NMBOP: 16.19.21 DRUG PRECURSORS

Question 1

Q: What does the board consider when determining the public interest in issuing a license for drug precursors?

Answer 1

A: The board may consider the following factors:

1. Maintenance of effective controls against diversion of drug precursors into other than legitimate medical, scientific, or industrial channels.
2. Compliance with applicable state and local law.
3. Any conviction of the applicant under federal or state laws relating to any controlled substance or drug precursor.
4. Past experience in the manufacture, possession, transfer, or transportation of drug precursors 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 Drug Precursor Act or the Controlled Substances Act.
6. Suspension or revocation of the applicant’s federal registration to manufacture, distribute, or dispense controlled substances or drug precursors as authorized by federal law.
7. Any other factors relevant to and consistent with the public health and safety.

Question 2

Q: What are the conditions under which the board may refuse to issue a license for drug precursors?

Answer 2

A: The board may refuse to issue a license if it determines that issuing the license would be inconsistent with the public interest, considering the factors listed in 16.19.21.8(A).

Question 3

Q: Does obtaining a license under 16.19.21.8 entitle a licensee to manufacture, possess, transfer, or transport any drug precursors?

Answer 3

A: No, licensing under this section does not entitle a licensee to manufacture, possess, transfer, or transport drug precursors other than those specifically allowed in the license.

Question 4

REGISTRATION AND EXPIRATION DATE:

Answer 4

A. Any person who is required to be registered under this part and who is not registered may apply for registration at any time.

B. The license for persons required to register under this part shall be renewed bi-ennially before the last day of December.

Question 5

REGISTRATION FEE:

Answer 5

The registration fee or annual renewal fee required by the Drug Precursor Act shall be $250.00 per year for a wholesaler, manufacturer, or distributor… application form is obtain from BOP

Question 6

Q: What is required for each principle place of business or professional practice distributing precursors?

Answer 6

A: Separate registration is required for each principle place of business or professional practice with the address indicated on the application if precursors are distributed from different locations.

Question 7

Q: What information is required on each application for registration?

Answer 7

A: Each application must include all information as required on the application form and must be signed by the applicant.

Question 8

Q: What is required before the board of pharmacy approves a registration application for wholesalers, manufacturers, or distributors?

Answer 8

A: The board of pharmacy may direct the drug inspector to inspect the facilities for security provisions and other applicable standards. A fee of $150.00 must be submitted before such inspection.

Question 9

Q: What should a scientific investigator or research applicant submit for their research?

Answer 9

A: A summary of procedures indicating the nature, extent, and duration of the research. This summary should include, but is not limited to, the names of individuals engaged in the project, the names of precursor substances to be used, safeguards against diversion, the source of supply of substances, and record keeping and forms for receipt, use, and destruction of precursor substances.

Question 10

Q: What are the requirements for analytical laboratory applicants regarding the application form?

Answer 10

A: Analytical laboratory applicants must submit the application on the form provided by the Board. All applicable questions on the application must be filled in and signed by the person in charge of the facility.

Question 11

Q: What are the limits on quantities of drug precursors for analytical laboratories?

Answer 11

A: Quantities of drug precursors in possession of analytical laboratories shall be limited to those required for reference standards, assays, or other analytical scientific purposes.

Question 12

Q: Who is exempt from registration under the Drug Precursor Act?

Answer 12

A: Registration is waived for:
1. Any officer or employee of the state or federal customs agency, state police, or any enforcement officer of any political subdivision of the state, engaged in the enforcement of drug precursor laws and authorized to possess drug precursors in the course of official duties.
2. Any official exempted by this section may procure drug precursors during inspections or criminal investigations.
3. Laboratory personnel, when acting within the scope of their official duties, are also exempt from registration.

Question 13

Q: When does registration terminate?

Answer 13

A: Registration shall terminate if:
1. The registrant dies.
2. The registrant discontinues business or professional practice.
3. The registrant’s professional license is revoked or suspended.
4. The registrant changes their name or address as shown on the registration.
- In such instances, the registrant or their estate must notify the Board of Pharmacy promptly and return the certificate of registration to the Board.

Question 14

Q: What must registrants do regarding inventories and records of drug precursors?

Answer 14

A: Inventories and records of drug precursors must be maintained separately from all other records or in a form that allows the information to be readily retrievable from ordinary business records.

Question 15

Q: What should a registrant do in the event of a change in name or address?

Answer 15

A: The registrant must file an application in the same manner as an application for a new registration. No fee is required for such modification.

Question 16

Q: Is registration under the Drug Precursor Act transferable?

Answer 16

A: No, registration under the Drug Precursor Act is not transferable.

Question 17

Q: How long must procurement records be kept by registrants?

Answer 17

A: All registrants are required to keep procurement records in a readily retrievable manner for 3 years.

Question 18

Q: What information must be recorded on order forms (invoices) for drug precursors to be deemed proper records of receipt?

Answer 18

A: The purchaser must record the following on their copy of the order form (invoice):
1. The number of commercial or bulk containers furnished of each item.
2. The date received.
3. The name of the person receiving the order.

Question 19

Q: Where must procurement records and all other records be kept?

Answer 19

A: Procurement records and all other records must be kept at the registered location and must be available for inspection.

Question 20

Q: How should a significant loss or theft of a drug precursor be reported?

Answer 20

A: A significant loss or theft of a drug precursor must be reported in writing to the Board of Pharmacy. “Significant loss” includes suspected diversions, in-transit losses, or any other unexplained loss.

Question 21

Q: What information must be included in distribution records for drug precursors?

Answer 21

A: Distribution records must include:
1. Purchaser’s name, address, telephone number, and drug precursor registration number or other license number issued by the board.
2. Quantity purchased.
3. Date supplied.
4. Supplier’s name, address, telephone number, and drug precursor registration number or other license number issued by the board.
- Distribution records must be retained for three (3) years.

Question 22

Q: How should a registrant dispose of damaged, outdated, or unwanted drug precursors?

Answer 22

A: The registrant must:
1. Abide by applicable federal, state, and local laws or regulations for the destruction of the substance.
2. Ensure the destruction is witnessed by at least one law enforcement officer certified in the State of New Mexico.
3. Keep appropriate records of the destruction.

Question 24

Q: What are the procedures for disposing of drug precursors upon the transfer of a business?

Answer 24

A: Upon transfer of a business:
1. The drug precursors may be:
- Destroyed as outlined in 16.19.21.24 NMAC.
- Transferred to the new owner.
2. All records related to the drug precursors being transferred must be handed over to the new owner.
- The transferor remains responsible for the accuracy of records up to the transfer date.
- The transferee assumes responsibility for custody and maintenance of the precursors.

Question 25

Q: What should be done with drug precursors upon discontinuance of a business?

Answer 25

A: If drug precursors are not transferred to another registrant:
- They must be handled as unwanted drug precursors under 16.19.21.24 NMAC.

Question 26

Q: What security requirements must be met by all applicants and registrants?

Answer 26

A: All applicants and registrants must:
1. Provide effective controls and procedures to guard against theft and diversion of drug precursors.

Question 27

Q: What factors may be considered when evaluating the overall security system of a registrant or applicant?

Answer 27

A: The following factors may be considered:
1. The type of activity.
2. The quantity of drug precursors.
3. The location of premises and its impact on security needs.
4. The type of building construction and general characteristics.
5. The adequacy of key and/or lock control systems.
6. The extent of unsupervised public access to the facility.
7. The adequacy of supervision over employees with access to storage and distribution areas.
8. The process for handling business guests, visitors, maintenance personnel, and non-employee service personnel.
9. The adequacy of the system for monitoring the receipt, manufacture, distribution, and disposition of drug precursors.

Question 28

Q: How are proceedings to suspend, revoke, or deny the renewal of a registration conducted?

Answer 28

A: Proceedings to suspend or revoke a registration or to refuse renewal of a registration shall be held pursuant to the Uniform Licensing Act.

Question 29

Q: What does an administrative inspection involve?

Answer 29

A: An administrative inspection includes:
1. Inspecting and copying records required by the Drug Precursor Act.
2. Inspecting the restricted area, equipment, containers, substances, and labeling.
3. Making a physical inventory of specific items or all drug precursors on hand.
4. Collecting samples, if applicable.
5. Checking records and information related to the distribution of substances.
6. Examining records and invoices for verification or related to the provisions of the Drug Precursor Act.

Question 30

Q: What is required for voluntary consent to an inspection by a Board inspector?

Answer 30

A: The Board inspector will:
1. Ask the registrant to voluntarily consent to the inspection.
2. Inform the registrant of their constitutional rights to an inspection warrant.
3. If the registrant consents without a warrant, the inspector will obtain a signed consent waiver statement before proceeding with the audit or inspection.

Question 31

Q: What must be included in the written consent for an inspection?

Answer 31

A: The written consent must include:
1. Information that the owner or agent has been informed of their constitutional rights not to have an administrative inspection without a warrant.
2. Information about their right to refuse consent to the inspection.
3. Notification that incriminating evidence found may be used in a Board hearing or criminal prosecution.
4. Presentation of a notice of inspection.
5. Confirmation that consent is voluntary and without threats.
6. Information that consent can be withdrawn at any time during the inspection.

The written consent must be produced in duplicate, with one copy retained by the person being inspected and one by the inspector.

Question 32

Q: What are the requirements for serving an administrative warrant?

Answer 32

A: When serving an administrative warrant:
1. A copy of the warrant does not need to be given to the registrant unless items are seized or confiscated.
2. The only requirement is to announce possession of the warrant; the contents do not need to be stated to the person upon whom the warrant is served.

Question 33

Q: What regulations do not extend to financial data, pricing data, or sales data other than shipping dates?

Answer 33

A: Unless the person in charge of the premises consents in writing, the regulations do not extend to financial data, pricing data, or sales data other than shipping dates.

Question 34

Q: When is an administrative warrant not required?

Answer 34

A: An administrative warrant is not required:
1. For a new facility applying for initial registration under the Drug Precursor Act.
2. In any situation where a warrant is not constitutionally required.

Question 35

Q: What happens if a registrant refuses to permit execution of an administrative warrant or impedes the inspection?

Answer 35

A: If a registrant or person subject to the Drug Precursor Act refuses to permit execution of an administrative warrant or impedes the inspection, they will be advised that such refusal or action constitutes a violation of the Drug Precursor Act.

Question 36

controlled substance precursors

Answer 36

A. phenyl acetone
B. ephedrine
C. phenyl-2-propanone
D. norephedrine
E. ethyl-1-methyl butyl diethyl malonate
F. allyl-1-methyl butyl diethyl malonate
G. hydroxyindole
H. 3,4,5-trimethoxybenzyl cyanide
I. 3,4,5-trimethoxybenzyl alcohol
J. 3,4,5-trimethoxyphenylacetonitrile
K. 3,4,5-trimethoxybenzoic acid amide
L. 4-benzyloxyindole
M. 4-chloro indole
N. indole
O. tryptophol
P. 3-indole glyoxylic acid
Q. 3-indole glyoxylic acid ethyl ester
R. lysergic acid
S. lysergic acid amide
T. ergotamine tartrate
U. 1-phenyl cyclohexylamine
V. 1-piperidinocyclohexanecarbonitrile
W. pseudoephedrine (unapproved form)
X. methylamine
Y. methylformamide
Z. phenylacetic acid
AA. anhydrous ammonia - (1) Possession is prohibited.
- (2) Must store in approved container.
- (3) Exceptions:
- (a) Agricultural land operators
- (b) Retail distributors
- (c) Wholesalers
- (d) Manufacturers
- (e) Warehousemen
- (f) Common carriers
- (g) Lawful business conductors
BB. red phosphorus
CC. iodine matrix - Retail distributors, pharmacies, hospitals, clinics can sell no more than 2 ounces in a single transaction.
DD. crystal iodine - Retail distributors, pharmacies, hospitals, clinics can sell no more than 2 ounces in a single transaction.