ATTENTION LICENSEES
Prescription labeling for Blind, Visually Impaired, or Otherwise Print Disabled Individuals Regulation
The informal comment period for the Prescription Labeling for Blind, Visually Impaired, or otherwise Print Disabled Individuals begins today, November 22, 2024 and goes through December 10, 2024. Please email your comments to:
Deena Speights-Napata, M.A.
Executive Director
Maryland Board of Pharmacy
deena.speights-napata@maryland.gov
The comment will be reviewed by the board and considered for incorporation in the regulation if appropriate. The formal comment period will begin when the regulations are sent to the Department of Regulations Office of Policy Coordination and accepted for posting in the Maryland Register.
Comments can be submitted during the informal and formal process.
Should you have any questions or concerns, please contact:
Deena Speights-Napata, M.A.
Executive Director
Maryland Board of Pharmacy
deena.speights-napata@maryland.gov
.01 Definitions.
A. In this chapter, the following terms have the meanings indicated.
B. Terms Defined.
(1) “Bag tag" means a receipt that may contain patient demographic information, drug information and cost which is affixed to the bag containing the prescription drug vial or package.
(2) “Blind" means:
(a) a visual acuity not exceeding 20/200 in the better eye with corrective lenses; or
(b)a visual field of which the widest diameter subtends an angle of not more than 20 degrees.
(2) “Board" means the State Board of Pharmacy.
(3) “Medical guide" means a medication guide approved by the Food and Drug Administration (FDA) as part of the prescription drug labeling for certain drugs when the FDA determines that:
(a) Patient labeling could prevent serious adverse reactions;
(b) The drug has serious risks that could affect the patient's decision to use, or to continue to use, the product; or
(c) Patient adherence to the directions for use is crucial to the drug's effectiveness.
(4) “Pharmacy" means an establishment holding a permit under Health Occupations Article, § 12-401, Annotated Code of Maryland.
(5) “Prescription label" means a label affixed to a prescription drug vial or package that contains the information required by State and Federal laws, including any warnings or other information contained in auxiliary labels.
(6) “Print disabled individual" means an individual who cannot effectively read print because of a visual, physical, perceptual, developmental, cognitive, or learning disability.
(7) “Visually Impaired Individual" means an individual who has difficulty seeing even when wearing glasses.
.02 General Requirements
A. A pharmacy shall adopt procedures necessary to ensure that a blind, visually impaired or print disabled individual has appropriate access to prescription labels, bag tags, and medical guides:
(1) At no additional cost to the individual;
(2) In a format option through which the information is fully accessible to the individual;
(3) Within a timeframe comparable to the timeframe within which the information is provided to an individual who is not blind, visually impaired or print disabled; and
(4) That contain the same information contained in a standard print prescription label, bag tag, or medical guide.
B. A prescription labeling, bag tag, or medical guide alternative provided under this chapter shall be in addition to the standard print prescription labeling, bag tag, or medical guide dispensed with a prescription drug.
.03 Prescription Labeling, Bag tag, and Medical Guide Alternative – Requirements.
A. A pharmacist shall, upon request, provide at least one of the following alternative formats appropriate to the needs of the blind, visually impaired or print disabled individual:
(1) Audio;
(2) Braille
(3) Digital format; or
(4) Large Print.
B. A pharmacy shall implement policies and procedures to ensure that pharmacy staff provides verbal notice to any patient who may be blind, visually impaired or print disabled that alternative prescription labeling, bag tags, and medical guides, including audio formats if applicable, are available at no additional cost.
C. A pharmacy shall notify the public that alternative prescription labeling, bag tags, and medical guides, including audio formats if applicable, are available for blind, visually impaired or print disabled individuals at no additional cost. The information shall be provided by:
(1) Posting signage in a conspicuous location;
(2) Including the information in the pharmacy's telephone recording, if applicable; and
(3) Including the information on the pharmacy's website, if applicable.
D. The Board may take disciplinary action against a pharmacy or pharmacist for a violation of this chapter.
The meeting will be in person with a virtual option (see below)
The Maryland Board of Pharmacy is currently live streaming board monthly public meetings
Please Note:
You will NOT get CE credits for attending virtually
Your video, audio, and chat will be disabled and
you will not be able to adjust these features
To join us, use this link:
Join before 9:30 am to ensure you are connected, attempts to connect after 9:30 will be accommodated when possible
Comments, questions or suggestions can be emailed to
All email will be read, but a response is not guaranteed
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Change of Pharmacy Benefits Manager (PBM) for
Maryland Physicians Care (MPC)
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Pharmacy Technicians Regulation Effective November 11, 2024
Subtitle 34
10.34.34 Pharmacy Technicians
Authority: Health Occupations Article, §§12-101, 12-205, 12-6B-02, and 12-6B-07, Annotated Code of Maryland
Notice of Proposed Action
[24-029-P]
The Secretary of Health proposes to amend Regulations .02, .03, .07, and .10 under COMAR 10.34.34 Pharmacy Technicians. This action was considered by the Board of Pharmacy during a public meeting held on August 16, 2023. The Board of Pharmacy informed the public that the proposed regulations would be discussed during an open session by publication on the Board’s website at https://health.maryland.gov/pharmacy/Pages/index.aspx pursuant to General Provisions Article, §3–302(c), Annotated Code of Maryland.
Statement of Purpose
The purpose of this action is to:
(1) Effectuate Ch. 218 (H.B. 693), Acts of 2023, State Board of Pharmacy, Delegated Pharmacy Acts, and Sunset Extension, by removing the prohibition on the administration of an influenza vaccine by a registered pharmacy technician in COMAR 10.34.34.02 and .03;
(2) Clarify that a registered pharmacy technician’s scope of practice does not include the administration of an injectable medication (COMAR 10.34.34.03);
(3) Effectuate Ch. 218 (H.B. 693), Acts of 2023, by developing a framework for the administration of certain vaccines by a registered pharmacy technician (COMAR 10.34.34.03);
(4) Effectuate Ch. 218 (H.B. 693), Acts of 2023, by developing a framework for the performance of off-site prescription data entry by a registered pharmacy technician (COMAR 10.34.34.03);
(5) Clarify that a pharmacy technician trainee must complete 160 hours of work experience within 6 months of enrollment in a pharmacy technician training program (COMAR 10.34.34.07);
(6) Clarify that a pharmacy must obtain approval, as a pharmacy technician training program, independent of that previously granted to a stand-alone didactic program that it selects to incorporate into its pharmacy technician trainee program (COMAR 10.34.34.07); and
(7) Require completion of vaccination specific continuing pharmaceutical education credit hours by a registered pharmacy technician who administers certain vaccines (COMAR 10.34.34.10).
Estimate of Economic Impact
The proposed action has no economic impact.
Economic Impact on Small Businesses
The proposed action has minimal or no economic impact on small businesses.
Impact on Individuals with Disabilities
The proposed action has no impact on individuals with disabilities.
Opportunity for Public Comment
Comments may be sent to Jourdan Green, Director, Office of Regulation and Policy Coordination, Maryland Department of Health, 201 West Preston Street, Room 512, Baltimore, MD 21201, or call 410-767-6499 (TTY 800-735-2258), or email to mdh.regs@maryland.gov. Comments will be accepted through June 17, 2024. A public hearing has not been scheduled.
.02 Definitions.
A. (text unchanged)
B. Terms Defined.
(1)––(2) (text unchanged)
(3) Delegated Pharmacy Act.
(a) (text unchanged)
(b) “Delegated pharmacy act” does not include:
(i) (text unchanged)
[(ii) The administration of an influenza vaccination in accordance with Health Occupations Article, §12-508, Annotated Code of Maryland, or this title;]
[(iii)] (ii)—[(v)] (iv) (text unchanged)
(4)—(16) (text unchanged)
.03 Delegated Pharmacy Acts.
A. A pharmacy technician may not:
(1)—(6) (text unchanged)
[(7) Administer an influenza vaccination in accordance with Health Occupations Article, §12-508, Annotated Code of Maryland;]
[(8)] (7)—[(15)] (14) (text unchanged)
[(16)] (15) Administer medications; [or]
[(17)] (16) Accept the return of prescription drugs or devices directly from a patient[.];
(17) Administer an injectable medication; or
(18) Except as provided in §B of this regulation, administer a vaccine.
B. Technician Administration of Certain Vaccines.
(1) A registered pharmacy technician that meets the requirements set forth in §B(2) and (3) of this regulation, may administer the following vaccines as a delegated pharmacy act:
(a) Coronavirus (COVID-19), influenza, or pneumococcal pneumonia vaccines to an individual 18 years old or older; or
(b) Respiratory syncytial virus (RSV) or herpes zoster vaccines to an individual 50 years old or older.
(2) In order for a registered pharmacy technician to administer a vaccine, the registered pharmacy technician shall submit notification to the Board on a form that the Board requires attesting to the following:
(a) Successful completion of a practical training program approved by the Accreditation Council for Pharmacy Education (ACPE) that includes:
(i) Hands-on injection technique;
(ii) Clinical evaluation of indications and contraindications of vaccines; and
(iii) Recognition and treatment of emergency reactions to vaccines; and
(b) Possession of an active certification in basic cardiopulmonary resuscitation (CPR) obtained through in-person classroom instruction.
(3) A registered pharmacy technician may not administer a vaccine as a delegated pharmacy act until the registered pharmacy technician receives written confirmation from the Board accepting the notification form.
(4) The delegating supervising pharmacist shall confirm that a registered pharmacy technician has met the requirements set forth in §B(2) and (3) of this regulation before delegating the administration of a vaccine to the registered pharmacy technician.
(5) A pharmacy technician trainee may not administer a vaccine.
[B.] C.––[C.] D. (text unchanged)
E. Off-Site Data Entry.
(1) Except as provided in §E(2) of this regulation, a registered pharmacy technician shall perform delegated pharmacy acts under the direct supervision of a licensed pharmacist.
(2) A registered pharmacy technician may perform prescription data entry at a remote location outside of a licensed pharmacy provided that:
(a) The registered pharmacy technician has immediate electronic access to a supervising pharmacist who can assist as needed;
(b) The data entry is not required to be performed by a pharmacist;
(c) The data entry is appropriate to the education, training, and experience of the registered pharmacy technician and supervising pharmacist; and
(d) If the data entry involves access to protected patient information under the Health Insurance Portability and Accountability Act (HIPAA), it can be performed in a manner that maintains the confidentiality of patient information.
.07 Standards for Pharmacy Technician Training Programs.
A. Minimum Standards.
(1)––(3) (text unchanged)
(4) Training programs shall include 160 hours of work experience, which shall be completed within 6 months of the date of the pharmacy technician trainee’s enrollment in the program.
B. Board Approval of Pharmacy Technician Training Programs.
(1)––(2) (text unchanged)
(3) A pharmacy that pairs 160 hours of on-site work experience with a pharmacy technician training program that is Board-approved for its didactic content only shall obtain independent Board approval as a pharmacy technician training program prior to the delegation of any pharmacy act to a pharmacy technician trainee.
[(3)] (4)––[(6)] (7) (text unchanged)
.10 Continuing Education.
A. Requirements.
(1) A pharmacy technician registered to practice in Maryland shall:
(a) [earn] Earn 20 hours of approved continuing pharmaceutical education within the 2-year period immediately preceding the registrant’s renewal application[.]; and
(b) If the registrant administers a vaccine in accordance with Regulation .03 of this chapter, earn 2 hours of continuing pharmaceutical education focused on vaccination as part of the 20 hours of continuing pharmaceutical education required for renewal.
(2)—(3) (text unchanged)
B.—C. (text unchanged)
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Nicotine Replacement Therapy Medication Regulation Posted
The Nicotine Replacement Therapy Medication regulation was posted in the Maryland Register on October 4, 2024 and became effective October 14, 2024. Md. Code Regs. 10.34.42 Pharmacist Prescribing of a Nicotine Replacement Therapy Medication (10.34.42.01-.03) This regulation will establish standard procedures for a pharmacist to use to prescribe and dispense to a patient the appropriate nicotine replacement therapy medication; and refer the patient to a primary care practitioner for treatment; and the conditions under which a pharmacist may prescribe and dispense nicotine replacement therapy.
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Maryland Overdose Response Program
Statewide Naloxone Standing Order
Guidance for Pharmacy Dispensing
Updated April 2024
Summary
Laura Herrera Scott, MD, MPH, (NPI # 1285684274), Secretary of the Maryland Department of Health (MDH), has issued an updated statewide standing order allowing all Maryland-licensed pharmacists to dispense any formulation of naloxone, including any necessary supplies for administration, to any individual. This document was created by the MDH Overdose Response Program (ORP) and provides information for pharmacists who wish to dispense naloxone under the statewide standing order.
Many individuals maybe lawfully prescribed naloxone directly by their healthcare provider. These prescriptions should be dispensed in the usual course of business and a pharmacist's professional practice. This document provides guidance specific to naloxone dispensing under Dr. Herrera Scott's statewide standing order. Click here to continue reading...
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"Prohibiting a health occupations board from requiring that an applicant provide proof that the applicant is lawfully present in the United States or have a Social Security number or Individual Taxpayer Identification Number as a condition for licensure, certification, or registration; ..." To continue reading the document, click here to visit the website.
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SPRING 2024 NEWSLETTER is available now
Expanded Vaccination Authority for Pharmacists
Effective April 25, 2024, Maryland law was amended (Chap. 232) to expand State vaccination authority for pharmacists. Specifically, Health Occ. Art., Sec. 12-508 now permits pharmacists to administer the following without a prescription:
- To an individual at least 3 years old, an influenza or COVID vaccine, or a vaccine authorized during a public health emergency.
- To an individual 7 years old or older, any vaccination recommended by the CDC's Advisory Council on Immunization Practices, or any FDA approved or authorized vaccine.
- To adults only, any vaccine recommended in the CDC's Health Information for International Travel.
Please note that pharmacists who vaccinate must still be registered with the Board and meet eligibility requirements, to include: a 20-hour ACPE practical training program; active CPR certification obtained through in-person instruction; and completion of 2 ACPE continuing education credits related to immunizations every renewal period after registration.
Existing recordkeeping and reporting requirements have not changed such as reporting to Immunet, vaccine-specific protocols, visit summary, patient referrals, patient consent and disclosures. Please reference Health Occ., Sec. 12-508 for the full text of the amended statute. The Board will be revising certain provisions in its vaccination regulations, COMAR 10.34.32, in order to align with the new legislation.
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Pharmacists Professional Services
In accordance with Senate Bill 678/House Bill 1151, the Maryland Department of Health (MDH), will allow Medicaid-enrolled pharmacist providers to bill Maryland Medicaid for Pharmacist Professional Services (PPS) rendered within their lawful scope of practice.
Medicaid-enrolled pharmacists can bill Maryland Medicaid using billing and coding information according to the CMS 1500 Billing Instructions at https://health.maryland.gov/mmcp/provider/Pages/ffsclaims.aspx
To bill Fee-for-Service (FFS) Medicaid for PPS, a pharmacist must be actively enrolled with Maryland Medicaid as a participating provider type “PH" through Maryland Medicaid's online Electronic Provider Revalidation and Enrollment Portal (ePREP).
The link to the Pharmacist Providers ePREP instructions and training for the enrollment process is https://health.maryland.gov/mmcp/provider/Pages/eprepresources.aspx. These materials are available under the "By Provider Type" heading by selecting "Pharmacist".
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Phishing Notification for PioneerRx
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RSV Update
Pursuant to Md. Code Ann., Health Occ. § 12-508(a)(3) and COMAR 10.34.32.03B-2, a licensed pharmacist registered with the Board may administer a vaccination listed on the Center for Disease Control and Prevention’s (“CDC”) Recommended Immunization Schedule to an adult without a prescription, subject to certain requirements. On September 22, 2023, the CDC released an addendum to the Schedule adding the RSV vaccine for pregnant people during weeks 32 to 36 of gestation and adults 60 years of age and older, as recommended by ACIP and adopted by the CDC. As such, a licensed pharmacist’s vaccination administration authority for adults currently includes the RSV vaccine administered to a pregnant person during weeks 32 to 36 of gestation or to an adult 60 years of age or older.
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Medicaid Prescriber Enrollment Notice
The DEA recently published a final rule, effective July 24, 2023, which amends the regulations regarding DEA Form 106, used by registrants to formally report thefts or significant losses of controlled substances. The final rule requires that all DEA Form 106s be submitted electronically. DEA will allow registrants 45 days from discovery of the theft or significant loss to submit the form, up from the agency’s original proposal of 15 days. (In comments to the proposed rule back in September 2020, NCPA requested a 60-day timeframe, and alternately supported the proposed 15-day timeframe if that was implemented after the COVID-19 PHE ended.) Notably, the final rule does not change the requirement that registrants preliminarily notify their area DEA Field Division Office of the theft or significant loss of any controlled substances in writing within one business day of discovering such loss or theft. Paper copies of DEA Form 106 will no longer be accepted once the final rule becomes effective.
Electronic Prescribing of Controlled Substances
Effective January 1, 2022, Senate Bill 0166 (CH0299)/House Bill 0512 (CH0230) (2020) Drugs and Devices – Electronic Prescriptions – Controlled Dangerous Substances requires licensed health care providers to electronically prescribe prescriptions for controlled dangerous substances. The Health General Article, 21-220(C) provides exceptions to this requirement, and the requirement to request a waiver. A health care practitioner who is unable to electronically transmit prescriptions for controlled dangerous substance drugs may request a waiver from the electronic prescribing requirement under certain circumstances. A waiver, if granted, may not exceed one year.
Pharmacists:
A pharmacist may continue to accept handwritten prescriptions. This bill allowed for a waiver and multiple exceptions. Many of the exceptions would be difficult for a pharmacist to verify. Therefore, the bill stated that a pharmacy is not required to verify the ability of a provider to issue non-electronic prescriptions. While a pharmacist does not need to verify that the prescription is an authorized exception to the electronic prescription requirement, the pharmacist must still follow due diligence requirements to ensure the prescription is written for a legitimate medical purpose.
Providers:
If you are a provider that is unable to issue controlled substance prescriptions electronically, please visit the OCSA website. On the left panel, select the “Electronic Prescribing Waiver Request". Please read the page completely to verify the need for a waiver. If you meet the criteria for one of the listed exceptions, you do not need to apply for a waiver or issue controlled substance prescriptions electronically. If you are required to apply for a waiver, click the link at the bottom of the page to submit an application for a waiver.
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Maryland Implicit Bias Training Requirement: Definition and Resources
Pursuant to MD. Code Ann., Health Occ. § 1-225, all health practitioners must attest to completing an implicit bias training program approved by the Cultural and Linguistic Health Care Professional Competency Program on their first license renewal after April 1, 2022.
Amended Governor's Orders
2023.01.18.01 - MDH Order - Amended Various Health Care Matters Order
2023.01.18.02 - MDH Order - Amended Nursing Home Matters Order
