An Act To Allow Pharmacists To Administer Certain Immunizations
Maine Legislature, Session 124, LD 1223
Committee Amendment CA_A_H473 (House)
Amends: 32 MRSA §13702-A, 32 MRSA §13735

COMMITTEE AMENDMENT "A" to H.P. 843, L.D. 1223, Bill, "An Act To 
Allow Pharmacists To Administer Certain Immunizations" 
Amend the bill by striking out everything after the enacting clause and before the 
summary and inserting the following: 
'Sec. 1. 32 MRSA §13702-A, sub-§28, as enacted by PL 2007, c. 402, Pt. DD, 
§2, is amended to read: 
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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 administration of 
influenza vaccine, intranasal influenza vaccine, pneumococcal vaccine, shingles or herpes 
zoster vaccine, tetanus-diphtheria-pertussis vaccine and tetanus-diphtheria vaccine; 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. 
Sec. 2. 32 MRSA §13735, as amended by PL 2007, c. 402, Pt. DO, § 16, is further 
amended to read: 
§13735. Continuing pharmacy education 
An annual renewal license may not be issued by the board until the applicant 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. Of the 15 hours to be 
·completed, at least 2 hours must be in board-approved courses on drug administration as 
described in section 13702-A, subsection 28. The continuing professional pharmaceutical 
educational courses consist of postgraduate studies, institutes, seminars, workshops, 
Page I - 124LR0033(02)-1 
COMMITTEE AMENDMENT 
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COMMITTEE AMENDMENT "A " 
to H.P. 843, L.D. 1223 
lectures, conferences, extension studies, correspondence courses or such other forms of 
continuing professional pharmaceutical education as may be approved by the board. 
These courses consist of subject matter pertinent to the following general areas of 
professional pharmaceutical education: +he the socioeconom ic 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, drug administration as it relates to 
the area of permitted practice, 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 the board 
or its representative. The board may make exceptions 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 fee 
as set under section 13724. 
Sec. 3. 32 MRSA c. 117, sub-c. 13 is enacted to read: 
SUBCHAPTER 13 
ADMINISTRATION OF DRUGS AND IMMUNIZATIONS 
§13831. Authority 
1. Administration of influenza vaccines. A pharmacist licensed in this State who 
meets the qualifications and requirements of section 13832 and rules adopted by the 
board may administer topically or by injection or by inhalation all forms of influenza 
vaccines, including intranasal influenza vaccines, to a person 9 years of age or older 
without a prescription. 
2. Administration of other vaccines. A pharmacist licensed in this State who meets 
the qualifications and requirements of section 13832 and rules adopted by the board, in 
addition to influenza vaccines under subsection I, may administer pneumococcal vaccine, 
shingles or herpes zoster vaccine, tetanus-diphtheria-pertussis vaccine, tetanus-diphtheria 
vaccine and booster tetanus-diphtheria vaccine to a person according to a valid 
prescription when the person has an existing primary care physician or other existing 
relationship with an authorized practitioner in this State. When the person does not have 
an existing relationship with a primary care physician or other practitioner in this State 
the pharmacist may proceed to administer according to a treatment protocol established 
by an authorized practitioner or a written standing order from a practitioner authorized 
under the laws of this State to issue an order, a prescription or a protocol to a person 18 
years of age or older for pneumococcal vaccine, shingles or herpes zoster vaccine, 
tetanus-diphtheria-pertussis vaccine, tetanus-diphtheria vaccine or booster tetanus-
diphtheria vaccine. 
COMMITTEE AMENDMENT 
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COMMIlTEE AMENDMENT ,A" to H.P. 843, L.D. 1223 
3. Emergency administration of certain drugs. A pharmacist may administer 
epinephrine or diphenhydramine, or both, to a person in an emergency situation resulting 
from an adverse reaction to an immunization administered by the pharmacist. 
§13832. Qualifications; requirements 
In order to administer a drug or immunization under this subchapter, a pharmacist 
must: 
1. Certificate; application and fee. 
Possess a current certificate of administration 
issued by the board pursuant to this subchapter. The pharmacist must submit an 
application in the form prescribed by the board together with the requirements set forth 
under this subchapter and certificate fee as set forth under section 13724. The certificate 
of administration expires and is subject to the conditions in the same manner as stated in 
section 13734; 
. 
2. License. Hold a valid unrestricted pharmacist license in this State; 
3. Training. Submit evidence acceptable to the board that the pharmacist, within the 
years immediately preceding application for a certificate of administration: 
A. 
Has completed a 20-hour course of study in the areas of drug administration 
authorized under this subchapter and as described in subsection 4; 
B. Has graduated with a Doctor of Pharmacy degree from a college of pharmacy 
accredited by the American Council on Pharmaceutical Education that includes 
completion of training in the areas of drug administration authorized under this 
subchapter satisfactory to the board, including instruction in the areas identified in 
subsection 4 received as part of the pharmacist's pharmacy degree program; or 
C. Possesses a current certificate of administration issued by another jurisdiction that 
authorizes the pharmacist to administer drugs comparable to those authorized under 
this chapter and that is based on the pharmacist's completion of training or course 
work as described in subsection 4, or its equiva·lent as determined by the board, and 
has continuous administration practice since the pharmacist received such training or 
since completion of a retraining program as required in this subchapter, as long as 
such retraining incorporates the areas identified in subsection 4; 
4. 
Didactic; practical course. 
Satisfactorily complete a didactic and practical 
course approved by the board that includes the current guidelines and recommendations 
of the federal Department of Health and Human Services, Centers for Disease Control 
and Prevention, the American Council on Pharmaceutical Education or a similar health 
authority or professional body, and that includes, but is not limited to, disease 
epidemiology, indications for use of vaccines, vaccine characteristics, injection 
techniques, adverse reactions to vaccines, emergency response to adverse events, 
immunization screening, informed consent, record keeping, registries, including the 
immunization information system established under Title 22, section 1064, registry 
training and reporting mechanisms, including reporting adverse events, life support 
training, biohazard waste disposal and sterile techniques and related topics; and 
5. 
Life support training. 
Submit evidence of completing cardiovascular life 
support training accepted by the American Heart Association, the American Red Cross or 
other similar training organization. 
COMMITTEE AMENDMENT 
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COMMITTEE AMENDMENT·A" to H.P. 843, L.D. 1223 
§13833., Treatment protocol 
The pharmacist shall administer drugs and immunizations in compliance with a 
treatment protocol established by a practitioner ~uthorized under the laws of this State to 
order administration of those drugs and immunizations approved by the board. A copy of 
the treatment protocol must be submitted to the board. At a minimum the treatment 
protocol must include: 
1. 
Standards. 
Standards for observation of the person receiving the drug or 
immunization to determine whether the person has an adverse reaction, as adopted in 
rules by the board; 
2. Procedures. Procedures to be followed by the pharmacist when administering 
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epinephrine, diphenhydramine, or both, to a person who has an adverse reaction to an 
immunization administered by the pharmacist; and 
3. 
Notification. 
Notification to the authorized practitioner who issued the 
prescription, standing order or protocol under section 13 831, subsection 2 of the 
administration by the pharmacist of the drug or immunization, or both, within 3 business 
days. 
§13834. Prohibited acts 
1. Delegate authority. A pharmacist may not delegate the pharmacist's authority to 
administer drugs or immunizations. 
2. Administer drugs. A pharmacist may not engage in the administration of drugs 
or immunizations unless the pharmacist meets the qualifications and requirements of 
section 
13832 and the pharmacist has obtained a board-issued certificate of 
administration. 
§1383S. Rules 
The board, after consultation with the Maine Center for Disease Control and 
Prevention and the Board of Licensure in Medicine, shall adopt rules to implement this 
subchapter. The rules must include, at a minimum: 
. 
1. Criteria. Criteria for the operation of a drug administration clinic within or 
outside a retail pharmacy, rural health clinic or free clinic licensed under section 13 751; 
2. Record keeping. Record keeping and documentation procedures and reporting 
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requirements, giving preference to electronic means when available; and 
3. Recipient assessment. Recipient assessment, consent and rights. 
Rules adopted pursuant to this section are routine technical rules as defined in Title 5, 
chapter 375; subchapter 2-A. 
Sec. 4. MaineCare program. Reimbursement under the MaineCare program for 
services provided under the Maine Revised Statutes, Title 32, chapter 117, subchapter 13 
is subject to the adoption ofa billing mechanism by the Department of Health and Human 
Services for the MaineCare program to implement the provisions of subchapter 13 and 
amendment of the rules of the MaineCare benefits manual to cover the service provided 
in subchapter 13 at a minimum of the current average wholesale price reimbursement rate 
COMMITTEE AMENDMENT 
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COMMIITEE AMENDMENT·A "to H.P. 843, L.D. ) 223 
plus a dispensing fee of $3.35. Prior to the adoption of a billing mechanism, a MaineCare 
member that receives a vaccination from a pharmacist as authorized by subchapter 13 
must be told in advance that the administration of vaccines provided by a pharmacist is 
not covered by MaineCare and the member will be responsible for payment. 
Sec. 5. Appropriations and allocations. 
The following appropriations and 
allocations are made. 
PROFESSIONAL AND FINANCIAL REGULATION, DEPARTMENT OF 
Licensing and Enforcement 0352 
Initiative: Allocates one-time funds to configure the agency licensing system and for the 
costs of rulemaking. 
1 
l3 
OTHER SPECIAL REVENUE FUNDS 
All Other 
OTHER SPECIAL REVENUE FUNDS TOTAL 
SUMMARY 
2009-10 
$7,000 
$7,000 
2010-11 
$0 
$0 
This amendment allows a pharmacist to administer certain drugs and immunizations, 
including the influenza vaccine, intranasal influenza vaccine, pneumococcal vaccine, 
shingles or herpes zoster vaccine, tetanus-diphtheria-pertussis vaccine and tetanus-
diphtheria vaccine with certain restrictions. It allows a licensed pharmacist to administer 
all forms of influenza vaccines to a person 9 years of age or older without a prescription. 
It also allows a licensed pharmacist to administer the pneumococcal vaccine, shingles or 
herpes zoster vaccine, tetanus-diphtheria-pertussis vaccine and tetanus-diphtheria vaccine 
to a person with a valid prescription when the person has an existing primary care 
physician or other existing relationship with an authorized Maine practitioner. In cases in 
which the person does not have an existing relationship with a primary care physician or 
other Maine practitioner the pharmacist may administer the vaccine according to a 
treatment protocol established by an authorized practitioner or a written standing order 
from a practitioner authorized under the laws of this State to issue an order, a prescription 
or a protocol to a person 18 years of age or older for pneumococcal vaccine, shingles or 
herpes zoster vaccine, tetanus-diphtheria-pertussis vaccine or booster tetanus-diphtheria 
vaccine. 
It also amends the continuing pharmacy education requirements for licensure renewal 
and establishes certain training requirements in order for a licensed pharmacist to be able 
to administer a drug or immunization. 
It establishes a treatment protocol for the 
administration of the drugs and immunizations. It provides that reimbursement under the 
MaineCare program is contingent on the adoption of a billing mechanism by the. 
Department ofHeaIth and Human Services for the MaineCare program and amendment 
of the rules of the MaineCare benefits manual to cover the service provided at a minimum 
of the current average wholesale price reimbursement rate plus a dispensing fee of $3.35. 
Prior to the adoption of a billing mechanism, a MaineCare member that receives a 
COMMITTEE AMENDMENT 
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COMMITIEE AMENDMENT ,A " 
to H.P. 843, L.D. 1223 
vaccination must be told in advance that the administration of vaccines provided by a 
pharmacist is not covered by MaineCare and the member will be responsible for payment. 
. FISCAL NOTE REQUIRED 
(See attached) 
COMMITTEE AMENDMENT 
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Approved: OS/25/09 Mac:.. 
LD 1223 
LR 33(02) 
An Act To Allow Pharmacists To Administer Certain Immunizations 
Fiscal Note for Bill as Amended by Committee Amendment "4,, 
Committee: Business, Research and Economic Development 
Fiscal Note Required: Yes 
Fiscal Note 
Projections 
2009-10 
2010-11 
2011-12 
Appropriations/Allocations 
Other Special Revenue Funds 
$7,000 
$0 
$0 
Projections 
2012-13 
$0 
(, 
,Fiscal Detail and Notes 
This bill includes a one-time Other Special Revenue Funds allocation of $7,000 in fiscal year 2009-10 for the 
Licensing and Enforcement program within the Department of Professional and Financial Regulation for the costs 
associated with rulemaking and with configuring the agency licensing system to track the qualification requirements. 
The Licensing and Enforcement prognim has sufficient cash balances within its account to support the one-time costs 
of this legislation. 
Additional costs to the MaineCare program in the Department of Health and Human Services can be absorbed by the 
department utilizing existing budgeted resources. 
LR0033(02) - Fiscal Note - Page I of I