NMBOP: 16.19.20 CONTROLLED SUBSTANCES Flashcards
(101 cards)
1
Q
Q: Who is required to register under the controlled substances regulations?
A
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.
2
Q
Q: What is the registration waiver for individual licensed practitioners?
A
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.
3
Q
Q: When can a person who is required to be registered but is not currently registered apply for registration?
A
A: Any person who is required to be registered and who is not registered may apply for registration at any time.
4
Q
Q: How were registrant renewal dates assigned in December 1982?
A
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.
5
Q
Q: What is the expiration date for the registration of individuals or businesses within a group?
A
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.
6
Q
Q: Are research applicants registered as a practitioner required to also register as a scientific investigator?
A
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.
7
Q
Q: What is the fee for a duplicate license?
A
A: The fee for a duplicate license is $10.00.
8
Q
Q: Is separate registration required for each principal place of business or professional practice?
A
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.
9
Q
Q: Under what condition will the board register an applicant to manufacture or distribute controlled substances?
A
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.
10
Q
Q: What factors does the board consider when determining if issuing a registration is consistent with the public interest?
A
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.
11
Q
Q: What information must each application include?
A
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.
12
Q
Q: What must a scientific investigator or research applicant include in the summary of procedures for a research project?
A
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.
13
Q
Q: What must analytical laboratory applicants submit to the board?
A
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.
14
Q
Q: What is the limit on quantities of controlled substances that analytical laboratories can possess?
A
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.
15
Q
Q: Who is exempt from registration under the Controlled Substances Act?
A
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.
16
Q
Q: How can a registrant modify their registration to authorize additional controlled substances?
A
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.
17
Q
Q: When does a registration terminate?
A
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.
18
Q
Q: How should inventories and records of controlled substances listed in schedules II, III, IV, and V be maintained?
A
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.
19
Q
Q: What must a person do if there is a change in name or address?
A
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.
20
Q
Q: Can registration under the Controlled Substances Act be transferred?
A
A: No, registration under the Controlled Substances Act shall not be transferable.
21
Q
Q: What inventory requirements must all registrants comply with?
A
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.
22
Q
Q: When must a registrant conduct an initial inventory of controlled substances?
A
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.
23
Q
Q: What is the annual inventory date requirement for registrants?
A
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).
24
Q
Q: What must registrants do when a substance is added to any schedule of controlled substances?
A
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.
25
**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.
26
**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.
27
**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.
28
**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:**
1. Name of the substance.
2. Each finished form of the substance (e.g., 10 milligram tablet).
3. The number of units or volume of each finished form in each commercial container (e.g., 100 tablet bottle).
4. The number of commercial containers of each such finished form.
**B. Controlled substances not included above:**
1. Information on substances such as damaged, defective, or impure substances awaiting disposal, including the total quantity and the name of the substance.
2. A statement of the reason for the substance being included in this category.
29
**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.
30
**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.
31
**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.
32
**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.
32
**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.
33
**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.
34
**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.
35
**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.
36
**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.
37
**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.
38
**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.)
39
**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”.
40
**Q: How may prescriptions marked as "C" be filed?**
A: Prescriptions marked with the letter "C" may then be filed with prescriptions for schedule II substances, or in the usual consecutively numbered prescription file for non-controlled drugs.
41
**Q: What must pharmacies employing automatic data processing systems or other electronic record-keeping systems for prescriptions comply with?**
A: Pharmacies employing automatic data processing systems or other electronic record-keeping systems for prescriptions must comply with 16.19.6.22 NMAC “Computerized Prescription Information”.
42
**Q: What information must be included in hospital floor stock records for controlled substances administered from floor stock?**
A: A record of controlled substances administered from floor stock in hospitals must include the following information:
1. Name of the patient.
2. Date and time administered.
3. Name of the drug.
4. Strength of the drug.
5. Amount administered.
6. Name of the prescribing physician.
7. Name of the person administering the controlled substance.
43
**Q: What are the record-keeping requirements for a registered person using controlled substances in research at a registered establishment?**
A: A registered person using controlled substances under FDA regulations in research at a registered establishment that maintains records in accordance with FDA approved research requirements is not required to keep additional records if they notify the DEA and the board of pharmacy of:
- The name,
- Address, and
- All registration numbers of establishments maintaining such records.
44
**Q: Are there record-keeping requirements for controlled substances used in preclinical research or teaching?**
A: A registered person using controlled substances in preclinical research or teaching at a registered establishment which maintains records of such substances is not required to keep additional records if they notify the DEA and the board of pharmacy of:
- The name,
- Address, and
- All registration numbers of the establishments maintaining the records.
45
**Q: What are the record-keeping requirements for manufacturers and repackagers of controlled substances?**
A: Manufacturers and repackagers must maintain disposition records on all controlled substances. Specifically:
- Schedule I and II records shall be maintained separately from all other records.
- Disposition records for schedules III, IV, and V shall be maintained either separately from all other records or in such a form that the information is readily retrievable from the ordinary business records of the registrant.
46
**Q: What information must wholesale distributors include in their disposition records?**
A: Wholesale distributors' disposition records must contain the same information required of manufacturers.
47
**Q: What information must analytical laboratories include in their records?**
A: Analytical laboratories records shall include:
- Name of the substance.
- The form or forms in which the substance is received, imported, or manufactured and the concentration of the substance.
- Quantity and strength received.
- Date of receipt.
- Name and DEA registry number of the supplier.
- Adequate record of distribution.
48
**Q: What is required of a registered supplier in the event of an in-transit loss of a controlled substance?**
A: The registered supplier is responsible for reporting in-transit losses of controlled substances by a common or contract carrier upon discovery of such loss or theft. The registrant must complete DEA Form 106 as required and furnish a copy to the board of pharmacy.
49
**Q: How should a significant loss or theft of a controlled substance be reported?**
A: A significant loss or theft of a controlled substance must be reported in writing to the board of pharmacy and DEA using Form 106 as required by federal regulations. “Significant loss” includes suspected diversions, in-transit losses, or any other unexplained loss and must be reported to the board of pharmacy within five days of becoming aware of that loss.
50
**Q: What procedures should hospitals, institutions, and clinics follow for the disposal of excess or undesirable controlled substances?**
A: For the disposal of excess or undesirable controlled substances, such as those resulting from injections from ampules or partial ampules, the registrant must:
- Record the disposal in accordance with DEA regulations (e.g., 21 CFR 1304.22(c) or successor regulation).
- Ensure that two persons, including at least one licensed health care professional, witness and record the disposal.
- Implement security controls and procedures to ensure that pharmaceutical wastage is not diverted.
- Use a disposal method that renders the substance irretrievable.
51
**Q: How should a registrant dispose of unusable, outdated, or unwanted controlled substances?**
A: Disposition should be in accordance with DEA regulation 21 CFR Part 1317 (or successor regulation). A registrant, other than a manufacturer, distributor, reverse distributor, importer, exporter, or narcotic treatment program, may contact the Special Agent in Charge of the DEA by submitting DEA Form 41 listing the controlled substances for disposal. The registrant must keep a written memorandum report and use DEA Form 41 to record the destruction.
52
**Q: What methods are available for a registrant to dispose of controlled substances?**
A: A registrant may:
1. Deliver the controlled substance to a reverse distributor's registered location by common or contract carrier pick-up or by reverse distributor pick-up at the registrant's location.
2. For return or recall, deliver the controlled substance to the registered person from whom it was obtained, the registered manufacturer, or another registrant authorized by the manufacturer to accept returns or recalls on the manufacturer's behalf.
53
**Q: How long must records of the disposition of controlled substances be maintained?**
A: Records of disposition must be maintained in proper form and be available for inspection for at least three years.
54
**Q: What are the requirements for a registrant registered to dispense controlled substances when distributing to another practitioner?**
A: A registrant who is registered to dispense controlled substances may distribute to a registered practitioner if:
1. The distribution is recorded by the pharmacist, indicating the number of units or volume of finished forms, commercial containers dispensed, date, and manner of disposition.
2. The same information is recorded as a procurement by the registrant receiving the substance.
3. For substances listed in Schedule I or II, an order form is used as required by federal regulations.
4. The total number of dosage units of all controlled substances distributed does not exceed five percent of the total number of dosage units distributed and dispensed by the pharmacy during the 12-month period.
55
**Q: What are the requirements for the transfer of controlled substances upon the transfer of business ownership?**
A: Upon transfer of business ownership:
1. A complete inventory of all controlled substances being transferred must be taken on the date of transfer in accordance with 16.19.20.20 NMAC and federal DEA regulations. This inventory must be recorded by both the registrant-transferee and the registrant-transferor, though not necessarily filed with DEA or the board of pharmacy unless requested.
2. All records related to the controlled substances being transferred must be transferred to the registrant-transferee. The transferor retains responsibility for the accuracy of records prior to the transfer, while the transferee is responsible for custody and maintenance.
3. Schedule I or II substances must be transferred using order forms as required by federal regulations. A copy of the inventory serves as a record of receipt for the purchaser.
56
**Q: What should be done with controlled substances if a business is discontinued?**
A: If controlled substances are not transferred to another registrant upon discontinuance of business, they shall be handled as unwanted controlled substances under 16.19.20.38 NMAC.
57
**Q: Who is responsible for the proper prescribing and dispensing of controlled substances?**
A: A prescription for a controlled substance must be issued by an individual practitioner registered under the Controlled Substances Act for a legitimate medical purpose and within the usual course of professional practice. The prescribing practitioner holds responsibility for proper prescribing, while a corresponding responsibility rests with the pharmacist who fills the prescription.
58
**Q: Can a prescription be issued to supply a practitioner with controlled substances for general dispensing to patients?**
A: No, a prescription may not be issued for a practitioner to obtain controlled substances for supplying the practitioner for general dispensing to patients.
59
**Q: Under what conditions can a prescription be issued for narcotic drugs to a narcotic dependent person?**
A: A prescription for narcotic drugs to a narcotic dependent person can be issued only if:
1. The narcotic controlled drug is in Schedule III, IV, or V and is FDA-approved specifically for use in maintenance or detoxification treatment.
2. The prescribing practitioner meets all state and federal requirements to prescribe the narcotic for maintenance or detoxification treatment (e.g., 21 CFR 1301.28 or successor regulation).
60
**Q: What are the requirements for writing a prescription for controlled substances?**
A: Prescriptions must be:
1. Dated and signed on the day when issued.
2. Include the full name and address of the patient.
3. Contain the drug name, strength, dosage form, quantity prescribed, directions for use, and the name, address, and registration number of the practitioner.
4. If handwritten, it must be written with ink, indelible pencil, typewriter, or printed by computer and manually signed. Computer-generated prescriptions must be manually signed.
61
**Q: How should electronic prescriptions for controlled substances be created and signed?**
A: Electronic prescriptions must be created and signed using an application that meets the requirements of Part 1311 of the Code of Federal Regulations. The practitioner must sign and transmit electronic prescriptions in a manner that complies with Part 1306.08 of the Code of Federal Regulations.
62
**Q: Are there any exceptions to the requirement for electronic prescriptions for controlled substances?**
A: Yes, exceptions to electronic prescriptions include:
1. Patients residing in intermediate care, skilled nursing, or correctional facilities.
2. Patients enrolled in hospice.
3. Prescriptions for animals by licensed veterinarians.
4. Prescriptions dispensed by federal facilities not subject to state regulation.
5. Prescriptions requiring information that makes electronic transmission impractical or for new medications not yet in electronic systems.
6. Compounded prescriptions.
7. Prescriptions issued during a temporary technical or electronic failure.
8. Prescriptions issued in emergencies or public health emergencies where non-patient specific prescriptions are permitted.
9. Under extenuating circumstances where the practitioner communicates directly with the pharmacist and documentation is provided.
63
**Q: How should a prescription for a Schedule II controlled substance be transmitted if it falls under an exception to the EPCS requirement?**
A: A prescription for a Schedule II controlled substance may be transmitted via facsimile, provided:
1. The original written, signed prescription is presented to the pharmacist for review prior to dispensing.
2. The facsimile serves as the original written prescription for purposes of maintaining records.
64
**Q: What are the requirements for prescriptions for Schedule II substances for long-term care facility residents or hospice patients?**
A: Prescriptions for Schedule II substances:
1. For residents of long-term care facilities may be transmitted by facsimile, which serves as the original written prescription.
2. For hospice patients must be transmitted by facsimile with the notation that the patient is a hospice patient, and the facsimile serves as the original written prescription.
65
**Q: How should Schedule III, IV, or V controlled substance prescriptions be handled?**
A: For Schedule III, IV, or V substances, prescriptions may be:
1. Written and signed by a practitioner.
2. Facsimile of a written, signed prescription.
3. Oral prescriptions made by an individual practitioner, promptly reduced to written form by the pharmacist, but a telephone order for new therapy may not exceed a 10-day supply unless a written prescription is on file within the past six months.
66
**Q: What is required for the verification of a patient’s identity when dispensing controlled substances?**
A: A pharmacy employee must verify the identity of the patient or the patient’s representative using a current state-issued driver’s license or other government-issued photo identification. The type, number, name, and state of the identification must be recorded, except for prescriptions filled for a patient known to the pharmacist, home deliveries, or deliveries to licensed facilities.
67
**Q: Can prescriptions for Schedule II drugs be refilled?**
A: No, prescriptions for Schedule II drugs may not be refilled.
68
**Q: What should be recorded for each refill of a Schedule III, IV, or V controlled substance prescription?**
A: Each refill of a Schedule III, IV, or V controlled substance prescription must be recorded, indicating:
1. The amount dispensed.
2. The date of the refill.
3. The initials of the pharmacist dispensing the substance.
4. If less than the amount called for, the amount dispensed should be noted.
69
**Q: How long after the date of issue can a prescription for any controlled substance be filled?**
A: Prescriptions for any controlled substance shall not be filled more than six months after the date of issue.
70
**Q: What is the refill policy for controlled substance prescriptions dispensed directly to a patient?**
A: Controlled substance prescriptions dispensed directly to a patient shall not be refilled before seventy-five percent of the prescription days’ supply has passed, unless the practitioner authorizes the early refill, which must be documented by the pharmacist.
71
**Q: What is the refill policy for controlled substance prescriptions delivered indirectly (e.g., mail order)?**
A: Controlled substance prescriptions delivered indirectly to a patient shall not be refilled before sixty-six percent of a 90-day supply or fifty percent of a 30-day supply has passed, unless the practitioner authorizes the early refill, which must be documented by the pharmacist.
72
**Q: What are the refill limitations for prescriptions for Schedule III, IV, or V controlled substances?**
A: Prescriptions for Schedule III, IV, or V controlled substances shall not be filled or refilled more than six months after the date of issue or be refilled more than five times unless renewed by the practitioner and a new prescription is placed in the pharmacy files.
73
**Q: Can a prescription for a Schedule II controlled substance be partially filled?**
A: Yes, a prescription for a Schedule II controlled substance may be partially filled if:
1. The total quantity dispensed in all partial fillings does not exceed the total quantity prescribed.
2. The partial fill amount is recorded on the written prescription or in the electronic prescription record.
3. The remaining portions must be filled within 30 days of the date on which the prescription is issued.
74
**Q: What should be done if a Schedule II controlled substance prescription is initially filled later than 30 days after the date issued?**
A: If a prescription for a Schedule II controlled substance is initially filled later than 30 days after the date issued:
1. The pharmacist is unable to dispense the total quantity prescribed.
2. The partial fill amount must be recorded on the written prescription or in the electronic prescription record.
3. The remaining portion must be filled within 72 hours of the partial filling.
4. The pharmacist must notify the prescribing physician if the remaining portion cannot be filled within the 72-hour period. No further quantity may be supplied beyond 72 hours without a new prescription.
75
**Q: How should partial fillings of prescriptions for Schedule III, IV, or V controlled substances be recorded?**
A: Partial fillings of prescriptions for Schedule III, IV, or V controlled substances shall be recorded in the same manner as a refill, ensuring that the total quantity of partial fillings does not exceed the total quantity prescribed and that no dispensing occurs after six months from the date of the prescription.
76
**Q: Can a Schedule II controlled substance prescription for a patient in a long-term care facility (LTCF) or with a terminal illness be partially filled?**
A: Yes, a Schedule II controlled substance prescription for a patient in an LTCF or with a terminal illness may be filled in partial quantities, including individual dosage units if:
1. The pharmacist contacts the practitioner if there is any doubt about the patient's classification.
2. The prescription is noted as for a “terminally ill” or “LTCF patient”.
3. The prescription must be recorded with the date of partial filling, quantity dispensed, remaining quantity authorized, and the identification of the dispensing pharmacist.
4. The total quantity dispensed in all partial fillings must not exceed the total quantity prescribed, and the prescription shall be valid for no more than 60 days from the issue date unless terminated earlier.
77
**Q: What constitutes an “emergency situation” for dispensing Schedule II controlled substances?**
A: An “emergency situation” means:
1. Immediate administration of a controlled substance is necessary for proper treatment.
2. No appropriate alternative treatment is available, including non-controlled substances.
3. It is not reasonably possible for the prescribing practitioner to provide an electronically prescribed or written prescription before dispensing.
78
**Q: What are the requirements for dispensing a Schedule II controlled substance during an emergency?**
A: During an emergency:
1. The quantity prescribed must be limited to the amount needed to treat the patient during the emergency period.
2. The pharmacist must reduce the prescription to writing with all required information except the signature of the prescribing practitioner.
3. The prescribing physician must provide a written, signed prescription within seven days, noting “AUTHORIZATION FOR EMERGENCY DISPENSING” and the date of the oral or facsimile order.
4. The signed prescription must be attached to the oral or facsimile order and filed as other Schedule II prescriptions.
79
**Q: What should a pharmacist do if the prescribing physician fails to deliver a signed prescription within the seven-day period?**
A: If the prescribing physician fails to deliver a signed prescription within seven days, the pharmacist must notify the nearest DEA office and the board of pharmacy.
80
**Q: What are the general security requirements for applicants and registrants handling controlled substances?**
A: All applicants and registrants shall provide effective controls and procedures to guard against theft and diversion of controlled substances.
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**Q: What factors may be considered when evaluating the overall security system of a registrant or applicant?**
A: The following factors may be considered:
1. The type of activity.
2. The type and form of controlled substances handled.
3. The quantity of controlled substances handled.
4. The location of the premises and its impact on security needs.
5. The type of building construction and general characteristics of the building.
6. The type of vault, safe, and secure enclosures or storage systems used.
7. The type of closures on vaults, safes, and secure enclosures.
8. The adequacy of key control and lock control systems.
9. The extent of unsupervised public access to the facility.
10. The adequacy of supervision over employees with access to storage or distribution areas.
11. The procedures for handling business guests, visitors, maintenance personnel, and non-employee service personnel.
12. The adequacy of the system for monitoring the receipt, manufacture, distribution, and disposition of controlled substances.
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**Q: What are the security requirements for manufacturers, repackagers, and wholesale distributors?**
A: Security requirements that meet the federal DEA provisions are deemed adequate under the New Mexico Controlled Substances Act.
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**Q: How should controlled substances listed in Schedule I be stored in pharmacies and hospitals employing staff pharmacists?**
A: Controlled substances listed in Schedule I shall be stored in a securely locked, substantially constructed cabinet.
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**Q: How should controlled substances listed in Schedule II, III, IV, and V be stored in pharmacies and hospitals employing staff pharmacists?**
A: Controlled substances listed in Schedule II, III, IV, and V shall be stored either in securely locked, substantially constructed cabinets or dispersed throughout the stock of non-controlled substances to obstruct theft or diversion.
85
**Q: How should controlled substances be stored in research registrants and chemical analysis laboratories?**
A: Controlled substances listed in Schedules I and II shall be stored in a securely locked, substantially constructed cabinet. Schedules III, IV, and V substances may be stored in a securely locked, substantially constructed cabinet or dispersed with non-controlled substances to obstruct theft or diversion.
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**Q: What are the requirements for dispensing controlled substances listed in Schedule V and substances listed in Schedules II, III, or IV not classified as prescription drugs?**
A: Dispensing by a pharmacist without a prescription is allowed if:
1. Dispensing is done by a pharmacist or registered pharmacist intern.
2. No more than eight ounces of any controlled substance containing opium or 48 dosage units is dispensed to the same person in any 48-hour period.
3. No more than four ounces of any other controlled substance or 24 dosage units is dispensed to the same person in any 48-hour period.
4. The purchaser is at least 18 years old.
5. The pharmacist requires suitable identification from every purchaser not known to them, including proof of age if appropriate.
6. A bound record book is maintained with the purchaser’s signature, address, name and quantity of the controlled substance, date of purchase, and the name or initials of the pharmacist dispensing the substance. The book must state that no purchase has been made within the given 48-hour period at another pharmacy and the purchaser must be made aware of this statement before signing.
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**Q: What are the requirements for dispensing pseudoephedrine products?**
A: For pseudoephedrine products:
1. They must be dispensed, sold, or distributed only by a licensed pharmacist, pharmacist intern, or registered pharmacy technician.
2. Without a valid prescription, a person must:
- Produce a driver’s license or other government-issued photo ID showing their date of birth.
- Sign a log indicating the date and time of the transaction, name, address, driver’s license number or ID number, name of the pharmacist, intern, or technician, the product sold, and total quantity in grams or milligrams. The log must be kept separate from other records, and customer information should not be visible to others.
- Be limited to no more than 3.6 grams per day or 9 grams in a 30-day period.
3. The purchaser statement must include: “I have not purchased more than 3.6 grams today or more than a total of 9 grams in the last 30 days. Entering false statements may subject me to criminal penalties.”
4. Prices for pseudoephedrine products should be monitored to prevent unwarranted increases.
5. Pharmacies must submit collected data electronically to the board or its agents every seven days. An alternative submission method may be petitioned from the board’s executive director.
6. The board may contract with another agency or private vendor for data collection, with confidentiality and penalty compliance as required by regulation.
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**Q: What are the requirements for a chemical preparation to be exempt under the regulations?**
A: A chemical preparation or mixture is exempt if it:
1. Contains no narcotic controlled substances and is packaged in a form or concentration that does not present any significant potential for abuse, or
2. Contains either a narcotic or nonnarcotic controlled substance and one or more adulterating or denaturing agents such that the preparation or mixture does not present any potential for abuse, and the narcotic substance cannot be removed in practice, and
3. Is exempt from federal regulations (CFR 21 Part 1308.24).
88
**Q: What procedures are followed for hearings related to denial, revocation, or suspension of registration?**
A: Proceedings to suspend or revoke a registration or to refuse renewal of a registration shall be held pursuant to the Uniform Licensing Act.
89
**Q: What does "administrative inspection" mean in the context of controlled substances?**
A: Administrative inspection means the inspection of any place where registrants are permitted to hold, manufacture, compound, process, sell, deliver, or otherwise dispose of controlled substances. When authorized by an administrative inspection warrant, the inspector may:
1. Inspect and copy records required by the Controlled Substances Act.
2. Inspect the restricted area and all pertinent equipment, container substances, containers, and labeling found at the controlled area.
3. Make a physical inventory of specific items or all controlled substances on-hand at the premises.
4. Collect samples, if applicable.
5. Check records and information related to the distribution of controlled substances by the registrant.
6. Examine records, invoices, or other documents for verification and compliance with the Controlled Substances Act.
90
**Q: What is required for a registrant to voluntarily consent to an inspection?**
A: The board inspector will ask the registrant to voluntarily consent to the inspection and inform them of their constitutional rights to an inspection warrant. If the registrant consents to the inspection without a warrant, the inspector will obtain a signed consent waiver statement from the registrant before proceeding with the accountability audit or inspection.
91
**Q: What information must be included in the written consent for an administrative inspection?**
A: The written consent must include:
1. That the owner or agent in charge has been informed of their constitutional right not to have an administrative inspection made without an administrative inspection warrant.
2. Their right to refuse consent to the inspection.
3. The possibility that anything incriminating found may be seized and used against them in a board hearing or criminal prosecution.
4. That they have been presented with a notice of inspection.
5. That the consent is given voluntarily and without threats.
6. That they may withdraw their consent at any time during the inspection.
92
**Q: How should written consent for an inspection be handled?**
A: Written consent must be produced in duplicate. One copy is retained by the person being inspected, and one copy is retained by the inspector for filing in the board office.
93
**Q: What is required when serving an administrative warrant?**
A: A copy of the administrative warrant need not be given to the registrant unless items are seized or confiscated. To serve the warrant, it is required only to announce possession of it; the contents of the warrant need not be stated to the person upon whom the warrant is served.
94
**Q: What data does consent to charges not extend to unless specifically agreed to?**
A: Unless the person in charge of the premises consents in writing, the regulations shall not extend to:
1. Financial data
2. Sales data other than shipping data
3. Pricing data
95
**Q: When is an administrative warrant not required?**
A: An administrative warrant is not required for:
1. A new pharmacy or drug distribution facility applying for initial registration under the Controlled Substances Act or the Pharmacy Act.
2. Any other situation where a warrant is not constitutionally required.
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**Q: What happens if a registrant refuses to permit execution of an administrative warrant or impedes the inspection?**
A: If a registrant or person subject to the Controlled Substances Act refuses to permit execution of an administrative warrant or impedes the inspection, they shall be advised that such refusal or action constitutes a violation of Section 30-31-32 NMSA 1978, Controlled Substances Act.
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STUDY THE CS TABLE
98
CIII math for Narcotic drugs
- Codeine (max 1.8g/100mL or 90mg/unit with isoquinoline alkaloid)
- Codeine (max 1.8g/100mL or 90mg/unit with non-narcotic ingredients)
- Dihydrocodeinone (max 300mg/100mL or 15mg/unit with isoquinoline alkaloid)
- Dihydrocodeinone (max 300mg/100mL or 15mg/unit with non-narcotic ingredients)
- Dihydrocodeine (max 1.8g/100mL or 90mg/unit with non-narcotic ingredients)
- Ethylmorphine (max 300mg/100mL or 15mg/unit with non-narcotic ingredients)
- Opium (max 500mg/100mL or 100g or 25mg/unit with non-narcotic ingredients)
- Morphine (max 50mg/100mL or 100g with non-narcotic ingredients)
.
.
.
(1) Not more than one and eight-tenths grams of codeine per 100 milliliters or not more than 90 milligrams per dosage unit, with an equal or greater quantity of an isoquinoline alkaloid of opium.
(2) Not more than one and eight-tenths grams of codeine per 100 milliliters or not more than 90 milligrams per dosage units, with one or more active nonnarcotic ingredients in recognized therapeutic amounts.
(3) Not more than 300 milligrams of dihydrocodeinone per 100 milliliters or not more than 15 milligrams per dosage unit, with a fourfold or greater quantity of an isoquinoline alkaloid of opium.
(4) Not more than 300 milligrams of dihydrocodeinone per 100 milliliters or not more than 15 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts.
(5) Not more than one and eight-tenths grams of dihydrocodeine per 100 milliliters or not more than 90 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts.
(6) Not more than 300 milligrams of ethylmorphine per 100 milliliters or not more than 15 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts.
(7) more than 500 milligrams of opium per 100 milliliters or per 100 grams or not more than 25 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts.
(8) Not more than 50 milligrams of morphine per 100 milliliters or per 100 grams, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts.
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CV math for narcotic
- Codeine: Not more than 200 mg per 100 ml/100 g
- Dihydrocodeine: Not more than 100 mg per 100 ml/100 g
- Ethylmorphine: Not more than 100 mg per 100 ml/100 g
- Diphenoxylate: Not more than 2.5 mg per dosage unit with at least 25 mcg atropine sulfate
- Opium: Not more than 100 mg per 100 ml/100 g
- Difenoxin: Not more than 0.5 mg per dosage unit with at least 25 mcg atropine sulfate.
.
.
(1) Not more than 200 milligrams of codeine per 100 milliliters or per 100 grams.
(2) Not more than 100 milligrams of dihydrocodeine per 100 milliliters or per 100 grams.
(3) Not more than 100 milligrams of ethylmorphine per 100 milliliters or per 100 grams.
(4) Not more than two and five-tenths milligrams of diphenoxylate and not less than 25 micrograms of atropine sulfate per dosage unit.
(5) Not more than 100 milligrams of opium per 100 milliliters or per 100 grams.
(6) Not more than five-tenths milligrams of difenoxin and not less than 25 micrograms of atropine sulfate per dosage unit.
