NMBOP: 16.19.20 CONTROLLED SUBSTANCES Flashcards
Q: Who is required to register under the controlled substances regulations?
A: The following persons are required to register:
- A. Manufacture - term includes repackagers.
- B. Distributors - term includes wholesale drug distributors.
- C. Dispensers - pharmacies, hospital pharmacies, clinics (both health and veterinarian).
- D. Practitioners - includes a physician, doctor of oriental medicine, dentist, physician assistant, certified nurse practitioner, clinical nurse specialist, certified nurse-midwife, veterinarian, pharmacist, pharmacist clinician, certified registered nurse anesthetists, psychologists, chiropractic examiner, euthanasia technicians or other person licensed or certified to prescribe and administer drugs that are subject to the Controlled Substances Act. Practitioners, excluding veterinarians, must register with the New Mexico prescription monitoring program in conjunction with their controlled substance registration.
- E. Scientific investigators or researchers.
- F. Analytical laboratories and chemical analysis laboratories.
- G. Teaching institutes.
- H. Special projects and demonstrations which bear directly on misuse or abuse of controlled substances - may include public agencies, institutions of higher education and private organizations.
Q: What is the registration waiver for individual licensed practitioners?
A: The registration waiver applies to an individual licensed practitioner (e.g., intern, resident, staff physician, mid-level practitioner) who is an agent or employee of a hospital or clinic, licensed by the board. The practitioner may, when acting in the usual course of employment or business, order controlled substances for administration to the patients of the facility under the controlled substance registration of the hospital or clinic in which he or she is employed, provided that:
- The ordering of controlled substances for administration to the patients of the hospital or clinic is in the usual course of professional practice and the hospital or clinic authorizes the practitioner to order controlled substances for the administration to its patients under its state controlled substance registration.
- The hospital or clinic has verified with the practitioner’s licensing board that the practitioner is permitted to order controlled substances within the state.
- The practitioner acts only within their scope of employment in that hospital or clinic.
- The hospital or clinic maintains a current list of practitioners given such authorization and includes the practitioner’s full name, date of birth, professional classification and license number, and home and business addresses and phone numbers.
- The list is available at all times to board inspectors, the DEA, law enforcement and health professional licensing boards.
- The hospital or clinic shall submit a current list of authorized practitioners with each hospital or clinic controlled substance renewal application.
Q: When can a person who is required to be registered but is not currently registered apply for registration?
A: Any person who is required to be registered and who is not registered may apply for registration at any time.
Q: How were registrant renewal dates assigned in December 1982?
A: In December 1982, all registrant renewal dates were assigned to one of 12 groups which correspond to the months of the year. Thereafter, any person who first registers will also be assigned to one of the 12 groups.
Q: What is the expiration date for the registration of individuals or businesses within a group?
A: The expiration date of the registration of all individuals or businesses within any group will be the last day of the month designated for that group. The renewal date will be within 30 days of the date shown on the registration permit and will expire on that date if not renewed by the registrant.
Q: Are research applicants registered as a practitioner required to also register as a scientific investigator?
A: Research applicants registered as a practitioner shall not be required to register as a scientific investigator if they are registered as a practitioner. However, this does not exempt them from the regulations applicable to a scientific investigator.
Q: What is the fee for a duplicate license?
A: The fee for a duplicate license is $10.00.
Q: Is separate registration required for each principal place of business or professional practice?
A: Yes, separate registration is required for each principal place of business or professional practice with the address indicated on the application if drugs are dispensed or distributed from the different locations.
Note: This does not include warehouse storage areas, offices used by agents for soliciting which contain no controlled substances other than samples, or a physician’s office where controlled substances are prescribed but not administered or otherwise dispensed.
Q: Under what condition will the board register an applicant to manufacture or distribute controlled substances?
A: The board shall register an applicant to manufacture or distribute controlled substances unless it determines that the issuance of that registration would be inconsistent with the public interest.
Q: What factors does the board consider when determining if issuing a registration is consistent with the public interest?
A: The board may consider the following factors from information listed on the application:
1. Maintenance of effective controls against diversion of controlled substances.
2. Compliance with applicable state and local law.
3. Any convictions of the applicant under any federal or state laws relating to any controlled substance.
4. Past experience in the manufacture or distribution of controlled substances, and the existence in the applicant’s establishment of effective controls against diversion.
5. Furnishing by the applicant of false or fraudulent material in any application filed under the Controlled Substances Act.
6. Suspension or revocation of the applicant’s federal registration to manufacture, distribute, or dispense controlled substances as authorized by federal law.
7. Any other factors relevant to and consistent with the public health and safety.
Q: What information must each application include?
A: Each application shall include all information as required on the application form, including but not limited to a current DEA registration and professional license, and shall be signed by the applicant.
Q: What must a scientific investigator or research applicant include in the summary of procedures for a research project?
A: The summary of procedures submitted by a scientific investigator or research applicant must include:
- The nature, extent, and duration of the research.
- The names of individuals engaged in the project (excluding those exempt under the Controlled Substances Act).
- The name or names of the substances to be used in the research project.
- The adequacy of safeguards against diversion of the controlled substance(s) to be used.
- The source of supply of controlled substance(s) if applicable.
- Evidence of FDA and DEA approval and registration if registered by the federal agencies.
Q: What must analytical laboratory applicants submit to the board?
A: Analytical laboratory applicants shall submit an application on the form provided by the board. All applicable questions on the application shall be filled in and signed by the person in charge of the facility.
Q: What is the limit on quantities of controlled substances that analytical laboratories can possess?
A: Quantities of controlled substances in possession of analytical laboratories shall be limited to such quantities as required for reference standards, assays, or other scientific purposes.
Q: Who is exempt from registration under the Controlled Substances Act?
A: The following persons are exempt from registration:
- Any officer or employee of the state or federal customs agency, the state police, or any enforcement officer of any political subdivision of the state, who is engaged in the enforcement of any federal, state, and local law relating to controlled substances and is duly authorized to possess controlled substances in the course of his official duties.
- Any official exempted by this section may procure any controlled substance in the course of an inspection pursuant to Section 31 of the Controlled Substances Act or in the course of any criminal investigation involving the person from whom the substance was procured.
- Laboratory personnel, when acting in the scope of their official duties, are also exempt from registration under the Controlled Substances Act.
Q: How can a registrant modify their registration to authorize additional controlled substances?
A: Modification of a registration to authorize additional controlled substances may be made by filing an application in the same manner as an application for a new registration. No fee shall be required for such modification.
Q: When does a registration terminate?
A: Registration shall terminate if and when a registrant:
1. Dies.
2. Discontinues business or professional practice.
3. Has their professional license revoked or suspended.
4. No longer possesses a DEA registration or has had their DEA registration revoked or suspended.
5. Changes their name or address as shown on the registration.
In such instances, the registrant or their estate shall notify the board of pharmacy promptly and return the certificate of registration to the board within 30 days.
Q: How should inventories and records of controlled substances listed in schedules II, III, IV, and V be maintained?
A: Inventories and records of controlled substances listed in schedules II, III, IV, and V shall be maintained either separately from all other records or in such a form that the information required is readily retrievable from ordinary business records of the registrant.
Q: What must a person do if there is a change in name or address?
A: In the event of a change in name or address, the person shall file an application in the same manner as an application for modification of a registration. No fee shall be required for such modification.
Q: Can registration under the Controlled Substances Act be transferred?
A: No, registration under the Controlled Substances Act shall not be transferable.
Q: What inventory requirements must all registrants comply with?
A: All registrants shall comply with the following inventory requirements:
- Schedule I, II, III, IV, and V initial, annual, newly controlled substances, change in pharmacist in charge, and transfer of pharmacy ownership.
Q: When must a registrant conduct an initial inventory of controlled substances?
A: All registrants shall conduct an initial inventory of all controlled substances on hand on the date they first engage in controlled substances activity. If a registrant commences business with no controlled substances on hand, they shall record this fact on the initial inventory.
Q: What is the annual inventory date requirement for registrants?
A: The annual inventory date shall be May 1 or on the registrant’s regular general physical inventory date, provided that the registrant shall notify the board of pharmacy of the set alternate annual inventory date. The actual taking of the inventory should not vary more than four days before or after the annual inventory date (May 1 or set alternate date).
Q: What must registrants do when a substance is added to any schedule of controlled substances?
A: On the effective date that a substance is added to any schedule of controlled substances, which was, immediately prior to that date, not listed on any schedule, every registrant who possesses that substance shall take an inventory of all stock of the substance on hand and file this record with the other inventory records as required.
Q: What must be done upon the change of a pharmacist-in-charge?
A: Upon the change of a pharmacist-in-charge, an inventory of all controlled substances shall be taken within 72 hours by the new pharmacist-in-charge.
Q: What must be done upon the transfer of ownership of a pharmacy?
A: Upon transfer of ownership of a pharmacy, an inventory of all controlled substances shall be taken by the pharmacist-in-charge.
Q: What details must be included in the inventory?
A: The inventory shall include:
1. The date.
2. Time taken (i.e., opening or close of business).
3. Drug name.
4. The drug strength.
5. The drug form (e.g., tablet, capsule, etc.).
6. The number of units or volume.
7. The total quantity. A commercial container which has been opened shall be the exact count or measure of substances listed in schedule I or schedule II. If the substance is listed in schedule III, IV, or V, an estimated count or measure of the contents is acceptable unless the container holds more than 1,000 tablets or capsules, in which case the count must be exact.
8. Expired or unusable controlled substances shall be documented as such and inventoried.
9. The name, address, and DEA registration number of the registrant.
10. The signature of the person or persons responsible for taking the inventory.
Q: What information must manufacturers and repackagers include in their inventory records?
A: Manufacturers and repackagers inventory records shall contain the following information:
A. Finished form:
- Name of the substance.
- Each finished form of the substance (e.g., 10 milligram tablet).
- The number of units or volume of each finished form in each commercial container (e.g., 100 tablet bottle).
- The number of commercial containers of each such finished form.
B. Controlled substances not included above:
- Information on substances such as damaged, defective, or impure substances awaiting disposal, including the total quantity and the name of the substance.
- A statement of the reason for the substance being included in this category.
Q: What information must a research registrant include in their inventory?
A: A research registrant shall include in their inventory:
- The name of the substance.
- Each finished form of the substance.
- The number of units or volume of each finished form in each commercial container (e.g., 100 tablet bottle).
- The number of commercial containers of each such finished form.
Q: How should an opened commercial container be counted or measured for controlled substances in research?
A: A commercial container that has been opened shall be the exact count or measure of substances listed in schedule I or schedule II. For substances listed in schedule III, IV, or V, an estimated count or measure of the contents is acceptable unless the container holds more than 1,000 tablets or capsules, in which case the count must be exact.
Q: How should pharmacies, hospitals, clinics, and practitioners handle inventories and records of controlled substances listed in schedules II and II-N?
A: Pharmacies, hospitals, clinics, and practitioners who dispense controlled substances shall maintain inventories and records of controlled substances listed in schedules II and II-N separately from all other prescription records.
Q: What are “order forms” in the context of procurement records for controlled substances?
A: “Order forms” refer to DEA Form 222 or its electronic equivalent required for the distribution or procurement of a schedule I or II controlled substance under the federal act.
Q: What does “readily retrievable” mean in the context of controlled substances records?
A: “Readily retrievable” means records are kept in such a manner as to be easily separated from all other records in a reasonable time or are kept with certain items redlined, starred, or visually identifiable apart from other items appearing on the record.
Q: How should order forms for schedule I and II controlled substances be used as records?
A: Order forms for schedule I and II controlled substances shall be deemed proper records of receipt if the purchaser records on copy 3 of the order form the number of commercial or bulk containers furnished of each item and the date on which such containers are received by the purchaser.
Q: How should schedule I and II narcotic substance inventory records and procurement records be maintained?
A: All schedule I and II narcotic substance inventory records and procurement records will be kept separate from other records of the registrant.
Q: Where may procurement records, other than inventory records, be kept?
A: Procurement records, other than the inventory, may be kept at a central location, rather than at the registered location, if prior approval has been obtained under federal regulations. Such records must be delivered, upon request of the board, to the registered location within 48 hours of the request.
Q: What information must be included in a practitioner’s disposition records?
A: Practitioner’s disposition records shall include:
- Date of dispensing.
- Name of patient.
- Name and strength of the substance.
- Amount dispensed.
Q: How should prescriptions for schedule II controlled substances be maintained?
A: Prescriptions for schedule II controlled substances shall be maintained in a separate file.
Q: What requirements must pharmacies without computerized prescription information meet for prescriptions for schedules II, III, IV, and V?
A: In pharmacies without computerized prescription information, prescriptions for schedules II, III, IV, and V must have the name of the dispensing pharmacist and the date filled inscribed on the face of the prescription. (Typewritten, printed, or rubber stamp are acceptable.)
Q: How should prescriptions for schedules III, IV, and V be maintained?
A: Prescriptions for schedules III, IV, and V shall be maintained either in a separate file only or in such a form that they are readily retrievable from other records of the pharmacy. “Readily retrievable” means that at the time of filing, the face of the prescription is stamped in red ink in the lower right-hand corner with the letter “C” no less than one inch high, or the records comply with 16.19.6.22 NMAC “Computerized Prescription Information”.
