reglab/statecodes huggingface dataset:
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 400 - Security Requirements › Section 61-4.400.409 - Employee Screening Procedures

Current through Register Vol. 48, No. 6, June 28, 2024
Registrants are required to screen all employees for criminal
				  convictions and/or unauthorized use of controlled substances. An employer's
				  comprehensive employee screening program will include the following
				  inquiries:
(1) Within the past five
				years have you been convicted of a felony or any misdemeanor or are you
				presently formally charged with committing a criminal offense? (Do not include
				any traffic violations, juvenile offenses, or military conviction, except by
				general court martial.) If the answer is yes, furnish details of the
				conviction, offense, location, date, and sentence.
(2) In the past three years, have you ever
				knowingly used any narcotic, barbiturates, or amphetamines, other than
				prescribed to you by a physician or other practitioner? If the answer is yes,
				furnish details.
Employers should obtain an authorization, in writing, that
				  allows inquires to be made of courts and law enforcement agencies for possible
				  pending charges or convictions. This authorization shall be executed by a
				  person who is allowed to work in an area where access to controlled substances
				  clearly exists. A person shall be advised that any false information or
				  omission of information will jeopardize his or her position with respect to
				  employment. The application for employment should inform a person that
				  information furnished or recovered as a result of any inquiry will not
				  necessarily preclude employment, but will be considered as part of an overall
				  evaluation of the person's qualifications. This person must also be informed
				  that the information contained in the application and any information disclosed
				  as a result of the authorization will be available to the Bureau of Drug
				  Control in the event of inquiry or investigation.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 400 - Security Requirements › Section 61-4.400.410 - Employee Responsibility to Report Drug Diversion

Current through Register Vol. 48, No. 6, June 28, 2024
An employee who has knowledge or suspicion of drug diversion
				  from his or her employer by a fellow employee shall report such information to
				  a responsible security official of the employer, or to a person in a management
				  position with the employer. The employer shall treat such information as
				  confidential and shall take all reasonable steps to protect the confidentiality
				  of the information and the identity of the employee furnishing information. A
				  failure to report information of drug diversion will be considered in
				  determining the feasibility of continuing to allow an employee to work in a
				  drug security area, or with access to controlled substances. The employer shall
				  inform all employees concerning this policy.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 400 - Security Requirements › Section 61-4.400.411 - Illicit Activities by Employees

Current through Register Vol. 48, No. 6, June 28, 2024
Employees who sell, possess, use, or divert controlled
				  substances will subject themselves not only to state and federal criminal
				  prosecution for any illicit activity, but shall also immediately become the
				  subject of independent action regarding their continued employment. The
				  employer will assess the seriousness of the employee's violation, the position
				  of responsibility held by the employee, and the past record of employment. in
				  determining whether to suspend, transfer, terminate, or take other action
				  against the employee.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 400 - Security Requirements › Section 61-4.400.412 - Separate Registration by Permitted Pharmacies for Installation and Operation of Automated Storage Machines at Long Term Care Facilities

Current through Register Vol. 48, No. 6, June 28, 2024
(a) A permitted
				pharmacy may install and operate automated storage machines, as defined in
				§102(c) of this Regulation, at long term care facilities. No person other
				than a permitted pharmacy may install and operate an automated storage machine
				at a long term care facility.
(b)
				Permitted pharmacies installing and operating automated storage machines at
				long term care facilities must maintain a separate registration at the location
				of each long term care facility at which automated storage machines are
				located.
(c) A permitted pharmacy
				applying for a separate registration to operate automated storage machines
				which contain controlled substances at a long term care facility is exempt from
				application fees for any such additional registrations.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 500 - Labeling and Packaging Requirements for Controlled Substances › Section 61-4.500.501 - Symbol Required; Exceptions

Current through Register Vol. 48, No. 6, June 28, 2024
(a) Each commercial container of a controlled
				substance shall have printed on the label the symbol designating the schedule
				in which such controlled substance is listed. Each such commercial container,
				if it otherwise has no label, shall bear a label complying with the requirement
				of this part.
(b) Each manufacturer
				shall print upon the labeling of each controlled substance distributed by him
				or her the symbol designating the schedule in which such controlled substance
				is listed.
(c) The following
				symbols shall designate the schedule corresponding thereto:
Schedule
Symbol
Schedule I
I or C-I
Schedule II
II or C-II
Schedule III
III or C-III
Schedule IV
IV or C-IV
Schedule V
V or C-V
The word "schedule" need not be used. No distinction need be
				  made between narcotic and non-narcotic substances.
(d) The symbol is not required on a carton or
				wrapper in which a commercial container is held if the symbol is easily legible
				through such carton or wrapper.
(e)
				The symbol is not required on a commercial container too small or otherwise
				unable to accommodate a label, if the symbol is printed on the box or package
				from which the commercial container is removed upon dispensing to an ultimate
				user.
(f) The symbol is not
				required on a commercial container containing, or on the labeling of, a
				controlled substance being utilized in clinical research involving blind and
				double blind studies.
(g) The
				symbol is not required on a commercial container containing, or on labeling of,
				a controlled substance intended for export from the United States.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 500 - Labeling and Packaging Requirements for Controlled Substances › Section 61-4.500.502 - Location and Size of Symbol on Label

Current through Register Vol. 48, No. 6, June 28, 2024
(a) The symbol shall be prominently located
				on the right upper corner of the principal panel of the label of the commercial
				container and/or the panel of the commercial container normally displayed to
				dispensers of any controlled substance listed in schedules I through V. The
				symbol shall be at least two times as large as the largest type otherwise
				printed on the label.
(b) In lieu
				of locating the symbol in the corner of the label, as prescribed in paragraph
				(a) of this section, the symbol may be overprinted on the label, in which case
				the symbol shall be printed at least one-half the height of the label and in a
				contrasting color providing clear visibility against the background color of
				the label.
(c) In all cases the
				symbol shall be clear and large enough to afford easy identification of the
				schedule of the controlled substance upon inspection without removal from the
				dispenser's shelf.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 500 - Labeling and Packaging Requirements for Controlled Substances › Section 61-4.500.503 - Location and Size of Symbol on Labeling

Current through Register Vol. 48, No. 6, June 28, 2024
The symbol shall be prominently located on all labeling other
				  than labels covered by Regulation Regulation 203. In all cases the symbol shall
				  be clear and large enough to afford prompt identification of the controlled
				  substance upon inspection of the labeling.
(a) All labels on commercial containers of,
				and all labeling of, a controlled substance which is listed in any schedule on
				July 1, 1971, and which is packaged after December 1, 1971, shall comply with
				the requirements of §
									501.
(b) All labels on commercial containers of,
				and all labeling of, a controlled substance which either is listed in any
				schedule on July 1, 1971, and thereafter transferred to another schedule or is
				added to any schedule after July 1, 1971, and which is packaged more than 180
				days following the dates on which the transfer or addition becomes effective
				shall comply with the requirements of §
									501.
(c) The Bureau Director may, in the case of
				any controlled substance, require compliance with the requirements of §
									501 within a period of time shorter
				than required by this section if he or she finds that public health or safety
				necessitates an earlier effective date.
(d) Until compliance is required under this
				section, the label on commercial container containing, and the labeling of, any
				controlled substance shall comply with any requirements under federal or state
				law as to labels of such containers and as to labeling of such substances
				existing prior to the effective date prescribed in this section.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 500 - Labeling and Packaging Requirements for Controlled Substances › Section 61-4.500.504 - Effective Dates of Labeling Requirements

Current through Register Vol. 48, No. 6, June 28, 2024
(a) All labels on commercial containers of,
				and all labeling of, a controlled substance which is listed in any schedule on
				July 1, 1971, and which is packaged after December 1, 1971, shall comply with
				the requirements of §
									501.
(b) All labels on commercial containers of,
				and all labeling of, a controlled substance which either is listed in any
				schedule on July 1, 1971, and thereafter transferred to another schedule or is
				added to any schedule after July 1, 1971, and which is packaged more than 180
				days following the dates on which the transfer or addition becomes effective
				shall comply with the requirements of §
									501.
(c) The Bureau Director may, in the case of
				any controlled substance, require compliance with the requirements of §
									501 within a period of time shorter
				than required by this section if he or she finds that public health or safety
				necessitates an earlier effective date.
(d) Until compliance is required under this
				section, the label on commercial container containing, and the labeling of, any
				controlled substance shall comply with any requirements under federal or state
				law as to labels of such containers and as to labeling of such substances
				existing prior to the effective date prescribed in this section.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 500 - Labeling and Packaging Requirements for Controlled Substances › Section 61-4.500.505 - Sealing of Controlled Substances

Current through Register Vol. 48, No. 6, June 28, 2024
(a) On each bottle, multiple dose vial, other
				commercial container of any controlled substance listed in schedules I and/or
				II, and of any narcotic controlled substance listed in schedule III or IV,
				there shall be securely affixed to the stopper, cap, lid, covering, or wrapper
				of such container a seal to disclose upon inspection any tampering or opening
				of the container.
(b) Any seal
				accepted for use, under federal law prior to July 1, 1971, shall be deemed
				acceptable for use under this section.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 500 - Labeling and Packaging Requirements for Controlled Substances › Section 61-4.500.506 - Labeling for Controlled Substances Dispensed Directly to Ultimate Users

Current through Register Vol. 48, No. 6, June 28, 2024
Controlled substances which are dispensed directly to an
				  ultimate user other than by a prescription dispensed by a pharmacy or by direct
				  administration or application of the substance into or upon the person for whom
				  it is intended, shall bear a label or labeling containing the drug name, the
				  quantity dispensed, the name and address of the dispenser, the name of the
				  ultimate user (i.e., the "patient"), specific directions for use, and the date
				  of the dispensing. The label or labeling shall include any necessary cautionary
				  statement, whether customary or required by state or federal law. A serial
				  number may be utilized at the discretion of the dispenser. The act of
				  dispensing controlled substances shall be performed by the registrant, and
				  shall not be delegated to any person other than a pharmacist acting in the
				  regular course of professional activity. Prescriptions shall be labeled
				  pursuant to the provisions of Part 1000 of this Regulation, unless specifically
				  exempted. No practitioner shall directly dispense more than a thirty-one day
				  supply.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 600 - Records and Reports of Registrants › Section 61-4.600.601 - Scope of Part 600

Current through Register Vol. 48, No. 6, June 28, 2024
Inventory and other records and reports required under the
				  Act shall be in accordance with, and contain the information required by, those
				  sections and by the sections of this Part.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 600 - Records and Reports of Registrants › Section 61-4.600.603 - Maintenance of Records and Inventories

Current through Register Vol. 48, No. 6, June 28, 2024
(a) Every inventory and other record required
				to be kept under this Part shall be kept by the registrant and be available,
				for at least two years from the date of such inventory or record, for
				inspecting and copying by authorized employees of the Bureau of Drug Control,
				except that financial and shipping records (such as invoices and packing slips
				but not executed order forms subject to 21 CFR §1305.13 ) may be kept at a
				central location rather than at the registered location if the registrant has
				notified the Bureau of Drug Control of its intention to keep central records.
				Written notification shall be submitted by registered or certified mail, return
				receipt requested, in triplicate to the Bureau Director. Unless the registrant
				is informed by the Bureau Director that permission to keep central records is
				denied, the registrant may maintain central records commencing 14 days after
				receipt of the return receipt accompanying the notification. All notifications
				shall include:
(1) The nature of the records
				to be kept centrally and the exact location where the records will be
				kept;
(2) The name, address, state
				and DEA registration numbers, and type of registration of the registrant whose
				records are being maintained centrally;
(3) Whether central records will be
				maintained in a manual, or computer readable form.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 700 - Inventory Requirements › Section 61-4.700.701 - General Requirements for Inventories

Current through Register Vol. 48, No. 6, June 28, 2024
(a) Each inventory shall contain a complete
				and accurate record of all controlled substances on hand on the date the
				inventory is taken. Controlled substances shall be deemed to be "on hand" if
				they are in the possession of or under the control of the registrant, including
				substances returned by a customer, substances ordered by a customer but not yet
				invoiced, substances stored in a warehouse on behalf of the registrant, and
				substances in the possession of employees of the registrant and intended for
				distribution as complimentary samples.
(b) A separate inventory shall be made by a
				registrant for each registered location. In the event controlled substances in
				the possession or under the control of the registrant at a location for which
				he is not registered, the substances shall be included in the inventory of the
				registered location to which they are subject to control or to which the person
				possessing the substance is responsible. Each inventory for a registered
				location shall be kept at the registered location.
(c) A separate inventory shall be made by a
				registrant for each independent activity for which he is registered, except as
				provided in §
									707.
(d) A registrant may take an inventory either
				as of the opening of business or as of the close of business on the inventory
				date. The registrant shall indicate on the inventory records whether the
				inventory is taken as of the opening or as of the close of business, and the
				date and time the inventory is taken.
(e) An inventory shall be maintained in an
				indelibly written, typewritten, or printed form. An inventory taken by use of
				an oral recording device shall be promptly transcribed. Such inventory shall be
				signed by a responsible individual, who attests to the completeness and
				accuracy of the inventory.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 700 - Inventory Requirements › Section 61-4.700.702 - Inventory upon Transfer of Business; Change of Pharmacist-in-Charge

Current through Register Vol. 48, No. 6, June 28, 2024
(a) Inventory upon
				transfer of business.
(1) Any registrant
				transferring his or her business to another person who shall become registered
				to continue such business shall inventory all controlled substances on hand at
				the close of business on the day of transfer. The receiving registrant shall
				either (a) certify the inventory taken as being correct, or (b) shall affect
				his or her own inventory at the start of business on the date of transfer. Any
				discrepancy in the inventory shall be reported within 5 days to the Bureau
				Director.
(2) A new establishment,
				never before having been registered, and having no prior inventory of
				controlled substances, shall be deemed to have a zero inventory as of the first
				day of business.
(3) A registrant
				discontinuing business shall upon the date of discontinuance inventory all
				controlled substances and place said controlled substances in sealed containers
				under adequate protection from theft, until such time as the controlled
				substances are transferred to another registrant. A copy of this inventory
				shall be placed with the controlled substances, and a copy retained by the
				discontinuing registrant.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 700 - Inventory Requirements › Section 61-4.700.703 - Annual Inventory Date

Current through Register Vol. 48, No. 6, June 28, 2024
Inventories shall be taken on May 1st of each year unless
				  written permission for another date is granted by the Bureau of Drug Control.
				  If permission for another date is granted, the registrant shall maintain
				  documentation of such permission for a period of two (2) years. In the event
				  that a person commences business with no controlled substances on hand, he or
				  she shall record this fact as his or her initial inventory.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 700 - Inventory Requirements › Section 61-4.700.704 - Inventories of Manufacturers

Current through Register Vol. 48, No. 6, June 28, 2024
Each registered manufacturer shall include the following
				  information in his or her inventory:
(a) For each controlled substance in bulk
				form to be used in (or capable of use in) the manufacture of the same or other
				controlled or non-controlled substances in finished form:
(1) The name of the substance; and
(2) The total quantity of the substance to
				the nearest metric unit weight consistent with unit size (except that for
				inventories made in 1971), avoirdupois weights may be utilized where metric
				weights are not readily available)
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 700 - Inventory Requirements › Section 61-4.700.705 - Inventories for Distributors

Current through Register Vol. 48, No. 6, June 28, 2024
Each registered distributor shall include in his or her
				  inventory the same information required of manufactures pursuant to
				  §§
									704(c) and
				  (d).
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 700 - Inventory Requirements › Section 61-4.700.706 - Inventories of Dispensers and Researchers

Current through Register Vol. 48, No. 6, June 28, 2024
Each person registered to dispense or conduct research with
				  controlled substances and required to keep records pursuant to §601 shall
				  include in his or her inventory the same information required of manufacturers
				  pursuant to §§
									704(c) and (d). In
				  determining the number of units of each finished form of a controlled substance
				  in a commercial container which has been opened, the dispenser shall do as
				  follows:
(a) If the substance is
				listed in schedule I or II, he or she shall make an exact count or measure of
				the contents; and
(b) If the
				substance is listed in schedule III, IV, V, he or she shall make an estimated
				count or measure of the contents, unless the container holds more than 1,000
				tablets or capsules in which case he or she shall make an exact count of the
				contents. If estimated counts are utilized, quantities shall be recorded as
				number of finished doses per container. Fractions of containers may not be
				utilized.
(c) It is the
				responsibility of the registrant to determine that any estimates are accurate,
				as audit procedures will be based upon the inventories maintained by the
				registrant. The Bureau of Drug Control utilizes exact counts in all audit
				procedures, and will allow only minor leeway for estimated
				inventories.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 700 - Inventory Requirements › Section 61-4.700.707 - Inventories of Importers and Exporters

Current through Register Vol. 48, No. 6, June 28, 2024
Each registered importer or exporter shall include in his or
				  her inventory the same information required of manufacturers pursuant to
				  §§
									704(a), (c), and
				  (d). Each registered importer or exporter who
				  is also registered as a manufacturer or as a distributor shall include in his
				  or her inventory as an importer or exporter only those stocks of controlled
				  substances that are actually separated from his or her stocks as a manufacturer
				  or as a distributor (e.g., in transit or in storage for shipment).
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 700 - Inventory Requirements › Section 61-4.700.708 - Inventories for Chemical Analysis

Current through Register Vol. 48, No. 6, June 28, 2024
Each analytical laboratory registered to conduct chemical
				  analysis with controlled substances shall include in its inventory the same
				  information required of manufacturers pursuant to §§
									704(a), (c), and
				  (d) as to substances which have been
				  manufactured, imported, or received by the laboratory conducing the inventory.
				  If less than 1 kilogram of any controlled substance (other than a
				  hallucinogenic controlled substance listed in schedule I), or less than 20
				  grams of a hallucinogenic substance listed in schedule I (other than lysergic
				  acid diethylamide), or less than 0.5 grams of lysergic acid diethylamide, is on
				  hand at the time of inventory, that substance need not be included in the
				  inventory.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 800 - Continuing Records › Section 61-4.800.801 - General Requirements for Continuing Records

Current through Register Vol. 48, No. 6, June 28, 2024
(a) On and after June 17, 1971 every
				registrant required to keep records pursuant to §602 shall maintain on a
				current basis a complete and accurate record of each such substance
				manufactured, imported, received, sold, delivered, exported, or otherwise
				disposed of by him or her, except that no registrant shall be required to
				maintain a perpetual inventory, except as provided in paragraph (e) of this
				section.
(b) Separate records shall
				be maintained by a registrant for each registered location except as provided
				in §602. In the event controlled substances are in the possession or under
				the control of a registrant at a location for which he or she is not
				registered, the substance shall be included in the records of the registered
				location to which they are subject to control or to which the person possessing
				the substance is responsible.
(c)
				Separate records shall be maintained by a registrant for each independent
				activity for which he or she is registered, except as provided in §
									804.
(d) In recording dates of receipt,
				importation, distribution, exportation or other transfers, the date on which
				the controlled substances are actually received, imported, distributed,
				exported or otherwise transferred shall be used as the date of receipt or
				distribution of any packing slips.
(e) DHEC, upon a finding that a registrant
				has maintained inadequate records, or upon a finding that the registrant has a
				history of poor or inadequate record keeping, may, in its discretion, require
				perpetual inventories of all or a part on the controlled substances possessed
				or otherwise utilized or handled by such registrant (or an applicant for new
				registration having a history of record keeping deficiencies) as a condition
				for granting or renewing controlled substances registration. DHEC, upon a
				finding that adequate record keeping has been maintained for two or more years,
				pursuant to a perpetual inventory requirement, may remove the requirement and
				permit the registrant to resume standard record keeping activities with or
				without a probationary period of registration, as DHEC deems proper.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 800 - Continuing Records › Section 61-4.800.802 - Records of Manufacture

Current through Register Vol. 48, No. 6, June 28, 2024
Each registered manufacturer shall maintain records with the
				  following information.
(a) For each
				controlled substance in bulk form to be used, or capable of use in, or being
				used in, the manufacture of the same or other controlled or non-controlled
				substance in finished form:
(1) The name of
				the substance;
(2) The quantity
				manufactured in bulk form by the registrant, including the date, quantity and
				batch or other identifying number of each batch manufactured;
(3) The quantity received from other persons,
				including the date and quantity of each receipt and the name, address, and
				registration number of the other person from whom the substance was
				received;
(4) The quantity imported
				directly by the registrant (under a registration as an importer) for use in
				manufacture by him or her, including the date, quantity, and import permit or
				declaration number for each importation;
(5) The quantity used to manufacture the same
				substance in finished form, including:
(i) The
				date and batch or other identifying number of each manufacturer;
(ii) The quantity used in the
				manufacture;
(iii) The finished
				form (e.g., 10-milligram tablets or 10 milligram concentrate per fluid ounce or
				milliliter);
(iv) The number of
				units of finished form manufactured;
(v) The quantity used in quality
				control;
(vi) The quantity lost
				during manufacturing and the causes thereof, if known;
(vii) The total quantity of the substance
				contained in the finished form;
(viii) The theoretical and actual yields;
				and
(ix) Such other information as
				is necessary to account for all controlled substances used in the manufacturing
				process.
(6) The
				quantity used to manufacture other controlled and non-controlled substances,
				including the name of each substance manufactured and the information required
				in subparagraph (5) of this paragraph;
(7) The quantity distributed in bulk form to
				other persons, including the date and quantity of each distribution and the
				name, address, and registration number of each person to whom a distribution
				was made;
(8) The quantity exported
				directly the registrant (under a registration as an exporter), including the
				date quantity, and export permit or declaration number of each
				exportation;
(9) The quantity
				distributed or disposed of in any other manner by the registrant (e.g., by
				distribution of complimentary samples or by destruction), including the date
				and manner of distribution or disposal, the name, address, and registration
				number of the person to whom distributed, and the quantity distributed or
				disposed.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 800 - Continuing Records › Section 61-4.800.803 - Records for Distributors

Current through Register Vol. 48, No. 6, June 28, 2024
Each registered distributor shall maintain records with the
				  following information for each controlled substance:
(a) The name of the substance;
(b) Each finished form (e.g. 10-milligram
				tablet or 10-milligram concentration per fluid ounce or milliliter) and the
				number of units or volume of finished form in each commercial container (e.g.,
				100-tablet bottle or 3-milliliter vial);
(c) The number of commercial containers of
				each such finished form received from other persons, including the date of and
				number of containers in each receipt and the name, address, and registration of
				the person from whom the containers were received;
(d) The number of commercial containers of
				each such finished form imported directly by the registrant (under a
				registration as an importer), including the date of and the number of
				containers in each importation;
(e)
				The number of commercial containers of each such finished form distributed to
				other persons, including the date of and number of containers in each
				distribution and the name, address and registration number of the person to
				whom the containers were distributed;
(f) The number of commercial containers of
				such finished form exported directly by the registrant (under a registration as
				an exporter), including the date of and the number of containers of each
				exportation; and
(g) The number of
				units or volume of finished forms and/or commercial containers distributed or
				disposed of in any other manner by the registrant (e.g., by distribution as
				complimentary samples), including the date and manner of distribution or
				disposal, the name and address, and registration number of the person to whom
				distributed or disposed.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 800 - Continuing Records › Section 61-4.800.804 - Records for Dispensers and Researchers

Current through Register Vol. 48, No. 6, June 28, 2024
Each person registered to dispense or conduct research with
				  controlled substances required to keep records pursuant to §602 shall
				  maintain records with the following information for each controlled
				  substance:
(a) The name of the
				substance;
(b) Each finished form
				(e.g., 10-milligram tablet or 10-milligram concentration per fluid ounce or
				milliliter) and the number of units or volume of finished form in each
				commercial container (e.g., 100-tablet bottle or 3-milliliter vial);
(c) The number of commercial containers of
				each such finished form received from other persons, including the date of and
				number of containers in each receipt and the name, address, and registration
				number of the person from whom the containers were received;
(d) The number of units or volume of such
				finished form dispensed, including the name and address of the person to whom
				it was dispensed, the date of dispensing, the number of units or volume
				dispensed, and the written or typewritten name or initials of the dispenser;
				and
(e) The number of units or
				volume of such finished form and/or commercial containers disposed of in any
				other manner by the registrant, including the date and manner of disposal and
				the quantity of the substance in finished form disposed.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 800 - Continuing Records › Section 61-4.800.805 - Records for Importers

Current through Register Vol. 48, No. 6, June 28, 2024
Each registered importer shall maintain records with the
				  following information for each controlled substance:
(a) The name of the substance;
(b) The quantity (or number of units or
				volume in finished form) imported, including the date, quantity (or number of
				units or volume), and import permit or declaration number for each
				importation;
(c) The quantity (or
				number of units or volume in finished form) distributed to other persons,
				including the date and quantity (or number of units or volume) of each
				distribution and the name, address, and registration number of each person to
				whom a distribution was made; and
(d) The quantity disposed of in any other
				manner by the registrant, except quantities used for manufacturing by an
				importer under a registration as a manufacturer, which quantities are to be
				recorded pursuant to §
									802(a)(4) or
				(b)(5) including the date and manner of
				disposal and the quantities disposed.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 800 - Continuing Records › Section 61-4.800.806 - Records of Exporters

Current through Register Vol. 48, No. 6, June 28, 2024
Each registered exporter shall maintain records with the
				  following information for each controlled substance:
(a) The name of the substance;
(b) The quantity or number of units (or
				volume in finished form) received from other persons, including the date and
				quantity (or number of units or volume) of each receipt and the name, address,
				and registration number of each person from whom the substance was
				received;
(c) The quantity (or
				number of units or volume in finished form) exported, including the date,
				quantity or number of units or volume), and the export permit or declaration
				number for each exportation, but excluding all quantities (and numbers of units
				and volumes) manufactured by an exporter under a registration as a
				manufacturer, which quantities (and numbers of units and volumes) are to be
				recorded pursuant to §
									802(a)(8) or
				(b)(8); and
(d) The quantity disposed of in any other
				manner by the registrant including the date and manner of disposal and the
				quantity disposed.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 800 - Continuing Records › Section 61-4.800.807 - Records for Chemical Analysis

Current through Register Vol. 48, No. 6, June 28, 2024
(a) Each person registered to conduct
				chemical analysis with controlled substances shall maintain records, with the
				following information (to the extent known and reasonably ascertainable by him
				or her) for each controlled substance:
(1)
				The name of the substance;
(2) The
				form or forms in which the substance is received, imported, or manufactured by
				the registrant (e.g., powder, granulation, tablet, capsules, or solution) and
				the concentration of the substance in such form (e.g., C.P., U.S.P., N.F.,
				10-milligram concentration per milliliter);
(3) The total number of the forms received,
				imported, or manufactured (e.g., 100 tablets, thirty 1- milliliter vials, or 10
				grams of powder), including the date and quantity of each receipt, importation,
				or manufacture and the name, address, and registration number, if any, of the
				person from whom the substance was received;
(4) The quantity distributed, exported, or
				destroyed in any manner by the registrant (except quantities used in chemical
				analysis or other laboratory work), including the date and manner of
				distribution, exportation or destruction, and the name, address, and
				registration number, if any, of each person to whom the substance was
				distributed or exported.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 800 - Continuing Records › Section 61-4.800.808 - Reports

Current through Register Vol. 48, No. 6, June 28, 2024
Manufacturers, re-packers, re-labelers, importers, exporters,
				  and distributors who are required to report to ARCOS systems of the DEA, U.S.
				  Department of Justice, need not file copies of such reports with the Bureau of
				  Drug Control, but such registrants shall make copies of the reports available
				  to the Bureau of Drug Control upon its written or oral request. Substantial
				  compliance with the provisions of 21 CFR §§1304.31 through 1304.33
				  shall be deemed sufficient compliance with state reporting requirements.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 800 - Continuing Records › Section 61-4.800.809 - Records for Maintenance Treatment Programs and Detoxification Treatment Programs

Current through Register Vol. 48, No. 6, June 28, 2024
(a) Each
				person registered or authorized by DHEC to maintain and/or detoxify controlled
				substances users in a narcotic treatment program shall maintain records with
				the following information for each narcotic controlled substance:
(1) Name of substance;
(2) Strength of substance;
(3) Dosage form;
(4) Date dispensed;
(5) Adequate identification of the patient
				(consumer);
(6) Amount
				consumed;
(7) Amount and dosage
				form taken home by patient; and
(8)
				Dispenser's initials.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 800 - Continuing Records › Section 61-4.800.810 - Records for Treatment Programs Which Compound Narcotics for Treatment Programs and Other Locations

Current through Register Vol. 48, No. 6, June 28, 2024
Each person registered or authorized under the provisions of
				  Section 107 of this Regulation to compound narcotic drugs for off-site use in a
				  narcotic treatment program shall maintain records which include the following
				  information for each narcotic drug:
(a) For each narcotic controlled substance in
				bulk form to be used in, or capable of being used in, or being used in the
				compounding of the same or other non-controlled substances in finished form:
(1) The name of the substance;
(2) The quantity compounded in bulk form by
				the registrant, including the date, quantity and batch or other identifying
				number of each batch compounded;
(3) The quantity received from other persons,
				including the date and quantity of each receipt and the name, address, and
				registration number of the other person from whom the substance was
				received;
(4) The quantity imported
				directly by the registrant (under a registration as an importer) for use in
				compounding by him or her, including the date, quantity, and import permit or
				declaration number of each importation;
(5) The quantity used to compound the same
				substance in finished form, including:
(i) The
				date and batch or other identifying number of each compounding;
(ii) The quantity used in the
				compound;
(iii) The finished form
				(e.g., 10-milligram tablets; 10 mg/ml per fluidounce, etc.);
(iv) The number of units of finished form
				compounded;
(v) The quantity used
				in quality control;
(vi) The
				quantity lost through compounding and the causes therefore, if known;
(vii) The total quantity of the substance
				contained in the finished form;
(viii) The theoretical and actual
				yields;
(ix) Such other information
				as is necessary to account for all controlled substances used in the
				compounding process;
(6)
				The quantity used to manufacture other controlled and non-controlled
				substances, including the name of each substance manufactured and the
				information required in paragraph (a) (5) of this section;
(7) The quantity distributed in bulk form to
				other programs, including the date and quantity of each distribution, and the
				name, address, and registration number of each program to whom a distribution
				was made;
(8) The quantity exported
				directly by the registrant (under a registration as an exporter), including the
				date, quantity, and export permit or declaration number of each exportation;
				and
(9) The quantity disposed of by
				destruction, including the reason, date, and manner of destruction. All other
				destruction of narcotic controlled substances will comply with
				§1501.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 900 - Order Forms › Section 61-4.900.901 - Execution of Order Forms

Current through Register Vol. 48, No. 6, June 28, 2024
DEA Form 222 as issued by the DEA, U.S. Department of
				  Justice, as required by the Federal Controlled Substances Act (
				  21
				  USC 828 ) when properly executed and filed
				  will be deemed a sufficient order form as required by the
				  Act.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 900 - Order Forms › Section 61-4.900.902 - Handling and Filing

Current through Register Vol. 48, No. 6, June 28, 2024
Handling and filing of order forms, and electronic orders,
				  shall be accomplished in the manner provided under Part 1305, 21 C.F.R.
				  (Regulations of the DEA, United States Department of Justice.)
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 900 - Order Forms › Section 61-4.900.903 - Power of Attorney

Current through Register Vol. 48, No. 6, June 28, 2024
Any purchaser may authorize one or more individuals, whether
				  or not located at the registered location of the purchaser, to obtain and
				  execute order forms on his or her behalf by executing a power of attorney for
				  each such individual. The power of attorney shall be signed by the same person
				  who signed (or was authorized to sign) the most recent application for
				  registration or re-registration and by the individual being authorized to
				  obtain and execute order forms. The power of attorney shall be filed with the
				  executed order forms of the purchaser, and shall be retained for the same
				  period as any order form bearing the signature of the attorney. The power of
				  attorney shall be available for inspection together with other order form
				  records. Any power of attorney shall be available for inspection together with
				  other order form records. Any power of attorney may be revoked at any time by
				  executing a notice of revocation, signed by the person who signed (or was
				  authorized to sign) the power of attorney or by a successor, whoever signed the
				  most recent application for registration or re-registration, and filing it with
				  the power of attorney being revoked. The forms are available from Director of
				  the Bureau of Drug Control, DHEC, 2600 Bull Street, Columbia, SC 29201.
South Carolina Code of Regulations › Chapter 61 - DEPARTMENT OF HEALTH AND ENVIRONMENTAL CONTROL › Subchapter 61-4 - Controlled Substances › Part 1000 - Prescriptions › Section 61-4.1000.1001 - Persons Entitled to Issue Prescriptions

Current through Register Vol. 48, No. 6, June 28, 2024
(a) A prescription for a controlled substance
				may be issued only by an individual practitioner who is:
(1) Licensed by the S.C. Board of Medical
				Examiners, S.C. Board of Dentistry, S.C. Board of Veterinary Medicine
				Examiners, S.C. Board of Nursing, S.C. Board of Examiners in Optometry, or the
				S.C. Board of Podiatry Examiners, and is authorized to prescribe under the type
				of license issued by the pertinent Board to the individual practitioner;
				and
(2) Acting in the regular
				course of professional practice, e.g., a veterinarian prescribing for a human
				is not within the regular course of professional practice, nor is a dentist
				when prescribing for illnesses or disease other than those of the oral cavity
				and adjacent tissues, nor is a podiatrist when prescribing for treatment of
				disease other than those manifesting themselves in the foot; and
(3) Registered with DHEC under the provisions
				of the Act.