NM Law Study Guide Flashcards

Question

Counseling requirments/ counseling for mailed out medications? :

Answer 1

- New Rx: pharmacist or pharmacist intern offer to counsel - Refill Rx: pharmacy technician offer counseling by the pharmacist or pharmacist intern - In person or by telephone - Not be required for hospital inpatients or institution where drugs administered - Mailed Rx: written notice of available counseling  > 50% prescriptions by mail: minimum of 60 hours per week six days per week, counseling within 15 minutes - Post notice of available counseling at pharmacy

Answer 2

- Proof of completion of 60 hour board approved physical assessment course, 150 hour/300 patient contact preceptorship supervised by physician or practitioner with prescriptive authority - Patient encounters must be completed within 2 years of application - Controlled substance registration required to prescribe schedule II-III drugs

Answer 3

Renewal: - 2.0 CEU 20 contact hours of (10 hr live) CPE or continuing medical education (CME) approved by (ACPE) or AACME beyond required hours for pharmacists - Controlled substance registration: minimum of 0.2 CEU (two contact hours) per renewal in responsible opioid prescribing practices

Answer 4

- Register with NM medical board or osteopathic examiners - Submit an application: supervising physicians’ name and current medical license, protocol of collaborative practice and other information requested by the board - Protocol:  File with board and maintain at place of practice (approved by practitioner)  Practitioner and pharmacist clinician authorized to prescribe  Includes types of prescriptive authority: types of diseases, dangerous drugs/categories, procedures  Review and revise: every two years if necessary - Prescribe controlled substances provided: NM CS Registration + DEA Registration, within guidelines/protocols

Answer 5

Register with board for PMP inquiry and reporting: Review 1-year PMP report:  Prescribing > 4 days CII-IV  Gap in prescribing for 30 days  Once every 3 months for continuous use of opioid, BZD or carisoprodol  Once every 6 months for continuous use of CII-IV (non-opioid)  In opioid treatment program: initial enrollment and every 3 months  Except: nursing facility or hospice patient

Answer 6

Preceptor requirements: - One year in practice of pharmacy, full-time, no violations of pharmacy laws or regulations . Intern requirements: - Completion of first semester courses in ACPE college of pharmacy - Wear standard identification tag - Computed time: max of 48 hr/week - Internship requirement: 1500 hours - Change of address, employment or preceptor: notify board in writing within 10 days - Display intern certificate in training area where intern is employed - Preceptor supervises repacking, labeling and dispensing - Renewal: due annually last day of September

Answer 7

- Required application and fee - Preliminary approval of application à applicant submits "request for inspection" **at least fourteen** days before requested date for inspection - Reviews license application and the inspection report at next board meeting - License terminates with sale or transfer of ownership

Answer 8

- Policies and procedures review annually - Supervision - Storage of drugs - Notify of technician employment/termination within 10 days - Immediately notify board for change of PIC, file new PIC application within 10 days, controlled substance inventory within 72 hours - Self-assessment inspection form completed with pharmacy renewal application (expire annually Dec 31st)

Answer 9

- 240 square feet - Floor area extends the full length of the prescription compounding counter - Private counseling space - 1 RPh: 16 sq-ft prescription compounding counter - 2 or more RPh: 24 sq-ft prescription compounding counter - Counter height: at least 36 inches - 5% or at least one work-station will comply with the American with Disabilities Act (note: applies with 15 or more employees) - Minimum width of 30 inches from the prescription compounding center

Answer 10

- License - Prohibition of drug return sign - Current BOP inspection - Current CS registration - Patients Bill of Rights (approved by BOP)

Answer 11

Send written notice to **DEA at least 14 days** prior to closure (return DEA registration + unused 222); notify the **PUBLIC and BOARD at least 30 days** prior to the final day of service + include notice in newspaper, radio or other method . Provide name/address/phone number for records (purchase records = 3 years, prescriptions = 10 years)

Answer 12

Return stock: - Patient name - Date filled - Rx number - Drug name/strength/quantity - **Maintain record, retrievable within 72 hours

Answer 13

Robbery, Burglary, Fire, Flood Report: Owner immediately files with the board a signed statement of the circumstances of such occurrence and evidence that local authorities were notified

Answer 14

- **Definition:** Labeling involves affixing or applying written, printed, or graphic matter on or in the immediate container of any human use drug, whether repackaged or dispensed on a practitioner’s order. - **Authorized Personnel:** Only a Registered Pharmacist (RPh) or an intern under their supervision can label the immediate container of a drug. - **Compounding Labeling:** A dispensing container for a compound with more than three drugs must be labeled as “compound.”

Answer 15

Transfer = - Sale - Addition/deletion of partners - Death of owner - Change in 30% of stock - **New license required - Expiration: Dec 31st annually

Answer 16

Prescriptions: - Faxed, Electronic, Verbal (via practitioner or agent), Written - Physician signature can be hand-written, stamped/printed, electronic - Must contain name and address of prescriber, name and address of patient, name and strength of drug, quantity, directions for use, date of issue, and preferably the diagnosis or indication

Answer 17

Emergency refills: - Pharmacist can refill script (INCLUDING CS) without prescriber authorization if: - Failure to refill will result in interruption of therapeutic regimen (essential for chronic therapy or serious health consequences) or create patient suffering - Unable to contact prescriber with reasonable effort - **Cannot provide > 72hrs supply** - Notify prescriber at earliest reasonable time

Answer 18

A: - The payer must provide 2 weeks' notice for an on-site audit. - Audits cannot cover a time period greater than 2 years. - Audits may not be conducted during the first 5 days of the month.

Answer 19

**FDA:** - Requires credentials and a notice of inspection (no warrant or explanation needed). They fill out a form without needing to go to a judge. **DEA:** - Requires credentials, a notice of inspection, and an administrative inspection warrant (does not require probable cause but explains the purpose of the inspection and must go before a judge). **Inspection Scope:** - Inspectors can look at all types of records (inventory, order forms, prescriptions, etc.) but cannot take them without a warrant or subpoena. - Cannot look at financial data, sales data, or pricing data. - Can take a physical inventory. **NMBOP (New Mexico Board of Pharmacy):** - Requires credentials (administrative warrant can be requested). - Can inspect inventory and copy records. - Can take samples but must pay for them.

Answer 20

censure Application: - Address of the nonresident pharmacy and pharmacists  Report annually and within 10 days after any change of office location or pharmacist in charge - Valid state license - Recent inspection report - CSP: recent CSP operations inspection report within the past 12 months - Policy and procedure manual - Proof that the nonresident pharmacy has a toll-free telephone service available to New Mexico patients (six days a week and for a minimum of 40 hours a week); - The name and address of a resident (agent of record) in New Mexico for service of process; - If the nonresident pharmacy wants to ship, mail or deliver controlled substances to New Mexico patients, then the pharmacy must submit an application for controlled substances

Answer 21

A: Pharmacies must have the same owner or a written contract and must share files/sufficient information.

Answer 22

A: Patients must be notified when outsourcing occurs.

Answer 23

A: There must be a minimum of 60 hours of phone counseling per week, available six days per week, within 15 minutes.

Answer 24

A: The requesting pharmacy must maintain records of the request for dispensing, the dispensed prescription, the method of delivery, and the name of the person accepting delivery.

Answer 25

A: The dispensing pharmacy must maintain records of the date the prescription was shipped, the name/address where it was shipped, and the method of delivery. Hard copies of records must be maintained within 48 hours.

Answer 26

A: There must be a minimum of 60 hours of phone counseling per week, available six days per week, within 15 minutes.

Answer 27

A: Policies and procedures must be reviewed annually.

Answer 28

- Notification: physical address of ADS, health facility registration type/number, managing pharmacy/PIC, policies + procedures - Written notification by PIC at least 60 days prior to the initial use of ADS - PIC notifies BOP within 10 days of taking permanently out of service - Stocking or restocking of an automated medication system: PIC/pharmacist responsible - Records: maintain for at least three years - Perpetual inventories of controlled substances

Answer 29

- Select/fill/label medication for dispensing - Does not include: counting devices, vacuum delivery device - Medication stocking: pharmacist/intern/supervised technician - Pharmacist verification: Daily random quality testing is conducted by a pharmacist on at least two percent of the prescriptions filled by the automated system, results documented and maintained in the pharmacy’s records - Recordkeeping: maintained for a minimum of three years

Answer 30

- name, address, and telephone number of repackaging pharmacy - name, strength, and quantity of the drug - lot number or control number - name of manufacturer - beyond use date - date drug was repackaged - name or initials of repackager - federal caution label, if applicable

Answer 31

- Confidential info or personally identified info disseminated – report within 15 days - Employee conviction for violating federal or state law – report within 15 days - Change of location – report within 15 days???? (10 days)

Answer 32

A: A hospital pharmacy can fill discharge prescriptions and scripts for employee benefits only. If the pharmacy dispenses to the general public, it must register as a retail pharmacy.

Answer 33

A: - The PIC can be part-time or full-time. - If part-time, the PIC must visit the facility at least every 72 hours. - The PIC is responsible for reviewing policies and procedures annually.

Answer 34

A: In hospitals without a pharmacy, prelabeled and prepackaged medications can be stored and distributed from a drug storage area or an automated medication management system under the supervision of a Registered Pharmacist (RPh).

Answer 35

- **Drug Withdrawal:** If the pharmacy is closed or drugs are not available, one designated licensed nurse per shift may remove drugs from the pharmacy. - **Record Keeping:** If withdrawing more than a 72-hour supply, an electronic record is required, including: - Name of the patient - Name of the drug, strength, dose, and dosage form - Quantity taken - Time and date of withdrawal, along with the nurse’s signature - **Pharmacist Verification:** The pharmacist must verify the withdrawal within 72 hours, which may be done electronically. - **Drug Regimen Review:** The pharmacist must review the drug regimen within 24 hours of a new medication order. - **Inpatient Medication Dispensing:** All medications for inpatients must be dispensed following a review of a physician’s order prior to dispensing. - **Pharmacy Technician Regulations:** Only one registered or certified pharmacy technician may be present when the pharmacist is not in the facility, performing only clerical tasks. A written log of activities must be maintained.

Answer 36

- **Separation:** The Pharmacy Service Unit must be separate from the central hospital pharmacy. - **Inpatient Services:** It provides limited and/or specialized inpatient pharmacy services. - **Space Requirements:** A minimum of 100 square feet is necessary, including space for references and equipment to perform the pharmacy service. - **Controlled Substances:** Controlled substances must be stored in a locked area.

Answer 37

- patient name and room number - name/strength/quantity and dosage form - tech filling order + RPh verifying - date filled - date and amount of unwanted/ unused drug returned to the pharmacy stock

Answer 38

- Records for schedule II controlled substances must be kept separate - Schedule III-V must be kept separate or if stored with non-controlled records, readily retrievable - Distribution, stock and med profiles can be stored electronically (readily retrievable within 72 hours)

Answer 39

 date  patient  drug/dose/quantity  nurse signature  beginning count & ending count; wasted amount  witness signature, if needed  prescriber (for controlled substances only)

Answer 40

clinic may operate under the license of the hospital pharmacy and is not required to obtain a separate license or permit from the Board

Answer 41

**A:** The following information is necessary for ER dispensing: - **Patient Name** - **Hospital** - **Drug Name, Strength, Quantity** - **SIG (Directions for Use)** - **Expiration Date** - **Name of Physician** - **Date Dispensed** (Note: Either a physician, pharmacist, or intern can dispense the medication.)

Answer 42

**A:** Inpatient hospital pharmacies not licensed as retail pharmacies must adhere to the following: - **Labeling Requirements:** Medications must be labeled with the patient's name, drug name, strength, quantity, and directions for use. - **Counseling Requirements:** Patients must receive appropriate counseling regarding their medications. - **Record Retention:** Records of dispensing must be retained for 3 years. - **Electronic Records:** Electronic records must be retrievable within 72 hours.

Answer 43

a person or entity who facilitates distribution of a prescription drug to a person other than a consumer or patient

Answer 44

an entity that provides or coordinates warehousing, or other logistics services of a product in interstate commerce on behalf of a manufacturer, wholesale distributor, or dispenser of a product, but does not take ownership of the product, nor have responsibility to direct the sale or disposition of the product

Answer 45

a person who owns or operates a facility that repackages and re-labels a product or package for further sale or distribution without a further transaction

Answer 46

a person or entity who engages in the production, preparation, propagation, conversion or processing of a drug or device, either directly or indirectly, by extraction from substances of natural origin or independently by means of chemical or biological synthesis; and includes packaging or repackaging, labeling or relabeling and the promotion and marketing of such drugs or devices

Answer 47

Radioactive pharmaceutical preparation: - Minimum equipment: fume hood (> 30 inches), laminar flow hood, dose calibrator, lead-lined refrigerator, Mettler balance, spectrophotometer, drawing station - Glassware: 3 50 mL beakers, 3 150 mL beakers, 1 500 mL beaker, 2 50 mL volumetric flasks, 6 100 mL volumetric flasks, 2 10 mL graduated cylinders, 2 100 mL graduated cylinders - Radiochromatographic strip scanner and/or well counter - Supplies: 1, 3, and 5 mL disposable syringes; 10, 20, and 30 mL multidose vials; alcohol swabs, disposable gloves - References: AHFS, National Formulary, USP - Space: minimum of 240 sq ft; sink with hot and cold water

Answer 48

- Minimum variety/quantity of medications to meet needs of station - Physician in charge of station orders drugs; controlled substances require separate controlled substance registration - Drugs kept locked unless nurse or physician present - Maintain record book for receipt and administration of drugs

Answer 49

- Veterinarian in charge of clinic specifies drugs to be used; controlled substances require separate controlled substance registration - Drugs kept locked unless veterinarian or designee present - Maintain record book for receipt and administration of drugs; schedule II must be separate - Any clinic licensed by the Board of Pharmacy is required to have a consultant pharmacist ---- Controlled substances: pharmacist visits at least quarterly ---- No controlled substances: pharmacist visits annually

Answer 50

- Developed by the pharmacy and therapeutics committee or pharmacist and medical director of the clinic - Drug procurement and storage is limited to the drugs listed in the administration formulary for on-site administration

Answer 51

**A:** The requirements for clinic drug stock maintained by a pharmacy include: - **Dispensing via Valid Rx:** Medications must be dispensed only with a valid prescription. - **Separation of Drugs:** Clinic drugs must be kept separate from other drugs in the pharmacy. - **Labeling:** Each medication must be labeled “Dispensed for clinic by pharmacy.” - **Patient Records:** Patient records related to clinic drug dispensing must be maintained separately.

Answer 52

**A:** Medications may be repackaged from bulk containers into multiple dispensing units by a physician, dentist, pharmacist, or a supervised technician. This process is intended for preparing medications for future patients.

Answer 53

References: adequate reference materials: product information reference, copy of state drug laws and regulations, poison treatment chart with poison control phone number

Answer 54

**A:** In Class E Clinics (NTP): - **Methadone for Take-Home:** A nurse may supply methadone for take-home to a clinic patient in a properly labeled dispensing unit, which is not considered dispensing. - **Mobile NTP Clinic:** A separate license is not required for mobile components of an NTP. However, controlled substances must be stored securely and returned to the main clinic location at the end of the day's operation.

Answer 55

- Supervised by RPh (part-time or full-time) - Policies and procedures: review annually - Receipt and destruction journal ---- date ---- patient name ---- pharmacy name ---- name of drug ---- strength and dosage form ---- prescription number ---- quantity ---- initials of person accepting delivery ---- inventory of drugs to be destroyed - Equipment: appropriate current drug reference sources - Emergency drug supply: maintained for medical emergencies (no controlled substances unless 24hr/365day per year on-site nurse

Answer 56

sterile NS and water (injectable/irrigation), tuberculin testing solution, vaccines as recommended by the CDC

Answer 57

- Customized patient medication packages: consent of patient, care-giver, prescriber, or institution . - Repackaging of patient medication packages: if drug added or discontinued from a patient's drug regimen, pharmacist may repackage the patient's patient medication package (removed drugs: destroy or relabel and return to patient; cannot return drug from med package with >1 drug to pharmacy stock under any circumstances)

Answer 58

Return of patient medication package drugs (only one drug within a container): - Non-Institutional: may not be returned to pharmacy stock - Institutional: storage and handling of the drugs are assured  (1) keep in patient medication package sealed and labeled until dispensed  (2) expiration date of drug = fifty percent of the time left of the expiration for the drug  (3) no schedule II drugs returned to inventory  (4) proper record keeping for other scheduled drugs into inventory

Answer 59

Class I – general controls: prohibits misbranding/adulteration, require federal registration and listing by manufacturer, require notifications of risks/repairs/replacement/refund, requirement restricting sale/distribution, require cGMP/record keeping/reports and inspections, authority to ban device

Answer 60

- Class II – performance standards: general controls not sufficient to assure safety/effectiveness, required by FDA, FDA regulations establish performance standard

Answer 61

Class III – pre-market approval: represents life sustaining, life-supporting or implanted in the body or which presents a potential

Answer 62

does not comply with performance standards, class II device with uncompleted pre-market approval, banned device, violates cGMPs, fails to comply with investigational device exemption protocol

Answer 63

Manufactured in nonregistered establishment, advertising fails to meet minimum disclosure requirements, device labeling fails to meet FDA performance standards, device manufacturers that fail to maintain records, labeling without adequate directions/warnings, label is false/misleading, restricted device without proper labeling

Answer 64

**A:** Prescription status devices must be labeled with the following statement: “CAUTION: Federal law restricts this device to sale by or on the order of a ______: physician, dentist, veterinarian, or with the descriptive designation of any other practitioner licensed by the laws of this State to prescribe or use the device in his practice.”

Answer 65

**A:** Oxygen may be provided without a prescription when used for: - Depressurization - Environmental oxygen deficiency - Emergency resuscitation All other medical gases require a prescription for dispensing.

Answer 66

Consultant pharmacists to retail distributors of veterinary prescription products are required to visit the facility every other month. Consultant pharmacists to retail distributors of veterinary prescription products that do not dispense controlled substances are required to visit the licensed facility quarterly. . No CS = Quarterly CS = every other month . . . Of NOTE: for Animal control Clinic (imited drug clinic) No CS = annually CS = Quarterly

Answer 67

- Therapeutically equivalent, bioequivalent, listed in FDA green book (approved animal drugs) - Unless: hand-written “no substitution” Authorization: Prescription valid for 12 months from written

Answer 68

- NS + SW (injectable/irrigation), acetic acid (irrigation), heparin flush, Tb testing solution, Hep B vaccine, flu vaccine, topical anesthetic, diphenhydramine and epinephrine injections - Keep drugs at home care service’s licensed location, except small quantities (not to exceed need for 96 hr period) may be transported to other locations - Purchase/Store CS: Separate NM CS Registration + DEA registration (under facility/physician) - Consultant Pharmacist: visits at least quarterly

Answer 69

- Name of institution - Date - Radiopharmaceutical + dose - Name of procedure - Date/time calibration (administration) - Name or pt (for blood components or therapeutic use) - Specific instructions

Answer 70

- Equipment: fume hood, laminar flow hood, dose calibrator, refrigerator (lead lined), balance, spectrophotometer, drawing station, glassware - Sink with hot/cold water - References: American Hospital Formulary Service, National Formulary, United States Pharmacopoeia, copy of city, state, and federal regulations governing the safe storage, handling, use, dispensing, transport and disposal of radiopharmaceuticals - Space: undivided area of not less than 240 square feet hot lab and storage area

Answer 71

**A:** To register with the DEA: - Use **DEA Form 224** (or **Form 224a** for renewal). - Registration must be renewed every **3 years**. - Renewal should occur within **60 days of expiration**. If renewal forms are not received within **45 days of expiration**, contact the DEA in writing.

Answer 72

A: Schedule I

Answer 73

A: Schedule IV

Answer 74

A: Schedule I

Answer 75

A: Schedule III

Answer 76

A: Schedule I

Answer 77

A: Schedule IV

Answer 78

A: Schedule V

Answer 79

A: Schedule II

Answer 80

A: Schedule III

Answer 81

A: Schedule II

Answer 82

A: Schedule IV

Answer 83

A: Schedule III

Answer 84

A: Schedule IV

Answer 85

A: Schedule IV

Answer 86

A: Schedule III

Answer 87

A: Schedule I

Answer 88

A: Schedule I

Answer 89

A: Schedule V

Answer 90

A: Schedule II

Answer 91

A: Schedule III

Answer 92

A: Schedule IV

Answer 93

A: Schedule II

Answer 94

A: Schedule III

Answer 95

A: Schedule IV

Answer 96

A: Schedule IV

Answer 97

A: Schedule IV

Answer 98

A: Schedule IV

Answer 99

A: Schedule II

Answer 100

A: Schedule III

Answer 101

A: Schedule I

Answer 102

Schedule III

Answer 103

Schedule III

Answer 104

A: Schedule V

Answer 105

A: Schedule V

Answer 106

A: Schedule IV

Answer 107

A: Schedule IV

Answer 108

Inventory Records: - Annually May 1st or other dates but need to tell BOP(DEA requires every 2 years) - Additional inventories: New pharmacy opening, Pharmacy closing, Change in ownership, Newly controlled substances, New PIC: notify BOP immediately, controlled substance inventory within 72 hours, new PIC application within 10 days - Maintain inventory records for 3 years (2 years per DEA) - Exact count required for CI-II (perpetual inventory required per NM) - Estimate for CIII-V unless container holds >1000 tablets/capsules then exact count required

Answer 109

A: Procurement records (excluding inventory) can be kept at a central location with prior federal approval. If the board requests these records, they must be delivered to the registered location within **48 hours**.

Answer 110

Maintain all controlled substance records for 3 years (NM, 2 years per DEA) - Invoices: --- Option 1: CI-II separate, CIII-V separate, non-CS separate --- Option 2: CI-II separate, CIII-V and non-CS together (CIII-V readily retrievable, stamped with 1in red “C”) - Prescriptions: Electronic maintain for 10 years (per DEA 2 years) - Must be maintained ON-SITE: --- Paper prescriptions --- Executed DEA form 222 --- Inventories --- All other records may be maintained at another location 14 days after DEA notification

Answer 111

- Record of quantity and date of dispensing by pharmacist and practitioner - Use DEA form 222 if CI-II - Total number of dosage units of all CS distributed in this method not >5%

Answer 112

DEA Number: XX1234567 - First letter identifies registrant type --- A, B, F if hospital/pharmacy/practitioner (MD, DPM, DDS, DVM) --- M if mid-level practitioner (CNP, PA, OD, etc.) --- P/R if manufacturer, distributor, researcher, analytical lab, importer, exporter, reverse distributor, narcotic treatment program - Second letter is the first letter of registrant’s last name

Answer 113

- **Copy 1 (brown)** = Supplier - **Copy 2 (green)** = DEA (supplier forwards within 2 business days) - **Copy 3 (blue)** = Purchaser **Note:** Errors cannot be corrected; write "VOID" on the form and retain it

Answer 114

- Name, address, and DEA # of purchaser - Name, address, and DEA # of supplier - Date ordered - Drug name/strength/quantity/# of packages - Number of completed lines - Signature of purchaser (must be DEA registrant or POA)

Answer 115

complete within 60 days; or else will need new DEA form 222

Answer 116

Patients in Skilled Nursing Facilities (SNF) or Intermediate Care Facilities (ICF) Correctional facilities Hospice patients Animals by licensed veterinarians Prescriptions dispensed by federal facilities (IHS, VA, etc.) Compounded prescriptions Situations involving temporary technical issues/emergencies or extenuating circumstances

Answer 117

A: If exceptions to electronic prescribing apply, prescriptions may be transmitted via fax. For prescriptions not involving long-term facilities, hospice patients, or compounded for direct administration, the original written prescription must be provided to the pharmacy prior to dispensing.

Answer 118

A: For CIII-V prescriptions, the following methods are acceptable: Written, fax, or verbal prescriptions Telephone prescriptions are limited to a 10-day supply with no refills unless a written prescription for the same drug is on file within 6 months.

Answer 119

A: All prescriptions for controlled substances must include: Date and prescriber’s signature Name and address of the patient Drug name, strength, dosage form, quantity prescribed, and directions for use Name, address, and DEA registration number of the practitioner Refills recorded electronically or on the face of the Rx Prescription number Date of dispensing Quantity dispensed RPH initials

Answer 120

Patient name Drug name Prescriber signature

Answer 121

**A: Under NM Senate Bill 221:** - Health care providers who prescribe or dispense opioids must provide counseling about overdose risk and the availability of opioid antagonists for first-time prescriptions. - For patients with previous prescriptions, this counseling must occur at least once a year. - If prescribing an opioid for more than a 5-day supply, the provider must co-prescribe an opioid antagonist.

Answer 122

Verify ID for CII-V unless patient is known to pharmacist/intern, home delivery or delivery to licensed facility

Answer 123

- Patient requested CII partial fill: --- Within 30 days of Rx written: fill within 30 days --- After 30 days of Rx written: fill within 72 hours --- If full amount unavailable: fill within 72 hours, notify physician if remaining portion cannot be filled within 72 hour period **Exception: LTCF or terminal**: May fill in partial quantities, valid for a period NTE 60 days from date of issue

Answer 124

CIII-V: Record like a refill, no dispensing after 6 months from date of prescription

Answer 125

- Immediate administration of a controlled substance is necessary for proper treatment - No appropriate alternative treatment is available - Not reasonably possible for the prescribing practitioner to provide a written prescription to be presented to the person dispensing the substance prior to the dispensing

Answer 126

- Oral authorization of a practitioner or authorization via facsimile machine - Quantity prescribed is limited to the amount needed to treat the patient during the emergency period - Written prescription from physician within seven days after authorization of the emergency dispensing “AUTHORIZATION FOR EMERGENCY DISPENSING” attach to oral/facsimile emergency prescription - If prescribing physician fails to deliver a signed written prescription to the pharmacist within seven days, notify DEA office and the board of pharmacy

Answer 127

**A: In hospitals:** - **C-I drugs** must be stored in a locked area. - **C-II to C-V drugs** can be stored either in a locked area or dispersed throughout the pharmacy, unless managed by a part-time or consultant pharmacist, in which case they must be locked.

Answer 128

Non-Rx CV: - Must be sold by pharmacist or intern - NTE 8oz(240mL) opium or 48 dosage units per 48 hours - NTE 4oz(120mL) of other CS (Robitussin AC) or 24 dose per 48 hours - Purchaser must be at least 18 years old - ID required unless purchaser is known - Log-book: maintain for 3 years --- Name/address of purchaser --- Date of sale --- Drug name/quantity --- Name of RPH --- Signature: no purchase made within the 48- hour period at another pharmacy

Answer 129

- Storage: behind counter or in locked cabinet - Sold by pharmacist, intern or technician (anyone with annual training + certificate) - Quantity: --- 3.6g/day --- 9g/30 days (7.5g if shipped) - Log-book: send to **BOP every 7 days** --- Name/address of purchaser --- ID of purchaser --- Drug name/quantity --- Date and time --- Signature --- Name of pharmacist/intern/tech

Answer 130

- DEA Form 41 (1x/year) - Hospital may apply for blanket authorization to destroy at anytime - Breakage/spillage: 2 witness signatures, DEA Form 41 for disposal

Answer 131

Theft/Loss: Report to DEA within 1 business day (DEA Form 106), Report to BOP within 5 days

Answer 132

**A: Regulations include:** - **Methadone:** - Cannot be prescribed for maintenance or detox outside of a treatment program. - Exception: A physician may administer 1 day's worth for up to 3 consecutive days while the patient is awaiting placement. - In a hospital, methadone can be used to prevent withdrawal if the patient is hospitalized for another reason or for intractable pain. - **Suboxone:** - Can be prescribed outside of a treatment program if the physician is registered (requires both X number and DEA registration).

Answer 133

Be at least 18 years of age. Not be addicted to drugs or alcohol. Follow the technician-to-pharmacist ratio determined by the Pharmacist-in-Charge (PIC).

Answer 134

A: Pharmacy technicians may engage in: Preparation, mixing, assembling, packaging, and labeling of medications. Processing routine orders of stock supplies. Preparation of non-sterile and sterile products, including bulk compounding. Filling prescriptions or medication orders that involve counting, pouring, labeling, or reconstituting medications. Initiating and receiving refill authorizations. Entering prescription data. Performing tasks assigned by the supervising pharmacist that do not require professional judgment.

Answer 135

A: Pharmacy technicians must: - Complete initial training and obtain board certification within one year of registration. - Complete an additional 100 hours of experiential training for sterile compounding.

Answer 136

A: For vaccine administration, pharmacy technicians must: Complete an ACPE accredited immunization course and obtain BLS/CPR certification. Complete 0.2 CEU of vaccine-related continuing education each registration period. Draw up vaccines into syringes under pharmacist verification. Work under the supervision of a pharmacist, who can supervise no more than 2 technicians giving vaccines (or up to 6 if dedicated solely to vaccine administration).

Answer 137

A: Identification and registration details include: An ID is required. Registration expires biennially on the last day of the birth month. Technicians must report any change of address or employment in writing to the board within 10 days.

Answer 138

Registration: DEA registration + NM CS Registration required to purchase and stock any controlled substance Consultant Pharmacist: - Review all controlled substances use + a sample of other drugs, at least every 90 days - Report to Medical Director/chief executive: - At least annually on EMS drug handling and exception handling - Within 24 hours in writing if exception Jump kit: contains emergency medical supplies and drugs (including controlled substances if registered) Administration: drug receipt and administration records must be readily retrievable and retained for at least three years

Answer 139

fifteen (15) days

Answer 140

Prescription requirements: - All information for manufacturer: lens manufacturer, type/power of lens, curve, size - Name of the patient - Date written - Name and address of the licensed optometrist - Expiration date (default = 2 years) Physician, optometrist or pharmacist may dispense

Answer 141

- Every 3 years - Requires web-based training

Answer 142

- Practitioner administration of CS or administration to inpatients at hospital - Practitioner/clinic/urgent care/emergency room dispensing no more than 12 units or 72-hour supply of CS - Wholesale distributor of CS - Veterinarian (non-human patient)

Answer 143

Reporting: conform to ASAP (automatic pharmacy) standards - Within one business day of the prescription being filled: - Dispenser and prescriber DEA number and NPI - Patient name, address, and date of birth - Rx #, date issued, and date filled - Drug NDC #, quantity dispensed, days supply - Classify as new or refill prescription - Payment classification - If no CS dispensed: zero report within one business day - corrections: submitted within 5 business days *board monitors dispensing of CII-V

Answer 144

- May prepare compounded drugs for prescriber office use (prescriber must order and product must be administered in office) - May prepare compounded drugs for veterinary use to be dispensed under specific conditions: emergency condition to be treated by compounded drug, dispensed amount is not to exceed 120 hr (5 days) supply, timely access to compounding pharmacy not available. For CS preparations, pharmacy must be registered through DEA as a manufacturer.

Answer 145

- name and strength - facility’s lot number - beyond-use date - quantity or amount in the container

Answer 146

- not available from normal distribution channels in a timely manner to meet patient’s needs + requested by practitioner - compounded product is changed significantly

Answer 147

- Equipment and supplies: Sink with hot and cold running water; Class A prescription balance, or analytical balance and weights when necessary

Answer 148

- Name and strength - Quantity - Date of compounding - Lot/batch number - BUD: (not later than an expiration date of any component)  Non-aqueous: 6 months  Water-containing oral: 14 days in fridge  Water-containing topical + mucosal liquid: 30 days

Answer 149

- Quality control: contain not less than 90.0 percent and not more than 110.0 percent of the theoretically calculated and labeled quantity/weight/volume of active ingredient per unit volume

Answer 150

Records: Maintained by the pharmacy for at least three (3) years: Formulation records & Compounding records Advertising: May advertise non-sterile compounding services including specific drug product/class - Note: per federal law do not advertise price

Answer 151

- Must have current pharmacist license in another state - Must be sponsored by pharmacy with active license in NM - Valid NTE 6 months, can be renewed for additional 6 months

Answer 152

**A: Both hub pharmacies and remote tele-pharmacies must:** - Be located in New Mexico and licensed by the New Mexico Board of Pharmacy (NMBOP). - Obtain a separate tele-pharmacy license. - If the hub and remote pharmacies have different owners, a contract is required. - A remote tele-pharmacy must be located more than 20 miles from an existing retail pharmacy and cannot exceed 200 prescriptions per day.

Answer 153

Indirect supervision: - Live video line - At least 4 cameras - Maintain recorded video for at least 90 days - Electronic link must be functional while tele-pharmacy open, if link malfunctions tele-pharmacy must close unless a pharmacist is physically present

Answer 154

**A: At a hub pharmacy when the tele-pharmacy is open:** - A designated pharmacy technician and a registered pharmacist (RPh) must be present. - **Pharmacy Technician:** Must have a minimum of 2,000 hours of experience as a certified technician. - **Pharmacist:** Cannot oversee more than four pharmacies and must conduct site visits and inspections at least monthly.

Answer 155

**A: The procedures include:** - Utilization of bar coding or an equivalent method for filling prescriptions. - The hub pharmacy may fill prescriptions and send them to the tele-pharmacy for dispensing. - Counseling is required for both new prescriptions and refills. - Compounding is not permitted at remote tele-pharmacies.

Answer 156

**A: Procedures include:** - Clinics or practitioners must register with the New Mexico Board of Pharmacy (NMBOP) before accepting donated prescription drugs. - The recipient of donated drugs must be a patient of the clinic. **Eligible drugs must:** - Be unused and stored in a tamper-evident container. - Have an expiration date of 6 months or more. - Not be re-dispensed more than once. **Ineligible drugs include:** - Controlled substances. - Drugs subject to Risk Evaluation and Mitigation Strategies (REMS), except for those requiring only a MedGuide. **Recordkeeping:** - Records must be maintained for 3 years.

Answer 157

two (2) working days

Answer 158

A: CSPs must comply with USP 797 and be certified every 6 months. Facilities must be clean, lighted, and maintain an average of 80-150 foot candles.

Answer 159

A: Facility requirements include: A minimum of 100 square feet dedicated to compounding sterile preparations. A minimum size of 240 square feet for retail pharmacies. Retail pharmacies with sterile product preparation capabilities must have at least 340 square feet, with 100 square feet exclusive to compounding sterile preparations. Standalone CSP facilities must have a minimum of 240 square feet, with 100 square feet dedicated to compounding.

Answer 160

A: Required equipment and references include: Current references (hard copy or electronic), such as: USP/NF or USP on Compounding: A Guide for the Compounding Practitioner. New Mexico pharmacy laws, rules, and regulations. Specialty references for stability, incompatibility, sterilization, preservation, pediatric dosing, and drug monographs. Automated compounding devices must have their accuracy verified at least every 30 days per manufacturer specifications and be observed monthly, with verification by a registered pharmacist (RPh).

Answer 161

A: BSCs must: Be certified every 6 months. Maintain certification records for 3 years. Recordkeeping for all CSP-related activities must be maintained for at least 3 years.

Answer 162

A: Training requirements include: Completion of 100 hours of documented experiential training in compounded sterile preparations. Initial training before beginning compounding. Annual refresher training and assessment in didactic topics. Annual testing of glove fingertip and media fill for low and medium risk compounding. Six-month testing of glove fingertip and media fill for high-risk compounding. Documentation must be maintained for 3 years.

Answer 163

**A: The Lynn Pierson therapeutic research program is limited to:** - Cancer chemotherapy patients - Glaucoma patients

Answer 164

**A: Key details include:** - **Supply:** Medical use of cannabis is limited to a maximum of 3 months uninterrupted supply from a source within New Mexico. - **Eligible Conditions:** Includes, but is not limited to, cancer, glaucoma, multiple sclerosis (MS), spinal cord injury, epilepsy, HIV, and hospice care. - **Prohibited Possession Areas:** Cannabis cannot be possessed in public vehicles, schools, workplaces, or public parks/recreation centers. - **Application Requirements:** Must include name, address, date of birth, provider name/address/phone, and primary caregiver information. - **Registry Identification Card:** Valid for 3 years from the date of issue. - **Dispensary Location:** Must be at least 300 feet away from schools, churches, or daycare facilities. - **Notification:** Changes in name, address, caregiver, practitioner, or medical condition must be reported to the board within 10 days.

Answer 165

**A: Key provisions include:** - Pharmacists may dispense any drug or interchangeable biological product listed on the FDA's approved prescription drug products with therapeutic equivalence evaluation list that is lower in cost than the prescribed drug/biological product. - This is not allowed if the prescription states “no substitution.” - The label must include both the original and the dispensed drug. - For interchangeable biologics, the pharmacist must notify the patient. - Within five business days of dispensing a biologic product, the pharmacist must notify the prescriber of the specific product provided to the patient, including the drug name and manufacturer (this notification can be electronic).

Answer 166

**A: Key points include:** - Drug paraphernalia is generally unlawful, except for hypodermic syringes and needles as part of a harm reduction program. - The Harm Reduction Act aims to: - Prevent hepatitis B and C, HIV, and opioid overdose. - Encourage substance abuse treatment. - Facilitate the exchange of sterile hypodermic syringes and needles. - Participation in this program is not a violation of the Controlled Substances Act for: - Patients in the program. - Employees of the department. - Private providers contracted with the department.

NM Law Study Guide Flashcards

(196 cards)