New Mexico Register / Volume XXXI, Issue 17 / September 15, 2020

NOTICE OF REGULAR BOARD MEETING AND RULE HEARING

The New Mexico Board of Pharmacy will convene for the purpose of conducting a regular board meeting on October 22nd at 9:00 a.m. and continue until finished. If the meeting agenda items are not finished by 5:00 p.m., the Board will convene on October 23rd at 9:00 a.m. and continue until finished. Pursuant to the June 12, 2020 Public Health Order restricting Mass Gatherings due to COVID-19, the meeting will be held as a virtual meeting.

Location: Virtual meeting

October 22, 2020

Meeting link: https://nmrld.webex.com/nmrld/onstage/g.php?MTID=e873be62b2c838388cc3d9accd04b02a8

Meeting number: 146 976 0229

Password: F2pm6KWry38

Join by phone +1-415-655-0002 United States Toll

Access code: 146 976 0229

October 23, 2020

Meeting link: https://nmrld.webex.com/nmrld/onstage/g.php?MTID=e6f2d977126609b31e0bb73dca02aadc7

Meeting number: 146 293 3380

Password: PHwPpXSM836

Join by phone +1-415-655-0002 United States Toll

Access code: 146 293 3380

The agenda is posted 72 hours prior to the scheduled meeting. You may view and download a copy of the agenda through the board’s website: www.rld.state.nm.us/boards/pharmacy.aspx. All proposed language regarding rule hearings is linked to the Agenda, the Notice to the Public on our website, and the New Mexico Sunshine Portal.

Individuals petitioning the board regarding requests/waivers and/or interested persons wishing to comment on proposed language regarding rule hearings must submit documentation for presentation; via fax (505) 222-9845, mail or email to the Executive Director, Cheranne McCracken, Cheranne.McCracken@state.nm.us at least one week in advance of the scheduled meeting, as public comment is allowed during the rule hearing. On the morning of the hearing beginning at 8:00 a.m. and ending when the rule hearing adjourns, a Board of Pharmacy representative will be stationed at the board office, located at 5500 San Antonio Drive NE, Albuquerque, NM 87109, to receive written comments regarding the rule hearings and also to convey them to the Board. Public attendance will be limited to remote participation. Oral participation by members of the public will be limited to those comments and discussion through audiovisual means.

The board may go into Executive Session to discuss items pursuant to Section 10-15-1H(1), Section 10-15-1H(2), Section 10-15-1H(3) or Section 10-15-1H(7) of the Open Meeting Act. Agenda items may be executed at any time during the meeting to accommodate hearings.

If you are an individual with a disability who is in need of a reader, amplifier, qualified sign language interpreter, or any other form of auxiliary aid or service to attend or participate in the hearing or meeting, please contact Cheranne McCracken 505-222-9830 at least one week prior to the meeting or as soon as possible. Public documents, including the agenda and minutes, can be provided in various accessible formats. Please contact Cheranne McCracken, at 505-222-9830 or e-mail cheranne.mccracken@state.nm.us if a summary or other type of accessible format is needed.

The Board will address:

All Board Matters:

Rule Hearings:

October 22, 2020 9:10 a.m.

16.19.6 NMAC – PHARMACIES: Sections 1, 2, 17, and 21 - administrative updates. Sections 23 and 24: Amendment to Section 23 - to allow the transfer of an original unfilled non-controlled substance prescription. Record keeping requirements are specified, and transfer or forwarding of controlled substance prescriptions is clarified for consistency with federal law. Amendment allowing prescription adaptation in filling a new non-controlled substance prescription, to change the quantity, dosage, dosage form or directions for use if it meets the intent of the prescriber, or to complete missing information. This is to facilitate timely filling of prescriptions, to avoid delays in medication therapy. Amendment to Section 24 - non-resident pharmacy application not successfully completed with 12 months of date received by the board will be considered withdrawn; requiring a non-resident pharmacy as a condition of licensure to submit the procedure for ensuring proper medication storage conditions until the medication is delivered to the patient.

STATUTORY AUTHORITY: Paragraph (6) of Subsection (A) of Section 61-11-6 NMSA 1978

16.19.12 NMAC – FEES: Section 1 - administrative updates; Sections 12, 13 and 20: Amendment to Section 12 - The board may issue a controlled substance registration for a time period determined by the board and shorter than three years if it is consistent with the public health and safety. Amendment to Section 13 - increase fees from $700 to 1000 bi-ennially for manufacturer, wholesale drug distributor, manufacturer/re-packager, re-packager, and third party logistics provider. The increased fee is due to the increased complexity and requirements of licensing associated with the Drug Supply Chain and Security Act. Amendment to Section 20 - limit controlled substance registration delinquent renewal fees to $180.

STATUTORY AUTHORITY: Sections 30-31-11, 30-31B-6, 61-11-12, 61-11-13, and 61-11-14 NMSA 1978

16.19.20 NMAC - CONTROLLED SUBSTANCES: Sections 1, 3, 44, 46, 47 - administrative updates. Sections 10, 42, and 69: Amendment to Section 10 - reference 16.19.12 NMAC for controlled substance registration fee, rather than duplicating language; Amendment to Section 42 - requiring electronic prescribing of controlled substance prescriptions and specifying exceptions. Electronic prescribing of controlled substances is an important tool in improving the safety and quality of patient care, to protect the public via reduction of medication errors, prescription forgery, and controlled substance diversion. Amendment to Section 69 - de-schedule a drug product approved for marketing by the U.S. Food and Drug Administration and which contains cannabidiol derived from cannabis and no more than 0.1 percent tetrahydrocannabinols.

STATUTORY AUTHORITY: Sections 30-31-1 through 30-31-42 NMSA 1978. Paragraph (2) of Subsection (B) of Section 61-11-6 NMSA 1978

16.19.30 NMAC – COMPOUNDING OF NON-STERILE PHARMACEUTICALS: Amendment to Sections 1, 2, and 3 - administrative updates - citation correction, and citation format; Amendment to Section 9 - allow a licensed pharmacy to compound non-sterile, non-controlled substance preparations in reasonable quantities for veterinarian office use. The office use preparation may be dispensed by a veterinarian for a patient under specific conditions, which include: the patient has an emergency condition that the compounded drug is necessary to treat, and timely access to a compounding pharmacy is not available. Up to a five day supply can be dispensed for use in a single course of treatment. Product from an outsourcing facility cannot be dispensed.

STATUTORY AUTHORITY: Paragraph (6) of Subsection (A) of Section 61-11-6 NMSA 1978

Disciplinary Hearing(s): At the time of publication in the NM Register, no disciplinary hearings are scheduled. Final hearing date and time for each case, if any, will be included in the agenda posted to the board’s website at least 72 hours before the meeting.

Executive Director’s Report:

Published in NM Register September 15, 2020

Published in Albuquerque Journal September 15, 2020