PURPOSE: These rules provide effective con-

0684-0102 trols on the manufacture, distribution, prescribing, dispensing and administration of 0032-1026 narcotics and dangerous drugs in an effort to prevent them from being diverted from their 0032-1023 intended uses to illicit markets, abuse and misuse. 0525-0175 PUBLISHER’S NOTE: The publication of the full text of the material that the adopting 0046-0879 agency has incorporated by reference in this rule would be unduly cumbersome or expen- 0046-0878 sive. Therefore, the full text of that material will be made available to any interested person at both the Office of the Secretary of State and the office of the adopting agency, pursuant to section 536.031.4, RSMo. Such material will be provided at the cost established by state law.

1. (1) Registration and Reregistration.

55553-257

1. (A) Fee Amounts. For each registration or reregistration to—

0536-9470

1. 1. Manufacture controlled substances,

the registrant shall pay an annual fee of two

0814-7737 hundred dollars ($200);

1. 2. Distribute controlled substances, the

registrant shall pay an annual fee of one hun-

54274-530 dred dollars ($100);

1. 3. Dispense controlled substances listed

in Schedules II—V or to conduct research or instructional activities with those substances,

0364-6611 the registrant shall pay an annual fee of thirty dollars ($30);

1. 4. Conduct research or instructional

0402-0257 activities with a controlled substance listed in Schedule I, the registrant shall pay an annual fee of thirty dollars ($30);

1. 5. Conduct chemical analysis with con-

trolled substances listed in any schedule, the registrant shall pay an annual fee of thirty dollars ($30); and

1. 6. Import or export controlled sub-

stances listed in any schedule, the registrant shall pay an annual fee of one hundred dollars ($100).

1. (B) Time and Method of Payment and Refunds. Registration and reregistration fees shall be paid at the time when the application for registration or reregistration is submitted for filing. Payment should be made in the form of a personal, certified or cashier’s check or money order made payable to Department of Health. This is a nonrefundable processing fee. Payments made in the form of stamps, foreign currency or third-party endorsed checks will not be accepted.

2. (C) Persons Exempt From Fee. The Department of Health shall exempt the following persons from payment of a fee for registration or reregistration:

   1. 1. Any official or agency of the United

States Army, Navy, Marine Corps, Air Force, Coast Guard, Veterans Administration or Public Health Service who is authorized to procure or purchase controlled substances for official use;

1. 2. Any official, employee or other civil

officer or agency of the United States or state or any political subdivision or agency who is authorized to purchase controlled substances, to obtain these substances from official stocks, to dispense or administer these substances, to conduct research, instructional activities or chemical analysis with these substances, or any combination of them, in the course of his/her official duties or employment;

1. 3. In order to claim exemption from

payment of a registration or reregistration fee, the registrant shall apply for exemption by completing appropriate sections of the application; and

1. 4. Exemption from payment of a regis-

tration or reregistration fee does not relieve the registrant of any other requirements or duties prescribed by law.

1. (D) Period of Registration.

   1. 1. At the time any person is first regis-

tered, s/he shall be assigned to one (1) of twelve (12) groups which shall correspond to the months of the year. The expiration date of the registrations of all persons within any group, will be the last day of the month designated for that group. In assigning any person to a group, the Department of Health may select a group, the expiration date of which is more than one (1) year from the date the person was registered.

1. 2. The preceding initial fee schedule

does not apply to manufacturers or distributors. These registrants will be registered on an annual basis only.

1. (E) Time for Application for Registration.

   1. 1. Any person who is required to be reg-

istered and who is not so registered may apply for registration at any time. No person required to be registered shall engage in any activity for which registration is required until the application for registration is granted and certificate of registration is issued by the Department of Health to that person.

1. 2. Application forms may be requested

from—Missouri Department of Health, 1738 East Elm, Jefferson City, MO 65101.

1. 3. Forms for renewal of registration will

be sent to each registrant sixty (60) days prior to the expiration of the current registration.

1. (F) Separate Registration for Independent Activities. The following eight (8) groups of activities are deemed to be independent of each other and require separate registration:

   1. 1. Manufacturing controlled substances;
   2. 2. Distributing controlled substances;
   3. 3. Dispensing narcotic and nonnarcotic

and conducting research with nonnarcotic and conducting instructional activities with narcotic and nonnarcotic controlled substances listed in Schedules II—V;

1. 4. Conducting research with narcotic

controlled substances listed in Schedules II— V;

1. 5. Conducting research and instruction-

al activities with controlled substances listed in Schedule I;

1. 6. Conducting chemical analysis with

controlled substances listed in any schedule;

1. 7. Importing controlled substances; and
2. 8. Exporting controlled substances listed

in Schedules I—IV.

1. (G) Separate Registration for Separate Location. A separate registration is required for each principal place of business or professional practice at one (1) general physical location where controlled substances are manufactured, distributed or dispensed by a person.

   1. 1. The following locations shall be

deemed not to be places where controlled substances are manufactured, distributed or dispensed:

1. A. A warehouse where controlled

substances are stored by or on behalf of a registered person, unless these substances are distributed directly from the warehouse to registrants other than the registered person or to persons not required to register;

1. B. An office used by agents of a reg-

istrant where sales of controlled substances are solicited, made or supervised but which neither contains these substances (other than substances for display purposes or lawful distribution as samples only) nor serves as a distribution point for filling sales orders; and

1. C. An office used by a practitioner

(who is registered at another location) where controlled substances are prescribed but neither administered nor otherwise dispensed as a regular part of the professional practice of the practitioner at the office and where no supplies of controlled substances are maintained.

1. 2. A separate registration is not required

for each separate practice location for an individual practitioner who holds a Missouri professional practice license; is registered with the federal Drug Enforcement Administration (DEA); anticipates practicing in Missouri within the next twelve (12) months for no more than fourteen (14) days at more than one (1) location on a temporary basis and provides a statement outlining the location(s) and date(s) of that practice activity at the time of application; maintains a record of the date(s) and location(s) of all practice activity in Missouri and makes the record available to the Bureau of Narcotics and Dangerous Drugs; and prescribes but does not dispense or stock controlled substances at any Missouri practice location.

1. 3. A controlled substance registration

shall be issued for a Missouri practice location only.

1. (H) Application Information. All applicants shall make full, true and complete answers on the application. The Department of Health may require an applicant to submit documents or written statements of fact relevant to the application as considered necessary to determine whether the application should be granted. The failure of the applicant to provide these documents or statements within a reasonable time after being requested to do so shall be considered to be a waiver by the applicant of an opportunity to present these documents or facts for consideration in granting or denying the application.
2. (I) Modification in Registration. Any registrant may apply to modify his/her registration to authorize the handling of additional controlled substances by filing an application in the same manner as an application for new registration. No fee shall be required to be paid for the modification. The application for modification shall be handled in the same manner as an application for registration.
3. (J) Termination of Registration. The registration of any person shall terminate if and when the person dies, ceases legal existence, discontinues business or professional practice or changes his/her name or address as shown 19 CSR 30-1

on the certificate of registration. Any registrant who ceases legal existence, discontinues business or professional practice, or changes his/her name or address as shown on the certificate of registration promptly shall notify the Department of Health of this fact. In the event of a change of name or address, the person may apply for a new certificate of registration in advance of the effective date of the change by filing an application and paying the appropriate fee in the same manner as an application for new registration. The application shall be handled in the same manner as an application for registration.

1. (K) Transfer of Registration. No registration or any authority conferred by registration shall be assigned or otherwise transferred.

1. (2) Requirements for the Physical Security of Controlled Substances by Registrants.

   1. (A) Security Requirements Generally.

      1. 1. All applicants and registrants shall

provide effective controls and procedures to guard against theft and diversion of controlled substances. In order to determine whether a registrant has provided effective controls against diversion, the Department of Health shall use the security requirement set forth in this section as standards for the physical security controls and operating procedures necessary to prevent diversion. Substantial compliance with these standards may be deemed sufficient by the Department of Health after evaluation of the overall security system and needs of the applicant or registrant.

1. 2. Physical security controls shall be

commensurate with the schedules and quality of controlled substances in the possession of the registrant in normal business operations. If a controlled substance is transferred to a different schedule, or a noncontrolled substance is listed on any schedule, or the quantity of controlled substances in the possession of the registrant in normal business operations significantly increases, physical security controls shall be expanded and extended accordingly.

1. 3. All registrants who receive or trans-

fer substantial quantities of controlled substances in normal business operations shall employ security procedures to guard against in-transit losses.

1. (B) Security Controls for Nonpractitioners.

   1. 1. Before distributing a controlled sub-

stance to any person who the registrant does not know to be registered to possess the controlled substance, the registrant shall make a good faith inquiry either with the federal DEA or with the Department of Health to determine that the person is registered to possess the controlled substance.

1. 2. The registrant shall design and oper-

ate a system to disclose to the registrant suspicious orders of controlled substances. The registrant shall inform the Department of Health of suspicious orders when discovered by the registrant. Suspicious orders include orders of unusual size, orders deviating substantially from a normal pattern and orders of unusual frequency.

1. 3. The registrant shall notify the Depart-

ment of Health of any theft or significant loss of any controlled substances upon discovery of this theft or loss.

1. 4. The registrant shall not distribute any

controlled substance as a complimentary sample to any potential or current customer without the prior written request of the customer, to be used only for satisfying the legitimate medical needs of patients of the customer and only in reasonable quantities. The request must contain the name, address and registration number of the customer and the name of the specific controlled substance desired. The request shall be preserved by the registrant with other records of distribution of controlled substances. In addition, the requirements for order forms shall be complied with for any distribution of a controlled substance listed in Schedule I or II.

1. (C) Physical Security Controls for Practitioners.

   1. 1. Controlled substances listed in Sched-

ules I and II shall be stored in a securely locked, substantially constructed cabinet.

1. 2. Controlled substances listed in Sched-

ules III, IV and V shall be stored in a securely locked, substantially constructed cabinet. However, pharmacies may disperse these substances throughout the stock of noncontrolled substances in such a manner as to obstruct the theft or diversion of the controlled substances.

1. 3. Subsection (2)(C) of this rule also

shall apply to nonpractitioners authorized to conduct research or chemical analysis under another registration.

1. (D) Other Security Controls for Practitioners.

   1. 1. The registrant shall not employ as an

agent or employee who has access to controlled substances any person who has been found guilty or entered a plea of guilty or nolo contendere in a criminal prosecution under the laws of any state or of the United States for any offense related to controlled substances or who has had an application for a state or federal controlled substance registration denied or has had his/her registration revoked or surrendered for cause at any time. For purposes of this subsection, the term for cause means a surrender in place of or as a consequence of any federal or state administrative, civil or criminal action resulting from an investigation of the individual’s handling of controlled substances.

1. A. A registrant may apply in writing

to the Department of Health for a waiver of paragraph (2)(D)1. of this rule for a specific employee.

1. B. The Department of Health may

issue a written waiver to any registrant upon determination that a waiver would be consistent with the public health and safety. In making this determination, the Department of Health shall consider—the duties of the employee, the circumstances surrounding the conviction, the length of time since the conviction was entered, whether a waiver has been granted by the federal DEA to 21 CFR 1301.76, the security measures taken by the employer to prevent the theft and diversion of controlled substances, and any other factors consistent with public health and safety.

1. 2. The registrant shall notify the Depart-

ment of Health of the loss or theft of any controlled substances upon discovery of the loss or theft.

1. (3) Recordkeeping Requirements for Registrants.

   1. (A) Definitions. As used in this rule, the following terms shall have the meanings specified:

      1. 1. The term commercial container

means any bottle, jar, tube, ampule or other receptacle in which a substance is held for distribution or dispensing to an ultimate user and, in addition, any box or package in which the receptacle is held for distribution or dispensing to an ultimate user. The term commercial container does not include any package liner, package insert of other material kept with or within a commercial container, nor any carton, crate, drug or other package in which commercial containers are stored or are used for shipment of controlled substances;

1. 2. The term dispenser means an individ-

ual practitioner, institutional practitioner, pharmacy or pharmacist who dispenses a controlled substance;

1. 3. The term home infusion pharmacy

means a pharmacy which compounds solutions for direct administration to a patient in a private residence, long-term care facility or hospice setting by means of parenteral, intravenous, intramuscular, subcutaneous or intraspinal infusion;

1. 4. The term individual practitioner

means a physician, dentist, veterinarian or other individual licensed, registered or otherwise permitted by the United States or Missouri to dispense a controlled substance in the course of professional practice, but does not include a pharmacist, a pharmacy or an institutional practitioner;

1. 5. The term institutional practitioner

means a hospital or other person (other than an individual) licensed, registered or otherwise permitted by the United States or Missouri to dispense a controlled substance in the course of professional practice, but does not include a pharmacy;

1. 6. The term name means the official

name, common or usual name, chemical name or brand name of a substance;

1. 7. The term long-term care facility

means a nursing home, retirement care, mental care, or other facility or institution which provides extended health care to resident patients;

1. 8. The term pharmacist means any phar-

macist licensed in Missouri to dispense controlled substances and shall include any other person (for example, pharmacist intern) authorized to dispense controlled substances under the supervision of a pharmacist licensed in Missouri;

1. 9. The term prescription means an order

for medication which is dispensed to or for an ultimate user but does not include an order for medication which is dispensed for immediate administration to the ultimate user. (For example, an order to dispense a drug to a bed patient for immediate administration in a hospital is not a prescription.);

1. 10. The term readily retrievable means

that certain records are kept by automatic data processing systems or other electronic or mechanized recordkeeping systems in a manner that they can be separated out from all other records in a reasonable time, records are kept on which certain items are asterisked, redlined or in some other manner visually identifiable apart from other items appearing on the records or a combination of these methods; and

1. 11. Any term not defined in this section

shall have the definition set forth in Chapter 195, RSMo.

1. (B) Persons Required to Keep Records.

   1. 1. Each registrant shall maintain the

records and inventory required by section (3) of this rule except as exempted by section (3) of this rule.

1. 2. Registered individual practitioners

and institutional practitioners are required to keep records with respect to controlled substances listed in Schedule II which are prescribed and Schedules II—V controlled substances which are administered or dispensed.

1. 3. A registered person using any con-

trolled substance in research conducted in conformity with an exemption granted under Section 505(i) or 512(j) of the federal Food, Drug and Cosmetic Act (21 U.S.C. 355(i) or 360(j)) at a registered establishment which maintains records in accordance with either of those sections is not required to keep records if s/he notifies the Department of Health of the name, address and registration number of the establishment maintaining these records.

1. 4. A registered person using any con-

trolled substance in preclinical research or in teaching at a registered establishment which maintains records with respect to these substances is not required to keep records if s/he notifies the Department of Health of the name, address and registration number of the establishment maintaining the records.

1. 5. Notice required by paragraphs

(3)(B)4. and 5. of this rule shall be given at the time the person applies for registration or reregistration and shall be made in the form of an attachment to the application, which shall be filed with the application.

1. (C) Maintenance of Records and Inventories. Every inventory and other record required to be kept under section (3) of this rule, shall be kept by the registrant and be available, for at least two (2) years from the date of the inventory or record, for inspecting and copying by authorized employees of the Department of Health, except that financial and shipping records (such as invoices and packing slips, but not executed order forms) may be kept at a central location rather than at the registered location if the registrant obtains from the Department of Health approval of his/her central recordkeeping system and permit to keep central records. The permit to keep central records shall be subject to the following conditions:

   1. 1. The permit shall specify the nature of

the records to be kept centrally and the exact location where the records will be kept;

1. 2. The registrant agrees to deliver all or

any part of these records to the registered location within forty-eight (48) hours of receipt of a written request from the Department of Health for these records and if the Department of Health chooses to do so in lieu of requiring delivery of records to the registered location, to allow authorized employees of the Department of Health to inspect the records at the central location upon request by the employees without a warrant of any kind; and

1. 3. The failure of the registrant to per-

form his/her agreements under the permit shall revoke, without further action, the permit and all other such permits held by the registrant under other registrations. In the event of a revocation of other permits under paragraph (3)(C)3. of this rule, the registrant, within thirty (30) days after the revocation, shall comply with the requirement that all records be kept at the registered location.

1. (D) Each registered manufacturer, distributor, importer and exporter shall maintain inventories and records of controlled substances as follows:

   1. 1. 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

1. 2. 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.

1. (E) Each registered individual practitioner required to keep records and institutional practitioner shall maintain inventories and records of controlled substances in the manner prescribed in subsection (3)(D) of this rule.

2. (F) Each registered pharmacy shall maintain the inventories and records of controlled substances as follows:

   1. 1. Inventories and records of all con-

trolled substances listed in Schedules I and II shall be maintained separately from all other records of the pharmacy and prescriptions for these substances shall be maintained in a separate prescription file; and

1. 2. 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 those substances shall be maintained either in separate prescription files 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 will be deemed 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 one inch (1") 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.

1. (G) General Requirements for Inventories.

   1. 1. Each inventory shall contain a com-

plete and accurate record of all controlled substances on hand on the date the inventory was 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 19 CSR 30-1

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.

1. 2. A separate inventory shall be made by

a registrant 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 s/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.

1. 3. A separate inventory shall be made by

a registrant for each independent activity for which s/he is registered.

1. 4. A registrant may take an inventory on

a date that is within four (4) days of his/her biennial inventory date if, in advance, s/he notifies the Department of Health of the date on which s/he will take the inventory. 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.

1. 5. An inventory must be maintained in a

written, typewritten or printed form. An inventory taken by use of an oral recording device must be transcribed promptly.

1. (H) Initial Inventory Date.

   1. 1. Every person required to keep

records who is registered with the Department of Health after May 1, 1971 and who was not registered previously shall take an inventory of all stocks of controlled substances on hand on the date s/he first engages in the manufacture, distribution or dispensing of controlled substances.

1. 2. Compliance with federal initial inven-

tory date requirements is deemed satisfactory. Duplicate inventories are not required.

1. (I) Biennial Inventory Date. Every two (2) years following the date on which the initial inventory is taken by a registrant, the registrant shall take a new inventory of all stocks of controlled substances on hand. The biennial inventory may be taken on the date of the year on which the initial inventory was taken, on the registrant’s regular general physical inventory date, if any, which is nearest to and does not vary by more than six (6) months from the biennial date that would otherwise apply or any other fixed date which does not vary by more than six (6) months from the biennial date that would otherwise apply. If the registrant elects to take the biennial inventory on his/her regular general physical inventory date or another fixed date, s/he shall notify the Department of Health of this election and of the date on which the biennial inventory will be taken.
2. (J) Inventory Date for Newly Controlled Substances. On the effective date of a rule by the Department of Health adding a substance to any schedule of controlled substances, which substance was not listed immediately prior to that date in any such schedule, every registrant required to keep records who is manufacturing, distributing or dispensing that substance shall take inventory of all stocks of the substance on hand. After that, this substance shall be included in each inventory made by the registrant.

3. (K) Inventories of Manufacturers. Each registered manufacturer shall include the following information in his/her inventory:

   1. 1. 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, the name of the substance and 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);

1. 2. For each controlled substance in the

process of manufacture on the inventory date the name of the substance, the quantity of the substance in each batch, stage of manufacture, or both, identified by the batch number or other appropriate identifying number and the physical form which the substance is to take upon completion of the manufacturing process (for example, granulations, tablets, capsules or solutions), identified by the batch number or other appropriate identifying number and if possible the finished form of the substance (for example, ten milligram (10 mg) tablet or ten milligram (10 mg) concentration per fluid ounce or milliliter) and the number or volume;

1. 3. For each controlled substance in fin-

ished form, the name of the substance; each finished form of the substance (for example, ten milligram (10 mg) tablet or ten milligram (10 mg) concentration per fluid ounce or milliliter); the number of units or volume of each finished form in each commercial container (for example, four (4) one hundred (100) tablet bottles or three milliliter (3 ml) vials); the number of commercial containers of each finished form (for example, four (4) one hundred (100) tablet bottles or six (6) three milliliter (3 ml) vials); and

1. 4. For each controlled substance not

included in paragraphs (3)(K)1.—3. of this rule (for example, damaged, defective or impure substances awaiting disposal, substances held for quality control purposes or substances maintained for extemporaneous compoundings), the name of the substance; the total quantity of the substance to the nearest metric unit weight or the total number of units of finished form; 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.

1. (L) Inventories of Distributors. Each registered distributor shall include in his/her inventory the same information required of manufacturers in paragraphs (3)(K)3. and 4. of this rule.

2. (M) Inventories of Dispensers and Researchers. Each person registered to dispense or conduct research with controlled substances and required to keep records shall include in his/her inventory the same information required of manufacturers in paragraphs (3)(K)3. and 4. 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:

   1. 1. If the substance is listed in Schedule

I or II, s/he shall make an exact count or measure of the contents; and

1. 2. If the substance is listed in Schedule

III, IV or V, s/he shall make an estimated count or measure of the contents, unless the container holds more than one thousand (1000) tablets or capsules in which case s/he must make an exact count of the contents.

1. (N) Inventories of Importers and Exporters. Each registered importer or exporter shall include in his/her inventory the same information required of manufacturers in paragraphs (3)(K)1., 3. and 4. of this rule. Each registered importer and exporter who also is registered as a manufacturer or as a distributor shall include in his/her inventory as an importer or exporter only those stocks of controlled substances that actually are separated from his/her stocks as a manufacturer or as a distributor (for example, in-transit or in storage for shipment).
2. (O) Inventories for Chemical Analysts. Each analytical laboratory registered to conduct chemical analysis with controlled substances shall include in its inventory the same information required of manufacturers in paragraphs (3)(K)1., 3. and 4. of this rule as to substances which have been manufactured, imported or received by the laboratory conducting the inventory. If less than one kilogram (1 kg) of any controlled substance (other than a hallucinogenic controlled substance listed in Schedule I) or less than twenty grams (20 g) of a hallucinogenic substance listed in Schedule I (other than lysergic acid diethylamide) or less than point five gram (0.5 g) of lysergic acid diethylamide, is on hand at the time of inventory, those substances need not be included in the inventory. Laboratories of the division may process up to one hundred fifty grams (150 g) of any hallucinogenic substance in Schedule I without regard to a need for an inventory of those substances.

3. (P) General Requirements for Continuing Records.

   1. 1. Every registrant required to keep

records 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/her, except that no registrant shall be required to maintain a perpetual inventory.

1. 2. Separate records shall be maintained

by a registrant for each registered location except as provided in subsection (3)(C) of this rule. In the event controlled substances are in the possession or under the control of a registrant at a location for which s/he 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.

1. 3. Separate records shall be maintained

by a registrant for each independent activity for which s/he is registered.

1. 4. In recording dates of receipt, impor-

tation, 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 documents of transfer (for example, invoices or packing slips).

1. (Q) Records of Manufacturers. Each registered manufacturer shall maintain records with the following information:

   1. 1. For each controlled substance in bulk

form to be used in or capable of use in or being used in the manufacture of the same or other controlled or noncontrolled substances in finished form—

1. A. The name of the substance;
2. B. The quantity manufactured in bulk

form by the registrant, including the date, quantity and batch or other identifying number of each batch manufactured;

1. C. 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;

1. D. The quantity imported directly by

the registrant (under a registration as an importer) for use in manufacture by him/her, including the date, quantity and import permit or declaration number for each importation;

1. E. The quantity used to manufacture

the same substance in finished form including the date and batch or other identifying number of each manufacture; the quantity used in the manufacture; the finished form (for example, ten milligram (10 mg) tablets or ten milligram (10 mg) concentration per fluid ounce or milliliter); the number of units of finished form manufactured; the quantity used in quality control; the quantity lost during manufacturing and the causes for the loss, if known; the total quantity of the substance contained in the finished form; the theoretical and actual yields and other information as is necessary to account for all controlled substances used in the manufacturing process;

1. F. The quantity used to manufacture

other controlled and noncontrolled substances, including the name of each substance manufactured and the information required in subparagraph (3)(Q)1.E. of this rule;

1. G. 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;

1. H. The quantity exported directly by

the registrant, including the date, quantity and export permit or declaration number of each exportation; and

1. I. The quantity distributed or dis-

posed of in any other manner by the registrant (for example, 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; and

1. 2. For each controlled substance in fin-

ished form—

1. A. The name of the substance;
2. B. Each finished form (for example,

ten milligram (10 mg) tablet or ten milligram (10 mg) concentration per fluid ounce or milliliter) and the number of units or volume of finished form in each commercial container (for example, one hundred (100) tablet bottle or three milliliter (3 ml) vial);

1. C. The number of containers of each

such commercial finished form manufactured from bulk form by the registrant, including the information required in subparagraph (3)(Q)1.E. of this rule;

1. D. The number of units of finished

forms, commercial containers, or both, received from other persons, including the date of and number of units, commercial containers, or both, in each receipt and the name, address and registration number of the person from whom the units were received;

1. E. The number of units of finished

form, commercial containers, or both, imported directly by the registrant, including the date of and the number of units, commercial containers, or both, in each importation;

1. F. The number of units, commercial

containers, or both, manufactured by the registrant from units in finished form received from others or imported including: the date and batch or other identifying number of each manufacture; the operation performed (for example, repackaging or relabeling); the number of units of finished form used in the manufacture, the number manufactured and the number lost during the manufacture, with the causes for these losses, if known, and other information as is necessary to account for all controlled substances used in the manufacturing process;

1. G. The number of commercial con-

tainers 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;

1. H. The number of commercial con-

tainers exported directly by the registrant, including the date, number of containers and export permit or declaration number for each exportation; and

1. I. The number of units of finished

forms, commercial containers, or both, 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 in finished form distributed or disposed.

1. (R) Records for Distributors. Each registered distributor shall maintain records with the following information for each controlled substance:

   1. 1. The name of the substance;
   2. 2. Each finished form (for example, ten

milligram (10 mg) tablet or ten milligram (10 mg) concentration per fluid ounce or milliliter) and the number of units or volume of finished form in each commercial container (for example, one hundred (100) tablet bottle or three milliliter (3 ml) vial);

1. 3. The number of commercial contain-

ers 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; 19 CSR 30-1

1. 4. The number of commercial contain-

ers of each finished form imported directly by the registrant including the date of and the number of containers in each importation;

1. 5. The number of commercial contain-

ers 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;

1. 6. The number of commercial contain-

ers of the finished form exported directly by the registrant, including the date of and the number of containers in each exportation; and

1. 7. The number of units or volume of fin-

ished forms, commercial containers, or both, 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.

1. (S) Records for Practitioners and Researchers.

   1. 1. Each individual practitioner, institu-

tional practitioner and pharmacy shall maintain records with the following information for each controlled substance received, maintained, dispensed or disposed:

1. A. The name of the substance;
2. B. Each finished form (for example,

ten milligram (10 mg) tablet or ten milligram (10 mg) concentration per fluid ounce or milliliter) and the number of units or volume of finished form in each commercial container (for example, one hundred (100) tablet bottle or three milliliter (3 ml) vial);

1. C. The number of commercial con-

tainers of each 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;

1. D. The number of units or volume of

the 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; and

1. E. The number of units or volume of

the finished forms, commercial containers, or both, 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.

1. 2. Each individual practitioner shall

maintain a record of the date, full name and address of the patient, the drug name, strength, dosage form and quantity for all Schedule II controlled substances prescribed and for all Schedule II—V controlled substances administered. This record may be maintained in the patient’s medical record.

1. 3. Individual practitioners shall maintain

the records listed in subparagraphs (3)(S)1.A.—E. of this rule separately from patient medical records.

1. 4. A registrant who transfers a con-

trolled substance to or receives a controlled substance from another registrant shall maintain a written record of the transfer which contains the following information: the date of transfer, drug name, strength, dosage form, quantity, name, address and registration number of the transferring registrant and the name, address and registration number of the receiving registrant.

1. 5. DEA Official Order Forms shall be

used for transfers of Schedule II controlled substances.

1. 6. A prescription may not be issued for

an individual practitioner to obtain controlled substances for dispensing or administering to patients.

1. 7. Prescriptions which are transmitted

by facsimile to a pharmacy for dispensing shall include the telephone number of the facsimile machine or computer from which it is sent and the date and time of transmission. Immediately after a Schedule III, IV or V prescription or a Schedule II prescription for a long-term care facility patient or home hospice patient is transmitted to a pharmacy by facsimile equipment, the practitioner or the practitioner’s agent shall sign and date the face of the prescription. The prescriptions shall be maintained in chronological order separately from patient files in a manner so each prescription is readily retrievable for inspection at the transmitting practitioner’s office.

1. 8. Any pharmacy receiving a controlled

substance prescription transmitted by facsimile equipment shall maintain the facsimile copy of the prescription along with the date and time of transmission and the number of the facsimile machine from which it originated, as a part of its original prescription records.

1. 9. Any practitioner who transmits a con-

trolled substance prescription by electronic computer transmission shall maintain a printout of each day’s transmissions. The practitioner shall verify that the information in the printout is correct and shall sign the printout.

1. 10. Each pharmacist who dispenses con-

trolled substances under a prescription sent by electronic computer transmission shall verify with each practitioner on a regular basis that the prescription was authorized by the practitioner. If verification is made by telephone, the pharmacist shall document the verification on the reverse of the prescription or in the computer. If verification is made by sending the practitioner a copy of a computer printout, the practitioner shall verify, sign and return the printout to the pharmacy. The pharmaccy shall maintain the verified printout in a separate file.

1. (T) Records for Importers. Each registered importer shall maintain records with the following information for each controlled substance:

   1. 1. The name of the substance;
   2. 2. 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;

1. 3. The quantity (or number of units or

volume in finished form) distributed to other persons, including the date, 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

1. 4. The quantity disposed of in any other

manner by the registrant except quantities used in manufacturing by an importer under a registration as a manufacture, which quantities are to be recorded, including the date and manner of disposal and the quantity disposed.

1. (U) Records of Exporters. Each registered exporter shall maintain records with the following information for each controlled substance:

   1. 1. The name of the substance;
   2. 2. 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;

1. 3. 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 manufacture, which quantities (and numbers of units and volumes) are to be recorded; and

1. 4. The quantity disposed of in any other

manner by the registrant including the date and manner of disposal and the quantity disposed.

1. (V) Records for Chemical Analysts.

   1. 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 by him/her) for each controlled substance:

1. A. The name of the substance;
2. B. The form(s) 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 (for example, Chemically Pure (CP), United States Pharmacopeia (USP), National Formulary (NF), ten milligram (10 mg) tablet or ten milligram (10 mg) concentration per milliliter);

1. C. The total number of the forms

received, imported or manufactured (for example one hundred (100) tablets, thirty (30) one milliliter (1 ml) vials or ten grams (10 g) 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

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 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.

1. 2. Order forms, import and export per-

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

1. 3. Records of controlled substances used

in chemical analysis or other laboratory work are not required.

1. 4. Records relating to known or suspect-

ed controlled substances received as samples for analysis are not required under paragraph (3)(V)1. of this rule.

1. (W) Records for Long-Term Care Facility (LTCF) Emergency Kits. LTCFs and their suppliers shall maintain written records of transfers of controlled substances from the supplier to the LTCF emergency kit.

   1. 1. The records shall include the date of

transfer; the name of each controlled substance, the strength, dosage form and quantity; the name, address and controlled substance registration number of the supplier and the name, address and controlled substance registration number of the LTCF. Federal DEA Official Order Forms shall not be used to record transfers of controlled substances to LTCF emergency kits.

1. 2. No physician’s order or prescription

shall be used for initial stocking or replacement of controlled substances in the emergency kit. Controlled substances contained in the kit shall be obtained from a pharmacy, hospital or practitioner who holds a controlled substances registration.

1. 3. The administration and medical staff

of the LTCF, in conjunction with the primary supplier, shall designate in written protocols and procedures who may have access to the emergency kit, who may administer controlled substances from the emergency kit and under what circumstances and a list of the controlled substances it intends to maintain in the emergency kit. These protocols and procedures shall be subject to review and approval by the Department of Health.

1. 4. Each administration of controlled

substances from the emergency kit shall be based upon a practitioner’s order and shall be recorded in an administration record separate from the patient’s medical record. This administration record shall include: the date, patient’s name, drug name, drug strength, dosage, ordering practitioner’s name and name of the person administering the controlled substance.

1. 5. For the purpose of this subsection,

the term LTCF means a nursing care, residential care, retirement care, mental care or other facility or institution which provides extended health care to resident patients and is licensed under Chapter 197 or 198, RSMo or operated by a state agency.

AUTHORITY: section 195.195, RSMo 1994.* This rule was previously filed as 13 CSR 50- 131.010. Original rule filed Jan. 31, 1972, effective April 1, 1972. Amended: Filed April 12, 1983, effective July 11, 1983. Amended: Filed May 31, 1989, effective Oct. 1, 1989. Amended: Filed Nov. 26, 1991, effective April 9, 1992. Amended: Filed Aug. 26, 1992, effective April 8, 1993. Amended: Filed Nov. 1, 1994, effective June 30, 1995. *Original authority 1957, amended 1971, 1989, 1993.