W. Va. Code R. § 15-2-7

Current through Register Vol. XLI, No. 25, June 21, 2024

Section 15-2-7 - Records And Reports Of Registrants

7.1. Records required to be kept shall be readily retrievable.

7.2. Maintenance of records and inventories.

7.2.1. Every inventory and other record required to be kept shall be kept by the registrant and be available, for at least five years from the date of the inventory or record, for inspecting and copying by authorized employees of the Board.

7.2.2. A registrant shall maintain inventories and records of controlled substances as follows:

7.2.2.a. Inventories and records of controlled substances listed in Schedules I and II shall be maintained separately from all of the records of the registrant; and

7.2.2.b. Inventories and records of controlled substances listed in Schedules III, IV and V shall be maintained either separately from all other records of the registrant or in a form that the information required is readily retrievable from the ordinary business records of the registrant.

7.2.3. Each registered individual practitioner and institutional practitioner required to keep records shall maintain inventories and records of controlled substances in the manner prescribed in subdivision 7.2.2. of this rule.

7.2.4. Each registered pharmacy shall maintain the inventories and records of controlled substances as follows:

7.2.4.a. Inventories and records of all controlled substances listed in Schedules I and II shall be maintained separately from all other records of the pharmacy, and prescriptions for the substances shall be maintained in a separate prescription file. Each pharmacy shall maintain a perpetual inventory of all Schedule II drugs received, dispensed, or otherwise distributed, with reconciliation at least monthly. Electronic monitoring at the pharmacy or by another entity that provides alerts for discrepancies between drugs received, drugs dispensed, or otherwise distributed is acceptable provided such alerts are reviewed at least monthly; and

7.2.4.b. Inventories and records of controlled substances listed in Schedules III, IV and V shall be maintained either separately from all other records of the pharmacy or in a form that the information required is readily retrievable from ordinary business records of the pharmacy, and prescriptions for the substances shall be maintained either in a separate prescription file for controlled substances listed in Schedules III, IV and V only, or in a form that they are readily retrievable from the other prescription records of the pharmacy. Prescriptions shall be considered readily retrievable if, at the time they are initially filed, the face of the prescription is stamped in red ink in the lower right corner with the letter "C" no less than 1 inch high and filed either in the prescription file for controlled substances listed in Schedules I and II or in the usual consecutively numbered prescription file for noncontrolled substances. However, if a pharmacy employs an automated data processing system or other electronic record-keeping system for prescriptions which utilizes identification by prescription number and retrieval of original documents by prescriber's name, patient's name, drug dispensed, and date filled, then the requirement to mark the hard copy prescription with a red "C" is waived.

7.3. General requirements for inventories.

7.3.1. Each inventory shall contain a complete and accurate record of all controlled substances on hand on the date the inventory is taken. Controlled substances are considered 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.

7.3.2. A registrant shall make a separate inventory for each registered location. In the event controlled substances are in the possession or under the control of the registrant at a location for which he or she 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.

7.3.3. A registrant shall make a separate inventory for each independent activity for which he or she is registered, except as provided in subsection 7.10. of this rule.

7.3.4. 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 the inventory is taken.

7.3.5. A registrant shall maintain an inventory in a written, typewritten or printed form. An inventory taken by use of an electronic or oral recording device shall be promptly transcribed.

7.4. Initial inventory date.

7.4.1. Every person required to keep records shall take an inventory of all stocks of controlled substances on hand on the date he or she first engages in the manufacture, distribution or dispensing of controlled substances, in accordance with subsections 7.4. through 7.7 of this rule, as applicable. In the event a person commences business with no controlled substances on hand, he or she shall record this fact as the initial inventory.

7.5. Biennial inventory date.

7.5.1. After the initial inventory is taken, the registrant shall take a new inventory of all stocks of controlled substances on hand at least every two years. The biennial inventory may be taken on any date which is within two years of the previous biennial inventory date.

7.6. Inventory date for new controlled substances.

7.6.1. On the effective date of a rule or statutory change by the Board or the DEA adding a substance to any schedule of controlled substances, when the substance was, immediately prior to that date, not listed on any such schedule, every registrant required to keep records who is manufacturing, distributing or dispensing that substance, shall take an inventory of all stocks of the substance on hand. Thereafter the substance shall be included in each inventory made by the registrant pursuant to subsection 7.5. of this rule.

7.7. Inventories of manufacturers.

7.7.1. Each registered manufacturer shall include the following information in the inventory:

7.7.1.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 noncontrolled substances in finished form:

7.7.1.a.1. The name of the substance; and

7.7.1.a.2. The total quantity of the substance to the nearest metric unit weight consistent with unit size.

7.7.1.b. For each controlled substance in the process of manufacture on the inventory date:

7.7.1.b.1. The name of the substance;

7.7.1.b.2. The quantity of the substance in each batch and/or stage of manufacture, identified by the batch number or other appropriate identifying number; and

7.7.1.b.3. The physical form which the substance is to take upon completion of the manufacturing process, identified by the batch number or other appropriate identifying number, and if possible the finished form of the substance and the number or volume of the substance.

7.7.1.c. For each controlled substance in finished form:

7.7.1.c.1. The name of the substance;

7.7.1.c.2. Each finished form of the substance;

7.7.1.c.3. The number of units or volume of each finished form in each commercial container; and

7.7.1.c.4. The total quantity of the substance in all forms to the nearest metric unit weight.

7.7.1.d. For each controlled substance not included in Subdivisions (a), (b) or (c) of this subsection:

7.7.1.d.1. The name of the substance;

7.7.1.d.2. The total quantity of the substance to the nearest metric unit weight or the total number of units of finished form; and

7.7.1.d.3. The reason for the substance being maintained by the registrant and whether the substance is capable of use in the manufacture of any controlled substance in finished form.

7.8. Inventories of distributors.

7.8.1. Each registered distributor shall include in the inventory the same information required of manufacturers pursuant to subdivision 7.7.1.c. and subdivision 7.7.1.d. of this rule.

7.9. Inventories of dispensers and researchers.

7.9.1. Each person registered to dispense or conduct research with controlled substances and required to keep records pursuant to section 7.4. of this rule, shall include in the inventory the same information required of manufacturers pursuant to subdivision 7.7.1.c. and subdivision 7.7.1.d. of this rule. 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:

7.9.1.a. If the substance is listed in Schedule I or II, the dispenser shall make an exact count or measure of the content; and

7.9.1.b. If the substance is listed in Schedule III, IV or V, the dispenser shall make an estimated count or measure of the contents, unless the container holds more than one thousand tablets or capsules in which case the dispenser shall make an exact count of the contents.

7.10. Inventories of importers and exporters.

7.10.1. Each registered importer or exporter shall include in the inventory the same information required of manufacturers pursuant to subdivision 7.7.1.c. and subdivision 7.7.1.d. of this rule. Each registered importer and exporter who is also registered as a manufacturer or as a distributor shall include in the inventory as an importer or exporter only those stocks of controlled substances that are actually separated from the stocks as a manufacturer or as a distributor.

7.11. Inventories for chemical analysts.

7.11.1. Each analytical laboratory registered to conduct chemical analysis with controlled substances shall include in its inventory the same information required of manufacturers pursuant to subdivision 7.7.1.c. and subdivision 7.7.1.d. of this rule, as to substances which have been manufactured, imported or received by the laboratory conducting the inventory. If less than one kilogram of any controlled substance, other than a hallucinogenic controlled substance listed in Schedule I, or less than twenty grams of a hallucinogenic substance listed in Schedule I, other than lysergic acid diethylamide, or less than five tenths gram of lysergic acid diethylamide, is on hand at the time of inventory, that substance need not be included in the inventory. Laboratories of the Board may possess up to one hundred fifty grams of any hallucinogenic substance in Schedule I without regard to a need for an inventory of those substances.

7.12. General requirements for continuing records.

7.12.1. Every registrant required to keep records pursuant to subsection 7.3. of this rule, shall maintain on a current basis a complete and accurate record of each substance manufactured, imported, received, sold, delivered, exported or otherwise disposed of by the registrant.

7.12.2. A registrant shall maintain separate records for each registered location. 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 registrant shall include the substances in the records of the registered location to which they are subject to control or to which the person possessing the substance is responsible.

7.12.3. A registrant shall maintain separate records for each independent activity for which he or she is registered.

7.12.4. In recording dates of receipt, importation, distribution, exportation or other transfer, the registrant shall use the date on which the controlled substances are actually received, imported, distributed, exported or otherwise transferred as the date of receipt or distribution of any documents of transfer.

7.13. Records of manufacturers.

7.13.1. Each registered manufacturer shall maintain records with the following information to account for all controlled substances used in the manufacturing process:

7.13.1.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 noncontrolled substances in finished form:

7.13.1.a.1. The name of the substance;

7.13.1.a.2. The quantity manufactured in bulk form by the registrant, including the date, quantity and batch or other identifying number of each batch manufactured;

7.13.1.a.3. The quantity received from other persons, including the date and quantity of each delivery and the name, address and registration number of the other person from whom the substance was received;

7.13.1.a.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;

7.13.1.a.5. The quantity used to manufacture the same substance in finished form, including:

7.13.1.a.5.A. The date and batch or other identifying number of each manufacture;

7.13.1.a.5.B. The quantity used in the manufacture;

7.13.1.a.5.C. The finished form;

7.13.1.a.5.D. The number of units of finished form manufactured;

7.13.1.a.5.E. The quantity used in quality control;

7.13.1.a.5.F. The quantity lost during manufacturing and the causes therefore, if known;

7.13.1.a.5.G. The total quantity of the substance contained in the finished form;

7.13.1.a.5.H. The theoretical and actual yields; and

7.13.1.a.5.I. Any other necessary information;

7.13.1.a.6. The quantity used to manufacture other controlled and noncontrolled substances, including the name of each substance manufactured and the information required in subdivision 7.13.1.a.5. of this rule;

7.13.1.a.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;

7.13.1.a.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

7.13.1.a.9. The quantity distributed or disposed of in any other manner by the registrant, for example, 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.

7.13.1.b. For each controlled substance in finished form:

7.13.1.b.1. The name of the substance;

7.13.1.b.2. Each finished form and the number of units or volume of finished form in each commercial container;

7.13.1.b.3. The number of containers of each commercial finished form manufactured from bulk form by the registrant, including the information required pursuant to subdivision 7.13.1.a.5. of this rule;

7.13.1.b.4. The number of units of finished forms and/or commercial containers received from other persons, including the date of and number of units and/or commercial containers in each delivery and the name, address and registration number of the person from whom the units were received;

7.13.1.b.5. The number of units of finished forms and/or commercial containers imported directly by the registrant under a registration as an importer, including the date of and the number of units and for commercial containers in each importation;

7.13.1.b.6. The number of units and/or commercial containers manufactured by the registrant from units in finished form received from others or imported, including:

7.13.1.b.6.A. The date and batch or other identifying number of each manufacture;

7.13.1.b.6.B. The operation performed;

7.13.1.b.6.C. The number of units of finished form used in the manufacture, the number manufactured and the number lost during manufacture, with the causes therefore, if known; and

7.13.1.b.6.D. Any other information necessary to account for all controlled substances used in the manufacturing process;

7.13.1.b.7. The number of commercial containers 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;

7.13.1.b.8. The number of commercial containers exported directly by the registrant under a registration as an exporter, including the date, number of containers and export permit or declaration number for each exportation; and

7.13.1.b.9. The number of units of finished forms and/or commercial containers distributed or disposed of in any other manner by the registrant, including the date and manner of distribution or disposal, the name, address and registration number of the person to whom distributed and the quantity in finished form distributed or disposed.

7.14. Records for distributors.

7.14.1. Each registered distributor shall maintain records with the following information for each controlled substance:

7.14.1.a. The name of the substance;

7.14.1.b. Each finished form, for example, ten milligram tablet or ten milligram concentration per fluid ounce or milliliter and the number of units or volume of finished form in each commercial container, for example, one hundred tablet bottle or three milliliter vial;

7.14.1.c. The number of commercial containers of each finished form received from other persons, including the date of and number of containers in each delivery and the name, address and registration number of the person from whom the containers were received;

7.14.1.d. The number of commercial containers of each 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;

7.14.1.e. The number of commercial containers of each 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;

7.14.1.f. The number of commercial containers of each finished form exported directly by the registrant under a registration as an exporter, including the date of and the number of containers in each exportation; and

7.14.1.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, for example, by distribution as complimentary samples, including the date and manner of distribution or disposal, the name, address and registration number of the person to whom distributed and the quantity of the substance in finished form distributed or disposed.

7.15. Records for dispensers and researchers.

7.15.1. Each person registered to dispense or conduct research with controlled substances and required to keep records pursuant to section 7.3. of this rule, shall maintain records with the following information for each controlled substance:

7.15.1.a. The name of the substance;

7.15.1.b. Each finished form, for example, ten milligram tablet or ten milligram concentration per fluid ounce or milliliter and the number of units or volume of finished form in each commercial container, for example, one hundred bottle or three milliliter vial;

7.15.1.c. The number of commercial containers of each finished form received from other persons, including the date of and number of containers in each delivery and the name, address and registration number of the person from whom the containers were received;

7.15.1.d. The number of units or volume of each 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 individual who dispensed or administered the substance on behalf of the dispenser; and

7.15.1.e. The number of units or volume of each finished form and/or commercial container 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.

7.16. Records for importers.

7.16.1. Each registered importer shall maintain records with the following information for each controlled substance:

7.16.1.a. The name of the substance;

7.16.1.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;

7.1.6.1.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;

7.16.1.d. The quantity disposed of in any other manner by the registrant except quantities used in manufacturing by an importer under a registration as a manufacturer, which is to be recorded pursuant to subdivision 7.13.1.a.4. or subdivision 7.13.1.b.5. of this rule, including the date and manner of disposal and the quantity disposed.

7.17. Records for chemical analysis.

7.17.1. Each person registered to conduct chemical analysis with controlled substances shall maintain records with the following information, to the extent known and reasonably ascertainable, for each controlled substance:

7.17.1.a. The name of the substance;

7.17.1.b. The form or forms in which the substance is received, imported or manufactured by the registrant, for example, powder, granulation, tablet, capsule or solution and the concentration of the substance in that form, such as C.P., U.S.P., N.F., ten milligram tablet or ten milligram concentration per milliliter;

7.17.1.c. The total number of the forms received, imported or manufactured, for example, one hundred tablets, thirty one milliliter vial, or ten 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; and

7.17.1.d. 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, the 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.

7.17.2. Order forms, import and export permits, import invoices and export declarations relating to controlled substances shall be maintained separately from all other records of the registrant.

7.17.3. Records of controlled substances used in chemical analysis are not required.

7.17.4. Records relating to known or suspected controlled substances received as samples for analysis are not required under this section.

W. Va. Code R. § 15-2-7