				before the date on which a notice of hearing on the application is published
				pursuant to §309 whichever is sooner. An application may be amended or
				withdrawn with permission of the Bureau Director at any time where good cause
				is shown by the applicant or where the amendment or withdrawal is in the public
				interest.
(b) After an application
				has been accepted for filing, the request by the applicant that it be returned
				or the failure of the applicant to respond to official correspondence regarding
				the application, when sent by registered or certified mail, return receipt
				requested, shall be deemed to be a withdrawal of the application.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 300 - Action on Application for Registration; Revocation or Suspension of Registration › Section 61-4.300.301 - Administrative Review Generally

Current through Register Vol. 48, No. 6, June 28, 2024
The Bureau Director may inspect, or cause to be inspected the
				  establishment of an applicant or registrant, pursuant to the Act or this
				  Regulation. The Bureau Director shall review the application for registration
				  and other information gathered by the Bureau of Drug Control regarding an
				  applicant in order to determine whether the applicable standards of the Act
				  have been met by the applicant.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 300 - Action on Application for Registration; Revocation or Suspension of Registration › Section 61-4.300.302 - Applications for Research in Controlled Schedule I Substances

Current through Register Vol. 48, No. 6, June 28, 2024
(a) In the case of
				an application for registration to conduct research with controlled substances,
				the Bureau Director shall refer such application to the Director who shall
				determine the qualifications and competency of the applicant as well as the
				merits of the research protocol. The Bureau Director, in determining the merits
				of a research protocol, shall consider procedures to effectively safeguard
				against diversion of such controlled substances from legitimate medical or
				scientific use. If the Bureau Director finds the applicant qualified and
				competent and the research protocol meritorious and adequately safeguarded, he
				shall register the applicant unless he finds registration should be denied on a
				ground specified in the Act.
(b) If
				the Bureau Director is unable to find the applicant qualified or finds that
				grounds exist for the denial of the application, the Bureau Director shall
				issue an order to show cause pursuant to §
									309 and, if requested by the
				applicant, hold a hearing on the application pursuant to §
									310.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 300 - Action on Application for Registration; Revocation or Suspension of Registration › Section 61-4.300.303 - Application for Bulk Manufacture of Schedules I and II Substances

Current through Register Vol. 48, No. 6, June 28, 2024
The Bureau Director shall coordinate applications for bulk
				  manufacture of schedules I and II controlled substances with the DEA of the
				  U.S. Department of Justice. Applications may be received by the Bureau Director
				  for such bulk manufacture, but shall not be acted upon until tentative or
				  conditional approval is made by the appropriate federal agency, and after such
				  notifications, publications, and other actions required by Chapter II, Title
				  21, Code of Federal Regulations [ 21 CFR §1301, ff.] are effected by the
				  applicant.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 300 - Action on Application for Registration; Revocation or Suspension of Registration › Section 61-4.300.304 - Provisional Registration

Current through Register Vol. 48, No. 6, June 28, 2024
(a) The
				Bureau Director, in his or her discretion, may grant provisional registration
				as a Researcher, Manufacturer, Distributor, Importer, or Exporter to any
				applicant, pending such applicant's obtaining a registration under Federal law.
				The duration of such provisional registration shall not exceed one year, and
				may not be renewed. Upon the granting of Federal registration, the provisional
				registration may be converted to a permanent registration by DHEC, which may
				renew such registration in the same manner as any other regular registration.
				If the Bureau Director does not find it in the public interest to grant a
				provisional registration, or to convert a provisional registration into a
				regular registration in the manner provided above, procedures set forth in S.C.
				Code Ann. §
									44-53-320
				for denial of registration shall be followed.
(b) Provisional registration does not entitle
				the applicant (i.e., the provisional registrant) to conduct any controlled
				substances activity within this State until such time as the applicant obtains
				a valid federal [DEA] registration for the identical activity at the same
				registered location.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 300 - Action on Application for Registration; Revocation or Suspension of Registration › Section 61-4.300.305 - Certificate of Registration; Denial of Registration

Current through Register Vol. 48, No. 6, June 28, 2024
(a) The Bureau Director shall issue a
				Certificate of Registration to an applicant if the issuance of registration or
				re-registration is required under the applicable provisions of the Act. In the
				event that the issuance of registration or re-registration is not required, the
				Bureau Director shall deny the application. Before denying any application, the
				Bureau Director shall issue an order to show cause pursuant to §
									309 and, if requested by the
				applicant, shall hold a hearing on the application pursuant to §
									310.
(b) The Certificate of Registration shall
				contain the name, address, and registration number of the registrant, the
				activity authorized by the registration, the schedules and/or Controlled
				Substances Code Number of the controlled substances which the registrant is
				authorized to handle, the amount of fee paid (or exemption), and the expiration
				date of the registration. The registrant shall maintain the Certificate of
				Registration at the registered location in a readily retrievable manner and
				shall permit inspection of the certificate by any official, agent or employee
				of the DEA or of any federal, state, or local agency engaged in enforcement of
				laws relating to controlled substances.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 300 - Action on Application for Registration; Revocation or Suspension of Registration › Section 61-4.300.306 - Suspension or Revocation of Registration

Current through Register Vol. 48, No. 6, June 28, 2024
(a) The Bureau Director may suspend any
				registration pursuant to the Act for any period of time he
				determines.
(b) The Bureau Director
				may revoke any registration pursuant to the Act.
(c) Before revoking or suspending any
				registration, the Bureau Director shall issue an order to show cause pursuant
				to §
									309 and, if requested by the
				registrant shall hold a hearing pursuant to §
									310. Notwithstanding the
				requirements of this section, however, the Director may suspend any
				registration pending a final order pursuant to §
									307.
(d) Upon service of the order of the Bureau
				Director suspending or revoking registration, the registrant shall immediately
				deliver his or her Certificate of Registration and any forms to his or her
				possession to the office of the Bureau of Drug Control. The suspension or
				revocation of a registration shall suspend or revoke any individual
				manufacturing or procurement quota fixed for the registrant. Also, upon service
				of the order of the Bureau Director suspending or revoking registration, the
				registrant shall:
(1) Deliver all controlled
				substances in his or her possession to the office of the Bureau of Drug Control
				or to authorized agents of the Bureau of Drug Control; or
(2) Place all controlled substances in his or
				her possession under seal as described in the Act.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 300 - Action on Application for Registration; Revocation or Suspension of Registration › Section 61-4.300.307 - Suspension of Registration Pending Final Order

Current through Register Vol. 48, No. 6, June 28, 2024
(a) The Bureau Director may suspend any
				registration simultaneously with or at any time subsequent to the service upon
				the registration of an order to show cause why such registration should not be
				revoked or suspended, in any case where he or she finds there is an imminent
				danger to the public health or safety. If the Bureau Director so suspends, he
				or she shall serve with the order to show cause pursuant to §
									309 an order of immediate
				suspension, which shall contain a statement of his or her findings regarding
				the danger in public health or safety.
(b) Upon service of the order of immediate
				suspension, the registrant shall promptly return his or her Certificate of
				Registration and any order forms in his or her possession to the office of the
				Bureau of Drug Control. The suspension of any registration under this section
				shall suspend any quota fixed for the registrant. Also, upon service of the
				order of the Bureau Director immediately suspending registration, the
				registrant shall, as instructed by the Bureau Director:
(1) Deliver all affected controlled
				substances in his or her possession to the office of the Bureau of Drug Control
				or to authorized agents of the Bureau of Drug Control; or
(2) Place all of such substances under seal
				as described in the Act.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 300 - Action on Application for Registration; Revocation or Suspension of Registration › Section 61-4.300.308 - Extension of Registration Pending Final Order

Current through Register Vol. 48, No. 6, June 28, 2024
(a) In the event that an applicant for
				re-registration (who is doing business under a registration previously granted
				and not revoked or suspended) has applied for re-registration of at least 45
				days before the date on which the existing registration is due to expire, and
				the Bureau Director has issued an order on the application on the date on which
				the existing registration is due to expire, the existing registration of the
				applicant shall automatically be extended and continue to effect until the date
				on which the Bureau Director so issues his or her order.
(b) The Bureau Director may extend any other
				existing registration under the circumstances contemplated in this section even
				though the registrant failed to apply for re-registration; at least 45 days
				before expiration of the existing registration, with or without request by the
				registrant, if the Bureau Director finds that such extension is not
				inconsistent with the public health and safety.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 300 - Action on Application for Registration; Revocation or Suspension of Registration › Section 61-4.300.309 - Order to Show Cause

Current through Register Vol. 48, No. 6, June 28, 2024
(a) If,
				upon examination of the application for registration from any applicant and
				other information gathered by the Bureau of Drug Control regarding the
				applicant, the Bureau Director is unable to make the determinations required by
				the applicable provisions of the Act to register the applicant, the Bureau
				Director shall serve upon the applicant an order to show cause why the
				registration should not be denied.
(b) If, upon information gathered by the
				Bureau of Drug Control regarding any registrant, the Bureau Director determines
				that the registration of such registrant is subject to suspension or revocation
				to the Act, the Bureau Director shall serve upon the registrant an order to
				show cause why the registration should not be revoked or suspended.
(c) The order to show cause shall call upon
				the applicant or registrant to appear before a hearing officer at a time and
				place stated in the order, which shall not be less than 30 days after the date
				of receipt of the order. The order to show cause shall also contain a statement
				of the legal basis for such hearing and for the denial, revocation, or
				suspension of registration and a summary of the matters of fact and law
				asserted.
(d) Upon receipt of an
				order to show cause, the applicant or registrant shall, if he or she desires a
				hearing, file a request for a hearing in writing. If a hearing is requested,
				the hearing officer shall hold a hearing at the time and place stated in the
				order, pursuant to §
									311.
(e) When authorized by the Bureau Director,
				any agent of the Bureau of Drug Control may serve the order to show cause, or
				service may be effected by registered or certified mail.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 300 - Action on Application for Registration; Revocation or Suspension of Registration › Section 61-4.300.310 - Hearing Generally

Current through Register Vol. 48, No. 6, June 28, 2024
(a) In
				any case where the hearing officer shall hold a hearing on any registration or
				application therefore, the procedures for such hearing shall be governed
				generally by the adjudication procedures set forth by statute or by the
				Attorney General's Office.
(b) Any
				hearing under this part shall be independent of, and not in lieu of, criminal
				prosecutions or other proceedings under the Act of any other law of this State
				or the United States.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 300 - Action on Application for Registration; Revocation or Suspension of Registration › Section 61-4.300.311 - Purpose of Hearing

Current through Register Vol. 48, No. 6, June 28, 2024
If requested by a person entitled to a hearing the hearing
				  officer shall hold a hearing for the purpose of receiving factual evidence
				  regarding the issues involved in the denial, revocation, or suspension of any
				  registration, and the granting of any application for registration to
				  manufacture in bulk a basic class of controlled substances listed in schedules
				  I or II. Extensive argument should not be offered into evidence but rather
				  presented in opening or closing statements of counsel or in memoranda or
				  proposed findings of fact and conclusions of law.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 300 - Action on Application for Registration; Revocation or Suspension of Registration › Section 61-4.300.312 - Waiver and Modification of Rules

Current through Register Vol. 48, No. 6, June 28, 2024
The Director or the presiding officer (with respect to
				  matters pending before him or her) may modify or waive any rules in this part
				  by notice in advance of the hearing, if he or she determines that no party in
				  the hearing will be unduly prejudiced and the ends of justice will thereby be
				  served. Such notice of modification or waiver shall be made a part of the
				  record of the hearing.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 300 - Action on Application for Registration; Revocation or Suspension of Registration › Section 61-4.300.313 - Request for Hearing or Appearance; Waiver

Current through Register Vol. 48, No. 6, June 28, 2024
(a) Any person entitled to a hearing pursuant
				to §§302-306 and desiring a hearing shall, within 30 days after the
				date of receipt of the order to show cause, file with the Director a written
				notice for a hearing.
(b) Any
				person entitled to and desiring to participate in a hearing pursuant to §
									309 shall, within 10 days of the
				date of the hearing, file with the Director a written notice of his or her
				intention to participate in such hearing.
(c) Any person entitled to a hearing or to
				participate in a hearing pursuant to §§302-306 may, within the period
				permitted for filing a request for a hearing or a notice of appearance, file
				with the Director a waiver of an opportunity for a hearing or to participate in
				a hearing, together with a written statement regarding his or her position on
				the matters of fact and law involved in such hearing. Such statement, if
				admissible, shall be made a part of the record and shall be considered in light
				of the lack of opportunity for cross-examination in determining the weight to
				be attached to matters of fact asserted therein.
(d) If any person entitled to a hearing or to
				participate in a hearing pursuant to §§302-306 fails to file a
				request for a hearing or a notice of appearance, or if he so files and fails to
				appear at the hearing, he shall be deemed to have waived his or her opportunity
				for the hearing or to participate in the hearing, unless he show good cause for
				such failure.
(e) If all persons
				entitled to a hearing or to participate in a hearing waive or are deemed to
				waive their opportunity for the hearing or to participate in the hearing, the
				Director may cancel the hearing if scheduled, and issue his or her final order
				pursuant to §
									316 without a hearing.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 300 - Action on Application for Registration; Revocation or Suspension of Registration › Section 61-4.300.314 - Burden of Proof

Current through Register Vol. 48, No. 6, June 28, 2024
(a) At any
				hearing on an application to manufacture any controlled substance listed in
				schedule I or II, the applicant shall have the burden of proving that the
				requirements for such registration pursuant to the Act are satisfied. Any other
				person participating in the hearing pursuant to §
									313 shall have the burden of
				proving any proposition of fact or law asserted to him or her in the
				hearing.
(b) At any hearing on the
				granting or denial of an application to be registered to conduct a narcotic
				treatment program or as a compounder, the applicant shall have the burden of
				proving that the requirements for each registration pursuant to S.C. Code Ann.
				§
									44-53-290(i)
				are satisfied.
(c) At any other
				hearing for the denial of a registration, DHEC shall have the burden of proving
				that the requirements for such registration pursuant to the Act are not
				satisfied.
(d) At any hearing for
				the revocation or suspension of a registration, DHEC shall have the burden of
				proving that the requirements of the Act for such suspension or revocation are
				satisfied.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 300 - Action on Application for Registration; Revocation or Suspension of Registration › Section 61-4.300.315 - Time and Place of Hearing

Current through Register Vol. 48, No. 6, June 28, 2024
The hearing will commence at the place and time designated in
				  the order to show cause or notice of hearing (unless expedited pursuant to
				  §
									307) but thereafter it may be moved
				  to a different place and may be continued from day to day or recessed to a
				  later day without notice other than announcement thereof by the presiding
				  officer at the hearing.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 300 - Action on Application for Registration; Revocation or Suspension of Registration › Section 61-4.300.316 - Final Order and Appeals

Current through Register Vol. 48, No. 6, June 28, 2024
(a) Final order. As soon as practicable after
				the hearing officer has certified the record to the Director, the Director
				shall certify his or her order on the granting, denial, revocation, or
				suspension of registration.
(b)
				Appeals. A Department decision involving the issuance, denial, renewal,
				suspension, or revocation of a permit, license, certificate or certification
				may be appealed by an affected person with standing pursuant to applicable law,
				including S.C. Code Title 44, Chapter 1 and Chapter 53; and Title 1, Chapter
				23. Any person to whom an order is issued may appeal it pursuant to applicable
				law, including S.C. Code Title 44, Chapter 1 and Chapter 53; and Title 1,
				Chapter 23.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 300 - Action on Application for Registration; Revocation or Suspension of Registration › Section 61-4.300.317 - Modification in Registration

Current through Register Vol. 48, No. 6, June 28, 2024
Any registrant may apply to modify his or her registration to
				  authorize the handling of additional controlled substances or to change his or
				  her name or address, by submitting a letter of request to the Bureau of Drug
				  Control, DHEC, 2600 Bull Street, Columbia, SC 29201. The letter shall contain
				  the registrant's name, address, and registration number as printed on the
				  Certificate of Registration, and the substances and/or schedules to be added to
				  his or her registration or the new name or address and shall be signed in
				  accordance with §202(d). If the modification in registration is approved,
				  the Bureau Director shall issue a new Certificate of Registration to the
				  registrant, who shall maintain it with the old Certificate of Registration
				  until expiration.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 300 - Action on Application for Registration; Revocation or Suspension of Registration › Section 61-4.300.318 - Termination of Registration

Current through Register Vol. 48, No. 6, June 28, 2024
The registration of any person shall terminate if and when
				  such person dies, ceases legal existence, or discontinues business or
				  professional practice. Any registrant who ceases legal existence or
				  discontinues business or professional practice shall notify the Bureau Director
				  promptly of such fact.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 300 - Action on Application for Registration; Revocation or Suspension of Registration › Section 61-4.300.319 - Termination of Registration; Partnerships and Corporations; Other Business Entities

Current through Register Vol. 48, No. 6, June 28, 2024
(a) Upon
				the transfer of ownership of a controlling interest in any partnership,
				corporation, holding company, association, or other business entity holding a
				registration under the Act, which is not a personal registration as an
				individual or a proprietorship registration involving a single individual
				registrant, the registration held prior to any transfer of any controlling
				interest or controlling ownership shall terminate upon the effective date of
				the transfer, and a new registration shall be obtained if the business entity
				is to continue controlled substances activity. DHEC may, in its discretion,
				permit a transferor-registrant to permit the transferee to continue operation
				pursuant to a written power of attorney for a period of not more than 60 days,
				during the pendency of obtaining a new registration for the
				transferee.
(b) If the control of a
				corporation already registered under the Act shall be acquired by another
				corporation not registered under the Act, the acquiring corporation need not
				obtain a separate registration for itself, unless merger takes place; the
				corporation acquired shall, however, obtain a new registration even if there is
				no change in corporate officers if it intends to continue controlled substances
				activity. In the event a merger is effected between the acquiring corporation
				and the acquired corporation (regardless of the surviving or ensuing name) the
				acquiring corporation shall obtain a new registration in its own name, or in
				the name of the successor or ensuing corporation (if different) prior to
				engaging in controlled substances activity. Successor corporations shall be
				deemed to be new business entities, and shall obtain new registration prior to
				conducting controlled substances activity.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 300 - Action on Application for Registration; Revocation or Suspension of Registration › Section 61-4.300.320 - Transfer of Registration

Current through Register Vol. 48, No. 6, June 28, 2024
No registration or authority conferred thereby shall be
				  assigned or otherwise transferred except upon conditions as the Bureau Director
				  may specifically designate and then only pursuant to his or her written
				  consent.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 400 - Security Requirements › Section 61-4.400.401 - Security Requirements Generally

Current through Register Vol. 48, No. 6, June 28, 2024
(a) All applicants and registrants shall
				provide effective controls and procedures to guard against theft and diversion
				of controlled substances. In order to determine whether a registrant has
				provided effective controls against diversion, the Bureau Director shall use
				the security requirements set forth in §§402-406 as standards for the
				physical security controls and operating procedures necessary to diversion.
				Materials and construction which will provide a structural equivalent to the
				physical security controls set forth in §§
									402, 403, and 405 may be used in
				lieu of the materials and construction described in those sections.
(b) Substantial compliance with the standards
				set forth in §§402-406 may be deemed sufficient by the Bureau
				Director after evaluation of the overall security system and needs of the
				applicant or registrant. In evaluating the overall security system of a
				registrant or applicant, the Bureau Director may consider any of the following
				factors as he may deem relevant to the need for strict compliance with security
				requirements:
(1) The type of activity
				conducted (e.g., processing of bulk chemicals, preparing dosage forms,
				packaging, labeling, cooperative buying, etc.);
(2) The type and form of controlled
				substances handled (e.g., bulk liquids or dosage units, usable powders or
				non-usable powders);
(3) The
				quantity of controlled substances handled;
(4) The location of the premises and the
				relationship such location bears on security needs;
(5) The type of building construction
				comprising the facility and the general characteristics of the building or
				buildings;
(6) The type of vault,
				safe, and secure enclosures or other storage systems (e.g., automatic storage
				and retrieval system) used;
(7) The
				type of closures on vaults, safes, and secure enclosures;
(8) The adequacy of key control systems
				and/or combination lock control system;
(9) The adequacy of electric detection and
				alarm systems if any, including use of supervised transmittal lines and standby
				power sources;
(10) The extent of
				unsupervised public access to the facility, including the presence and
				characteristics of perimeter fencing, if any;
(11) The adequacy of supervision over
				employees having access to manufacturing and storage area;
(12) The procedures for handling business
				guests, visitors, maintenance personnel, and non-employees service
				personnel;
(13) The availability of
				local police protection or of the registrant's or applicant's security
				personnel; and
(14) The adequacy of
				the registrant's or applicant's system for monitoring the receipt, manufacture,
				distribution, and disposition of controlled substances in its
				operations.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 400 - Security Requirements › Section 61-4.400.402 - Physical Security Controls for Non-practitioners; Storage Areas

Current through Register Vol. 48, No. 6, June 28, 2024
(a) Schedules I and
				II. Raw materials, bulk materials awaiting further processing, and finished
				products which are controlled substances listed in schedules I and II shall be
				stored in one of the following secure storage areas:
(1) Where small quantities permit, a safe or
				steel cabinet:
(i) Which safe or steel
				cabinet shall have the following specifications or the equivalent: 30
				man-minutes against surreptitious entry, 10 man-minutes against forced entry,
				20 man-minutes against lock manipulation, and 20 man-minutes against
				radiological techniques.
(ii) Which
				safe or steel cabinet, if it weighs less than 750 pounds, is bolted or cemented
				to the floor or wall in such a way that it cannot be readily removed;
				and
(iii) Which safe or steel
				cabinet, if necessary, depending upon the quantities and type of controlled
				substances stored, is equipped with an alarm system which, upon attempted
				unauthorized entry, shall transmit a signal directly to a central protection
				company or a local or state police agency which has a legal duty to respond, or
				a 24-hour control station operated by the registrant, or such other protection
				as the Bureau Director may approve.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 400 - Security Requirements › Section 61-4.400.403 - Physical Security Controls for Non-practitioners; Manufacturing Areas

Current through Register Vol. 48, No. 6, June 28, 2024
All manufacturing activities (including processing,
				  packaging, and labeling) involving controlled substances listed in any schedule
				  and all activities of compounders shall be conducted in accordance with the
				  following:
(a) All in-process
				substances shall be returned to the controlled substances storage area at the
				termination of the process. If the process is not terminated at the end of a
				workday (except where a continuous process or other normal manufacturing
				operation should not be interrupted), the processing area or tanks, vessels,
				bins or bulk containers containing such substances shall be securely locked,
				with adequate security for the area or building. If such security requires an
				alarm, such alarm, upon unauthorized entry, shall transmit a signal directly to
				a central station protection company, or local or state police agency which has
				a legal duty to respond, or a 24-hour control station operated by the
				registrant.
(b) Manufacturing
				activities with controlled substances shall be conducted in an area or areas of
				clearly defined limited access which is under surveillance by an employee or
				employees designated in writing as responsible for the area. "Limited access"
				may be provided in the absence of physical dividers such as walls or
				partitions, by traffic control lines or restricted space designation. The
				employee designated as responsible for the area may be engaged in the
				particular manufacturing operation being conducted, provided, that he is able
				to provide continuous surveillance of the area in order that unauthorized
				persons may not enter or leave the area without his or her knowledge.
(c) During the production of controlled
				substances, the manufacturing areas shall be accessible to only those employees
				required for efficient operation. When it is necessary for employee maintenance
				personnel, non-employee maintenance personnel, business guests, or visitors to
				be present in or pass through manufacturing areas during production of
				controlled substances, the registrant shall provide for adequate observation of
				the area by an employee specifically authorized in writing.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 400 - Security Requirements › Section 61-4.400.405 - Physical Security Controls for Practitioners

Current through Register Vol. 48, No. 6, June 28, 2024
(a) Controlled substances listed in schedule
				I shall be stored in a securely locked, substantially constructed
				cabinet.
(b) Controlled substances
				listed in schedules II, III, IV, and V shall be stored in a securely locked,
				substantially constructed cabinet. However, pharmacies may disperse such
				substances throughout the stock of non-controlled substances in such a manner
				as to obstruct the theft or diversion of the controlled substances.
(c) This section shall also apply to
				non-practitioners authorized to conduct research or chemical analysis under
				another registration.
(d) Etorphine
				hydrochloride and diprenorphine shall be stored in a safe or steel cabinet
				equivalent to a U.S. Government Class V security container.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 400 - Security Requirements › Section 61-4.400.406 - Other Security Controls of Practitioners

Current through Register Vol. 48, No. 6, June 28, 2024
(a) The registrant shall not knowingly employ
				as an agent or employee, who has access to controlled substances, any person
				who has been convicted of a felony offense relating to controlled substances or
				who, at any time, had an application for registration denied, or has had his or
				her registration revoked, at any time.
(b) The registrant shall notify the Bureau of
				Drug Control, DHEC, of the loss or theft of any controlled substances upon
				discovery of such loss or theft. The registrant shall also complete DEA Form
				106 regarding such loss or theft.
(c) The supplier shall be responsible for
				reporting in-transit losses of controlled substances by the common or contract
				carrier selected pursuant to 21 CFR §1301.74(e), upon discovery of such
				theft or loss.
(d) Whenever the
				registrant distributes a controlled substance (without being registered as a
				distributor, as permitted by §107(b) and/or §§1401 through 1404
				of this Regulation) he or she shall comply with the requirements imposed on
				non-practitioners in §
									404(a), (b), and
				(e).
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 400 - Security Requirements › Section 61-4.400.407 - Loss by Diversion Due to Repeated Thefts

Current through Register Vol. 48, No. 6, June 28, 2024
(a) Any registrant who suffers repeated
				losses of controlled substances by theft due to break-ins, employee theft,
				mysterious disappearance, or other than through an armed robbery shall be
				deemed to be providing inadequate security for such controlled
				substances.
(b) Upon the first such
				diversion, the registrant shall cause such physical security measures to be
				instituted to prevent reoccurrence.
(c) Upon the second such diversion, the
				registrant shall be required to appear before the designated hearing officer of
				DHEC to provide, under oath, the security measures that the registrant has
				effected and plans to effect in the future to prevent further diversion by
				theft.
(d) Upon the third such
				diversion, the registrant shall be cited to show cause, if any he or she may
				have, why his or her registration under the Controlled Substances Act should
				not be revoked, suspended, or denied pursuant to the provisions of S.C. Code
				Ann. §
									44-53-310(e).
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 400 - Security Requirements › Section 61-4.400.408 - Filing of Theft Reports

Current through Register Vol. 48, No. 6, June 28, 2024
Theft reports (DEA Form 106) as required by this regulation
				  shall be filed with the Bureau of Drug Control not later than 30 days following
				  the discovery of the theft. Failure to file theft reports within the thirty-day
				  period shall result in the issuance of an order to show cause for revocation or
				  suspension of registration under the Act.