Source: http://nmdigital.contentdm.oclc.org/cdm/ref/collection/p267801coll5/id/868/
Timestamp: 2017-06-22 18:34:04
Document Index: 264962082

Matched Legal Cases: ['ART 17', 'art 17', 'ART 30', 'art 30', 'ART 21', 'art 21', 'ART 3', 'art 3', 'ART 12', 'art 12']

Board of Pharmacy minutes (6/5-6/06) :: NM State Documents
Board of Pharmacy minutes (6/5-6/06)	Reference URL
Board of Pharmacy minutes (6/5-6/06)
New Mexico Board of Pharmacy Regular Board Meeting
PLACE AND TIME: The meeting was held at the Pharmacy Board Conference Room at 5200 Oakland Ave., Albuquerque, NM.
CALL TO ORDER: The meeting was called to order by the Vice- Chairman, Amy Buesing, R. Ph., at 9: 05am. The Chairman Woodrow Storey R. Ph. was momentarily delayed until 9: 20am.
MEMBERS PRESENT: Woodrow Storey, R. Ph., Chairman
Danny Cross, R. Ph., Secretary
Amy Buesing, R. Ph., Vice- Chairman
Howard Shaver, Public Member
Brenda Padilla, R. Ph., Member
Rudy Nolasco, R. Ph., Member
Allen Carrier, Public Member
MEMBERS ABSENT: Buffie Saavedra, Public Member
Thomas Ortega, R. Ph. Member
STAFF ATTENDING: Alvin Garcia, Assistant Attorney General
Francine Chavez
William Harvey, Executive Director
Debra Wilhite, Administrative Assistant
Larry Loring, Inspector
Adela Padilla, Inspector
Ben Kesner, Inspector
Bill Weast, Inspector
Mr. Harvey stated that an updated agenda was handed out to all Board members. Mr. Harvey stated the following changes; Under the Executive Director’s Report the following items were added; lettet ” k” for update Wholesale Drug regulation/ NABP, letter “ l” for disposal of property NMBOP, cases numbers 2005- 053, 2005- 100, 2005- 105, 2005- 116, 2005- 122, 2006- 002, 2006- 009, 2006- 010, 2006- 116, 2006- 117, 2006- 119, 2006- 127, 2006- 129, 2006- 130, 2006- 131, 2006- 132, 2006- 133, 2006- 141.
A motion was made by Mr. Shaver, seconded by Mr. Nolasco to approve the agenda with changes. The Board voted unanimously to pass the motion.
APPROVAL OF THE MARCH 13 & 14, 2006 MEETING MINUTES:
Mr. Storey asked if the Board members had any changes to the minutes. Mr. Shaver stated that on page 9 line 50, that the apostrophe after the word inspectors should be removed and on page 12 line 40, that the word “ and” should follow the word duty.
A motion was made by Mr. Shaver, seconded by Mr. Nolasco to approve the minutes for the March 13 & 14, 2006 Board Meeting with the changes as presented. The Board voted unanimously to pass the motion.
APPROVAL OF THE MAY 15, 2006, SPECIAL MEETING MINUTES:
Ms. Buesing asked if the Board members had any changes to the minutes. Mr. Cross stated that he could not see any changes and would like to approve the minutes.
A motion was made by Mr. Cross, seconded by Ms. Padilla to approve the minutes for the May 15, 2006 Special Meeting. The Board voted unanimously to approve the motion.
Mr. Storey introduced Mr. Alvin Garcia as the board’s temporary council from the AG’s office.
Mr. Story asked if all the parties were in attendance for the hearing regarding Kerry Doucet case # 2005- 073. The only one present at the time was council for the board, Francine Chavez. Mr. Storey stated that there were still a few minutes before the hearing starts. The Chairman asked Mr. Harvey if he had any items he’d like to bring up.
Mr. Harvey stated that letters had been sent out to all licensees for drug precursors explaining how the board will no longer license them and the sales are restricted to pharmacies for pseudoephedrine. The letters to pharmacies went out last Friday. Mr. Harvey stated that our website has current information regarding the state and federal requirements. Mr. Harvey stated that the regulation for pseudoephedrine becomes effective June 30, 2006, but the actual effective date is posted as July 1, 2006. Ms. Buesing asked that a follow- up be presented at the next board meeting to discuss any feedback received by the board.
Mr. Harvey stated that there was a letter from the executive director from the California board of Pharmacy that asked for any topics that would like to be presented from the board in October at the district meeting in Anaheim, CA. Please submit your feedback as soon as possible so that they can be forwarded to Patty Harris.
Mr. Nolasco congratulated Mr. Harvey regarding his and the inspector’s involvement in the Target 7 news report that reported on fraud and forgeries that the NMBOP drug diversion unit was battling.
The Chairman called for a 10- minute recess at 9: 30am.
The Chairman reconvened at 9: 40 am.
The Chairman took roll call and stated that Mr. Thomas Ortega and Ms. Buffie Saavedra were absent at this time.
DISCIPLINARY HEARING - CASE # 2005- 083 - KERRY DOUCET:
Bean and Associates were present to record the hearing.
The Chairman asked that the parties identify themselves for the record. Ms Francine Chavez and Mr. Kerry Doucet were present. The witnesses present were Mr. William Harvey and Mr. Jerry Montoya.
After a lengthy discussion between all the parties involved, the Chairman stated that any documents would be entered into evidence and marked accordingly as exhibits. Ms. Francine Chavez gave a closing statement and Mr. Doucet stated that he wanted to thank the board for allowing him to present his case.
The Chairman asked for a motion to go into closed session.
A motion was made by Ms. Padilla, seconded by Ms. Buesing to go into closed session to discuss case # 2005- 083. The board voted unanimously to pass the motion.
The board went into closed session at 10: 25 a. m.
The board went back into open session at 11: 45 a. m.
A motion was made by Mr. Cross, seconded by Ms. Padilla to go back into open session and all that was discussed was case # 2005- 083. The Board voted unanimously to pass the motion.
A motion was made by Mr. Cross, seconded by Mr. Shaver to approve the licensure for Kerry Doucet with the following stipulations; the license will have a five year probation, within that five year period he can not act as the pharmacist in charge, he must notify any employer of his status and those employers must provide an annual report of his performance and any credible information of violations of this agreement or pharmacy laws or regulations will result in a summary suspension of license. The Board voted unanimously to pass the motion. Brenda Padilla voted as opposed.
REGULATION HEARING - 16.19.17 NMAC - DANGEROUS DRUGS:
Mr. Cross read the proposed language with the changes as follows:
This is an amendment to 16.19.17 NMAC, Sections 1, 2, 3, 6, 7, and adding new Section 8, effective 07- 31- 06.
PART 17 DANGEROUS DRUGS and DANGEROUS DRUG RESEARCH
16.19.17.1 ISSUING AGENCY: Regulation and Licensing Department -- Board of Pharmacy, [ 1650 University Blvd, NE - Ste. 400B,] Albuquerque, NM [ 87102, ( 505) 841- 9102] 87113 ( 505) 222- 9830.
[ 02- 15- 1889... 02- 15- 96; 16.19.17.1 NMAC - Rn, 16 NMAC 19.17.1, 03- 30- 02; A, 07- 31- 06]
16.19.17.2 SCOPE: All individuals or entities who sell, dispose of or possess any dangerous drug[.], including institutions of higher education, private organizations, or other applicants who do not possess a pharmacy license, and are not subject to licensure with any professional licensing board or the New Mexico department of health.
[ 02- 15- 96; 16.19.17.2 NMAC - Rn, 16 NMAC 19.17.2, 03- 30- 02; A, 07- 31- 06]]
16.19.17.3 STATUTORY AUTHORITY: Section 26- 1- 18 of the New Mexico Drug, Device and Cosmetic Act, Chapter 26, Article 1 NMSA 1978, authorizes the Board of Pharmacy to promulgate regulations for the efficient enforcement of the Act and to declare, by regulation, a substance a dangerous drug. Section 61- 11- 6. A( 6) NMSA 1978 authorizes the board to provide for the licensing of all places where dangerous drugs are stored, distributed, dispensed or administered and provide for the inspection of the facilities and activities. Section 26- 1- 16. A( 2) NMSA 1978 authorizes the board to license any person to sell, dispose of or possess any dangerous drug. Appropriate records of receipt and disposition must be kept.
[ 02- 15- 96; 16.19.17.3 NMAC - Rn, 16 NMAC 19.17.3, 03- 30- 02; A, 07- 31- 06]
16.19.17.4 DURATION: Permanent.
[ 02- 15- 96; 16.19.17.4 NMAC - Rn, 16 NMAC 19.17.4, 03- 30- 02]
16.19.17.5 EFFECTIVE DATE: February 15, 1996, unless a later date is cited at the end of a section.
[ 02- 15- 96; A, 04- 30- 98; 16.19.17.5 NMAC - Rn, 16 NMAC 19.17.5, 03- 30- 02; A, 07- 15- 2004]
16.19.17.6 OBJECTIVE: The objective of Part 17 of Chapter 19 is to provide notice of the Board's designation of particular substances as dangerous drugs[.] and for the licensure of dangerous drug researchers. A dangerous drug researcher will be allowed to possess dangerous drugs for the purpose of conducting research, including demonstrations or special projects, after receiving approval from the board.
[ 02- 15- 96; 16.19.17.6 NMAC - Rn, 16 NMAC 19.17.6, 03- 30- 02; A, 07- 31- 06]]
16.19.17.7 DEFINITIONS:
[ A. Sympathomimetic means an agent that produces effects similar to those of impulses conveyed by adrenergic fibers of the sympathetic nervous system.]
A. “ Board” means the New Mexico board of pharmacy.
B. “ Dangerous Drug” as defined in the New Mexico Drug, Device and Cosmetic Act 26- 1- 2F.
( 1) The following substance( s) has( have) been declared by the N. M. board of pharmacy as " Dangerous Drugs" in accordance with the Drug, Device and Cosmetic Act 26- 1- 18 NMSA and the Uniform Licensing Act ( 61- 1- 1 to 61- 1- 31 NMSA 1978). The board of pharmacy shall by regulation declare a substance a " dangerous drug" when necessary and notification shall be sent to all registered pharmacies in the state within sixty days of the adoption of the regulation. Ephedrine, USP, as ephedrine hydrochloride or ephedrine sulfate or as any other salt form. Any compound, mixture, or preparation containing one- half percent ( 0.5%) or less of ephedrine or of any salt form of ephedrine is exempt from the above. The following drug products containing ephedrine, USP, as ephedrine hydrochloride or ephedrine sulfate are exempted from this schedule: Bronkaid ® Caplets and Primatene ® Tablets. These products are exempt because they are approved for sale over the counter without a prescription under
federal law, are labeled and marketed in a manner consistent with the pertinent OTC tentative final or final monograph, are manufactured and distributed for legitimate medical use in a manner that reduces or eliminates the likelihood for abuse, and are not marketed, advertised or labeled for an indication of stimulation, mental alertness, energy, weight loss, appetite control, or muscle enhancement.
( 2) A dangerous drug shall be dispensed only upon the prescription of a practitioner licensed by law to administer or prescribe such drug.
C. “ Drug storage area” means the area restricted to the storage, dispensing and distribution of dangerous drugs.
D. “ Research protocol” is the written documentation stating the objective, method, means of measurement, and utilization procedure of the dangerous drug.
[ 04- 19- 92; 16.19.17.7 NMAC - Rn, 16 NMAC 19.17.7, 03- 30- 02; A, 07- 15- 2004; A, 07- 31- 06]]
16.19.17.8 RESEARCH LICENSING REQUIREMENTS:
A. Authorized persons to be licensed: public agencies, institutions of higher education and private organizations, or individuals for the purpose of conducting research, demonstration or special projects with the use of a dangerous drug.
B. The person applying for licensure must fill out a license for dangerous drug research application prior to purchasing any dangerous drug. The applicant must provide information pertinent to the research including:
( 1) persons who will be involved in handling of dangerous drug:
( a) name, address, date of birth, and if they have been convicted of a felony;
( 2) drug protocol:
( a) formulary of dangerous drugs for research;
( b) how will the dangerous drug be utilized;
( c) how much of the dangerous drug will be used for each administered dose or experiment;
( d) how much drug will be purchased annually.
( 3) policy and procedure manual including:
( a) drug security: storage area, list of individuals with access to dangerous drugs;
( b) drug procurement: invoices, receipts, and drug sources;
( c) drug usage: records or logs for accountability;
( d) drug waste/ destruction: memorandum report describing accountability;
( e) drug storage area;
( f) research protocol: proprietary or trade secrets are confidential and not subject to public disclosure.
( 4) qualifications of the applicant to conduct such research with dangerous drugs which may include:
( a) degrees;
( b) higher education;
( c) specialized training.
C. The board will review all applicants for licensure for consistency with the public’s best interest.
[ 16.19.17.8 NMAC - N, 07- 31- 06]
HISTORY OF 16.19.17 NMAC:
Pre- NMAC History: The material in this part was derived from that previously filed with the state records center and archives:
Regulation No. 17, Dangerous Drugs, filed 3- 19- 92.
History of Repealed Material: [ RESERVED]
Regulation No. 17, Dangerous Drugs ( filed 3- 19- 92) renumbered, reformatted and replaced by 16 NMAC 19.17, Pharmacists - Dangerous Drugs, effective 02- 15- 96.
16 NMAC 19.17, Pharmacists - Dangerous Drugs ( filed 02- 02- 96) renumbered and replaced by 16.19.17 NMAC, Dangerous Drugs, effective 03- 30- 2002.
Changes were made during the Board meeting on the overhead projector and will be formatted based on the New Mexico Administrative Code. ( 161917WH03- 02- 06)
A motion was made by Mr. Cross, seconded by Ms. Padilla to approve the rule as amended. The Board voted unanimously to pass the motion.
The Chairman asked to include the attendance sheet as exhibit # 3.
The Chairman asked to recess for lunch at 12: 12 p. m.
RECONVENE MONDAY JUNE 5, 2006:
The Chairman reconvened at 1: 51 p. m.
FINAL DRAFT OF 16.19.30 NAMC - COMPOUNDING OF NON- STERILE PHARMACEUTICALS:
The board briefly discussed the final draft that would be submitted for filing.
PART 30 COMPOUNDING OF NON- STERILE PHARMACEUTICALS
16.19.30.1 ISSUING AGENCY: Regulation and Licensing Department - Board of Pharmacy
[ 16.19.30.1 NMAC - N, 07- 31- 06]
16.19.30.2 SCOPE: All pharmacies as defined in 61- 11- 2 ( S), ( Y) NMSA 1978, and all persons or entities that own or operated, or are employed by a pharmacy for the purpose of providing pharmaceutical products or services.
[ 16.19.30.2 NMAC - N, 07- 31- 06]
16.19.30.3 STATUTORY AUTHORITY: Sections 61- 11- 9( A)( 6) NMSA 1978 requires that the board of pharmacy provide for the licensing or retail pharmacies and nonresident pharmacies and for the inspection of their facilities and activities.
[ 16.19.30.3 NMAC - N, 07- 31- 06]
16.19.30.4 DURATION: Permanent
[ 16.19.30.4 NMAC - N, 07- 31- 06]
16.19.30.5 EFFECTIVE DATE: 07- 31- 06, unless a later date is cited at the end of a section.
[ 16.19.30.5 NMAC - N, 07- 31- 06]
16.19.30.6 OBJECTIVE: The objective of part 30 of chapter 19 is to provide standards for the compounding of non- sterile pharmaceuticals. Pharmacies compounding non- sterile pharmaceuticals shall comply with the requirements of this section in addition to all provisions for their specific license classification.
[ 16.19.30.6 NMAC - N, 07- 31- 06]
16.19.30.7 DEFINITIONS: In addition to the definitions for specific license classifications, the following words and terms, when used in this section, shall have the following meanings unless the context clearly indicates otherwise.
A. “ Beyond- use date” the date after which a compounded preparation should not be used and is determined from the date the preparation was compounded. 6
B. “ Component” any ingredient intended for use in the compounding of a drug product, including those that may not appear in such product labeling.
C. “ Compounding” the preparation, mixing assembling, packaging, or labeling of a drug or device ( reconstitution of commercial products is not considered compounding for purposes of this article).
( 1) as the result of a practitioner’s prescription order, based on the practitioner- patient- pharmacist relationship in the course of professional practice;
( 2) preparing limited quantities of prescription orders based upon a history of receiving valid prescriptions issued within an established practitioner- patient- pharmacist relationship in the course of professional practice;
( 3) reconstitution of commercial products not considered compounding for purpose of this article. D. “ FDA” Food and Drug Administration.
E. “ SOP’s” standard operating procedures.
F. “ USP/ NF” the current edition of the United States Pharmacopeia/ National Formulary.
[ 16.19.30.7 NMAC - N, 07- 31- 06]
16.19.30.8 PERSONNEL:
A. Pharmacist- in- charge. The pharmacist- in- charge shall have the responsibility for, at a minimum, the following concerning non- sterile compounding:
( 1) determining that all personnel involved in non- sterile compounding possess the education, training, and proficiency necessary to properly and as safely perform compounding duties undertaken or supervised;
( 2) determining that all personnel involved in non- sterile compounding obtain continuing education appropriate for the type of compounding done by the personnel;
( 3) assuring that the equipment used in compounding is properly maintained;
( 4) maintaining an appropriate environment in the area where non- sterile compounding occurs and;
( 5) assuring that effective quality control procedures are developed and followed.
B. Pharmacists. Special requirements for non- sterile compounding.
( 1) All pharmacists engaged in compounding shall:
( a) possess the education, training and proficiency necessary to properly and safely perform compounding duties undertaken or supervised and;
( b) obtain continuing education for the type of compounding done by the pharmacist.
( 2) A pharmacist shall inspect and approve all components, drug product containers, closures, labeling and any other material involved in the compounding process.
( 3) A pharmacist shall review all compounding records for accuracy and conduct in- process and final checks to assure that errors have not occurred in the compounding process.
( 4) A pharmacist is responsible for the proper maintenance, cleanliness and use of all equipment used in the compounding process,
C. Pharmacy technicians. All technicians engaged in compounding shall:
( 1) possess the education, training and proficiency necessary to properly and safely perform compounding duties undertaken;
( 2) obtain continuing education for the type of compounding done by the pharmacy technician and;
( 3) perform compounding duties under the direct supervision of and responsible to a pharmacist.
( 1) All personnel involved in non- sterile compounding shall be trained and must participate in continuing relevant training programs.
[ 16.19.30.8 NMAC - N, 07- 31- 06]
16.19.30.9 OPERATIONAL STANDARDS:
( 1) Non- sterile drug products may be compounded in licensed pharmacies as a result of a practitioner’s prescription order based on the practitioner- patient- pharmacist relationship in the course of professional practice.
( 2) Preparing limited quantities of prescription drug orders in anticipation based upon a history of receiving valid prescriptions issued within an established practitioner- patient- pharmacist relationship in the course of professional practice.
( a) The beyond- use date should be based on the criteria outlined in USP Chapter &lt; 795&gt;.
( b) Any product compounded in anticipation of future prescription drug or medication orders shall be labeled. Each label shall contain:
( i) name and strength of the compounded medication or list of the active ingredient and strengths:
( ii) facility’s lot number;
( iii) beyond- use date
( iv) quantity or amount in the container.
( 3) Commercially available product may be compounded for dispensing to individual patients provided the following conditions are met:
( a) the commercial product is not reasonably available from normal distribution channels in a timely manner to meet patient’s needs and;
( b) the prescribing practitioner has requested that the drug be compounded, or
( c) if the compounded product is changed to produce for that patient a significant difference, as authorized by the prescriber, between the compounded drug and the comparable commercially available drug product, or if use of the compounded product is in the best interest of the patient. “ Significant difference” would include the removal of a dye for medical reason such as an allergic reaction. When a compounded product is to be dispensed in place of a commercially available product, the prescriber and patient shall be informed that the product will be compounded.
( 4) Compounding for a prescriber’s office use:
( a) Pharmacies may prepare compounding drug products for a duly authorized prescriber’s office use.
( b) An order by the duly authorized prescriber, indicating the formula and quantity ordered will be filed in the pharmacy.
( c) The product is to be administered in the office.
( d) A record of the compounded drug product may be kept as a prescription record in the pharmacy computer or hard- copy record.
( e) A label may be generated and a number assigned by the pharmacy computer for the compounded drug product.
( 5) Compounding veterinarian products:
( a) Prescriptions for animals may be compounded based on an order or prescription from a duly authorized veterinarian.
( b) These prescriptions are to be handled and filled the same as the human prescriptions.
( 6) Compounding pharmacies/ pharmacists may advertise and promote the fact that they provide non- sterile prescription compounding services which may include specific drug products and classes of drugs.
( 1) Pharmacies regularly engaging in compounding shall have a designated and adequate area for the safe and orderly compounding of drug products including the placement of equipment and materials. Pharmacies involved in occasional compounding shall prepare an area prior to each compounding activity, which is adequate for safe and orderly compounding.
( 2) Only personnel authorized by the responsible pharmacist shall be in the immediate vicinity of a drug compounding operation.
( 3) A sink with hot and cold running water, exclusive of rest room facilities, shall be accessible to the compounding areas and be maintained in a sanitary condition.
( 4) When drug products that require special precautions to prevent contamination, such as penicillin, are involved in a compounding operation, appropriate measures, including dedication of equipment for such operations or the meticulous cleaning of contaminated equipment prior to its’ use for the preparation of other drug products, must be used in order to prevent cross- contamination.
C. Equipment and Supplies. The pharmacy shall:
( 1) have a Class A prescription balance, or analytical balance and weights when necessary which shall be properly maintained and subject to inspection by the New Mexico board of pharmacy and;
( 2) have equipment and utensils necessary for the proper compounding of prescription or medication drug orders. Such equipment and utensils used in the compounding process shall be:
( a) of appropriate design and capacity, and be operated within designated operational limits;
( b) of suitable composition so that surfaces that contact components, in- process material or drug products shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality or purity of the drug product beyond the desired result;
( c) cleaned and sanitized appropriately prior to each use and;
( d) routinely inspected, calibrated when necessary or checked to ensure proper performance.
D. Labeling. In addition to the labeling requirements of the pharmacy’s specific license classification, the label dispensed or distributed pursuant to a prescription or medication drug order shall contain the following:
( 1) The generic name( s) or the designated name and the strength of the compounded preparation.
( 2) The quantity dispensed.\;
( 3) The date on which the product was compounded;
( 4) A lot or batch number, and
( 5) The beyond- use date after which the compounded preparation should not be used.
( a) In the absence of stability information applicable for a specific drug in the USP/ NF the preparation shall adhere to the following maximum beyond- use date guidelines:
( i) Non- aqueous liquids and solid formulations ( where the manufactured drug product is the source of active ingredient) 25% of the time remaining until the manufacturer’s product’s expiration date or six ( 6) months, whichever is earlier.
( ii) Water- containing formulations ( prepared from ingredients in solid form) not later than fourteen ( 14) days when refrigerated between 2- 8 degrees Celsius or 36- 46 degrees Fahrenheit.
( iii) All other formulations: Intended duration of therapy or 30 days, whichever is earlier.
( b) Beyond- use date limits may be exceeded when supported by valid scientific stability information for the specific compounded preparation.
E. Drugs, components and material used in non- sterile compounding.
( 1) Drugs used in non- sterile compounding shall preferably be a USP/ NF grade substance manufactured in a FDA registered facility.
( 2) In the event that USP/ NF grade substances are not available, documentation of stability and purity must be established and documented.
( 3) A pharmacy may not compound a drug product which has been withdrawn or removed from the market for safety reasons.
F. Compounding Process.
( 1) The safety, quality and performance of compounded prescriptions depend on correct ingredients and calculations, accurate and precise measurements, appropriate formulation conditions and procedures, and prudent pharmaceutical judgment. Each pharmacy shall develop and follow written SOP’s based on established compounding procedures as outlined in Chapter 795 of the USP/ NF concerning Pharmacy Compounding of Non- Sterile Preparations designed to ensure accountability, accuracy, quality, safety, and uniformity in the compounding process.
G. Quality Control.
( 1) The safety, quality, and monitoring is used to insure that the output of compounded drug products for uniformity and consistency such as capsule weight variations, adequacy of mixing, clarity or pH of solutions are met. When developing these procedures, pharmacy personnel shall consider the provisions of Chapter 795 of the USP/ NF concerning Pharmacy Compounding of Non- Sterile preparations, Chapter 1075 of the USP/ NF concerning Good Compounding Practices, and Chapter 1160 of the USP/ NF concerning Pharmaceutical Calculations in Prescription Compounding. Such procedures shall be documented and be available for inspection.
( 2) Compounding procedures that are routinely performed, including batch compounding, shall be completed and verified according to written procedures. The act of verification of a compounding procedure involves checking to ensure that calculations, weighing and measuring, order of mixing, and compounding techniques were appropriate and accurately performed.
( 3) Unless otherwise indicated or appropriate, compounded preparations are to be prepared to ensure that each preparation shall contain not less than 90.0 percent and not more than 110.0 percent of the theoretically calculated and labeled quantity of active ingredient per unit volume and not less than 90.0 percent and not more than 110.0 percent of the theoretically calculated weight or volume per unit of the preparation.
[ 16.19.30.9 NMAC - N, 07- 31- 06]
16.19.30.10 RECORDS:
A. Maintenance of records. Every record required by this section shall be kept by the pharmacy for at least three ( 3) years.
B. Compounding records: 9
( 1) Formulation records:
( a) provides a consistent source document for preparing the preparation ( recipe);
( b) is a file of individual compounded preparations;
( c) must list the name, strength, and dosage form of the preparation compounded;
( d) must list all ingredients and their quantities;
( e) must list equipment needed to prepare the preparation, when appropriate, and mixing instructions;
( f) other environmental controls, such as the duration of mixing and other factors pertinent to the replication of the preparation as compounded, and:
( g) must contain beyond- use date and methodology, the container used in dispensing, the storage requirements, and any quality control procedures.
( 2) Compounding records:
( a) document the actual ingredients in the preparation and the person responsible for the compounding activity;
( b) contain the name and strength of the compounded preparation, the formulation record reference for the preparation, and the sources and lot numbers of the ingredients;
( c) contain information on the total number of dosage units compounded, the name of the person who prepared the preparation and the name of the pharmacist who approved the preparation;
( d) contain the date of the preparation, the assigned internal identification number or the prescription number and an assigned beyond- use date, and;
( e) for all compounded preparations, results of quality control procedures are to be recorded.
[ 16.19.30.10 NMAC - N, 07- 31- 06]
Changes were made during the Board meeting on the overhead projector and will be formatted based on the New Mexico Administrative Code. ( 161930RN/ DC/ LL11- 14- 05)
PROPOSED CHANGES TO 16.19.. 21 NMAC - DRUG PRECURSORS:
Mr. Cross read the proposed language with changes as follows:
PART 21 DRUG PRECURSORS
16.19.21.1 ISSUING AGENCY: Regulation and Licensing Department - Board of Pharmacy, Albuquerque, NM.
[ 02- 14- 1889... 02- 15- 96; 16.19.21.1 NMAC - Rn, 16 NMAC 19.21.1, 03- 30- 02; A, 01- 15- 2005]
16.19.21.2 SCOPE: All individuals and entities that manufacture, possess, transfer, or transport drug precursors.
[ 02- 15- 96; 16.19.21.2 NMAC - Rn, 16 NMAC 19.21.2, 03- 30- 02]
16.19.21.3 STATUTORY AUTHORITY: Pursuant to 30- 31B- 6 of the Drug Precursor Act, 30- 31B- 1 through 30- 31- B- 18 NMSA 1978, the Board of Pharmacy may promulgate regulations and charge reasonable fees relating to the licensing and control of the manufacture, possession, transfer and transportation of drug precursors. Section 30- 31B- 4 NMSA 1978 authorizes the Board to add substances to the list of precursors enumerated in the Drug Precursor Act.
[ 02- 15- 96; 16.19.21.3 NMAC - Rn, 16 NMAC 19.21.3, 03- 30- 02]
16.19.21.4 DURATION: Permanent.
[ 02- 15- 96; 16.19.21.4 NMAC - Rn, 16 NMAC 19.21.4, 03- 30- 02]
16.19.21.5 EFFECTIVE DATE: February 15, 1996, unless a different date is cited at the end of a Section or Paragraph. This Part reformatted for inclusion into the New Mexico Administrative Code ( NMAC) effective 2- 15- 96.
[ 02- 15- 96, A, 04- 30- 98; 16.19.21.5 NMAC - Rn, 16 NMAC 19.21.5, 03- 30- 02] 10
16.19.21.6 OBJECTIVE: The objective of Part 21 of Chapter 19 is to protect the public health and welfare of the citizens of New Mexico by establishing effective controls against unlawful diversion of drug precursors.
[ 02- 15- 96; 16.19.21.6 NMAC - Rn, 16 NMAC 19.21.6, 03- 30- 02]
16.19.21.7 DEFINITIONS: [ RESERVED]
[ 02- 15- 96; 16.19.21.7 NMAC - Rn, 16 NMAC 19.21.7, 03- 30- 02]
16.19.21.8 PERSONS REQUIRED TO REGISTER:
A. The board shall license an applicant to manufacture, possess, transfer or transport drug precursors unless it determines that the issuance of that license would be inconsistent with the public interest. In determining the public interest, 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 manufacturer, 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; and
( 7) any other factors relevant to and consistent with the public health and safety.
B. Licensing under this section does not entitle a licensee to manufacture, possess, transfer or transport drug precursors other than those allowed in the license.
C. Entities currently licensed by the board shall be exempt from this registration, but not exempt from the regulation.
[ 03- 07- 80... 08- 27- 90; 16.19.21.8 NMAC - Rn, 16 NMAC 19.21.8, 03- 30- 02; A, 01- 15- 2005]
16.19.21.9 REGISTRATION AND EXPIRATION DATE:
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.
[ 03- 07- 80... 08- 27- 90; 16.19.21.9 NMAC - Rn, 16 NMAC 19.21.9, 03- 30- 02; A, 01- 15- 2005]
16.19.21.10 REGISTRATION FEE: The registration fee or annual renewal fee required by the Drug Precursor Act shall be:
A. for a wholesaler, manufacturer, or distributor shall be $ 250.00 per year;
B. for a retail distributor with fewer than 10 employees shall be $ 25.00 per year;
C. for a retail distributor with 10 or more employees shall be $ 50.00 per year.
[ 03- 07- 80... 08- 27- 90; 16.19.21.10 NMAC - Rn, 16 NMAC 19.21.10, 03- 30- 02; A, 01- 15- 2005]
16.19.21.11 APPLICATION FORMS: Application forms may be obtained from the Board of Pharmacy.
[ 03- 07- 80... 08- 27- 90; 16.19.21.11 NMAC - Rn, 16 NMAC 19.21.11, 03- 30- 02]
16.19.21.12 SEPARATE REGISTRATION OF EACH PRINCIPLE PLACE OF BUSINESS: 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 the different locations.
[ 03- 07- 80... 08- 27- 90; 16.19.21.12 NMAC - Rn, 16 NMAC 19.21.12, 03- 30- 02]
16.19.21.13 INFORMATION REQUIRED: Each application shall include all information as required on the application form and shall be signed by the applicant.
[ 03- 07- 80... 08- 27- 90; 16.19.21.13 NMAC - Rn, 16 NMAC 19.21.13, 03- 30- 02]
16.19.21.14 FACILITY INSPECTION: The board of pharmacy may direct the drug inspector to inspect the facilities prior to approval of any registration application filed under this part of any wholesaler, manufacturer, or distributor, for security provisions and other applicable standards as required by the Drug Precursor Act or regulations passed by the board. A fee of $ 150.00 must be submitted before such inspection of any wholesaler, manufacturer, or distributor.
[ 03- 07- 80... 08- 27- 90; 16.19.21.14 NMAC - Rn, 16 NMAC 19.21.14, 03- 30- 02; A, 01- 15- 2005]
16.19.21.15 PROCEDURE SUMMARY: A scientific investigator or research applicant shall submit a summary of procedures indicating the nature, extent and duration of such research. This summary shall include, but is not limited to, the names of individuals engaged in the project, the name or names of the precursor substances to be used, safeguards to be used against diversion, the source of supply of substances, record keeping and forms to be used in receipt, use, and destruction of precursor substances.
[ 03- 07- 80... 08- 27- 90; 16.19.21.15 NMAC - Rn, 16 NMAC 19.21.15, 03- 30- 02]
16.19.21.16 ANALYTICAL LABORATORIES:
A. Analytical laboratory applicants shall submit 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.
B. Quantities of drug precursors in possession of analytical laboratories shall be limited to such quantities as required for reference standards, assays, or other analytical scientific purposes.
[ 03- 07- 80... 08- 27- 90; 16.19.21.16 NMAC - Rn, 16 NMAC 19.21.16, 03- 30- 02]
16.19.21.17 EXEMPTION OF LAW ENFORCEMENT OFFICIALS: Registration is waived for the following persons:
A. 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 federal, state and local law relating to drug precursors and is duly authorized to possess drug precursors in the course of his official duties.
B. Any official exempted by this section may procure any drug precursor in the course of an inspection pursuant to any section of the Drug Precursor Act or in the course of any criminal investigation involving the person from whom the substance was procured.
C. Laboratory personnel, when acting in the scope of his official duties, are also exempt from registration under the Drug Precursor Act.
[ 03- 07- 80... 08- 27- 90; 16.19.21.18 NMAC - Rn, 16 NMAC 19.21.18, 03- 30- 02]
16.19.21.18 TRANSFER AND TERMINATION OF REGISTRATION:
A. Registration shall terminate if and when a registrant dies, discontinues business or professional practice, has his professional license revoked or suspended, or changes his name or address as shown on the registration. In such instance, the registrant or his estate shall notify the Board of Pharmacy promptly of such fact and return certificate of registration to the Board.
B. Inventories and records of drug precursors shall be maintained separately from all other records or in such form that the information is readily retrievable from ordinary business records of the registrant.
C. In the event of a change in name or address, the registrant shall file an application in the same manner as an application for a new registration. No fee shall be required for such modification.
D. Registration under the Drug Precursor Act is not transferable.
16.19.21.19 INVENTORY RECORDS: All registrants are required to keep procurement records in a readily retrievable manner for 3 years.
[ 03- 07- 80... 08- 27- 90; 16.19.21.19 NMAC - Rn, 16 NMAC 19.21.19, 03- 30- 02; A, 01- 15- 2005]
16.19.21.20 ORDER FORMS ( INVOICES) AS RECORDS: Order forms ( invoices) for drug precursors shall be deemed proper records of receipt if the purchaser records on their copy the number of commercial or bulk containers furnished of each item, the date received and the name of person receiving the order.
[ 03- 07- 80... 08- 27- 90; 16.19.21.20 NMAC - Rn, 16 NMAC 19.21.20, 03- 30- 02]
16.19.21.21 PROCUREMENT RECORDS: Procurement records, and all other records, must be kept at the registered location and must be available for inspection.
[ 03- 07- 80... 08- 27- 90; 16.19.21.21 NMAC - Rn, 16 NMAC 19.21.21, 03- 30- 02]
16.19.21.22 REPORT OF LOSS OR THEFT OF A DRUG PRECURSOR: A significant loss or theft of a drug precursor shall be reported in writing to the Board of Pharmacy. " Significant loss" includes suspected diversions, in- transit losses or any other unexplained loss.
[ 03- 07- 80... 08- 27- 90; 16.19.21.22 NMAC - Rn, 16 NMAC 19.21.22, 03- 30- 02]
16.19.21.23 DISTRIBUTION RECORDS:
A. All wholesaler, manufacturer, or distributor registrants shall include the following in distribution records for drug precursors under this part:
( 1) purchaser's name, address and telephone number, and drug precursor registration number or other license number issued by the board in lieu of a drug precursor registration number;
( 2) quantity purchased;
( 3) date supplied;
( 4) suppliers name, address, telephone number, and drug precursor registration number or other license number issued by the board in lieu of a drug precursor registration number;
( 5) distribution records must be retained for three ( 3) years.
B. All retail distributor registrants, pharmacies, hospitals and clinics shall adhere to the following record keeping and distribution requirements concerning pseudoephedrine or pseudoephedrine containing products regulated by the board:
( 1) that a retail distributor registrant, pharmacies, hospitals and clinics shall transfer ( sell) no more than 2 blister packages not to exceed 6 grams of pseudoephedrine to any one individual in a single transaction and may not knowingly or intentionally transfer cumulative total exceeding 2 blister packages or 6 grams of pseudoephedrine during any seven day period to that one individual;
( 2) that a retail distributor registrant, pharmacies, hospitals and clinics must place all products regulated by the board in direct sight of an employee of the facility and no more than 20 feet from a checkout or in a locked case accessible only by employee or by adhering to the following alternative security measures:
( a) all packages of any drug having a single active ingredient of pseudoephedrine or any of its salts, optical isomers, or salts of optical isomers, shall be displayed behind a store counter , in an area not accessibleto customers, or shall display those products in a locked case so that customers wanting access to the product must receive seller assistance;
( b) except as provided in subparagraph ( a) all packages of any drug having pseudoephedrine as an active ingredient of or any of its salts, optical isomers, or salts of optical isomers, can be displayed so that customers wanting access to the product can do so under the following circumstances:
( i) a reliable anti- theft device that uses special package tags and detection alarms designed to prevent theft of product from the place of business is employed; at a minimum, one ( 1) of every four ( 4) packages must be tagged in this manner;
( ii) packages are kept under constant video surveillance in a manner that satisfies the following conditions; a video camera must be positioned so that the area where the products are displayed are visible; any recording must have the capability to allow video image playback in real time format; these images must be preserved for a minimum of twenty- one ( 21) days; these images must be available to law enforcement authorities within 72 hours upon request; and a sign must be posted in a prominent manner stating the following, " For your protection, New Mexico Board of Pharmacy Regulations require that certain products containing pseudoephedrine be displayed in an area under constant video surveillance"; lettering on the sign must measure at least 1 inch in height;
( c) nothing in this section shall prevent board staff from requiring additional security requirements, as prescribed in subparagraph ( a), of any pseudoephedrine preparation product that is found in an illegal laboratory; the board shall give the retail distributor registrants, pharmacies, hospitals and clinics adequate notice of such a requirement and twenty- one ( 21) days from the time of notification to comply with change.
( 3) that a retail distributor registrant, pharmacies, hospitals and clinics owner or manager must develop a written or electronic training program, to be read and signed ( written or electronic) by all employees involved in the sale of regulated products that makes the employee aware of all statutes and regulations concerning the sale of regulated products; 13
( 4) that a retail distributor registrant, pharmacies, hospitals and clinics will retain all invoices of purchases of regulated products in a readily retrievable manner for a period of three ( 3) years;
( 5) that a retail distributor registrant, pharmacies, hospitals and clinics will purchase regulated products only from wholesalers, manufacturers, or distributors registered to distribute drug precursors or otherwise licensed with the board.
[ 03- 07- 80... 08- 27- 90; 16.19.21.23 NMAC - Rn, 16 NMAC 19.21.23, 03- 30- 02; A, 01- 15- 2005; A, 09- 30- 2005]
16.19.21.24 DISPOSITION OF DAMAGED, OUTDATED, OR UNWANTED DRUG PRECURSORS: Any registrant in possession of any drug precursor and desiring to dispose of such substance must abide by any applicable federal, state, local law or regulation for the destruction of such substance. This destruction must be witnessed by at least one law enforcement officer certified in the State of New Mexico. Appropriate records must be kept of the destruction.
[ 03- 07- 80... 08- 27- 90; 16.19.21.24 NMAC - Rn, 16 NMAC 19.21.24, 03- 30- 02]
16.19.21.25 DISTRIBUTION UPON TRANSFER OR DISCONTINUANCE OF BUSINESS:
A. Upon transfer of a business from one owner to another, the owner may dispose of the drug precursors in the following manner:
( 1) have the drug precursor destroyed as discussed in 16.19.21.24 NMAC;
( 2) transfer the drug precursors to the new owner. All records required to be kept by the registrant- transferor with reference to the drug precursors being transferred shall be transferred to the registrant- transferee. Responsibility for the accuracy of records prior to the date of transfer remains with the transferor, but responsibility for custody and maintenance shall be upon the transferee.
B. Upon discontinuance of business, if there are drug precursors which are not transferred to another registrant, these substances shall be handled as unwanted drug precursors under 16.19.21.24 NMAC.
[ 03- 07- 80... 08- 27- 90; 16.19.21.25 NMAC - Rn, 16 NMAC 19.21.25, 03- 30- 02]
16.19.21.26 SECURITY REQUIREMENTS:
A. All applicants and registrants shall provide effective controls and procedures to guard against theft and diversion of drug precursors.
B. In evaluating the overall security system of a registrant or applicant, the following factors may be considered:
( 1) the type of activity;
( 2) the quantity of drug precursors;
( 3) the location of premises and the relationship such location plays on security needs;
( 4) the type of building construction of the facility and the general characteristic of the building;
( 5) the adequacy of key control systems and/ or lock control systems;
( 6) the extent of unsupervised public access to the facility;
( 7) the adequacy of supervision over employees having 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 registrant's or applicant's system for monitoring the receipt, manufacture, distribution and disposition of drug precursors in its' operation.
[ 03- 07- 80... 08- 27- 90; 16.19.21.26 NMAC - Rn, 16 NMAC 19.21.26, 03- 30- 02]
16.19.21.27 HEARINGS, DENIAL OF REGISTRATION, REVOCATION OR SUSPENSION OF REGISTRATION: Proceedings to suspend or revoke a registration or to refuse renewal of a registration shall be held pursuant to the Uniform Licensing Act.
[ 03- 07- 80... 08- 27- 90; 16.19.21.27 NMAC - Rn, 16 NMAC 19.21.27, 03- 30- 02]
16.19.21.28 ADMINISTRATIVE INSPECTION - DEFINED: Administrative inspection means: the inspection of any place where registrants are permitted to hold, manufacture, compound, process, sell, deliver, transport, or otherwise dispose of any drug precursors. When authorized by an administrative inspection warrant, the inspector may:
A. inspect and copy records required by the Drug Precursor Act;
B. inspect the restricted area and all pertinent equipment, all containers, substances, and labeling found at the controlled area;
C. make a physical inventory of the specific items or all drug precursors on hand at the premises;
D. collect samples, if applicable;
E. check records and information of distribution of substances by the registrant as they relate to total distribution;
F. examination of records, invoices, appropriate for verification of the records or otherwise bearing on the provisions of the Drug Precursor Act.
[ 03- 07- 80... 08- 27- 90; 16.19.21.28 NMAC - Rn, 16 NMAC 19.21.28, 03- 30- 02]
16.19.21.29 VOLUNTARY CONSENT TO INSPECTION: The Board inspector will ask the registrant to voluntarily consent to the inspection. He will inform the registrant of his constitutional rights to an inspection warrant. However, if the registrant consents to inspection without warrant, the inspector will obtain a signed consent waiver statement from the registrant before proceeding with an accountability audit or inspection.
[ 03- 07- 80... 08- 27- 90; 16.19.21.29 NMAC - Rn, 16 NMAC 19.21.29, 03- 30- 02]
16.19.21.30 WRITTEN CONSENT:
A. The written consent shall contain the following information:
( 1) that the owner, or agent in charge of the premises has been informed of his constitutional rights not to have an administrative inspection made without an administrative inspection warrant;
( 2) of his right to refuse to consent to such an inspection;
( 3) of the possibility that anything of an incriminating nature which may be found may be seized and used against him in a Board hearing or a criminal prosecution;
( 4) that he had been presented with a notice of inspection;
( 5) that the consent given by him is voluntary and without threats of any kind; and
( 6) that he may withdraw his consent at any time during the course of inspection.
B. Written consent shall be produced in duplicate and one copy shall be retained by the person being inspected and one copy shall be retained by the inspector for filing in the Board office.
[ 03- 07- 80... 08- 27- 90; 16.19.21.30 NMAC - Rn, 16 NMAC 19.21.30, 03- 30- 02]
16.19.21.31 ADMINISTRATIVE WARRANT:
A. A copy of the administrative warrant need not be given to the registrant unless items are seized or confiscated.
B. To serve the warrant, all that is required, is to announce possession of it, the contents of the warrant need not e stated to the person upon whom the warrant is served.
[ 03- 07- 80... 08- 27- 90; 16.19.21.31 NMAC - Rn, 16 NMAC 19.21.31, 03- 30- 02]
16.19.21.32 CONSENT: Unless the person in charge of the premises so consents in writing, these regulations shall not extend to financial data; pricing data; or sales data other than shipping dates.
[ 03- 07- 80... 08- 27- 90; 16.19.21.32 NMAC - Rn, 16 NMAC 19.21.32, 03- 30- 02]
16.19.21.33 ADMINISTRATIVE WARRANT - NOT REQUIRED: An administrative warrant shall not be required for a new facility applying for initial registration under the Drug Precursor Act, or in any situation where a warrant is not constitutionally required.
[ 03- 07- 80... 08- 27- 90; 16.19.21.33 NMAC - Rn, 16 NMAC 19.21.33, 03- 30- 02]
16.19.21.34 ADMINISTRATIVE WARRANT - REFUSAL: If a registrant or any person subject to the Drug Precursor Act refuses to permit execution of an administrative warrant or impedes the inspection in the execution of that warrant, he shall be advised that such refusal or action constitutes a violation of the Drug Precursor Act.
[ 03- 07- 80... 08- 27- 90; 16.19.21.34 NMAC - Rn, 16 NMAC 19.21.34, 03- 30- 02]
16.19.21.35 CONTROLLED SUBSTANCE PRECURSORS: The following substances are designated as immediate precursors used in the manufacture of controlled substances:
A. phenyl acetone;
B. ephedrine;
C. phenyl- 2- propanone;
D. norephedrine; 15
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- trimethoxyphenylacetonitraile;
K. 3,4,5- trimethoxybenzoic acid amide;
L. 4- benzyloxyindole;
M. 4- chloro indole;
N. indole;
O. tryntophol;
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 single ingredient solid oral dosage form and any combination solid oral dosage form containing pseudoephedrine excluding liquid products including liquid gel products for oral administration, inhalation, injection, any product intended for pediatric use, and any solid oral dosage form for which the manufacturer of said product presents scientific evidence to the board verifying that the product cannot be converted into a controlled substance; as a substance in a form not approved in 26- 1- 14 NMSA.
X. methylamine;
Y. methylformamide
Z. phenylacetic acid;
AA. anhydrous ammonia:
( 1) a person shall not possess any amount of anhydrous ammonia;
( 2) a person must store anhydrous ammonia in a container approved for the transport of anhydrous ammonia;
( 3) the provisions of this section do not apply to a:
( i) person who is actively operating land used for agricultural purposes;
( ii) retail distributor;
( iii) wholesaler;
( iv) manufacturer;
( v) warehouseman;
( vi) common carrier; or
( vii) person engaged in the regular course of conducting a lawful business;
BB. red phosphorous;
CC. iodine matrix, a retail distributor registrant, pharmacy, hospital, clinic may not sell more than 2 ounces of iodine matrix in a single transaction;
DD. crystal iodine, a retail distributor registrant, pharmacy, hospital, clinic may not sell more than 2 ounces of iodine crystals in a single transaction.
[ 03- 07- 80… 08- 27- 90; 16.19.21.35 NMAC - Rn, 16 NMAC 19.21.35, 03- 30- 02; A, 12- 01- 03; A, 01- 15- 2005]
HISTORY OF 16.19.21 NMAC:
Regulation No. 21, Drug Precursors, 8- 28- 89.
Regulation No. 21, Drug Precursors, 7- 27- 90.
Other History: 16 NMAC 19.21, Pharmacists - Drug Precursors, filed 02- 02- 96, reformatted and renumbered to 16.19.21 NMAC, Drug Precursors, effective 03- 30- 2002.
The Board would like to see 16.19.21 NMAC noticed for the next Board meeting in August 2006.
Changes were made during the Board meeting on the overhead projector and will be formatted based on the New Mexico Administrative Code. ( 161921BK03- 13- 06)
A motion was made by Mr. Cross, seconded by Ms. Buesing to notice 16.19.21 NMAC at the August 2006 board meeting. The Board voted unanimously to pass the motion.
Mr. Harvey discussed changes being made regarding reciprocity and addressed Ms. Buesing suggestions.
Proposed Changes to 16.19.3 NMAC - Reciprocity:
PART 3 RECIPROCITY
16.19.3.1 ISSUING AGENCY: Regulation and Licensing Department - Board of Pharmacy, [ 1650 University Blvd, NE, Ste. 400B,] Albuquerque, NM [ 87102,] ( 505)[ 841- 9102] 222- 9830.
[ 02- 15- 96; 16.19.3.1 NMAC - Rn, 16 NMAC 19.3.1, 03- 30- 02]
16.19.3.2 SCOPE: All applicants for licensure as pharmacists by reciprocity.
[ 02- 15- 96; 16.19.3.2 NMAC - Rn, 16 NMAC 19.3.2, 03- 30- 02]
16.19.3.3 STATUTORY AUTHORITY: Section 61- 11- 10 NMSA 1978 authorizes the Board of Pharmacy to issue a certificate of registration as a pharmacist, with or without examination, by reciprocity.
[ 02- 15- 96; 16.19.3.3 NMAC - Rn, 16 NMAC 19.3.3, 03- 30- 02]
16.19.3.4 DURATION: Permanent.
[ 02- 15- 96; 16.19.3.4 NMAC - Rn, 16 NMAC 19.3.4, 03- 30- 02]
16.19.3.5 EFFECTIVE DATE: February 15, 1996, unless a different date is cited at the end of a Section or Paragraph. This Part reformatted for inclusion into the New Mexico Administrative Code ( NMAC) effective 2- 15- 96.
[ 02- 15- 96; A, 04- 30- 98; 16.19.3.5 NMAC - Rn, 16 NMAC 19.3.5, 03- 30- 02]
16.19.3.6 OBJECTIVE: The objective of Part 3 of Chapter 19 is to recognize qualifications of pharmacists registered by examination in other states that grant reciprocal privileges in New Mexico and to establish uniform criteria for obtaining licensure as a pharmacist by reciprocity.
[ 02- 15- 96; 16.19.3.6 NMAC - Rn, 16 NMAC 19.3.6, 03- 30- 02]
16.19.3.7 DEFINITIONS: [ RESERVED]
[ 02- 15- 96; 16.19.3.7 NMAC - Rn, 16 NMAC 19.3.7, 03- 30- 02]
16.19.3.8 RECIPROCAL REGISTRATION: Reciprocal registration shall be granted to those persons registered by examination as a registered pharmacist in other states or territories of the United States which grant reciprocal privileges in New Mexico. Provided, they were apprentices in pharmacy prior to November 20, 1934 and licensed in pharmacy prior to May 20, 1940, after which date applicant must be a graduate of an approved college of pharmacy and have completed required intern training - or have worked one year as a registered pharmacist in the state in which the applicant has registered by examination.
[ 08- 27- 90; 16.19.3.8 NMAC - Rn, 16 NMAC 19.3.8, 03- 30- 02]
16.19.3.9 APPLICANT INELIGIBLE:
A. An applicant may be deemed to be ineligible to reciprocate if registration in the state of examination is not current; or if the pharmacist has worked less than one year and his internship requirements, at the time of examination, did not meet New Mexico's internship requirements.
B. An applicant who has not been active in pharmacy for a period of twelve months or more, may be required to complete such internship as the Board may deem necessary, but not to exceed 750 hours, and/ or may be required to complete the NABPLEX and/ or Jurisprudence examination.
[ 08- 27- 90; 16.19.3.9 NMAC - Rn, 16 NMAC 19.3.9, 03- 30- 02]
16.19.3.10 APPLICANT INELIGIBLE, NON- RECIPROCAL STATE REGISTRATION: An applicant who qualifies for and acquired a license in a state that does not grant reciprocal privileges with New Mexico may be deemed ineligible for reciprocal registration.
[ 08- 27- 90; 16.19.3.10 NMAC - Rn, 16 NMAC 19.3.10, 03- 30- 02]
16.19.3.11 JURISPRUDENCE EXAMINATION:
A. An applicant for reciprocity will be required to submit all paperwork required for reciprocity, take the jurisprudence examination and shall make a score of not less than 75% in the New Mexico Jurisprudence examination prior to issuance of a license.
B. Failure to appear and take the jurisprudence examination within one year after the application is received shall nullify the application and a refund of fees will not be made.
[ 07- 28- 91; 16.19.3.11 NMAC - Rn, 16 NMAC 19.3.11, 03- 30- 02]
16.19.3.12 PHOTO REQUIRED: Each applicant for registration shall furnish two permanent photographs, head and shoulders only, approximately 3 x 4 inches and signed and dated on the back.
[ 07- 28- 91; 16.19.3.12 NMAC - Rn, 16 NMAC 19.3.12, 03- 30- 02]
16.19.3.13 EVIDENCE OF QUALIFICATIONS: The New Mexico Board of Pharmacy may deem an applicant ineligible to be registered by reciprocity if the application that he submits fails to furnish evidence:
A. that the license which applicant acquired by examination in the state which he applies is in good standing;
B. that applicant, if examined after July 1, 1936, passes written examination in pharmacy, chemistry, pharmacology, pharmacognosy, pharmaceutical and chemical math, and a practical examination with a general average of 75% in the written examination or less than 75% in the practical examination; or that applicant, if examined prior to July 1, 1936, obtained a general average of 75% and not less than 60% in any written or practical examination;
C. that the applicant is, in fact, competent and qualified to function as a pharmacist;
D. that applicant is of good moral character and is not addicted to the use of alcohol, narcotic or hypnotic drugs;
E. that the applicant has not been charged with, convicted, fined or had his license suspended or revoked for violation of pharmacy, liquor, narcotic or drug laws.
[ 08- 27- 90; 16.19.3.13 NMAC - Rn, 16 NMAC 19.3.13, 03- 30- 02]
16.19.3.14 PENDING INDICTMENT OR ALLEGED VIOLATIONS: An applicant shall be ineligible for reciprocal registration against whom there is pending an indictment or alleged violation of any pharmacy, liquor, narcotic or drug laws or has been convicted of a felony within five years prior to application.
[ 08- 27- 90; 16.19.3.14 NMAC - Rn, 16 NMAC 19.3.14, 03- 30- 02]
16.19.3.15 TEMPORARY LICENSE:
A. Persons who provide acceptable evidence of being currently licensed by examination under the laws of other states in the United States and the District of Columbia, shall be authorized to practice pharmacy for a period of sixty ( 90) days from the date on receipt of a complete application and $ 50.00 fee which will go towards the eventual licensing fee. Persons must become duly licensed in this state within sixty ( 60) days.
B. The licensing agency in each state in which the applicant holds or has held a license shall submit a statement to board confirming the applicant to be or have been in good standing in that state.
C. The temporary license shall not allow persons to act as the pharmacist- in- charge unless there is no other pharmacist in the designated facility, a preceptor, or supervisor of interns or externs. 18
D. The holders of the temporary license shall be subject to discipline in the same manner as those holding a full license, and shall be subject to immediate suspension upon reasonable evidence of false or incorrect statements in the documents submitted or if found not to be in good standing in other states.
E. The temporary license shall not be renewed or extended.
HISTORY OF 16.19.3 NMAC:
BOP 69- 2, Rules and Regulations of the State Board of Pharmacy, 6- 13- 69.
BOP 69- 3, New Mexico Laws and Regulations, Pharmacy Act, Drug and Cosmetic Act, Narcotic Drug Act, Poisons Act, Board of Pharmacy Rules and Regulations, 8- 15- 69.
BOP 72- 1, New Mexico Board of Pharmacy Rules and Regulations Promulgated Pursuant to New Mexico Drug and Cosmetic Act, Pharmacy Act, Controlled Substances Act, 7- 31- 72.
Regulation No. 3, Reciprocity, 2- 7- 80.
Regulation No. 3, Reciprocity, 10- 23- 85.
Regulation No. 3, Reciprocity, 2- 2- 87.
Regulation No. 3, Reciprocity, 7- 27- 90.
BOP 72- 1, New Mexico Board of Pharmacy Rules and Regulations Promulgated Pursuant to New Mexico Drug and Cosmetic Act, Pharmacy Act, Controlled Substances Act - Repealed, 10- 29- 85.
Other History: 16 NMAC 19.3, Pharmacists - Reciprocity, filed 02- 02- 96, reformatted and renumbered to 16.19.3 NMAC, Reciprocity, effective 03- 30- 2002.
Changes were made during the Board meeting on the overhead projector and will be formatted based on the New Mexico Administrative Code. ( 16193WH06- 05- 06)
A motion was made by Mr. Shaver, seconded by Mr. Cross to notice for hearing 16.19.3 NMAC at the August 2006 board meeting. The Board voted unanimously to pass the motion.
Proposed Changes to 16.19.12 NMAC - Fees:
Mr. Harvey discussed the need for waiving fees for active duty personnel. The board was in agreement and also suggested to include the “ drug research” fee in this section.
PART 12 FEES
16.19.12.1 ISSUING AGENCY: Regulation and Licensing Department, Board of Pharmacy, Albuquerque, NM, ( 505)[ 841- 9102] 222- 9830.
[ 02- 15- 1889... 02- 15- 96; 16.19.12.1 NMAC - Rn, 16 NMAC 19.12.1, 03- 30- 02; A, 12- 15- 02]
16.19.12.2 SCOPE: All applicants for licensure, registration or certification by the Board of Pharmacy, 1650 University Blvd, NE - Ste. 400B, Albuquerque, NM 87102, ( 505) 841- 9102.
[ 02- 15- 96; 16.19.12.2 NMAC - Rn, 16 NMAC 19.12.2, 03- 30- 02]
16.19.12.3 STATUTORY AUTHORITY: Sections 61- 11- 12, 61- 11- 13, and 61- 11- 14 NMSA 1978 authorize the Board of Pharmacy to charge, and limit the maximum charges for, ( i) applications for registration and renewal of registration as a pharmacist or pharmacist intern; and ( ii) applications for the registration of retail pharmacies, wholesale drug distributors, nonresident pharmacies, pharmaceutical sales representatives, drug
manufacturers, hospital pharmacies, drug rooms, nursing homes, industrial or public health clinics, the Department of Health, and home care services, and wholesalers, retailers and distributors of legend- bearing veterinary drugs.
[ 02- 15- 96; 16.19.12.3 NMAC - Rn, 16 NMAC 19.12.3, 03- 30- 02]
16.19.12.4 DURATION: Permanent.
[ 02- 15- 96; 16.19.12.4 NMAC - Rn, 16 NMAC 19.12.4, 03- 30- 02]
16.19.12.5 EFFECTIVE DATE: February 15, 1996, unless a different date is cited at the end of a Section or Paragraph. This Part reformatted for inclusion into the New Mexico Administrative Code ( NMAC) effective 2- 15- 96.
[ 02- 15- 96; A, 07- 31- 98; 16.19.12.5 NMAC - Rn, 16 NMAC 19.12.5, 03- 30- 02]
16.19.12.6 OBJECTIVE: The objective of Part 12 of Chapter 19 is to ensure uniform imposition and collection of fees that conform to statutory requirements for individuals and entities that provide pharmaceutical products and services.
[ 02- 15- 96; 16.19.12.6 NMAC - Rn, 16 NMAC 19.12.6, 03- 30- 02]
16.19.12.7 DEFINITIONS: [ RESERVED]
[ 02- 15- 96; 16.19.12.7 NMAC - Rn, 16 NMAC 19.12.7, 03- 30- 02]
16.19.12.8 FEES: All fees shall be paid in advance of the issuance of any license, permit, certificate or replacement of a certificate.
[ 03- 07- 80... 08- 27- 90; 16.19.12.8 NMAC - Rn, 16 NMAC 19.12.8, 03- 30- 02]
16.19.12.9 REGISTRATION FEES:
A. Registration by Examination $ 200.00
B. Registration by Reciprocity $ 200.00
C. Registration as an Intern $ 30.00
D. Registration as a Pharmacy Technician $ 30.00
[ 03- 07- 80… 08- 27- 90; A, 07- 15- 97; A, 07- 31- 98; 16.19.12.9 NMAC - Rn, 16 NMAC 19.12.6, 03- 30- 02; A, 12- 15- 02; A, 09- 30- 03]
16.19.12.10 CERTIFICATE OF REGISTRATION OR REPLACEMENT: Any replacement of a certificate shall be accompanied by a notarized statement of the reason or cause of the loss of the original, or by the original certificate to be replaced in case of damage or name change. All replacement certificates will be given the same number as the original certificate and will be marked " DUPLICATE".
A. Certificate of Registration $ 20.00
B. Replacement of a Certificate of Registration $ 20.00
C. NOTE: Any replacement of a certificate shall be accompanied by a notarized statement of the reason or cause of the loss of the original, or by the original certificate to be replaced in case of damage or name change. All replacement certificates will be given the same number as the original certificate and will be marked “ DUPLICATE”.
[ 03- 07- 80... 08- 27- 90; 16.19.12.10 NMAC - Rn, 16 NMAC 19.12.10, 03- 30- 02]
16.19.12.11 CERTIFICATION OF GRADES AND INTERNSHIP HOURS:
A. Certification of Grades $ 10.00
B. Certification of Internship Hours $ 10.00
[ 03- 07- 80... 08- 27- 90; 16.19.12.11 NMAC - Rn, 16 NMAC 19.12.11, 03- 30- 02]
16.19.12.12 LICENSE/ REGISTRATION RENEWAL:
A. Pharmacist license renewal for active $ 200.00 bi- ennialy
B. Pharmacist license renewal for in- active $ 70.00 bi- ennialy
C. Intern renewal $ 30.00 per year
D. Duplicate license for interns and pharmacists $ 10.00
E. Controlled substance registration $ 60.00
F. Duplicate license for controlled substance $ 10.00 20
G. Pharmacy technician renewal $ 30.00 bi- ennialy
H. Pharmacist clinician $ 70.00 bi- ennialy
I. Pharmacist license renewal for active pharmacists with 50 or more years of service - $ 70.00 bi- ennialy
J. NOTE: WAIVER OF LICENSE RENEWAL FEES: The board of pharmacy waives the renewal fee set forth in regulation 16.19.12.12, for individuals who are currently serving in the United States Military in an active war zone or who serve in direct support of operation in active war zones.
[ 03- 07- 80... 08- 27- 90; A, 07- 31- 98; A, 11- 14- 98; 16.19.12.12 NMAC - Rn, 16 NMAC 19.12.12, 03- 30- 02; A, 12- 15- 02; A, 09- 30- 03; A, 07- 15- 04; A, 12- 15- 05]
16.19.12.13 LICENSE FEES:
A. License fee for drug manufacturer $ 700.00 bi- ennialy
B. Wholesale drug distributor $ 700.00 bi- ennialy
C. Drug manufacturer/ repackager $ 700.00 bi- ennialy
D. Repackager $ 700.00 bi- ennialy
E. Retail pharmacy license $ 300.00 bi- ennialy
F. Hospital pharmacy license $ 300.00 bi- ennialy
G. Hospital drug room pursuant to Section 61- 11- 7 of Pharmacy Act $ 60.00
H. Duplicate license $ 10.00
I. Nonresident pharmacies $ 400.00 bi- ennialy
J. Seller or dispenser of contact lenses $ 400.00 bi- ennialy
K. Alternative reduced licensure fee for wholesale drug distributor/ manufacturer/ repackager as determined by the board or board's designee.
L. Dangerous drug research $ 200.00 bi- ennialy
[ 03- 07- 80... 05- 01- 93; 16.19.12.13 NMAC - Rn, 16 NMAC 19.12.13, 03- 30- 02; A, 09- 30- 03; A, 07- 15- 04; A, 01- 15- 2005; A, 12- 15- 05]
16.19.12.14 DRUG ROOM PERMIT:
A. Drug Room Permit in Adult Shelter Care or Custodial Care Facility:
( 1) 10 or fewer beds: $ 100.00 bi- ennialy
( 2) 11 or more beds: $ 200.00 bi- ennialy
B. Drug Room Permit in an Intermediate Nursing Home Facility $ 200.00 bi- ennialy
C. Drug Room Permit in a Skilled Nursing Home Facility $ 200.00 bi- ennialy
D. Duplicate License $ 10.00
[ 03- 07- 80... 08- 27- 90; 16.19.12.14 NMAC - Rn, 16 NMAC 19.12.14, 03- 30- 02; A, 09- 30- 03]
16.19.12.15 CLINIC LICENSE FEES: Clinic license fees shall be:
A. Limited Clinic $ 300.00 bi- ennialy
B. Intermediate Clinic $ 300.00 bi- ennialy
C. Major Clinic $ 300.00 bi- ennialy
E. Animal Control Clinics $ 100.00 bi- ennialy
[ 03- 07- 80... 08- 06- 94; 12- 15- 99; 16.19.12.15 NMAC - Rn, 16 NMAC 19.12.15, 03- 30- 02; A, 09- 30- 03]
16.19.12.16 HOME CARE SERVICES DRUG PERMIT FEE: $ 75.00
[ 03- 07- 80... 08- 06- 94; 16.19.12.16 NMAC - Rn, 16 NMAC 19.12.16, 03- 30- 02]
16.19.12.17 LIMITED VETERINARY DRUG RETAIL OR WHOLESALE LICENSE: Limited veterinary drug retail or wholesale license shall be $ 150.00
[ 03- 07- 80... 02- 22- 93; 16.19.12.17 NMAC - Rn, 16 NMAC 19.12.17, 03- 30- 02]
16.19.12.18 INSPECTION FEE: Fee for required inspections shall be $ 150.00
[ 03- 07- 80... 02- 22- 93; 16.19.12.18 NMAC - Rn, 16 NMAC 19.12.18, 03- 30- 02]
16.19.12.19 DRUG PRECURSOR LICENSE: Drug Precursor License $ 500.00
[ 03- 07- 80... 02- 22- 93; 16.19.12.19 NMAC - Rn, 16 NMAC 19.12.19, 03- 30- 02] 21
16.19.12.20 REINSTATEMENT FEES:
A. Any person whose Board registration or license has expired and who seeks reinstatement of the certificate of license must pay the following reinstatement fee in addition to all delinquent renewal fees:
( 1) Pharmacists $ 25.00
( 2) All other licenses issued by the Board of Pharmacy under the Pharmacy Act and the Drug Precursor Act including, but not limited to, licenses for retail pharmacy, non- resident pharmacy, wholesale drug distributor, drug manufacturer, hospital pharmacy, drug room, nursing home, clinic facility, wholesalers, retailers or distributors of veterinary drugs, and drug precursor, 25% of the license renewal fee not exceed $ 100.00
B. Controlled substance registrations are exempt from reinstatement fees.
[ 03- 07- 80... 02- 22- 93; 16.19.12.20 NMAC - Rn, 16 NMAC 19.12.20, 03- 30- 02]
16.19.12.21 EMS LICENSURE FEES: Annual license fees shall be paid to the Board according to the following schedule:
A. The home office or headquarters shall pay $ 50.00;
B. Every additional location shall pay $ 25.00.
[ N, 12- 15- 99; 16.19.12.21 NMAC - Rn, 16 NMAC 19.12.21, 03- 30- 02]
HISTORY OF 16.19.12 NMAC:
Regulation No. 12, Fees, 2- 7- 80.
Regulation No. 12, Fees, 5- 5- 83.
Regulation No. 12, Fees, 10- 24- 85.
Regulation No. 12, Fees, 2- 2- 87.
Regulation No. 12, Fees, 7- 27- 90.
Other History: 16 NMAC 19.12, Pharmacists - Fees, filed 02- 02- 96, reformatted and renumbered to 16.19.12 NMAC, Fees, effective 03- 30- 2002.
Changes were made during the Board meeting on an overhead projector and will be formatted based on the New Mexico Administrative Code. ( 161912WH06- 05- 06)
A motion was made by Ms. Buesing, seconded by Mr. Shaver to notice for hearing 16.19.12 NMAC at the August 2006 board meeting. The board voted unanimously to pass the motion
Clinic Applications:
Mr. Cross stated that there are 25 applications in this category and all are in order.
A motion was made by Mr. Cross, seconded by Mr. Nolasco to approve all 25 applications in this category as presented. The Board voted unanimously to pass the motion. Mr. Cross abstained from voting on # 3.
Custodial Home Applications:
Mr. Cross stated that there are 26 applications in this category and all are in order.
A motion was made by Mr. Cross, seconded by Mr. Shaver to approve all 26 applications in this category as presented. The Board voted unanimously to pass the motion.
Mr. Cross stated that there is only 1 application in this category as presented and all is in order.
A motion was made by Mr. Cross, seconded by Mr. Shaver to approve the one application in this category as presented. The Board voted unanimously to pass the motion.
Non- Resident Pharmacy:
Mr. Cross stated that there are 21 applications in this category and all are in order.
A motion was made by Mr. Cross, seconded by Ms. Buesing to approve all 21 applications in this category as presented. The Board voted unanimously to pass the motion.
Mr. Cross stated that there are 31 applications in this category as presented and all are in order.
A motion was made by Mr. Cross, seconded by Ms. Buesing to approve all 31 applications in this category as presented. The Board voted unanimously to pass the motion.
Mr. Cross stated that there was only 1 application in this category as presented and all is in order.
A motion was made by Mr. Cross, seconded by Ms. Buesing to approve the one application in this category as presented. The Board voted unanimously to pass the motion.
Wholesale/ Broker:
Mr. Cross stated that there are 43 applications in this category as presented. A correction was made on the spelling of # 26. The name of the wholesale/ broker should be “ Mallinchrodt”.
A motion was made by Mr. Cross, seconded by Ms. Buesing to approve all 43 applications in this category as presented. The Board voted unanimously to pass the motion.
Pharmacist Credentialing Committee:
Mr. Cross presented 3 applications that were discussed by the committee on May 25, 2006. The applicants are Kenneth Romp, Edward N. Yale and Maggie Jaeger.
A motion was made by Mr. Cross, seconded by Ms. Buesing to approve the 3 applications as presented. The Board voted unanimously to pass the motion.
A motion was made by Mr. Cross, seconded by Ms. Buesing to attach the application lists to the minutes. The Board voted unanimously to pass the motion.
REQUEST FROM UNMH TO ALLOW OFF- SITE REFILL CENTER:
Mr. Louis Achusim was present to discuss the plan UNM has for an off- site refill service. Issues such as objectives, UNM hospital statistics, outpatient pharmacy overviews, and the current situations and resolutions that will have an impact on the plan were discussed in detail with the board. Mr. Achusim handed out an overview to the board, which will be attached to the minutes. Mr. Harvey will have the authority to review the call center security and how it will operate. The pharmacist clinician issues will be addressed after the medical board meeting and UNMH will be put on the agenda for August 2006 board meeting.
A motion was made by Mr. Cross, seconded by Ms. Padilla to authorize Mr. Harvey to review the off- site extension policy and procedures and it’s security and have UNMH report the progress at the next board meeting and incorporate the medical board and pharmacy boards recommendations for the pharmacy clinician responsibilities in this system. The Board voted unanimously to pass the motion.
The Chairman asked for a 10- minute recess.
The Chairman reconvened at 3: 45 p. m.
EXECUTIVE DIRECTOR’S REPORT CONT’D:
Proposed Changes to 16.19.20.31 NMAC - Pharmacy and Hospital Dispensing Records:
After a brief discussion Mr. Harvey explained that the language change would be addressing the exclusion of the pharmacist’s name on the face of the prescription.
16.19.20.31 PHARMACY AND HOSPITAL PRESCRIPTION AND DISPENSING RECORDS:
A. Prescriptions for Schedule II shall be maintained in a separate file. [ The name of the pharmacist 24
filling the prescription and the date filled shall be inscribed on the face of the prescription. ( A rubber stamp or typewritten or printed name are accepted.]
B. In pharmacies without computerized prescription information, prescriptions for Schedules II, III, IV and V shall 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.)
C. Prescriptions for Schedule III, IV and V shall be maintained either in a separate file only, or in such 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 1” high. , or the records comply with 16.19.6.22 COMPUTERIZED PRESCRIPTION INFORMATION.
D. Prescriptions so marked may then be filed with prescriptions for Schedule II substances, or in the usual consecutively numbered prescription file for non- controlled drugs.
E. Pharmacies employing automatic data processing systems or other electronic record keeping systems for prescriptions [ which permits identification by prescription number and retrieval of original documents by prescriber’s name, patient’s name, drug dispensed, and date filled, need not mark the hard copy of the prescription with a red “ C”.] must comply with 16.19.6.22 COMPUTERIZED PRESCRIPTION INFORMATION.
Changes were made during the board meeting on the overhead projector and will be formatted based on the New Mexico Administrative Code. ( 16192031WH06- 05- 06)
A motion was made by Ms. Padilla, seconded by Mr. Nolasco to notice for hearing 16.19.20.31 NMAC at the August 2006 board meeting. The Board voted unanimously to pass the motion.
Proposed Changes to 16.19.20.67( G) - Exempt Anabolic Steroids:
Ms. Jeane Johnson explained the language changes to the board.
G. [ The following anabolic steroid containing compounds, mixtures, or preparations have been exempted by the Board from 16.19.20.67. E NMAC, Schedule III:]
Exempt Anabolic Steroids: Compounds, mixtures, or preparations that contain an anabolic steroid that have been exempted by the Board from 16.19.20.67. E NMAC, Schedule III to the same extent that the substance has been exempted from the application of the Federal Controlled Substance Act, if the substance is listed as an exempt anabolic steroid product under 21 C. F. R. Section 1308.34 and its subsequent amendments.
TABLE OF EXEMPT ANABOLIC STEROID PRODUCTS
Androgyn L. A.
Forest Pharmaceuticals, St. Louis MO
0456- 1005
90 mg/ ml
4mg/ ml
Andro- Estro 90- 4
Rugby Laboratories, Rockville Centre, NY
0536- 1605
Forest Pharmaceuticals, St. Louis, MO
0456- 1020
DEPO- T. E
Pharm., Carmel, IN
52728- 257
Martica Pharmaceuticals, Phoenix, AZ
51698- 257
52047- 360
90mg/ ml
W. E. Hauck
43797- 016
DUP- SPAN II
0684- 0102
0032- 1026
0032- 1023
0525- 0175
0046- 0879
0046- 878
in process granulation
Estradiol bensoate
TEST- ESTRO
0536- 9470
55553- 257
Testosterone Cyp 50
Estradiol Cyp 2
I. D. E. Interstate
0814- 7737
Cypionate- Estradiol
Cypionate injection
Best Generics, No.
54274- 530
0182- 3069
50mg/ ml 26
0364- 6611
Steris Labs Inc.
0402- 0257
Enanthate- Estradiol
Valerate Injection
0182- 3073
Port Washinfton, NY
0364- 6618
0402- 0360
0009- 0253
Changes were made during the board meeting on the overhead projector and will be formatted based on the New Mexico Administrative Code. ( 16192067JJ06- 05- 06)
A motion was made by Mr. Cross, seconded by Ms. Buesing to notice for hearing 16.19.20.67 NMAC at the August 2006 board meeting. The Board voted unanimously to pass the motion.
Mr. Harvey presented correspondence from Wanka A. Ndifor requesting a waiver. The waiver request was denied by the board.
A motion was made by Ms. Padilla, seconded by Mr. Cross to deny the request for a waiver. The Board voted unanimously to pass the motion.
Mr. Harvey discussed numerous resolutions passed by NABP. Mr. Harvey asked for feedback on the district meeting in October 2006 and attendees. Allen Carrier, Ms. Padilla, and possibly Ms. Buesing will attend. Mr. Harvey will check with the other board members that were not present. The board asked
when Mr. Edward Lopez, Superintendent would be attending to meet the board members. Mr. Harvey stated that he is in the process of making arrangements for the August 2006 board meeting.
Issues listed were discussed by the board to be addressed at the 2007 Legislative session; “ Drug Repository Program”, “ Senior Drug Program” fees and language, “ Pharmacy Act” language changes regarding temporary facility license provisions and the restriction of public records and changes allowing therapeutic interchange of pharmaceuticals in the “ Drug, Product Selection Act”. Ms Buesing suggested that planning sessions for committees be addressed so that they can be presented in a timely manner to be ready for the legislative sessions.
Discussion regarding updating the language of the Wholesale Drug regulation to clarify the use of fees and proposals by NABP to address bonding and criminal background checks were addressed.
Mr. Harvey will have an update for the Senior Drug Program and the use of funds at the August 2006 boar meeting.
Mr. Harvey and Mr. Storey discussed the re- use of pharmaceuticals and the protocols that would have to be addressed in the different entities that exist such as; correctional facilities, nursing homes, and hospitals.
Mr. Harvey presented the MTP report. Mr. Harvey stated because of the sensitive nature of this document that it would be destroyed after discussion was held in closed session if need be.
Mr. Harvey asked for approval of disposal of property ( file cabinets, computers, etc.) no longer in use.
A motion was made by Mr. Shaver, seconded by Mr. Cross to approve the disposal of property no longer in use. The Board voted unanimously to pass the motion.
The Chairman asked to adjourn the meeting at 4: 50 p. m.
RECONVENE TUESDAY JUNE 6, 2006:
The Chairman reconvened at 9: 07 a. m. and took roll call. Mr. Ortega and Ms. Saavedra were excused.
TECHNICIAN COMMITTEE REPORT:
Mr. Storey discussed numerous issues regarding the �� pharmacy technicians” scope of duties, clinical definitions, policy and procedures and the direction the committee wants to take to clarify the regulations that directly impact pharmacy technicians and pharmacists. Mr. Storey and Mr. Larry Loring are in the process of making changes to the regulations that have a direct impact on pharmacy technicians and pharmacists and will present them to the board when completed. Mr. Storey stated that the committee should have language to present at the August 2006 boar meeting.
The Chairman asked for a 5- minute recess at 10: 15 a. m.
The Chairman reconvened at 10: 20 a. m. 28
VOLUNTARY SURRENDER OF LICENSURE - PROPOSED STIPULATED AGREEMENT - CASE # 2006- 012:
The Chairman asked that the board go into closed session to discuss case # 2006- 012.
A motion was made by ( tape inaudible) to go into closed session to discuss case # 2006- 012. The Board voted unanimously to pass the motion.
The Chairman went back into open session and the only thing discussed was case # 2006- 012.
Mr. Storey asked Ms. Hauge if she was in agreement with the order and the monitoring of MTP and their reporting to the board when she can return to work. Ms. Hauge said that she understood and agreed.
A motion was made by Mr. Shaver, seconded by Mr. Cross to approve the order for voluntary surrender of license under the “ Impaired Healthcare Provider Act” for case # 2006- 012. The Board voted unanimously to pass the motion.
DR. KEN SCHAFERMEYER REQUEST FOR APPROVAL OF “ EXCPT” CERTIFICATION EXAM FOR PT’S:
Mr. Schafermeyer made his presentation regarding a certification exam for pharmacy technicians. Mr. Storey asked for copies of the test, so that, a comparison can be done by the Pharmacy Technician Committee.
REQUEST FROM “ PHARMACIST’S LETTER” FOR LAW CE:
Pharmacist’s Letter would like to video tape the New Mexico Board of Pharmacys’ Law update and make that presentation available via the Web for New Mexico pharmacists who want to take it. Mr. Harvey recommended that the board try the video CE for a year and evaluate its effectiveness. Mr. Storey asked to table the discussion until the August 2006 board meeting.
STEPHANIE SALAS REQUEST FOR REINSTATEMENT:
Mr. Harvey stated that Ms. Salas would not be in attendance due to her admittance into the hospital due to health issues.
ACTION ON 16.19.20.68 NMAC:
Mr. Storey stated that he received a call from the governor’s office claiming that Johnson & Johnson had submitted new data to the governor at a fundraising event and asked that the board hold off on scheduling Tramadol until the board evaluates the new data. Mr. Harvey stated that the data the board had received was the same data that the WHO received and the WHO report on scheduling Tramadol will not be
available until next year, and at this point the WHO does not recommend scheduling Tramadol. Mr. Storey suggested that the board address these issues again at the August 2006 board meeting.
Executive Director’s Report Con’d:
The Chairman asked that the board go into closed session for case presentations. The Board voted unanimously to pass the motion.
A motion was made by Mr. Shaver, seconded by Mr. Nolasco to go into closed session to discuss case presentations.
Mr. Storey asked to go back into open session and the only item discussed were case presentations and no action was taken.
A motion was made by Ms. Buesing, seconded by Mr. Shaver to close cases # 2006- 002, # 2006- 127, # 2006- 009, # 2006- 010, # 2006- 116, # 2006- 117, # 2006- 129, # 2006- 130, # 2006- 131, # 2005- 122, # 2005- 116, # 2005- 105, # 2006- 100, issue and advisory letter to case # 2005- 093, pharmacist in charge and the pharmacist involved, issue an NCA to case # 2006- 119, # 2005- 053, and prepare and order to show cause in case # 2006- 133, and accept the voluntary surrender and prepare the order for case # 2006- 132 which is Michael Flannigan, and voluntary surrender of controlled substance registration for case # 2006- 141 which is for Brian Wayne, MD.
A motion was made by Mr. Shaver, seconded by Ms. Buesing to adjourn the meeting. The Board voted unanimously to pass the motion.
The board meeting was adjourned at 12: 44 p. m.
Description	Title Board of Pharmacy minutes (6/5-6/06) Title-Alternative [Minutes] Publication or Issue Date 2006-06-06; * Creator New Mexico. Board of Pharmacy. Contributors New Mexico. Board of Pharmacy. Transcript New Mexico Board of Pharmacy Regular Board Meeting
( a) The beyond- use date should be based on the criteria outlined in USP Chapter < 795>.
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