105 CMR, § 700.006

Current through Register 1535, November 22, 2024

Section 700.006 - Requirements for Records, Inventories, and Reports

(A)Records Required, Generally. Every person registered with the Commissioner shall keep records, maintain inventories, and make reports in conformance with the requirements of the Federal Comprehensive Drug Prevention and Control Act of 1970 and the Federal Food, Drug and Cosmetic Act, and 105 CMR 700.006.

(B)Time for Keeping Records. A registrant shall keep for at least two years from the date of preparation, every report, inventory and record they are required to keep by 105 CMR 700.000.

(C)Central Record Keeping. Any registrant may keep central records if they hold a valid permit to keep central records issued by the DEA and notifies the Commissioner thereof. The registrant must keep records in a manner that makes them easily available for inspection upon request of the Commissioner.

(D)Exemptions from Record Keeping. A registered practitioner who uses any controlled substance in research or teaching at a registered health care facility or health care entity which maintains records, is exempt from the requirement to keep their own records, if they have notified the DEA and the Commissioner of the name, address and registration number of the institution registered by the DEA, which maintains their records; and a registered chemical analyst employed by a analytical laboratory which maintains records, is exempt from the requirement to keep their own records if they have notified the Commissioner of the name, address and registration number of the analytical laboratory which maintains their records.

(E)Inventory Requirements. Every registrant shall take an initial inventory and biennial inventories thereafter.

(1) Every registrant required to take inventories under federal law and regulations shall follow those requirements, which are deemed to include Schedules I, II, III, IV, and V only.

(2) Every registrant shall take an initial inventory of all their controlled substances in Schedules II through V on the day they first engage in the manufacture, distribution, or dispensing of controlled substances.

(3) Every registrant shall take a new inventory of all stocks of controlled substances in Schedules II through V every two years following the date on which either the Federal or State initial inventory was taken, as applicable:

(a) On the day of the year on which the initial inventory was taken;

(b) On the registrant's regular physical inventory date, if any, which is nearest to and does not vary by more than six months from the biennial date and which would otherwise apply; or

(c) Any other fixed date which does not vary by more than six months from the biennial date which would otherwise apply.

(4) A registrant who elects to take their biennial inventory on their regular general physical inventory date or another fixed date, shall inform the Commissioner of this election and of the date on which they will take his biennial inventory upon request.

(5) Whenever the Commissioner by regulation adds to any schedule a controlled substance which was not immediately prior to that date listed in a schedule on which a registrant was required to keep records, a registrant who possesses that substance shall:

(a) Take, on the effective date of the regulation, an inventory of all stocks of that substance on hand and;

(b) Thereafter, include such substance in each inventory made by such registrant.

(F)Additional Records and Inventories Required of Practitioners. All practitioners and pharmacists shall maintain records and inventories in accordance with 105 CMR 700.000, for each location where they are registered to receive or store controlled substances. Such records must be kept regarding, all controlled substances in Schedules II through V which they dispense or administer in any manner, any exemptions for individual practitioners in Federal law and regulations notwithstanding. Such records must be accessible at the location reflected in the records.

(1) All practitioners shall include in their inventories of controlled substances that they dispense or administer in any manner, in Schedules II through V, the following information:

(a) For each controlled substance in finished form:

1. The name of the substance; and

2. The size of each finished form in metric weight or volume; and

3. The number of units or volume of each finished form.

(b) For each controlled substance not in finished form:

1. The name of the substance; and

2. The total quantity of the substance to the nearest metric unit of weight.

(2) Records maintained by practitioners and pharmacists shall be closed to the public, and shall not be used in the criminal prosecution of any person in connection with their treatment as a patient by such practitioner or pharmacist nor shall they be admissible in evidence against any such patient in connection with such treatment in any criminal, civil, legislative or administrative proceeding.

(3)Records for Schedules II through V. A practitioner and pharmacist shall maintain on a current basis, separately for each registration they possess, a complete and accurate record of each substance in Schedules II through V received, distributed, administered, dispensed, and otherwise disposed of as follows:

(a) The name of the substance and the form of the substance; and

(b) The size of each finished form in metric weight or volume; and

(c) The number of units or volume of each finished form received from other persons; the date received; and the name, address, and DEA registration number of the person from whom the substance was received; and

(d) The name, dosage and strength per dosage unit of each controlled substance administered or dispensed; the name and address of the person for whom the controlled substance was administered or dispensed and whether administered or dispensed by delivery or dispensed by prescription; the date of the administration or dispensing, and the written or typewritten name or initials of the person who administered or dispensed the substance; and

(e) The number of units or volume of such finished forms disposed of in any other way by the registrant, including the date and manner of disposal.

(4)Records for Schedule VI. A registered practitioner who dispenses, other than by prescribing and administering, Schedule VI sample medications shall maintain a record, which may be kept in the patient's medical record, of the following information:

(a) the name, dosage and strength of the substance dispensed;

(b) the volume of units dispensed;

(c) the date of the dispensing; and

(d) the name and address of the person to whom the medication was dispensed.

(G)Additional Reporting Required by Manufacturers. Each registered manufacturer must make available to the Commissioner upon request the reports accounting for all controlled substances appearing in Schedules I, II, and III required by federal law and regulations.

(H)Disposition upon Discontinuance of Business or Professional Practice.

(1) Any registrant who desires to cease legal existence or discontinues business or professional practice or moves their principal place of business or professional practice from the Commonwealth shall notify the Commissioner in writing at least 30 days before such event.

(2) Any registrant whose registration terminates pursuant to 105 CMR 700.004(J), or is voided pursuant to 105 CMR 700.120, shall inform the Commissioner how the registrant proposes to dispose of all the controlled substances in the registrant's possession associated with the discontinued professional practice.

(a) For registrations terminating pursuant to 105 CMR 700.004(I), such disposition plan must accompany the notice required under 105 CMR 700.006(H)(1).

(b) For registrations suspended, voided or revoked pursuant to 105 CMR 700.110, 105 CMR 700.115, or 105 CMR 700.120, such disposition plan must be filed with the Department within ten days of the mailing of the Department's notice regarding voiding or revocation of the registration. If the Commissioner does not notify the registrant by the date the registrant has proposed to dispose of such substances that they should postpone or cancel such disposal, they may proceed as they proposed to the Commissioner.

(c) Any registrant whose registration has expired, the executor of the estate of any deceased person in possession of controlled substances, any registrant in possession of controlled substances which are safeguarded for or intended to be dispensed to any patient who has died, or been transferred from the jurisdiction of the registrant without such controlled substances being transferred, and any other person in possession of controlled substances for which they are not registered shall dispose of all controlled substances in their possession through one or more of the following methods:

1. Under the authorization and instructions of the Regional Director of the DEA by transfer to a person registered to possess the controlled substances; or

2. By delivery to an agent of the DEA; or

3. By delivery to an expressly authorized agent of the Commissioner; or

4. By destruction of the substances in the presence of an agent of the DEA; or

5. By destruction of the substances in the presence of an expressly authorized agent of the Commissioner; or

6. By transfer of the substance to a registered reverse distributer; or

7. By such other means as said Regional Director may determine; and

(3) Persons transferring controlled substances pursuant to 105 CMR 700.006(H)(2)(c) may make such transfers without being registered to do so; and upon the completion of such disposition, shall file with the Commissioner on a form approved or provided by him a final report of such disposition.

(I)Filing of Prescriptions by Pharmacies in Registered Health Facilities. Every pharmacy located in a health facility registered with the Commissioner shall file prescriptions for controlled substances as follows:

(1) Prescriptions for controlled substances listed in Schedules I and II shall be filed separately from all other prescriptions of the pharmacy in a file identified for controlled substances listed in Schedules I and II only;

(2) Prescriptions for controlled substances listed in Schedules III, IV, and V shall be filed separately from all other prescriptions of the pharmacy in a file identified for controlled substances listed in Schedule III, IV and V only; and

(3) Prescriptions for controlled substances listed in Schedule VI and prescriptions for non-controlled substances shall be filed separately from all other prescriptions of the pharmacy in a file identified for controlled substances listed in Schedule VI and non-controlled substances.