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    Maryland Department of Health
    Maryland Board of Pharmacy

     

    September 1, 2020 Announcement:
     


    August 24, 2020 Announcement:

    PHARMACISTS ADMINISTRATION OF CHILDHOOD VACCINES PURSUANT TO

    THE THIRD AMENDMENT TO THE HHS SECRETARY'S DECLARATION UNDER THE PREP ACT FOR MEDICAL COUNTERMEASURES AGAINST COVID-19

     

    On August 24, 2020, HHS Secretary Azar issued a third amendment to his Declaration authorized under the PREP Act ('Declaration') that allows pharmacists to order and administer, and pharmacy interns to administer, ACIP-recommended vaccines to children ages 3 and older in accordance with certain requirements set forth in the Declaration.  The Declaration preempts any conflicting State law that restricts the ability of pharmacists and interns to order and administer such vaccines; however, it also includes additional requirements not currently mandated in Maryland.

     

    In the event that a pharmacist wishes to engage in the expanded scope of practice permitted under the Declaration, it is strongly encouraged that the pharmacist obtain professional consultation to ensure compliance with the various requirements contained in the Declaration.  Information regarding specific ACIP-recommended vaccines or the Maryland Vaccine Registry (ImmuNet), can be found on the Department of Health, Center for Immunization's website (https://phpa.health.maryland.gov/OIDEOR/IMMUN).  ​


    June 12, 2020 Announcement:
     
     
    AMENDED MDH Order on COVID-19 Testing and reporting
    and other health matters--JUNE 12, 2020

     

    May 19, 2020 Announcement:

     

     

     May 15, 2020 Announcement:

     

     

    May 6, 2020 Announcement:
     
     
    Online Technician Exam Testing Available Now:

    On May 4, 2020 The Pharmacy Technician Certification Board (PTCB) began offering online test delivery for all PTCB exams, including the Pharmacy Technician Certification Exam® (PTCE®) for candidates seeking to earn their Certified Pharmacy Technician (CPhT) credential, the Certified Compounded Sterile Preparation Technician® (CSPT®) Exam, and the Assessment-Based Certificate Exams in Technician Product Verification (TPV) and Medication History.
    For more information please visit https://www.ptcb.org/testing-during-covid19
     
     
    April 23, 2020 Announcement:

     
    Pharmacy students who are graduating from pharmacy school and are currently registered with the Board as registered interns may continue to work under the registration after graduation.  Pursuant to Governor Hogan's Executive Order, dated March 12, 2020, in the event that a pharmacy intern's registration expires during the state of emergency, the intern may continue to work on the expired registration until 30 days after the state of emergency is terminated.  

     

     

    April 22, 2020 Announcement:
     
     

     Maryland Board of Pharmacy Guidance on FDA Temporary Compounding policy 

     
    Earlier this week the FDA issued temporary policy guidance on compounding of certain drugs for hospital patients by pharmacy compounders not registered as outsourcing facilities.
    The Maryland Board of  Pharmacy generally supports the policy.  However, Maryland-licensed pharmacies that want to implement this temporary policy will be required to submit their request in writing to the board for consideration.  Board authorization is required before any pharmacy may provide compounded products under the auspices of this FDA policy guidance.  
    Requests and inquiries should be submitted to: mdh.mdbop@maryland.gov  

    ​April 9, 2020 Announcement: Updated April 17, 2020

     
    Exams:
     
    The Board understands that all Pearson Professional Centers were closed to testing for a period of time, making it impossible for applicants to complete the NAPLEX and MPJE exams.  NABP has communicated to the Board that, as of March 31, 2020, 130 Pearson testing sites have reopened across the country, with plans to reopen the remaining locations some time in April.  PLEASE NOTE:  The Board has recently learned that none of the reopened Pearson VUE testing centers are located in Maryland, Virginia, or the District of Columbia.  Please contact Pearson directly for plans about opening testing centers in these jurisdictions.
    Due to limited capacity and significant demand, it may take longer than usual to receive a test date.  Rescheduling a date offered by Pearson may also result in lengthy delays, so they are recommending every effort be made to avoid rescheduling a test.  For further information, please check the Pearson and/or NABP websites.
     
    Criminal Background Checks:
     
    The Board has received a number of inquiries related to criminal background checks, specifically related to difficulties in fingerprinting..  Although all CJIS MVA locations remain closed, the CJIS Fingerprinting Storefront located at 6776 Reisterstown Road, Baltimore, is now open for fingerprinting (please note, fingerprinting is currently BY APPOINTMENT ONLY at this facility).  In addition, the Board understands a number of private fingerprinting facilities remain open.  Please check the CJIS website for further information, at https://www.dpscs.state.md.us/publicservs/fingerprint.shtml.
     
    Live Continuing Education:
     
    Pursuant to Governor Hogan’s March 12, 2020 Executive Order, all licenses set to expire during the state of emergency have been extended until 30 days after the state of emergency is terminated.  The Board, however, understands that many pharmacists may want to renew their licenses during the state of emergency. The Board also understands that many “live” continuing education courses and conferences have been canceled for the foreseeable future.  As such, the Board has determined that it will waive the requirement that two (2) hours of continuing education be obtained via live instruction for pharmacists who renew their licenses during the state of emergency.
     
     

    March 30, 2020 Announcement
     
     On March 5, 2020, Governor Hogan issued a State of Emergency tn response to the COVID-19 pandemic. COVID-19 is a respiratory virus that can cause serious illness and death. Due to recent information circulated about possible ameliorative effects of certain drugs, the Board has been informed by pharmacists and patients regarding inappropriate and unethical prescribing by physicians for themselves, family members and friends of drugs such as Chloroquine, Hydroxychloroquine, Lopinavir-ritonavir, Ribavirin, Oseltamivir, Darunavir, and Azithromycin, and in high quantities to suggest hoarding or other similar stockpiling activities. These drugs are typically used to treat lupus, malaria, rheumatoid arthritis, HIV, and bacterial infections, but are purportedly being written as a prophylaxis for COVID-19 or to treat undiagnosed COVID-19 symptoms.
     
    To date, there is no FDA-approved medication to treat or prevent COVID-19 . Research is currently underway, but prescribers should be mindful that any evidence of effectiveness is scant and that there are known contraindications with the use of these medications.
     
    Pharmacists are reminded of their right to refuse to fill prescriptions that, in the pharmacist’s professional judgment, are not clinically appropriate. Health Occ., Sec. 12-501. Community pharmacists may utilize their professional judgment to ensure that prescription drugs are available for all patients, to include the use of partial fills, limited days’ supply or other means to promote continuity of care for patients taking these medications for established, and approved, indications. Pharmacists should also exercise their professional judgment in determining whether there is a valid prescriber-patient relationship in assessing the legitimacy of any prescription.
     
     Board of Physicians guidance: https://www.mbp.state.md.us/forms/ALERT_RX.pdf
     
    March 17, 2020 Announcement
    To prevent the spread of COVID-19 (Coronavirus), Governor Hogan declared a State of Emergency on March 5, 2020. The Governor subsequently issued Executive Orders on March 12 and 16, 2020, which contain provisions affecting the Board and its licensees. Currently, all pharmacies should remain open if able. As this situation evolves, pharmacists and pharmacies should continue to provide services in a manner that assures access and safety.
    The Maryland State Board of Pharmacy (the “Board”) would like to provide the following information and guidance regarding compliance with the Maryland Pharmacy Act during the declared State of Emergency:

    All Pharmacies
    • Review or create interim emergency policies to anticipate and react to this emergency and disseminate to all staff. It is recommended to incorporate recommendations in the CDC’s Interim Guidance for Employers and additional guidance and information for pharmacies on the APHA and ASHP websites.
    • Keep up to date with the state of conditions in Maryland.
    • If required by or requested of the pharmacy, the FDA has provided a temporary Guidance Document on a Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency in accordance with USP 795 standards.
    • If able, consider facilitating prescription dispensing at curbside or drive-through pickup.
    • Consistently monitor the health of pharmacy staff. Any staff member exhibiting flu-like systems or respiratory illness should stay at home.
    Remote Processing
    • In order to support the Governor and Secretary of Health with their directives to telework and social distance to the extent possible, the Board will not enforce requirements regarding the direct supervision of pharmacy technicians by a licensed pharmacist if the technicians are engaged in remote processing of delegated pharmacy acts. Remote processing of delegated pharmacy acts includes prescription or order entry, other data entry, and may also include insurance processing and other administrative functions.
    • Pharmacists currently have the ability to engage in remote processing, which may also include clinical functions such as drug utilization review, authorizing release of medications from automated medication systems, providing drug information, and other similar pharmaceutical services.
    • Remote processing does not include the physical handling of any prescription drugs or devices.
    Refills
    • The Maryland Pharmacy Act, Sec. 12-506(c), allows a pharmacist, during a state of emergency, to refill a prescription for which a refill has not been authorized if: (1) the pharmacist is unable to obtain authorization from the prescriber; (2) the refill is not for a controlled dangerous substance; (3) the quantity dispensed does not exceed a 30-day supply or unit of use; and (4) the pharmacist notifies the prescriber of the refill within 7 days.
    Sterile Compounding
    • Follow established, recognized guidelines (CDC, CDC on N95 Respirators, FDA, or equivalent) for guidance on conserving garb and alternatives and strategies for managing potential extended use of face masks, gowns, and shoe covers. It is recommended that pharmacies keep a copy of the guidance used to adjust practice and to continue to follow protocols which prohibit the use of contaminated or unusable supplies.
    • ​​ Please note, at a minimum, weekly surface sampling inside an ISO-5 space is highly recommended when garbing in a manner that is not consistent with USP standards. If surface sampling frequency is increased to weekly testing, the Board will accept testing standards set out in the 2019 USP 797, which only require actionable growth to be identified and subsequently reported to the Board.​
    • ​​The Board recognizes the need to delay certain activities such as personnel annual competencies or other quality assurance activities in order to reduce supply needs. Inspectors are aware of the challenges being presented to pharmacies and will take these into account when inspecting pharmacies.
    • If you use a compounding aseptic isolator, regulation 10.34.19.13(B) states: 'The requirements of this regulation [10.34.19.13(A) Garbing] are not applicable if a compounding aseptic isolator is used to compound sterile preparations in accordance with USP 797 Standards and isolator vendor/manufacturer specifications.'
    Licensing
    • Pursuant to an Executive Order issued by Governor Hogan on March 12, 2020, all licenses, registrations, and permits issued by the Board set to expire during the state of emergency and catastrophic health emergency shall be extended to the 30th day after the date the state of emergency is terminated and the catastrophic health emergency is rescinded. No late fees or reinstatement fees will be imposed during this time period. To the extent it is able, the Board will accept and continue to process renewal applications during the state of emergency and catastrophic health emergency.
    • In keeping with the Governor’s policy extending expiration dates for licenses, and maintaining the ability of the pharmacist workforce to administer influenza and other CDC-recommended vaccinations, the Board will not take enforcement action based on expired or inactive CPR certifications held by pharmacists registered to administer vaccinations if the CPR certification becomes inactive or expires during the state of emergency. Upon the termination of the state of emergency, the Board will allow affected pharmacists 30 days to update their live CPR certification.
    • Pursuant to an Executive Order issued by Governor Hogan on March 16, 2020, any pharmacist or pharmacy technician actively licensed in another state or with an expired license or registration issued by the Board may be able to work in a health care facility (the definition of which does NOT include a pharmacy) in Maryland under certain circumstances.
    • The Board will not impose the 30-day notice requirement associated with a change of business hours for a permitted pharmacy or wholesale distributor pursuant to COMAR 10.34.30.05(A). The Board will instead require advanced notice as soon as practicable if an establishment location is forced to change its hours or temporarily close. Please note that all other requirements still apply, such as notice to patients, transfer of prescriptions, and documentation of transfers of any drug inventory
     
    Any changes to pharmacy practice should only be viewed as short term solutions to deal with the current crisis. All policies should return to normal practice as the crisis begins to resolve. This event is not an excuse to lower quality assurance standards, and the Board expects all of its pharmacies to uphold and follow practices and policies which ensure utmost patient care and safety while aiding in preventing the spread of COVID-19.
     
    ​​ ​​​