Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 5 - LICENSE DENIAL AND PROFESSIONAL DISCIPLINE › Chapter 38 - LICENSURE OF CLOSED-SHOP PHARMACIES › Appendix 392-5-38-A

Current through 2024-29, July 17, 2024
VIOLATIONS FOR WHICH
CITATION MAY BE ISSUED
CHAPTER 4: LICENSURE OF PHARMACISTS
Failure of a pharmacist to notify the board of a change of
					 contact address within 30 days...................... §
										3
CHAPTER 7: REGISTRATION AND EMPLOYMENT OF PHARMACY
					 TECHNICIANS
Failure of a pharmacy technician to notify the board of a
					 change in work site, change of contract address or change in enrollment status
					 within 30 days............................................ §
										1(5)
Failure to supply adequate training to a pharmacy
					 technician................................................................
					 §
										2
Failure to have a copy of the pharmacy technician training
					 program on site at the drug outlet................. §
										2
Failure of a pharmacist in charge to ensure proper
					 registration of a pharmacy technician................... §
										3(1)
Failure of a pharmacist in charge to conspicuously display
					 a pharmacy technician's registration at the work
					 site...............................................................................................
					 §
										3(2)
Failure of a pharmacist in charge to notify the board of
					 the commencement or cessation of a pharmacy technician's employment within 14
					 days...............................................................................................
					 §
										3(3)
Permitting a pharmacy technician to practice beyond the
					 scope of permissible duties
					 ....................................................................................................................
					 §§
										5,
					 7(1),
					 7(3)(A)
Violation of pharmacy technician deployment
					 ratios..................................................... §§
										6,
					 7(2),
					 7(3)(B)
CHAPTER 8: REGISTRATION OF RETAIL DRUG OUTLETS
Alteration of prescription filling area prior to receiving
					 board approval.................................................. §
										7
CHAPTER 13: OPERATION OF RETAIL DRUG OUTLETS
Retail drug outlet not open to the public for a minimum of
					 40 hours per week................................... §
										2(1)
Failure to prominently post in a public area of the store
					 the days and hours that a retail drug outlet is scheduled to be open to the
					 public.................................................................. §
										2(2)
Failure of a retail drug outlet to timely report a
					 deviation from its posted schedule............................. §
										2(5)
Operation of a retail drug outlet without a pharmacist in
					 charge....................................................... §
										3(1)
Failure to perform duties and responsibilities of a
					 pharmacist in charge............................................. §
										3(2)
Filling or dispensing a prescription outside the
					 prescription filling area of a retail drug outlet.................... §
										5
Failure to properly secure the prescription filling
					 area..........................................................................
					 §
										6
Failure to identify a retail drug outlet with proper
					 signage.....................................................................
					 §
										7
Failure to follow all procedures for the permanent closing
					 of a retail drug outlet.................................... §
										8
CHAPTER 14: PHARMACY SERVICES AT RURAL HEALTH
					 CENTERS
Failure to comply with rule requirements applicable to
					 pharmacy services at a rural health
					 center............................................................................
					 entire chapter other than §
										5
CHAPTER 15: OPERATION OF FREE CLINICS
Failure to comply with rule requirements applicable to the
					 operation of a free pharmacy clinic...................
					 ......................................................................................................
					 entire chapter other than §
										2
CHAPTER 16: OPERATION OF WHOLESALE DRUG OUTLETS AND
					 MANUFACTURERS
Failure to comply with rule requirements applicable to the
					 operation of wholesale drug outlet or
					 manufacturer.............................................................................
					 entire chapter other than §
										2(10)
CHAPTER 18: STERILE PHARMACEUTICALS
Failure to maintain at the drug outlet a policy and
					 procedure manual relating to sterile pharmaceuticals... §
										2
Failure to comply with the physical requirements for the
					 making of sterile pharmaceuticals.................... §
										3
Failure to comply with patient profile, labeling,
					 recordkeeping, disposal and other requirements............... §
										5
Failure to protect personnel against cytotoxic
					 drugs.............................................................................
					 §
										6
Failure to provide proper clinical
					 services...........................................................................................
					 §
										7
Failure to follow patient care
					 guidelines..............................................................................................
					 §
										8
Failure to implement and follow an adequate quality
					 assurance program............................................... §
										9
CHAPTER
					 1 9: RECEIPT AND HANDLING OF
					 PRESCRIPTION DRUG ORDERS
Failure to include all required information on a
					 prescription drug order..................................................
					 §1
Failure to comply with requirements for prescription drug
					 orders for controlled substances.................... §
										2
Failure to comply with requirements for telephone
					 prescription drug orders....................................... §
										3(1)
Failure to comply with requirements for facsimile
					 prescription drug orders........................................ §
										3(2)
Refilling prescriptions more than 15 months after the date
					 written........................................................ §5
Failure to maintain required dispensing records of
					 prescription drug orders............................................ §
										6
Failure to comply with requirements for automated data
					 processing systems......................................... §
										7
Failure to comply with prescription drug transfer
					 requirements...................................................... §§
										8,
					 9
Filling a prescription drug order 6 months or longer after
					 the prescribing practitioner first became
					 unavailable......................................................................................................
					 §
										10
Failure to ensure the security and confidentiality of
					 prescription drug orders, dispensing records, patient profiles and all other
					 patient records..............................................................
					 § 12
CHAPTER 20: AUTOMATED PHARMACY SYSTEMS
Failure to comply with inspection
					 requirements...................................................................................
					 §
										9
CHAPTER 21: CENTRAL PRESCRIPTION PROCESSING
Failure to comply with labeling
					 requirements.......................................................................................
					 §
										4
Failure to maintain an audit
					 trail.....................................................................................................
					 §
										5(1)
Failure of a retail drug outlet that utilizes central fill
					 services to notify patients that prescription drug orders accepted at the
					 retail drug outlet may be filled by a central fill drug
					 outlet........................................................................................................
					 §
										5(4)
CHAPTER
					 2 2: SALE OF SCHEDULE V CONTROLLED
					 SUBSTANCES
Improper sale of Schedule V controlled
					 substances......................................................................
					 §§2,
					 3
CHAPTER 23: ACCOUNTING FOR PRESCRIPTION DRUGS
Failure to maintain contemporaneous perpetual inventory
					 records for Schedule II controlled substances for 5
					 years......................................................................
					 §
										1
Failure to report the theft, loss or unresolved inventory
					 discrepancy of prescription drugs....................... §
										3
CHAPTER 24: RETENTION OF RECORDS BY DRUG OUTLETS
Failure to comply with retention
					 requirements.....................................................................
					 entire chapter
CHAPTER 30: UNPROFESSIONAL CONDUCT
Failure to display or carry proof of licensure or
					 registration............................................................ §
										1(10)
Failure to establish and maintain effective controls to
					 prevent prescription errors or misfills.............. §
										1(15)
Failure to address or attempt to resolve a possible
					 prescription error or situation of potential harm to a
					 patient...............................................................................................
					 §
										1(16)
Failure to properly preserve, refrigerate, secure or store
					 all drugs in the drug outlet or pharmacy
					 department.................................................................................................
					 §
										1(18)
Failure of a drug outlet to notify the board within 7 days
					 of the termination of employment of a pharmacist for any drug-related
					 reason..........................................................................
					 § 26
MAINE PHARMACY ACT
32 M.R.S.A.
					 §§13701 -
					 13810
Failure to keep an adequate record of the sale of exempt
					 narcotic
					 preparations............................................................................................
					 § 13722(1)(E), last par.
Failure to substitute a generic drug when required to do
					 so, or improper substitution of a generic
					 drug...........................................................................................................
					 § 13781
Failure to properly explain directions the for use of a
					 newly-prescribed medication or
					 device...................................................................................................................
					 § 13784(1)
Failure to maintain a patient profile record system with
					 all required information.............................. § 13785
Improper purchase, sale or distribution of a manufacturer's
					 drug sample........................................ § 13789
Failure to label a prescription drug with all required
					 information..................................................... §
					 13794