Chapter 402
S.P. 659 - L.D. 1842
PART DD
Sec. DD-1. 32 MRSA §13702, as amended by PL 2005, c. 430, §6, is repealed.
Sec. DD-2. 32 MRSA §13702-A is enacted to read:
As used in this chapter, unless the context otherwise indicates, the following terms have the following meanings.
1. Automated pharmacy systems.
"Automated pharmacy systems" means mechanical systems that perform operations or activities, other than compounding, relative to the storage, packaging, labeling, dispensing or distribution of medications, and systems that collect, control and maintain all transactional information.
2. Board.
"Board" means the Maine Board of Pharmacy.
3. Commissioner.
"Commissioner" means the Commissioner of Professional and Financial Regulation.
4. Compounding.
"Compounding" means the preparation, mixing, assembling, packaging or labeling of a drug or device by a pharmacist for the pharmacist's patient either for dispensing as the result of a practitioner's prescription drug order, or for the purpose of, or as an incident to, research, teaching or chemical analysis and not for sale or dispensing. "Compounding" includes the preparation of drugs or devices in anticipation of prescription drug orders to be received by the pharmacist based on routine, regularly observed prescribing patterns.
5. Dangerous substance.
"Dangerous substance" means a substance described in section 13731, subsection 2.
6. Deliver or delivery.
"Deliver" or "delivery" means the actual, constructive or attempted transfer of a drug or device from one person to another, whether or not for a consideration.
7. Department.
"Department" means the Department of Professional and Financial Regulation.
8. Device.
"Device" means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or other similar or related article, including any component part or accessory, that is required under federal or state law to be prescribed by a practitioner and dispensed by a pharmacist.
9. Dispense or dispensing.
"Dispense" or "dispensing" means the preparation and delivery of a prescription drug in a suitable container appropriately labeled for subsequent administration to or use by a patient or other individual entitled to receive the prescription drug pursuant to a lawful order of a practitioner.
10. Distribute.
"Distribute" means the delivery of a drug other than by administering or dispensing.
11. Drug.
"Drug" means: A. Articles recognized as drugs in the official United States Pharmacopeia and National Formulary, other drug compendiums or any supplement to any of them;
B. Articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans or other animals;
C. Articles, other than food, intended to affect the structure or any function of the body of humans or other animals; and
D. Articles intended for use as a component of any articles specified in paragraphs A to C.
12. Electronic transmission.
"Electronic transmission" means transmission of information in electronic form or the transmission of the exact visual image of a document by way of electronic equipment.
13. Free clinic.
"Free clinic" means an incorporated nonprofit health facility that provides health care to people at no charge.
14. Generic and therapeutically equivalent drug.
"Generic" and "therapeutically equivalent drug" means any drug that has identical amounts of the same active ingredients in the same dosage form and in the same concentration that, when administered in the same amounts, will produce or can be expected to have the same therapeutic effect as the drug prescribed.
15. Labeling.
"Labeling" means the process of preparing and affixing a label to the outside of any drug container, exclusive of the labeling by a manufacturer, packer or distributor of a nonprescription drug or commercially packaged legend drug or device. Any such label must include all information required by federal law or regulation and state law or rule.
16. Mail order contact lens supplier.
"Mail order contact lens supplier" means a person or entity, other than an optometrist or physician licensed in this State, that fills contact lens prescriptions by mail or carrier for a patient who resides in this State.
17. Mail order prescription pharmacy.
"Mail order prescription pharmacy" means an entity that dispenses prescription medications by mail or carrier from a facility not located in this State to a patient who resides in this State.
18. Manufacture.
"Manufacture" means the production, preparation, propagation, compounding, conversion or processing of a device or drug, either directly or indirectly, by extraction from substances of natural origin or independently by means of chemical synthesis or by a combination of extraction and chemical synthesis and includes any packaging or repacking of the substances or labeling or relabeling of its container, except that manufacture does not include the preparation or compounding of a drug by an individual for personal use or the preparation, compounding, packaging or labeling of a drug: A. By a pharmacist or practitioner incidental to administering or dispensing a drug in the course of professional practice; or
B. By a practitioner or by authorization under the practitioner's supervision for the purpose of or incidental to research, teaching or chemical analysis and not for sale.
19. Manufacturer.
"Manufacturer" means a person engaged in the manufacture of prescription drugs.
20. Nonprescription drugs.
"Nonprescription drugs" means nonnarcotic drugs that may be sold without a prescription and that are prepackaged for use by the consumer and labeled in accordance with the requirements of the laws and rules of this State and the Federal Government.
21. Person.
"Person" means an individual, corporation, partnership, association or any other legal entity.
22. Pharmacist.
"Pharmacist" means an individual licensed by this State to engage in the practice of pharmacy. A. "Chain pharmacist" means an individual who is engaged in the practice of pharmacy within a chain; that is, where there is a corporate grouping of 4 or more pharmacies.
B. "Hospital pharmacist" means an individual who is engaged in the practice of pharmacy in a hospital setting.
C. "Independent pharmacist" means an individual who is engaged in the practice of pharmacy in an independent pharmacy; that is, where there are fewer than 4 pharmacies under the same ownership.
D. "Qualified assistant pharmacist" means an individual licensed by this State as a qualified assistant apothecary, qualified assistant or assistant pharmacist, provided that the license is in full force and effect, except for the right to serve as a pharmacist in charge.
23. Pharmacist in charge.
"Pharmacist in charge" means the pharmacist who is responsible for the licensing of the pharmacy.
24. Pharmacy.
"Pharmacy" means: A. Any pharmacy or drug outlet located in a retail store, mail order business, free clinic or rural health center with facilities located in this State that is engaged in dispensing, delivering or distributing prescription drugs; or
B. Any mail order prescription company, or wholesaler, with facilities located in this State or doing business in this State that is engaged in dispensing, delivering or distributing prescription drugs.
25. Pharmacy technician.
"Pharmacy technician" means a person employed by a pharmacy who works in a supportive role to, and under the direct supervision of, a licensed pharmacist.
26. Physician.
"Physician" means an allopathic physician or osteopathic physician.
27. Poison.
"Poison" means an agent that when ingested, inhaled or otherwise absorbed by a living organism is capable of producing a deleterious response seriously injuring function or producing death.
28. Practice of pharmacy.
"Practice of pharmacy" means the interpretation and evaluation of prescription drug orders; the compounding, dispensing, labeling of drugs and devices, except labeling by a manufacturer, packer or distributor of nonprescription drugs and commercially packaged legend drugs and devices; the participation in drug selection and drug utilization reviews; the proper and safe storage of drugs and devices and the maintenance of proper records for these drugs and devices; the responsibility for advising, when necessary or regulated, of therapeutic values, content, hazards and use of drugs and devices; and the offering or performing of those acts, services, operations or transactions necessary in the conduct, operation, management and control of a pharmacy.
29. Practitioner.
"Practitioner" means an individual who is licensed, registered or otherwise authorized in the appropriate jurisdiction to prescribe and administer drugs in the course of professional practice.
30. Prescription drug or legend drug.
"Prescription drug" or "legend drug" means a drug that: A.
Under federal law is required, prior to being dispensed or delivered, to be labeled with either of the following statements:
(1) "Caution: Federal law prohibits dispensing without prescription."; or
(2) "Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian."; or
B. Is required by an applicable federal or state law or rule to be dispensed on prescription only or is restricted to use by practitioners only.
31. Prescription drug order.
"Prescription drug order" means a lawful written or oral order of a practitioner for a drug or device. Written orders may be issued on a prescription form or by electronic transmission.
32. Rural health center.
"Rural health center" means an incorporated nonprofit health facility that provides comprehensive primary health care to citizens in rural areas.
33. Targeted methamphetamine precursor.
"Targeted methamphetamine precursor" means any product containing any amount of ephedrine, pseudoephedrine or phenylpropanolamine or their salts, isomers or salts of isomers, either alone or in combination with other ingredients: A. In dry or solid nonliquid form; or
B. In liquid, liquid-filled capsule or glycerin matrix form if designation as a targeted methamphetamine precursor has been completed by rule adopted pursuant to section 13795, subsection 5, paragraph A.
34. Wholesaler.
"Wholesaler" means a person who buys prescription drugs for resale and distribution to persons other than consumers.
Sec. DD-3. 32 MRSA §13712, as enacted by PL 1987, c. 710, §5, is amended to read:
The board shall consist consists of 7 members, two of whom shall must be representatives of the public members as defined in Title 5, section 12004-A and the remainder of whom shall must be licensed pharmacists who possess the qualifications specified in section 13713. At the time of the appointment, at least one of the licensed pharmacists must be a hospital pharmacist, at least one must be a chain pharmacist and at least one must be an independent pharmacist.
Sec. DD-4. 32 MRSA §13715-A, sub-§1, as enacted by PL 1993, c. 600, Pt. A, §269, is amended to read:
1. Length.
Members of the board are appointed for terms of 3 years. Appointments of members must comply with Title 10, section 60 8009.
Sec. DD-5. 32 MRSA §13716, as amended by PL 1995, c. 397, §108, is further amended to read:
1. Officers.
The board shall elect from its members a president and other officers as it deems considers appropriate and necessary to conduct its business. The president of the board shall preside at all meetings of the board and shall be responsible for the performance of all of the duties and functions of the board required or permitted by this Act. Each additional officer elected by the board shall perform those duties normally associated with that position and those other duties assigned from time to time by the board.
2. Terms of office.
Officers elected by the board shall serve terms of one year commencing with the day of their elections and ending upon elections of their successors and shall serve no more than 3 consecutive full terms in each office to which elected.
Sec. DD-6. 32 MRSA §13718, as enacted by PL 1987, c. 710, §5, is amended to read:
1. Number.
The board shall meet at least once every 2 months a year to transact its business , which includes the election of officers and the reorganization of the board. The December meeting shall be designated as the annual meeting and shall be for the purpose of electing officers and for the reorganization of the board. The board shall meet at additional times as it may determine. Additional meetings may be called by the president or by 2/3 of the members of the board.
2. Place.
The board shall meet at such place as it may from time to time determine. The place for each meeting shall be determined prior to giving notice of the meeting and shall not be changed after the notice is given without adequate subsequent notice.
3. Notice.
Notice of all meetings of the board shall be given in the manner and pursuant to requirements prescribed by the State's applicable laws and rules.
4. Quorum.
A majority of the Four members of the board constitutes constitute a quorum for the conduct of a board meeting and, except when a greater number is required by this Act or by any rule of the board, all actions of the board shall be by a majority of a quorum.
5. Open meeting.
All board meetings and hearings shall be open to the public. The board may conduct portions of its meetings in executive session pursuant to the freedom of access laws, Title 1, section 405.
Sec. DD-7. 32 MRSA §13721, sub-§1, ¶E, as enacted by PL 1987, c. 710, §5, is amended to read:
E. The registration licensing of any drug outlet pharmacy as set out in section 13751 and any manufacturer or wholesaler whose products are distributed in this State;
Sec. DD-8. 32 MRSA §13721, sub-§1, ¶H, as amended by PL 2005, c. 262, Pt. B, §1, is further amended to read:
H. The registration licensing of pharmacy technicians, including the required fee as set under section 13724, and adoption of rules governing the training, qualification and employment of pharmacy technicians.
Sec. DD-9. 32 MRSA §13722, sub-§1, ¶D, as enacted by PL 1987, c. 710, §5, is amended to read:
D. Issue and renew certificates of registration licenses for purposes of ascertaining those persons engaged in the manufacture and distribution of drugs;
Sec. DD-10. 32 MRSA §13723, as amended by PL 2005, c. 262, Pt. B, §2, is further amended to read:
The board has such other duties, powers and authority as may be necessary to enforce this Act and the board may adopt rules pursuant to this Act, which include, but are not limited to, the following.
1. Professional associations.
The board may join professional organizations and associations organized exclusively to promote the improvement of the standards of the practice of pharmacy for the protection of the health and welfare of the public and whose activities assist and facilitate the work of the board.
2. Bond.
In addition to any statutory requirements, the board may require such surety bonds as it deems considers necessary to guarantee the performance and discharge of the duties of any officer or employee receiving and disbursing funds.
3. Seal.
The executive director of the board or the secretary of the board shall keep the seal of the board at the department and shall affix it only in such manner as may be prescribed by the board.
4. Reports.
The board shall submit to the commissioner no later than August 1st of each year a report summarizing its proceedings and activities during the fiscal year, together with a report of all money received and disbursed by the board.
6. Grants.
The board may receive and expend funds, in addition to its annual allocation, from parties other than the State, provided that as long as:A. The funds are awarded for the pursuit of a specific objective which that the board is authorized to accomplish by this Act or which that the board is qualified to accomplish by reason of its jurisdiction or professional expertise;
B. The funds are expended for the pursuit of the objective for which they are awarded;
C. Activities connected with or occasioned by the expenditures of the funds do not interfere with or impair the performance of the board's duties and responsibilities and do not conflict with the exercise of the board's powers as specified by this Act;
D. The funds are kept in a separate, special state account; and
E. Periodic reports are made to the commissioner concerning the board's receipt and expenditure of the funds.
7. Investigatory powers.
The board shall notify the Department of the Attorney General upon receipt of a complaint. Upon receipt of the notifications, the Attorney General shall notify the department within a timely period if the alleged violation requires criminal investigation. If a case does not require criminal investigation, the board or its authorized representatives may investigate and gather evidence concerning alleged violations of this Act or of the rules of the board. The board or an officer authorized representative pursuant to paragraph A may remove from any premises authorized for inspection pursuant to section 13721, subsection 1, paragraph D certain original records relating to scheduled drugs or controlled substances, including, but not limited to, prescription records, shipping and delivery records, patient profiles, inventories and other drug records for the purposes of analysis, duplication and furthering the investigation. A signed inventory receipt of any records being removed must be furnished to the premises by the board or an authorized officer representative. When a means of producing legible photocopies is readily available at the site of the records being removed, an authorized officer representative removing the records shall leave photocopies of the records as part of an inventory receipt in accordance with this subsection. Except when photocopies are left as part of an inventory receipt, the board or an authorized officer representative removing records from the premises shall, within 48 hours from the time of removal, provide to a representative of the premises photocopies of any removed records, together with a certificate identifying the agency in possession of the records, or return the original records. Inventory receipts and photocopies of any removed records provided by the board or an authorized officer representative are admissible as evidence if offered by any representative of the premises to prove compliance with any rule of the board or requirement of law.A. Prescriptions, orders and records required by this chapter and stocks of prescription and legend drugs are open only to the board, the board's inspectors and investigators authorized representatives, federal and state law enforcement officers whose duty it is to enforce the laws of this State or of the United States relating to scheduled drugs or controlled substances and other law enforcement officers authorized by the board or the Attorney General for the purposes of inspecting, investigating and gathering evidence of violations of law or any rule of the board. No officer person having knowledge by virtue of the officer's person's office of any such prescription, order or record may divulge that knowledge, except before a licensing or registration board or officer representative or in connection with a prosecution or proceeding in court.
B. The Bureau of Health, the board, their officers, agents, inspectors and representatives, all peace officers within the State and all prosecuting attorneys shall enforce all provisions of this chapter, except those specifically delegated, and shall cooperate with all agencies charged with the enforcement of the laws of the United States, of this State and of all other states relating to prescription or legend drugs or their equivalent.
8. Embargo.
The board may embargo certain drugs or devices as follows.A. Notwithstanding anything in this Act to the contrary, if a duly authorized representative of the board finds or has probable cause to believe that any drug or device is adulterated or misbranded within the meaning of the United States Food and Drug Act, the board representative shall affix to the drug or device a tag or other appropriate marking giving notice that the article is or is suspected of being adulterated or misbranded and has been detained or embargoed, and warning all persons not to remove or dispose of the article by sale or otherwise until provision for removal or disposal is given by the board, its agent representative or the court. No person may remove or dispose of the embargoed drug or device by sale or otherwise without the permission of the board or its agent representative or, after summary proceedings have been instituted, without permission from the court.
B. When a drug or device detained or embargoed under paragraph A has been declared by a representative of the board to be adulterated or misbranded, the board shall, as soon as practical, report the declaration to the Attorney General's office, along with sufficient information to permit the Attorney General to bring a petition for an injunction to the judge of the court in whose jurisdiction the article is detained or embargoed. If the judge determines that the drug or device so detained or embargoed is not adulterated or misbranded, the board shall direct the immediate removal of the tag or other marking.
C. If the court finds the detained or embargoed drug or device is adulterated or misbranded, that drug or device, after entry of the decree, shall be destroyed at the expense of the owner under the supervision of the board representative and all court costs and fees, storage and other proper expense shall be borne by the owner of the drug or device. When the adulteration or misbranding may be corrected by proper labeling or processing of the drug or device, the court, after entry of the decree and after the costs, fees and expenses have been paid and a good and sufficient bond has been posted, may direct that the drug or device be delivered to the owner for labeling or processing under the supervision of a board representative. The expense of the supervision shall be paid by the owner. The bond shall be returned to the owner of the drug or device on representation to the court by the board that the drug or device is no longer in violation of the embargo and the expense of supervision has been paid.
10. Procedure.
Except as otherwise provided, the board shall exercise all of its duties, powers and authority in accordance with the Maine Administrative Procedure Act, Title 5, chapter 375.
11. Exemption.
The board may exempt a free clinic from all fees, in whole or in part, required set under this chapter.
Sec. DD-11. 32 MRSA §13724, as enacted by PL 2005, c. 262, Pt. B, §3, is amended to read:
The Director of the Office of Licensing and Registration within the Department of Professional and Financial Regulation may establish by rule fees for purposes authorized under this chapter in amounts that are reasonable and necessary for their respective purposes, except that the fee for any one purpose may not exceed $325. Rules adopted pursuant to this section are routine technical rules as defined in Title 5, chapter 375, subchapter 2-A. All fees received by the board must be paid to the Treasurer of State and used to carry out this chapter. Any balance of these fees may not lapse but must be carried forward as a continuing account to be expended for the same purposes in the following years.
Sec. DD-12. 32 MRSA §13731, sub-§2, as enacted by PL 1987, c. 710, §5, is amended to read:
2. Authorization to deal with dangerous substances.
Practitioners, drug jobbers, drug wholesalers, drug manufacturers, pharmacists and pharmacies registered licensed under this chapter and approved animal shelters as provided in Title 7, section 3913, are authorized to deal professionally with dangerous substances. A dangerous substance is:A. Any substance listed under the Federal Uniform Controlled Substance Act, sections 1 through 5; or
B. Anything deemed to be dangerous by the Federal Drug Administration, other federal agency, or the Attorney General of the United States.
Sec. DD-13. 32 MRSA §13732, sub-§2, ¶B, as enacted by PL 1987, c. 710, §5, is repealed.
Sec. DD-14. 32 MRSA §13733, as amended by PL 2005, c. 262, Pt. B, §§6 to 8, is further amended to read:
1. Requirements.
To obtain a license as a pharmacist by reciprocity an applicant for licensure must:A. Have submitted a written application in the form prescribed by the board together with the required fee as set under section 13724;
B. Have attained the age of 21 years;
C. Have demonstrated good moral character and temperate habits trustworthiness and competency;
D. Have possessed at the time of initial licensure as a pharmacist such other qualifications necessary to have been eligible for licensure at that time in this State, except that if the state requirement of graduation from a pharmacy degree program accredited by the American Council on Pharmaceutical Education applies, this requirement may be waived for an applicant who, notwithstanding paragraph E, has graduated from a college of pharmacy in the United States prior to June 1, 1985, has engaged in the practice of pharmacy within the United States for a period of at least 5 years within the 10 years immediately preceding the application and who has passed the national pharmacy examination prepared by the National Association of Boards of Pharmacy;
E. Have engaged in the practice of pharmacy for a period of at least one year or have met the internship requirements of this State within the one-year period immediately previous to the date of the application;
F. Have passed the state pharmacy law exam as administered approved by the board; and
G. Have presented to the board proof of initial licensure by examination and proof that the license and any other license or licenses granted to the applicant by any other state or states have not been suspended, revoked, canceled or otherwise restricted for any reason except nonrenewal or the failure to obtain required continuing education credits in any state where the applicant is licensed, but not engaged in the practice of pharmacy. If an otherwise qualified applicant for licensure by reciprocity has had a license suspended, revoked, cancelled or otherwise restricted for any reason, the board may assess the prior disciplinary event and in its discretion issue the license.
2. Eligibility.
No applicant is eligible for licensure by reciprocity unless the state in which the applicant was initially licensed as a pharmacist also grants reciprocal licensure to pharmacists duly licensed by examination in this State under like circumstances and conditions.
Sec. DD-15. 32 MRSA §13734, as amended by PL 2005, c. 262, Pt. B, §9, is further amended to read:
1. Renewal.
A license expires on the date set by the Commissioner of Professional and Financial Regulation commissioner pursuant to Title 10, section 8003, subsection 4 for the licensing period for which the license was issued. A renewal license is issued for each ensuing licensing period in the absence of any reason or condition that might warrant the refusal to grant a license, upon receipt by the board of the written request of the applicant and the required fee for the license as set under section 13724 and upon the applicant's presenting evidence of compliance with the requirements of section 13735.Licenses may be renewed up to 90 days after the date of expiration upon payment of a late fee as set under section 13724 in addition to a required the renewal fee as set under section 13724. Any person who submits an application for renewal more than 90 days after the license renewal date is subject to all requirements governing new applicants under this chapter, including a late fee, renewal fee and filing additional late fee as set under section 13724, except that the board may, giving due consideration to the protection of the public, waive examination if that renewal application is made within 2 years from the date of that expiration.
2. Inactive renewal license.
Every registered A licensed pharmacist not practicing pharmacy within this State shall pay, on or before the expiration date as determined by the commissioner, a renewal fee as set under section 13724, in return for which a nonactive an inactive renewal registration license must be issued. Every registered A licensed pharmacist holding a nonactive an inactive renewal registration license who desires to practice pharmacy in this State is required to submit proof satisfactory to the board that, during the calendar year preceding application for active registration licensure, the pharmacist has participated in not less than 15 hours of approved courses of continuing professional pharmaceutical education as defined in section 13735. The board may make exceptions from the operation of to the continuing education requirement of this section in emergency or hardship cases.
If any person fails or neglects to procure the annual nonactive inactive renewal registration license, notice of that failure having been mailed to that person's last known address by the board, after the expiration of 30 days following the issue of notice, that person's original registration license expires. That person, in order to regain registration licensure, is required to pay one renewal fee as set under section 13724 in addition to the sum of all fees that person may be in arrears.
Sec. DD-16. 32 MRSA §13735, as amended by PL 2005, c. 262, Pt. B, §10, is further amended to read:
An annual renewal certificate license may not be issued by the board until the applicant submits proof satisfactory certifies to the board that, during the calendar year preceding an application for renewal, the applicant has participated in not less than 15 hours of approved courses of continuing professional pharmaceutical education as set out in this section. The continuing professional pharmaceutical educational courses consist of postgraduate studies, institutes, seminars, workshops, lectures, conferences, extension studies, correspondence courses or such other forms of continuing professional pharmaceutical education as may be approved by the board.
These courses shall consist of subject matter pertinent to the following general areas of professional pharmaceutical education: The socioeconomic and legal aspects of health care; the properties and actions of drugs and dosage forms; and the ideology, characteristics and therapeutics of the disease state. The specific subject matter of the courses may include, but is not limited to, pharmacology, biochemistry, physiology, pharmaceutical chemistry, pharmacy administration, pharmacy jurisprudence, public health and communicable diseases, pharmaceutical marketing, professional practice management, anatomy, histology and such other subject matter as represented in curricula of accredited colleges of pharmacy. The content of each course offered for credit under this continuing professional educational program must be approved in advance of the course by a committee composed of equal representation from the board, hospital pharmacy and retail pharmacy within the State. The number and members of the committee shall be selected by the board and shall serve for a period of 2 years the board or its representative. The board may make exceptions from the operation of to this section in emergency or hardship cases.
Each application for approval of a continuing education program or course must be submitted according to the guidelines prescribed by rule by the board, together with a required fee as set under section 13724.
Sec. DD-17. 32 MRSA §13741, as amended by PL 1999, c. 130, §9, is further amended to read:
The board shall investigate civil complaints regarding noncompliance with or violation of this chapter or of any rules adopted by the board.
The board shall notify the licensee of the content of a complaint filed against the licensee as soon as possible, but in no event later than within 60 days of receipt of this information. The licensee shall respond within 30 days. If the licensee's response to the complaint satisfies the board that the complaint does not merit further investigation or action, the matter may be dismissed, with notice of the dismissal to the complainant, if any.
If , in the opinion of the board, the factual basis of the a complaint is or may be true and the complaint is of sufficient gravity to warrant further action, the board may request an informal conference with the licensee. The board shall provide the licensee with adequate notice of the conference and of the issues to be discussed. The conference may be conducted in executive session of the board, pursuant to Title 1, section 405. Statements made at the conference may not be introduced at a subsequent formal hearing unless all parties consent.
If the board finds that the factual basis of the complaint is true and is of sufficient gravity to warrant further action, it may take any of the following actions it deems appropriate as set forth in Title 10, section 8003, subsection 5 and including:
1. Warning.
Warning, censuring or reprimanding the licensee;
2. Consent agreement.
With the consent of the licensee, entering into a consent agreement which fixes the period and terms of probation best adapted to protect the public health and safety and to rehabilitate or educate the licensee. A consent agreement may be used to terminate a complaint investigation if entered into by the board, the licensee and the Attorney General's office;
3. Negotiate stipulations.
In consideration for acceptance of a voluntary surrender of the license, negotiating stipulations, including terms and conditions for reinstatement which ensure protection of the public health and safety and which serve to rehabilitate or educate the licensee. These stipulations shall be set forth only in a consent agreement signed by the board, the licensee and the Attorney General's office; or
4. Adjudicatory hearing.
If the board concludes that modification or nonrenewal of the license might be in order, holding an adjudicatory hearing in accordance with the Maine Administrative Procedure Act, Title 5, chapter 375, subchapter IV.
Sec. DD-18. 32 MRSA §13742, as amended by PL 1999, c. 130, §10, is repealed.
Sec. DD-19. 32 MRSA §13742-A is enacted to read:
1. Disciplinary action.
In addition to the grounds enumerated in Title 10, section 8003, subsection 5-A, paragraph A, the board may deny a license, refuse to renew a license or impose the disciplinary sanctions authorized by Title 10, section 8003, subsection 5-A for: A. Habitual substance abuse that has resulted or is foreseeably likely to result in the applicant or licensee performing duties in a manner that endangers the health or safety of patients;
B. A professional diagnosis of a mental or physical condition that has resulted or may result in the applicant or licensee performing duties in a manner that endangers the health or safety of patients;
C. Engaging in unprofessional conduct by violating any standard of professional behavior, including but not limited to a breach of confidentiality of health care information pursuant to state law, that has been established in the practice for which the licensee is licensed; or
D. Engaging in false, misleading or deceptive advertising.
This subsection applies to all types of licenses issued by the board.
2. Crime in course of business.
If any licensed pharmacist is convicted in state or federal court of a crime that is committed during the course of duties performed as a licensed pharmacist or committed through the use of the pharmacy in which the pharmacist is employed, or that the pharmacist owns or operates, and that demonstrates unfitness to practice as a pharmacist, including, but not limited to, convictions for defrauding the Medicaid program and for illegally distributing prescription drugs, the pharmacist's license is subject to disciplinary action as set forth in subsection 1.
3. Criminal prosecutions.
Nothing in this chapter bars criminal prosecution for any violation of this chapter when that violation is a criminal offense under the laws of this State or of the United States.
Sec. DD-20. 32 MRSA §13743, as enacted by PL 1987, c. 710, §5, is amended to read:
1. Penalties.
Upon finding grounds for discipline of any person holding a license or seeking a license or a renewal of a license under this chapter, the board may take one or more of the following actions: A. Request the Attorney General's office to institute appropriate judicial proceedings which may lead to suspension or revocation of license;
B. Restrict the offender's license to prohibit the offender from performing certain acts or engaging in the practice of pharmacy in a particular manner for a term to be determined by the board; or
C.
Hold an adjudication hearing which may result in:
(1) Refusal to renew offender's license; or
(2) Placement of the offender on probation and supervision by the board for a period to be determined by the board.
2. Reinstatement.
Any person whose license to practice pharmacy in this State has been suspended, revoked or restricted pursuant to this chapter, whether voluntarily or by action of the board, may at reasonable intervals petition the board for reinstatement of the license. The petition must be made in writing in a form prescribed by the board. Upon investigation and hearing, the board may grant or deny the petition or it may modify its original finding to reflect any circumstances which have changed sufficiently to warrant those modifications.
3. Criminal prosecutions.
Nothing in this chapter bars criminal prosecution for any violation of this chapter where that violation is a criminal offense under the laws of this State or of the United States.
4. Judicial review.
All final decisions by the board are subject to judicial review pursuant to the Maine Administrative Procedure Act, Title 5, chapter 375.
Sec. DD-21. 32 MRSA §13751, sub-§1, as amended by PL 1997, c. 117, §10, is further amended to read:
1. Licensure.
All drug outlets pharmacies, manufacturers, wholesalers and mail order contact lens suppliers shall annually register with obtain a license from the board.
Sec. DD-22. 32 MRSA §13751, sub-§2, as amended by PL 1999, c. 42, §§4 and 5, is further amended to read:
2. Classifications.
Drug outlets shall Pharmacies must be registered licensed in classifications set out in this subsection.Each drug outlet pharmacy must apply for a certificate of registration license in one of the following classifications:
A. Retail drug outlet pharmacy;
B. Mail order prescription drug outlet pharmacy;
C. Wholesale drug outlet pharmacy;
D. Rural health center; or
E. Free clinic.
Sec. DD-23. 32 MRSA §13751, sub-§3, as enacted by PL 1987, c. 710, §5, is amended to read:
3. Rules.
The board shall establish by rule the criteria which that each drug outlet pharmacy must meet to qualify for registration licensure in each classification designated in subsection 2. The board may issue various types of certificates licenses with varying restrictions to the outlets pharmacies referred to in subsection 2, paragraph A when the board determines it necessary by reason of the type of drug outlet pharmacy requesting a certificate license.
Sec. DD-24. 32 MRSA §13752, as amended by PL 2005, c. 262, Pt. B, §§12 to 14, is further amended to read:
1. Procedures.
The board shall specify by rule the registration licensing procedures to be followed, including, but not limited to, specification of forms for use in applying for registration licensure and the times and places for filing an application.
2. Required information.
Applications for certificates of registration licenses must include the required fee as set under section 13724 and the following information about the proposed drug outlet pharmacy and pharmacist in charge:A. Ownership of the outlet pharmacy;
B. Location of the outlet pharmacy;
C. Identity of the pharmacist licensed to practice in the State who will be the pharmacist in charge of the drug outlet pharmacy, when one is required by this chapter, and such further information as the board may determine necessary. A pharmacist may be the pharmacist in charge for only one drug outlet pharmacy, except upon the pharmacist applying for and receiving written authorization from the board. The position of pharmacist in charge may not be held by a qualified assistant pharmacist; and
D. A certification by the pharmacist identified as the pharmacist in charge that the pharmacist has read and understands the requirements and duties of a pharmacist in charge set forth in board rules.
3. Transferability.
Certificates of registration Licenses issued by the board pursuant to this chapter are not transferable or assignable.
4. Professional responsibility.
The board shall specify by rule minimum standards for the professional responsibility in the conduct of any drug outlet pharmacy that has employees or personnel engaged in the practice of pharmacy. The board may require that the portion of the facility to which the certificate of registration license applies be operated only under the direct supervision of no less than one pharmacist licensed to practice in this State and not otherwise and to provide such other special requirements as necessary. A change in the pharmacist in charge who is responsible for the drug outlet pharmacy must be reported to the board together with the required fee as set under section 13724.
5. Minimum inventory.
The board shall ascertain that the applicant has a sufficient amount of prescription inventory on location to respond appropriately to prescription orders.
Sec. DD-25. 32 MRSA §13752-A, as enacted by PL 1999, c. 130, §12, is amended to read:
1. Opening facility.
Successful applicants for registration of a drug outlet Pharmacies licensed pursuant to this subchapter may open and operate the approved facility only:A. Upon the completion of a site inspection of the facility by a member approval of the board or its representative; or
B. Upon the pharmacist in charge certifying to the board, on forms prescribed by the board, that the facility is secure, suitable for operation as a drug outlet pharmacy and in compliance with applicable federal and state laws, rules and regulations governing the practice of pharmacy.
2. Facility inspection.
Registered drug outlets Licensed pharmacies that open and operate pursuant to subsection 1, paragraph B must be inspected by a member of the board or an inspector for the board its representative within 30 days of opening. Facilities that are found to be insecure, not suitable for operation as a drug outlet pharmacy or not in compliance with applicable federal and state laws, rules and regulations governing the practice of pharmacy are subject to a board-ordered emergency revocation of registration the license. The outlet pharmacy may not operate after revocation. The emergency revocation is a final agency action and is not subject to judicial review, but a new application for registration licensure may be submitted pursuant to section 13752, and if approved, a site inspection must be performed pursuant to subsection 1, paragraph A.
Sec. DD-26. 32 MRSA §13753, sub-§1, as enacted by PL 1987, c. 710, §5, is amended to read:
1. Changes.
All registered drug outlets licensed pharmacies shall report to the board, by registered mail or fax, the occurrence of any of the following changes:A. Permanent closing which requires 14 days' prior notice to the public and to the board;
B. Change of ownership which requires 7 days' prior notice to the board;
C. Change of pharmacist in charge which requires notice no later than 7 days after the change; and
D. Any other matters and occurrences as the board may require by rule.
Sec. DD-27. 32 MRSA §13754, as enacted by PL 1987, c. 710, §5, is amended to read:
1. Unlicensed practice.
No drug outlet registered pharmacy licensed pursuant to section 13751 may be operated until a certificate of registration license has been issued to that facility by the board. Upon the finding of a violation of this section, the board may impose one or more of the penalties enumerated in section 13731 or 13743. Any person who violates this section is subject to the provisions of Title 10, section 8003-C.
2. Reinstatement.
Reinstatement of a certificate license that has been suspended, revoked or restricted by the board may be granted in accordance with the procedures specified by section 13743, subsection 2.
Sec. DD-28. 32 MRSA §13758, as amended by PL 2005, c. 262, Pt. B, §15, is further amended to read:
1. Purpose; statement of intent.
The purpose of this section is to require registration licensure of manufacturers and wholesalers without facilities in this within or outside the State. The intent of the Legislature is that the board shall may not promulgate adopt rules regarding companies without wholesale facilities or manufacturers' facilities located in this State which that are more restrictive than federal law or regulation.
2. Licensure, manufacturers and wholesalers.
All manufacturers and wholesalers whose products are distributed in the State in any manner shall register with must be licensed by the board.
3. Licensure, individuals.
No An individual who is employed by a manufacturer or wholesaler which that is registered licensed under this subchapter need register not obtain licensure under this subchapter.
4. Form.
Registration License forms shall must state: Applicant's name; address; day phone; 24-hour phone; ownership status; manufacturer or wholesaler designation; Drug Enforcement Agency and Federal Drug Administration numbers; and date executed. Registration License forms shall must be executed by an owner or officer of the entity, providing printed name and title.
5. Fees.
Each registrant licensee shall pay a required fee as set under section 13724.
6. Violations.
It shall be is unlawful for manufacturers or wholesale companies to distribute prescription drugs in this State unless registered licensed under the provisions of this subchapter or subchapter V 5.
Sec. DD-29. 32 MRSA §13762, sub-§2, as amended by PL 2005, c. 262, Pt. B, §17, is further amended to read:
2. Renewal.
A license expires on the date set by the Commissioner of Professional and Financial Regulation commissioner pursuant to Title 10, section 8003, subsection 4 for the licensing period for which the license was issued. A renewal license is issued for each ensuing licensing period in the absence of any reason or condition that might warrant the refusal to grant a license and upon receipt by the board of the written request of the applicant and the required fee for the license as set under section 13724.Licenses may be renewed up to 90 days after the date of expiration upon payment of a late fee in addition to a required renewal fee , both of which are as set under section 13724. Any person who submits an application for renewal more than 90 days after the license renewal date is subject to all requirements governing new applicants under this chapter, including a late fee, renewal fee and filing additional late fee as set under section 13724.
Sec. DD-30. 32 MRSA §13782-A, sub-§1, as enacted by PL 1997, c. 245, §15, is amended to read:
1. Price disclosure required.
A pharmacist or pharmacy technician employed by a drug outlet pharmacy shall disclose upon the request of any person making an inquiry in person or by telephone the price of any brand or generic drug sold by that drug outlet pharmacy.
Sec. DD-31. 32 MRSA §13789, as enacted by PL 1987, c. 710, §5, is amended to read:
No person may purchase manufacturers' drug samples from any person for purposes of resale. If those samples are given gratuitously to a registered licensed pharmacist, qualified assistant pharmacist or medical practitioner, any such sample may be given to any person, provided that any such as long as the sample is kept in containers suitably labeled to conform to the Federal Food and Drug Act and the state food and drug laws and provided that this gift shall be is subject to the laws relating to the sale of drugs.
Sec. DD-32. 32 MRSA §13796, sub-§1, ¶B, as enacted by PL 2005, c. 430, §8 and affected by §10, is amended to read:
B. "Retailer" or "retail store" means a person or business entity engaged in this State in the business of selling products to the general public on a retail basis, including drug outlets pharmacies.
Sec. DD-33. 32 MRSA §13796, sub-§3, ¶C, as enacted by PL 2005, c. 430, §8 and affected by §10, is amended to read:
C.
Except with regard to single-dose packages of not more than 60 milligrams that are kept within 30 feet and in direct line of sight of a staffed cash register or store counter, the sale of targeted methamphetamine precursors must be completed by:
(1) A licensed pharmacist or registered licensed pharmacy technician; or
(2) An employee of the retailer who accepts payment for the targeted methamphetamine precursor as long as:
(a) The employee works under the direct supervision of a pharmacist in the pharmacy area of the retail store; and
(b) A licensed pharmacist or registered licensed pharmacy technician has given individual, express approval for the purchase.
Sec. DD-34. Maine Revised Statutes headnote amended; revision clause. In the Maine Revised Statutes, Title 32, chapter 117, subchapter 5, in the chapter headnote, the words "registration of pharmacy facilities" are amended to read "pharmacy facilities" and the Revisor of Statutes shall implement this revision when updating, publishing or republishing the statutes.
Sec. DD-35. Maine Revised Statutes headnote amended; revision clause. In the Maine Revised Statutes, Title 32, chapter 117, subchapter 6, in the chapter headnote, the words "manufacturers and wholesalers without facilities in this state" are amended to read "manufacturers and wholesalers" and the Revisor of Statutes shall implement this revision when updating, publishing or republishing the statutes.