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
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
