reglab/statecodes huggingface dataset:
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 1000 - Prescriptions › Section 61-4.1000.1002 - Purpose of Issue of Prescription

Current through Register Vol. 48, No. 6, June 28, 2024
(a) A prescription for a controlled substance
				to be effective shall be issued for a legitimate medical purpose by an
				individual practitioner acting in the usual course of his or her professional
				practice. The responsibility for the proper prescribing and dispensing of
				controlled substances is upon the prescribing practitioner but a corresponding
				responsibility rests with the pharmacist who fills the prescription. An order
				purporting to be a prescription issued not in the usual course of professional
				treatment or in legitimate and authorized research is not a prescription within
				the meaning and intent of the Act and the person knowingly filling such a
				purported prescription, as well as the person issuing it, shall be subject to
				the penalties provided for violations of the provisions of law relating to
				controlled substances.
(b) A
				prescription may not be issued in order for an individual practitioner to
				obtain controlled substances for supplying the individual practitioner for the
				purpose of general dispensing to patients.
(c) A prescription may not be issued for the
				dispensing of narcotic drugs listed in any schedule to a narcotic drug
				dependent person for the purpose of continuing his or her dependence upon such
				drugs whether or not in the course of conducting an authorized clinical
				investigation in the development of a narcotic rehabilitation
				program.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 1000 - Prescriptions › Section 61-4.1000.1003 - Manner of Issuance of Prescription

Current through Register Vol. 48, No. 6, June 28, 2024
All prescriptions for controlled substances shall be dated as
				  of the day when issued and shall bear the full name and address of the patient,
				  the drug name, strength, dosage form, quantity prescribed, directions for use
				  and the name, address, and registration number of the practitioner.
(a) Written prescriptions. A practitioner
				shall sign a prescription on the day when issued and in the same manner as he
				or she would sign a check or legal document (e.g., J. H. Smith or John H.
				Smith). Where an oral order is not permitted, prescriptions shall be written
				with ink or indelible pencil or typewriter, or other mechanical means of
				printing, and shall 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 in case the prescription does
				not conform in all essential respects to the law and regulations. A
				corresponding liability rests upon the pharmacist who fills a prescription not
				prepared in the form prescribed by this regulation. See also §
									1001(b).
(b) Electronic prescriptions. Existing DEA
				regulations provide practitioners with the option of transmitting electronic
				prescriptions for controlled substances in lieu of paper prescriptions. In an
				effort to ensure the integrity of these electronic prescriptions, the
				electronic application shall comply with the current DEA regulations prior to
				use.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 1000 - Prescriptions › Section 61-4.1000.1004 - Registration Number Required on Prescriptions

Current through Register Vol. 48, No. 6, June 28, 2024
All prescriptions for controlled substances, whether written
				  by the practitioner or telephoned and subsequently reduced to writing, shall
				  bear the Federal Controlled Substances Registration Number (DEA Number) of the
				  prescribing practitioner.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 1000 - Prescriptions › Section 61-4.1000.1005 - Persons Entitled to Fill Prescriptions

Current through Register Vol. 48, No. 6, June 28, 2024
A prescription for controlled substances may only be filled
				  by a pharmacist acting in the usual course of his or her professional practice
				  and either registered individually or employed in a registered pharmacy or
				  registered institutional practitioner.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 1000 - Prescriptions › Section 61-4.1000.1006 - Information Required for Filled Prescriptions

Current through Register Vol. 48, No. 6, June 28, 2024
A notation shall be placed upon any prescription for
				  controlled substances when originally filled that shall indicate the date
				  filled, the identity or initials of the pharmacist dispensing the prescription
				  and, if different from the quantity prescribed, the quantity
				  dispensed.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 1000 - Prescriptions › Section 61-4.1000.1007 - Dispensing of Narcotic Drugs for Maintenance Purposes

Current through Register Vol. 48, No. 6, June 28, 2024
The administering or dispensing directly (but not prescribing
				  of) narcotic drugs listed in any schedule to a narcotic drug dependent person
				  for the purpose of continuing his or her dependence upon such drugs in the
				  course of conducting an authorized clinical investigation in the development of
				  a narcotic addict rehabilitation program shall be deemed to be within the
				  meaning of the term "in the course of his or her professional practice or
				  research" in the Act, provided, that approval is obtained prior to the
				  initiation of such a program by submission of a Notice of Claimed
				  Investigational Exemption for a New Drug to the Food and Drug Administration
				  which will be reviewed concurrently by the Food and Drug Administration for
				  scientific merit and by the DEA for drug control requirements, and that the
				  clinical investigation thereafter accords with such approval.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 1000 - Prescriptions › Section 61-4.1000.1008 - Federal Approval of Maintenance Programs Required

Current through Register Vol. 48, No. 6, June 28, 2024
DHEC will not register any person to conduct an authorized
				  maintenance program for drug dependent persons until approval of such program
				  has been made by the appropriate federal agencies. Upon approval by these
				  agencies, the Bureau of Drug Control shall accept the application for
				  registration as complete.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 1000 - Prescriptions › Section 61-4.1000.1009 - Withdrawal of Drug Dependent Persons by Use of Methadone or Other Narcotic Controlled Substances

Current through Register Vol. 48, No. 6, June 28, 2024
Practitioners desiring to withdraw, but not maintain, drug
				  dependent persons addicted to narcotic controlled substances from such
				  substances by the use of methadone or any other schedule II narcotic controlled
				  substance, may do so provided that all of the following criteria are
				  met:
(a) The drug dependent person
				shall be a narcotic addict.
(b) The
				drug dependent person shall be confined to a hospital, clinic, rest home, or
				other appropriate location that properly segregates the drug dependent person
				from contact with possible illicit suppliers.
(c) The withdrawal program shall be on a
				reducing dosage basis, preferably through use of oral administration of the
				narcotic controlled substance used for withdrawal.
(d) Withdrawal treatment shall not exceed 21
				days in length and shall not be available to any drug dependent person more
				often than once every six months. If, in the opinion of the withdrawing
				practitioner, longer periods of withdrawal treatment are necessary, application
				for such longer treatment shall be made to the Director stating the reasons
				therefore, along with pertinent medical facts including, but not limited to,
				the following:
(1) Medical condition of
				subject at onset of withdrawal treatment;
(2) Amount of drug intake and name of drug at
				onset of treatment;
(3) Initial
				withdrawal dosage of methadone (or other narcotic controlled
				substance);
(4) Reduction schedule
				of withdrawal substance;
(5)
				Current medical evaluation of withdrawal regimen;
(6) Statement concerning presence or absence
				from urine sample of drug dependent person of the drug to which he or she was
				addicted; and
(7) Any other
				pertinent facts deemed necessary by the withdrawing practitioner or by the
				Director.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 1000 - Prescriptions › Section 61-4.1000.1010 - Approved Uses of Methadone in Hospitals. Methadone is Approved for the Following Uses for Inpatients of Hospitals Licensed by DHEC

Current through Register Vol. 48, No. 6, June 28, 2024
(a) Analgesia;
(b) Pertussis;
(c) Detoxification (withdrawal) of drug
				dependent persons under conditions set forth in Section
				1009 of this regulation;
				or
(d) Temporary maintenance of
				methadone treatment of a drug dependent person enrolled in a methadone
				maintenance program licensed by any state or the federal government while such
				person is institutionalized within a licensed hospital for medical treatment of
				an illness or malady medically unrelated to drug dependence.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 1000 - Prescriptions › Section 61-4.1000.1011 - Departmental Approval; When Required

Current through Register Vol. 48, No. 6, June 28, 2024
(a) Prior approval by DHEC for methadone use
				as set forth in §
									1010 of this regulation is not
				required.
(b) Prior approval of
				DHEC and registration as provided by Title 21, §1301.22(a)(6) of the Code
				of Federal Regulations and S.C. Code Ann. §
									44-53-290(i),
				is required of all persons desiring to operate a treatment program utilizing
				methadone (i.e., a "methadone maintenance program").
(c) Prior approval by DHEC in the manner set
				forth by §
									1012 of this regulation is not
				required to dispense methadone to outpatients of a hospital licensed by DHEC.
				Prior approval of DHEC is not required for "take home" methadone preparations
				which are lawfully dispensed by a methadone maintenance treatment
				facility.
(d) Approvals by DHEC, as
				required by §§
									1009 through
				1012 of this regulation, may be
				granted by the Bureau of Drug Control in its discretion. If the Bureau finds
				that it cannot approve a request, the request shall be submitted to the
				Director, along with the Bureau's reasons for non-approval. The Director, in
				his or her discretion, may then approve or deny the request, but if he or she
				shall deny such request, the person making the request shall be entitled to a
				hearing to determine the public interest, in the manner provided for "contested
				cases" in the South Carolina Administrative Procedures Act.
(e) DHEC may require further information from
				any applicant in order to obtain sufficient information to be utilized in
				approving or denying any request.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 1000 - Prescriptions › Section 61-4.1000.1012 - Treatment of Outpatients with Methadone

Current through Register Vol. 48, No. 6, June 28, 2024
(a) If a physician determines that methadone
				would be the drug of choice as an analgesic for a particular patient, the
				physician may issue prescriptions for methadone to the patient. Such
				prescriptions may be dispensed by any pharmacy that has agreed to perform such
				dispensing function.
(b) The
				treating physician shall agree to maintain adequate records to substantiate the
				use of methadone as an analgesic for the patient and shall make such records
				available to DHEC upon request.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 1100 - Controlled Substances Listed in Schedule II › Section 61-4.1100.1101 - Requirement of Prescription

Current through Register Vol. 48, No. 6, June 28, 2024
(a) A
				pharmacist may dispense directly a controlled substance listed in schedule II,
				which is a prescription drug as determined under the Act, pursuant to one of
				the following methods:
(1) As a written
				prescription signed by the prescribing individual practitioner;
(2) As an electronic prescription transmitted
				in accordance with §1003(b); or
(3) As provided in paragraphs (d) through (g)
				of this section.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 1100 - Controlled Substances Listed in Schedule II › Section 61-4.1100.1102 - Limitations on Prescriptions for Schedule II Substances

Current through Register Vol. 48, No. 6, June 28, 2024
Prescriptions for schedule II controlled substances shall not
				  be issued for more than a thirty-one day supply of the substance. No
				  prescription for schedule II controlled substances shall be dispensed later
				  than 90 days from the date of issue.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 1100 - Controlled Substances Listed in Schedule II › Section 61-4.1100.1103 - Practitioner-Patient Relationship Required

Current through Register Vol. 48, No. 6, June 28, 2024
Prior to the issuance of a prescription for, or the direct
				  dispensing of any schedule II controlled substances, the prescribing
				  practitioner shall have a valid practitioner-patient relationship established
				  with the recipient of the prescription, such relationship to include, but not
				  be limited to, a sufficient knowledge of the medical need of the patient for
				  such schedule II controlled substance, determination of the benefit to risk
				  ratio of the use of such substance, good faith determination of the identity
				  and address of the patient, a determination of the physical condition of the
				  patient, and such practitioner shall be in personal attendance of the patient
				  at the time of issuance of the prescription. Any prescription issued by any
				  practitioner for any person outside of the reasonable bounds of a
				  practitioner-patient relationship shall be deemed issued other than in the
				  course of professional practice required by the Act. A practitioner cannot
				  usually acquire a valid patient-practitioner relationship with himself or
				  herself, or with a member of his or her immediate family, due to the likelihood
				  of the loss of or the vitiation of the objectivity required in making the
				  necessary medical decisions in order to properly prescribe or dispense
				  controlled substances. The practitioner may not be able to acquire a sufficient
				  practitioner-patient relationship with non-family members (i.e., fiancé
				  or fiancée, close personal friend, paramour, etc.) if total objectivity
				  in deciding to prescribe or dispense controlled substances cannot be maintained
				  due to such factors as extreme compassion, ardor, extortion, etc. which would
				  vitiate such objectivity. In the event of a bona fide emergency situation,
				  where great detriment to the health or safety of a patient may be involved, a
				  practitioner may administer, dispense or prescribe limited amounts of
				  controlled substances to any person, notwithstanding the provisions of this
				  Section, until such time as another objective practitioner can be
				  contacted.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 1100 - Controlled Substances Listed in Schedule II › Section 61-4.1100.1104 - Refilling Prescription

Current through Register Vol. 48, No. 6, June 28, 2024
The refilling of a prescription for a controlled substance
				  listed in schedule II is prohibited.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 1100 - Controlled Substances Listed in Schedule II › Section 61-4.1100.1106 - Labeling of Substance

Current through Register Vol. 48, No. 6, June 28, 2024
The pharmacist filling a written or emergency oral
				  prescription for a controlled substance listed in schedule II shall affix to
				  the package a label showing the drug name, the quantity dispensed, the date of
				  filling, the pharmacy name and address, the serial number of the prescription,
				  the name of the patient, the name of the prescribing practitioner, and
				  directions for use and cautionary statements, if any, contained in such
				  prescription or required by law. See also § 1918.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 1100 - Controlled Substances Listed in Schedule II › Section 61-4.1100.1107 - Filing of Prescriptions

Current through Register Vol. 48, No. 6, June 28, 2024
All written prescriptions and written records of emergency
				  oral prescriptions shall be kept in accordance with requirements of §
				  603.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 1200 - Controlled Substances Listed in Schedules III, IV and V › Section 61-4.1200.1201 - Requirement of Prescription

Current through Register Vol. 48, No. 6, June 28, 2024
(a) A
				pharmacist may dispense a controlled substance listed in schedule III, IV, or V
				which is a prescription drug as determined under the Act, only pursuant to one
				of the following methods:
(1) A written
				prescription signed by a prescribing individual practitioner;
(2) An electronic prescription transmitted in
				accordance with §1003(b);
(3)
				An oral prescription made by a prescribing individual practitioner and promptly
				reduced to writing by the pharmacist containing all information required in
				§1003, except for the signature of the prescribing individual
				practitioner; or
(4) A facsimile of
				a written, signed prescription, transmitted by the practitioner or the
				practitioner's agent to the pharmacy. A prescription transmitted by facsimile
				must be received at the pharmacy as it was originally transmitted by facsimile
				and must include the name and address of the practitioner, the phone number for
				verbal confirmation, the time and date of transmission, and the name of the
				pharmacy intended to receive the transmission, as well as any other information
				required by federal or state law.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 1200 - Controlled Substances Listed in Schedules III, IV and V › Section 61-4.1200.1203 - Limitations on Prescriptions for Schedules III, IV, and V Substances

Current through Register Vol. 48, No. 6, June 28, 2024
Prescriptions for controlled substances listed in Schedules
				  III, IV, and V shall not be issued for more than a 90 day supply of the
				  substance. If authorized for refill, no prescription shall be refilled sooner
				  than 48 hours prior to the time that the prescription should be consumed if the
				  prescribed daily dosage is divided into the total prescribed amount. (Example:
				  4 daily divided into 100 dosage units = 25 days.) Carry over time shall not
				  accrue between refills. In the event that the practitioner does not specify an
				  exact daily dosage, the dispenser shall calculate date of refill from the usual
				  daily dosage recommended by the manufacturer of the controlled
				  substance.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 1200 - Controlled Substances Listed in Schedules III, IV and V › Section 61-4.1200.1204 - Practitioner-Patient Relationship Required

Current through Register Vol. 48, No. 6, June 28, 2024
Prior to the issuance of a prescription for controlled
				  substances listed in Schedule III, IV, or V the prescribing practitioner shall
				  have a valid practitioner-patient relationship established with the recipient
				  of the prescription, such relationship to include, but not be limited to, a
				  sufficient knowledge of the medical need of the patient for such schedule III,
				  IV, or V controlled substance, determination of the benefit to risk ratio of
				  the use of such substance, good faith determination of the identity and address
				  of the patient, a determination of the physical condition of the patient, and
				  such practitioner shall be in personal attendance of the patient at the time of
				  issuance of the prescription. Any prescription issued by any practitioner for
				  any person outside of the reasonable bounds of a practitioner-patient
				  relationship shall be deemed issued other than in the course of professional
				  practice required by the Act. A practitioner cannot usually acquire a valid
				  patient-practitioner relationship with himself or herself, now with a member of
				  his or her immediate family, due to the likelihood of the loss or vitiation of
				  the objectivity required in making the necessary medical decisions in order to
				  properly prescribe or dispense controlled substances. The practitioner may not
				  be able to acquire a sufficient practitioner-patient relationship with
				  non-family members (i.e., fiancé or fiancée, close personal
				  friend, paramour, etc.) if total objectivity in deciding to prescribe or
				  dispense controlled substances cannot be maintained due to such factors as
				  extreme compassion, ardor, extortion, etc. which would vitiate such
				  objectivity. In the event of a bona fide emergency situation, where great
				  detriment to the health or safety of a patient may be involved, a practitioner
				  may administer, dispense or prescribe limited amounts of controlled substances
				  to any person, notwithstanding the provisions of this Section, until such time
				  as another objective practitioner can be contacted.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 1200 - Controlled Substances Listed in Schedules III, IV and V › Section 61-4.1200.1205 - Partial Filling of Prescriptions

Current through Register Vol. 48, No. 6, June 28, 2024
The partial filling (dispensing) of a prescription for a
				  controlled substance listed in Schedules III, IV, or V is permissible, provided
				  that:
(a) Each partial filling is
				recorded in the same manner as a refilling;
(b) The total quantity dispensed in all
				partial fillings does not exceed the total quantity prescribed; and
(c) No dispensing occurs after six months
				from the date on which the prescription was issued.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 1200 - Controlled Substances Listed in Schedules III, IV and V › Section 61-4.1200.1206 - Labeling of Substances

Current through Register Vol. 48, No. 6, June 28, 2024
The pharmacist filling a prescription for a controlled
				  substance listed in schedule III, IV, or V shall affix to the package a label
				  showing the pharmacy name and address, the drug name, the quantity dispensed,
				  the serial number of the prescription and the date of the initial filling, the
				  name of the patient, the name of the practitioner issuing the prescription, and
				  directions for use and cautionary statements, if any, contained in such
				  prescriptions as required by law.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 1200 - Controlled Substances Listed in Schedules III, IV and V › Section 61-4.1200.1207 - Filing Prescriptions

Current through Register Vol. 48, No. 6, June 28, 2024
All prescriptions for controlled substances listed in
				  schedules III, IV, and V shall be kept in accordance with § 603.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 1200 - Controlled Substances Listed in Schedules III, IV and V › Section 61-4.1200.1208 - Controlled Substances Listed in Schedule V - Dispensing Without Prescription

Current through Register Vol. 48, No. 6, June 28, 2024
A controlled substance in Schedule V, which is not a
				  prescription drug as determined under the Act, may be dispensed by a pharmacist
				  without a prescription to a purchaser at retail, provided that:
(a) Such distribution is made only by a
				pharmacist and not by a non-pharmacist employee even if under the direct
				supervision of a pharmacist (although after the pharmacist has fulfilled his or
				her professional and legal responsibilities set forth in this section, the
				actual cash, credit transaction, or delivery, may be completed by a
				non-pharmacist):
(b) Not more than
				120 ml. (4 ounces) of any controlled substance listed in Schedule V may be
				distributed at retail to the same purchaser in any given 48-hour
				period;
(c) The purchaser is at
				least 18 years of age;
(d) The
				pharmacist requires every purchaser of a controlled substance listed in
				Schedule V not known to him or her to furnish suitable identification
				(including proof of age where appropriate);
(e) A bound record book for distributions of
				controlled substances listed in Schedule V (other than by prescription) is
				maintained by the pharmacist, which book shall contain the name and address of
				the purchaser, the name and quantity of controlled substance purchased, the
				date of each purchase, and the name or initials of the pharmacist who
				distributed the substance to the purchaser (the book shall be maintained in
				accordance with the record keeping requirement of §603 of this chapter);
				and
(f) A prescription is not
				required for distribution or dispensing of the substance pursuant to the Act or
				any other law.
(g) Repetitive sales
				without prescription of Schedule V controlled substances without positive
				determination of medical need by the pharmacist selling the non-prescription
				controlled substance shall be deemed dispensing for other than medical
				purposes, and shall be prima facie evidence of detriment to the public health
				and safety.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 1300 - Miscellaneous › Section 61-4.1300.1301 - Severability

Current through Register Vol. 48, No. 6, June 28, 2024
If a provision of any section of Part 100 through 1900 of
				  this regulation is held invalid, all valid provisions that are severable shall
				  remain in effect. If a provision of any of this regulation is held invalid in
				  one or more of its applications, the provision shall remain in effect in all
				  its valid applications that are severable.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 1300 - Miscellaneous › Section 61-4.1300.1302 - Application of Other Laws

Current through Register Vol. 48, No. 6, June 28, 2024
Nothing in this regulation shall be construed as authorizing
				  or permitting any person to do any act which such person is not authorized or
				  permitted to do under federal laws or obligations under international treaties,
				  conventions or protocols, or under the law of the state in which he desires to
				  do such act nor shall compliance with such Parts be construed as compliance
				  with other federal or state laws unless expressly provided in such other
				  laws.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 1300 - Miscellaneous › Section 61-4.1300.1303 - Exceptions in Regulations

Current through Register Vol. 48, No. 6, June 28, 2024
Any person may apply for an exception to the application of
				  any provision of these regulations by filing a written request stating the
				  reasons for such exception. Requests shall be filed with the Bureau Director.
				  The Bureau Director may grant an exception in his or her discretion, but in no
				  case shall he or she be required to grant an exception to any person which is
				  not otherwise required by law or the regulations cited in this section.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 1400 - Special Exceptions for Manufacture and Distribution of Controlled Substances › Section 61-4.1400.1401 - Distribution by Dispenser to Another Practitioner

Current through Register Vol. 48, No. 6, June 28, 2024
(a) A practitioner who is registered to
				dispense a controlled substance may distribute (without being registered to
				distribute) a quantity of such substance to another practitioner for the
				purpose of general dispensing by the practitioner to his or her patients,
				provided that;
(1) The practitioner to whom
				the controlled substance is to be distributed is registered under the Act to
				dispense that controlled substance;
(2) The distribution is recorded by the
				distributing practitioner in accordance with §804(e) of this regulation
				and by the receiving practitioner in accordance with §804(c) of this
				regulation;
(3) If the substance is
				listed in Schedule I or II, an order form (DEA Form 222) is used as required by
				Part 4 of this regulation;
(4) The
				total number of dosage units of all controlled substances distributed by the
				practitioner pursuant to this section during any 12 month period does not
				exceed five percent of the total number of dosage units of all controlled
				substances distributed and dispensed by the practitioner during the twelve
				month period. Registrants in existence less than 12 months shall prorate the
				time period, and shall not distribute more than five percent of the dispensings
				for any monthly period.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 1400 - Special Exceptions for Manufacture and Distribution of Controlled Substances › Section 61-4.1400.1402 - Manufacture and Distribution of Narcotic Solutions and Compounds by a Pharmacist

Current through Register Vol. 48, No. 6, June 28, 2024
As an incident to a distribution under §
									1401, a pharmacist may
				  manufacture (without being registered to manufacture) an aqueous or oleaginous
				  solution or solid dosage form containing a narcotic controlled substance in a
				  proportion not exceeding 20 percent of the complete solution, compound, or
				  mixture.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 1400 - Special Exceptions for Manufacture and Distribution of Controlled Substances › Section 61-4.1400.1403 - Distribution to Supplier

Current through Register Vol. 48, No. 6, June 28, 2024
Any person lawfully in possession of a controlled substance
				  listed in any schedule may distribute (without being registered to distribute)
				  that substance to the person from whom he or she obtained it or to the
				  manufacturer of the substance, provided that a written record is maintained
				  which indicates the date of the transaction, the name, form and quantity of the
				  substance, the name, address, and registration number, if any, of the person
				  making the distribution, and the name, address, and registration number, if
				  know, of the supplier or manufacturer. In the case of returning a controlled
				  substance listed in schedule I or II, an order form shall be used in the manner
				  prescribed in Part 900 of these regulations and be maintained as the written
				  record of the transaction.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 1400 - Special Exceptions for Manufacture and Distribution of Controlled Substances › Section 61-4.1400.1404 - Distribution upon Discontinuance or Transfer of Business

Current through Register Vol. 48, No. 6, June 28, 2024
(a) Any registrant desiring to discontinue
				business activities altogether or with respect to controlled substances
				(without transferring such business activities to another person) shall return
				for cancellation his or her South Carolina Controlled Substances Certificate of
				Registration to the Bureau of Drug Control, DHEC, 2600 Bull Street, Columbia,
				SC 29201. His or her Federal Controlled Substances Certificate of Registration
				and any un-executed order forms shall be returned to the DEA, 1835 Assembly
				Street, Suite 1229, Columbia, SC 29201.
(b) Any registrant desiring to discontinue
				business activities altogether or with respect to controlled substances (by
				transferring such business activities to another person) shall submit in person
				or by registered or certified mail, return receipt requested, to the Bureau
				Director at least 14 days in advance of the date of the proposed transfer
				(unless the Bureau Director waives this time limitation in individual
				instances), the following information:
(1)
				The name, address, registration number, and authorized business activity of the
				registrant discontinuing the business (registrant-transferor);
(2) The name, address, registration number,
				and authorized business activity of the person acquiring the business
				(registrant-transferee);
(3)
				Whether the business activities will be continued at the location registered by
				the person discontinuing business, or moved to another location (if the latter,
				the address of the new location should be listed);
(4) Whether the registrant-transferor has a
				quota to manufacture or procure any controlled substance listed in schedule I
				or II (if so, the basic class or class of the substance should be indicated);
				and
(5) The date on which the
				transfer of controlled substances will occur.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 1500 - Disposal of Controlled Substances › Section 61-4.1500.1501 - Procedure for Disposing of Controlled Substances

Current through Register Vol. 48, No. 6, June 28, 2024
(a) Any person in possession of any
				controlled substance and desiring or required to dispose of such substance may
				request the Bureau Director for authority and instructions to dispose of such
				substance.
(b) The Bureau Director
				shall authorize and instruct the individual in possession to dispose of the
				controlled substance in one of the following manners:
(1) By transfer to person registered under
				the Act and authorized to possess the substance;
(2) By destruction in the presence of an
				agent of the Bureau of Drug Control or other authorized person, or
(3) By such other means as the Bureau
				Director may determine to assure that the substance does not become available
				to unauthorized persons.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 1600 - Inspections › Section 61-4.1600.1601 - Authority to Make Inspections

Current through Register Vol. 48, No. 6, June 28, 2024
In carrying out his or her functions under the Act, the
				  Bureau Director, through his or her inspectors, is authorized in accordance
				  with the Act to enter controlled premises and conduct administrative
				  inspections thereof, for the purpose of:
(a) Inspecting, copying, and verifying the
				correctness of records, reports, or other documents required to be kept or made
				under the Act and any regulations promulgated under the Act, including, but not
				limited to, inventory and other records required to be kept pursuant to Parts
				600 through 800 of this chapter, order form records required to be kept
				pursuant to Part 900 of this chapter, prescription and distribution records
				required to be kept pursuant to Part Parts 1000 through 1200 of this chapter,
				shipping records identifying the name of each carrier used and the date and
				quantity of each shipment, and storage records identifying the name of each
				warehouse used and the date and quantity of each storage;
(b) Inspecting within reasonable limits and
				in a reasonable manner all pertinent equipment, finished and unfinished
				controlled substances and other substances or materials, containers, and
				labeling found at the controlled premises relating to this Act;
(c) Making a physical inventory of all
				controlled substances on hand at the premises;
(d) Collecting samples of controlled
				substances or precursors (in the event any samples are collected during an
				inspection, the inspector shall issue a receipt for such samples on DEA Form 84
				to the owner, operator, or agent in charge of the premises);
(e) Checking of records and information on
				distribution of controlled substances by the registrant as they relate to total
				distribution of the registrant (i.e., has the distribution in controlled
				substances increased markedly within the past year, and if so, why);
				and
(f) Except as provided in
				§
									1602, all other things therein
				(including records, files, papers, processes, controls and facilities)
				appropriate for verification of the records, reports, documents referred to
				above or otherwise bearing on the provisions of the Act and the regulations
				thereunder.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 1600 - Inspections › Section 61-4.1600.1602 - Exclusion from Inspection

Current through Register Vol. 48, No. 6, June 28, 2024
(a)
				Unless the owner, operator, or agent in charge of the controlled premises so
				consents, no inspection authorized by the regulations shall extend to:
(1) Financial data;
(2) Sales data other than shipping data;
				or
(3) Pricing data.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 1600 - Inspections › Section 61-4.1600.1603 - Entry

Current through Register Vol. 48, No. 6, June 28, 2024
An inspection shall be carried out by an inspector. Any such
				  inspector, upon:
(a) Stating his or
				her purpose and
(b) Presenting to
				the owner, operator, or agent in charge of the premises to be inspected:
(1) Appropriate credentials, or
(2) Written notice of his or her inspection
				authority under §
										1601 and the Act, or
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 1600 - Inspections › Section 61-4.1600.1604 - Notice of Inspection

Current through Register Vol. 48, No. 6, June 28, 2024
The notice of inspection shall contain:
(a) The name and title of the owner,
				operator, or agent in charge of the controlled premises;
(b) The controlled premises name;
(c) The address of the controlled premises to
				be inspected;
(d) The date and time
				of the inspection;
(e) A statement
				that a notice of inspection is given pursuant to the Act;
(f) A reproduction of the pertinent parts of
				the Act; and
(g) The signature of
				the inspector.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 1600 - Inspections › Section 61-4.1600.1605 - Consent to Inspection

Current through Register Vol. 48, No. 6, June 28, 2024
(a) An
				administrative inspection warrant shall not be required if informed consent is
				obtained from the owner, operator, or agent in charge of the controlled
				premises to be inspected.
(b)
				Wherever possible, informed consent obtained by the inspector shall consist of
				a written statement signed by the owner, operator or agent in charge of the
				premises to be inspected.
(c) After
				August 17, 1974, informed consent may be shown by the production of a completed
				registration application or certificate, which shall contain printed thereon a
				preamble and conditions of registration.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 1600 - Inspections › Section 61-4.1600.1606 - Application for Administrative Inspection Warrant

Current through Register Vol. 48, No. 6, June 28, 2024
(a) An administrative inspection warrant
				application shall be submitted to any judge or any magistrate and shall contain
				the following information:
(1) The name and
				address of the controlled premises to be inspected;
(2) A statement of statutory authority for
				the administrative inspection warrant, and that the fact that the particular
				inspection in question is designed to insure compliance with the regulations
				promulgated under those acts;
(3) A
				statement relating to the nature and extent of the administrative inspection,
				including, where necessary, a request to seize specified items and/or to
				collect samples of finished or unfinished controlled substances;
(4) A statement that the establishment
				either:
(i) Has not been previously inspected,
				or
(ii) Was last inspected on a
				particular date.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 1600 - Inspections › Section 61-4.1600.1607 - Administrative Probable Cause

Current through Register Vol. 48, No. 6, June 28, 2024
If the judge or magistrate is satisfied that "administrative
				  probable cause" exists, he shall issue an administrative warrant.
				  Administrative probable cause shall not mean criminal probable cause as defined
				  by federal or state statute or case law.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 1600 - Inspections › Section 61-4.1600.1608 - Execution of Warrants

Current through Register Vol. 48, No. 6, June 28, 2024
An administrative inspection warrant shall be executed and
				  returned as required by, and any inventory or seizure made shall comply with
				  the requirements of the Act. The inspection shall begin as soon as is
				  practicable after the issuance of the administrative inspection warrant and
				  shall be completed with reasonable promptness. The inspection shall be
				  conducted during regular business hours and shall be completed in a reasonable
				  manner.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 1600 - Inspections › Section 61-4.1600.1609 - Refusal to Allow Inspection with an Administrative Warrant

Current through Register Vol. 48, No. 6, June 28, 2024
If a registrant or any person subject to the Act refuses to
				  permit execution of an administrative warrant or impedes the inspector in the
				  execution of that warrant, he shall be advised that such refusal or action
				  constitutes a violation of the Act. If the individual persists and the
				  circumstances warrant, he or she shall be arrested and the inspection shall
				  commence or continue.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 1700 - Protection of Researchers and Research Subjects › Section 61-4.1700.1701 - Confidentiality of Research Subjects

Current through Register Vol. 48, No. 6, June 28, 2024
(a) Any person registered to conduct a bona
				fide research project with controlled substances under the Act who intends to
				maintain the confidentiality of those persons who are the subjects of such
				research, shall, upon registration or within a reasonable time thereafter,
				submit to the Bureau of Drug Control, DHEC, 2600 Bull Street, Columbia, SC
				29201, a separate request for each research project involving controlled
				substances, which shall contain the following:
(1) The researcher's registration number for
				that project;
(2) The location of
				the research project;
(3) A general
				description of the research or a copy of the research protocol;
(4) A specific request to withhold the names
				and/or any other identifying characteristics of the research subjects;
				and
(5) The reasons supporting the
				request.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 1700 - Protection of Researchers and Research Subjects › Section 61-4.1700.1702 - Exemption from Prosecution for Researcher

Current through Register Vol. 48, No. 6, June 28, 2024
(a) Upon registration of a practitioner to
				engage in research in controlled substances under the Act, the Bureau of Drug
				Control, DHEC, on its own motion or upon request in writing from the Director
				or from the practitioner, may exempt the registrant when acting within the
				scope of his or her registration, from prosecution under State or local laws
				for offenses relating to possession, distribution or dispensing of those
				controlled substances within the scope of his or her exemption. However, this
				exemption does not diminish any requirement of compliance with the Federal
				Food, Drug and Cosmetic Act (
				21
				USC 301, et seq.) or with the Federal
				Controlled Substances Act (84 Stat. 1242;
				21
				U.S.C. 801, et seq.).
(b) All petitions for Grants of Exemption
				from Prosecution for the Researcher shall be addressed to the Director, Bureau
				of Drug Control, SCDHEC, 2600 Bull Street, Columbia, SC 29201, and shall
				contain the following:
(1) The researcher's
				registration number, if any, for the project;
(2) The location of the research of the
				research project;
(3) The
				qualifications of the principal investigator;
(4) A general description of the research or
				a copy of the research protocol;
(5) The source of funding for the research
				project;
(6) A statement as to the
				risks posed to the research subjects by the research procedures and what
				measures of protection will be afforded to the research subjects;
(7) A statement as to the risks posed to
				society in general by the research procedures and what measures will be taken
				to protect the interests of society;
(8) A specific request for exemption from
				prosecution by Federal, State, or local authorities for offenses related to the
				possession, distribution, and dispensing of controlled substances in accord
				with the procedures described in the research protocol;
(9) A statement establishing that a grant of
				exemption from prosecution is necessary to the successful completion of the
				research project;