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Law State Board of Pharmacy

Published on January 2017 | Categories: Documents | Downloads: 8 | Comments: 0
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Arizona State
Board of
Pharmacy
-Governing body of pharmacy affairs.
-License for: Pharmacists, Interns, technicians, pharmacies, drug wholesalers and
manufacturers.
-9 Members = 6 pharmacist(at least 1 active community pharm and 1 hospital) and,
1 pharmacy tech, 2 members of public
-To be one need to be member of board of pharmacy for 10 yrs. and 5 years
experience as pharmacist in Arizona.
-Pharmacist’s serve 5 years
-All members are appointed by the governor.
Pharmacy Set Up
and Security
-At least 300 feet
2

-If minimum size (as above) no more than three personnel may work at the same
time.
-Each additional staff requires 60 feet
2

-At least 3 feet
2
of counter space (16 inches deep and 24 inches long)(minimize
error)
-Counter contained by barrier at least 66 inches tall (patient privacy)
-At least 36 inches wide the floor space along the dispensing and compounding
counter
-Separate patient counseling area (only for new pharmacies)
-Controlled substance in locked cabinet or distributed throughout the stock of meds
Rx Requirements Rx must meet the following requirements:
1. Written by authorized prescriber
2. Handwritten must include prescriber’s actual signature
3. If electronic must include prescriber’s electronic signature (needs to be
printed or reduced to writing)
4. Oral Rx can be called in but must be reduced to writing immediately.
5. Refills only authorized by prescriber and must be documented and filed
6. Rx orders may be sent by office via FAX or ELECTRONIC MAIL.
7. Patient can fax or e-mail if Rx is presented by patient upon pickup
8. All Rx must be printed on tamper-resistant paper unless it was faxed, email,
or verbally (by the office not patient)
-All Rx must be kept for at least 7 years
-Must be issued a serial number and must have fill date before filling and filled in
order in which they were dispensed and readily retrievable if upon request if
scanned electronically (same for hospitals).
-Rx from authorized prescriber for NON-CONTROLLED substance from CANADA or
MEXICO can be filled in Arizona.
-Rx written for FEDERALLY CONREOLLED substance from Canadian or Mexican
prescriber MAY NOT be filled in ARIZONA.
-CANADIAN and MEXICAN RX must be kept in separate file for retrieval for 7 years.
Generic
Substitution and
DAW
-Rx in Arizona should be dispensed as they are written if prescriber writes DAW,
dispense as written, or DO NOT SUBSTITUTE.
-Otherwise dispense generic if FDA approved to be bioequivalent (Orange Book).
-Don’t give generic if: No expiration date by manufacture or no recall protocol.
-Patient may choose Brand if MD did not specify brand name.
Refills -Non-Controlled substance valid for one year from written date, refill only within
this time frame.
-Schedule III-IV substance good only for 6 months since date written and may be
refilled up to 5x
-Schedule II only valid for 90 days and may not be refilled.
Dispensing
Controlled
Substance
WITHOUR Rx
Must be 18 years old, and ALL of the following criteria must be met:
1. For legitimate medical treatment
2. Not more than 240 mL or 48 dosage units of controlled substance
containing opium OR 120 mL or 24 units of any other controlled substance
dispensed to same person within 48 hrs.
3. No more than 120 dosage units of any product that contain only ephedrine
may be dispensed within 30 days.
4. Must provide ID and proof of age if not known to pharmacist.
5. Must keep record book of purchases including NAME, ADDRESS, PRODUCT,
DATE, and NAME OR INITIALS OF PHARMACIST overseeing the sale.
6. Bottle must be labeled with:
a. Pharmacy name and address
b. Date dispensed
c. Serial number
d. Prescriber’s name
e. Patient’s name
f. Directions
g. Any warning statement necessary (If controlled must include
federally required warning: “Caution: federal law prohibits the
transfer of this drug to any person other than the patient for
whom it was prescribed”
Pseudoephedrine -Used in manufacture of methamphetamine.
-Arizona state regulations on pseudoephedrine sales are less restrictive than federal
law, thus federal law MUST be followed:
I. All sales must be recorded in a logbook
a. Paper or electronic
b. Maintained for at least 2 years
c. Must include NAME and ADDRESS of purchaser, DATE and TIME,
DRUG NAME and QUANTITY, and SIGNATURE of purchaser.
II. A state issued photo ID at the time of purchase.
III. All products containing pseudoephedrine must be kept behind counter or
locked cabinet and sold only under supervision of license pharmacist.
IV. No more than 9 grams/person/30 days
V. No more than 3.6 grams/person/day
VI. No more than 7.5 grams/30 days (when shipping via mail order)
VII. This rules do not apply to RX written pseudoephedrine-ONLY OTC
Patient
Counseling
-MUST occur on ALL NEW Rx dispensed to patient.
-Interns may counsel under direct supervision of licensed pharmacist.
-Counseling is not required on refills unless there is a change in directions or
dosage.
Transferring Rx -May transfer between pharmacies by pharmacist or interns.
-When transferring out the Rx must be invalidated by writing VOID on the original
Rx or invalidated in dispensing computer system.
-The name, address, and phone # of receiving pharmacy shall be copied on the back
of hard copy or in computer system.
-The Rx of non-controlled taken down by receiving pharmacy must include:
1. The word “Transfer”
2. The ORIGINAL WRITTEN DATE of RX
3. The 1
st
and last dates the RX was dispensed
4. The ORIGINAL NUMBER of refills
5. The number of refills remaining
6. Name, address, and phone number of the original pharmacy
7. Rx number at the original pharmacy
8. Name of Pharmacist or Intern the Rx was transferred from
9. Name of Pharmacist or Intern of the receiving pharmacy
-Rx for Schedule III, IV, and V can only be transferred between 2 pharmacists and
may transfer ONLY ONE TIME. (Record same info above as for non-controlled sub.)
AND BOTH PHARMACIES MUST RECORD DEA number of the other pharmacy on
transfer order.
-Rx may be transferred to Arizona from other states if all of the above is met and
prescriber is has prescriptive authority in Arizona (see below of who can prescribe)
Record Keeping
Requirements
-Must be kept for 7 years, includes: hard copies, daily sales records, immunization
records, prescription transfer records, logbooks for pseudoephedrine and controlled
substance sales, etc.
Pharmacy
Licensure
-All pharmacies, drug wholesalers, drug storage facilities and drug manufacturers
must be licensed with the Board of Pharmacy.
-Renewed every other year
-Pharmacies not located in Arizona but deliver to Arizona must also be registered
with the state Board of Pharmacy in Arizona.
-Application for licensure must include:
1. Name of person responsible for the operations of the facility
2. Location (physical street address)
3. Description of activities to be performed in facility
-If several facilities then need a separate application for each location
-Types of permits issues by Board of Pharmacy:
1. Permit to sell non-Rx medications (not required to sell at one fixed location)
2. Pharmacy permit
3. Limited service pharmacy permit (closed door pharmacy; only counseling,
no dispensing)
4. Full service wholesale drug permits (stock Rx and non-Rx)
5. Non-Rx drug wholesale permits
6. Drug manufacturer permits
7. Drug packager or pre-packager permit
8. Compressed medical gas distributor or supplier permit (ex. Oxygen)
-Permits can be revoked if medical provider is receiving compensation.
-If business-closing permit should be surrendered immediately and Board of
Pharmacy must be notified and drugs removed or destroyed.
Pharmacist
Licensure and CE
-Must graduate and pass all the exams
-Be of good moral character
-License renewed every other year
-All pharmacist license expires on October 31 (failure may result in additional fees)
-Must complete 30 hrs. of continued education with at least 3 hrs. on pharmacy law.
-Proof of CE should be kept for 5 years.
-Credits may not be carried over to next renewal period.
-If you have not been practicing as a pharmacist for more than one year, must
complete a board-approved training program of 400 hrs.
-Position of “Pharmacist-in-charge” must be reported to Board of Pharmacy.
-If termination or change in position must also be reported to the board.
-To Serve as preceptor for interns must register for license with the board.
1. Responsible for practical instructions of intern
2. Are to act as teachers and mentors to the student
3. Must verify intern hours worked by pharmacy intern
-To be eligible for preceptor license must:
1. Have unrestricted license
2. At least 1 year of experience as a pharmacist
-Pharmacists’ with preceptor licenses working in a community setting may only be a
preceptor to two pharmacy interns per calendar quarter.
Pharmacy Intern
Responsibilities
-Graduate intern license (those who graduate from school)
-Need 1,500 intern hours before becoming pharmacists.
-No more than 500 hours per quarter (three months)
-Hours recorded only if worked under a preceptor (pharmacist with preceptor
license)
-Intern hours may be registered after the beginning of the first year of professional
pharmacy education.
-Intern license are issued for 5 years and may be issues for additional year with
board approval.
-Intern license is NOT eligible for renewal.
-If not completed education within 6 year must explain to board that they are going
to work towards completing the education for renewal to be issued.
-Intern may perform the following under immediate supervision of licensed
pharmacist:
1. Dispense and sell meds, medical devices and poisons to pts.
2. Compound medications
3. Perform duties of pharmacist as long as directly supervised by pharmacist.
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Type of Prescribers Prescription Authority
Medical Doctor (MD) Independent prescribing authority, unlimited
Doctor of Osteopathy (DO) Independent prescribing authority, unlimited
Dentist (DDS) OR (DMD) “Doctor of Dental
Surgery” OR “Doctor of Dental Medicine”
Independent prescribing authority
LIMITED TO SCOPE OF PRACTICE.
Limited to TX of mouth, teeth and gums.
Podiatrist (DPM) “Doctor of Podiatric Medicine” Independent prescribing authority
LIMITED TO SCOPE OF PRACTICE.
Limited to Tx of feet.
CAN PRESCRIBE CONTROLLED RX WITH BOARD
APPROVAL.
Veterinarian (DVM, VMD) Doctor of Veterinary
Medicine
Independent prescribing authority
LIMITED TO SCOPE OF PRACTICE.
Limited to Tx of animals.
Physician Assistant (PA) Can prescribe NON-controlled substance without
limits.
Controlled substance can only be prescribed with
written consent of a supervising physician and
only up to a 30 day supply may be prescribed at
once.
Registered Nurse Practitioner (NP) Can prescribe non-controlled and controlled
medication with board approval, independent
prescribing authority.
EMT/Paramedic Does NOT have any prescribing authority
Chiropractor Does NOT have any prescribing authority
Naturopathic Doctor (ND) LIMITED independent prescribing authority.
CANNOT PRESCRIBE:
1)Chemotherapy
2)Antipsychotics
3)IV meds
CAN PRESCRIBE:
1)Schedule II (ONLY MORPHINE)
2)Schedule III-V
Optometrist LIMITED independent prescribing authority.
CAN prescribe NON-controlled meds with board
approval.
ONLY Schedule III analgesics.
Pharmacist Can START, ALTER, or D/C meds with collaborative
agreement with a supervising physician.

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