PROPOSAL
Maryland Register
Issue Date: July 7, 2017
Volume 44 • Issue 14 • Pages 668—669
Title 10
MARYLAND DEPARTMENT OF HEALTH [AND MENTAL HYGIENE]
Subtitle 34 BOARD OF PHARMACY
10.34.37 Pharmacy Permit Holder Requirements — Wholesale Distribution and Nonresident Pharmacy Operations
Authority: Health-Occupations Article, §§12-205, 12-403, and 12-406, Annotated Code of Maryland
Notice of Proposed Action
[17-177-P]
The Secretary of Health proposes to amend Regulation .01 and adopt new Regulation .04 under COMAR 10.34.37 Pharmacy Permit Holder Requirements — Wholesale Distribution and Nonresident Pharmacy Operations. This action was considered by the Board of Pharmacy at an open meeting held on April 19, 2017, notice of which was given by publication on the Board’s website, http://health.maryland.gov/pharmacy/Pages/index.aspx from March 23, 2017 — April 19, 2017, pursuant to General Provisions Article, §3-302(c) Annotated Code of Maryland.
Statement of Purpose
The purpose of this action is to establish operational requirements for nonresident pharmacies. The proposed regulations will ensure that the nonresident pharmacy is practicing at the standard of care required of pharmacies domiciled in Maryland and provide the necessary regulatory tools when a nonresidential pharmacy may pose a threat to the public safety for the citizens of Maryland.
Comparison to Federal Standards
There is a corresponding federal standard to this proposed action, but the proposed action is not more restrictive or stringent.
Estimate of Economic Impact
I. Summary of Economic Impact. This proposal may have a minimal economic impact on out-of-State pharmacies because this proposal requires them to have a licensed pharmacist readily available and to have a toll-free telephone service for the patient to facilitate communication with the pharmacist. The pharmacy will incur a minimum operation cost to supply these requirements. The pharmacy may see a decrease in costs related to medication errors, such as additional medical attention and litigation costs.
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Revenue (R+/R-) |
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II. Types of Economic Impact. |
Expenditure
(E+/E-) |
Magnitude |
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A. On issuing agency: |
NONE |
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B. On other State agencies: |
NONE |
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C. On local governments: |
NONE |
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Benefit (+)
Cost (-) |
Magnitude |
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D. On regulated industries or trade groups: |
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Nonresident pharmacies |
(+) |
Minimal |
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E. On other industries or trade groups: |
NONE |
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F. Direct and indirect effects on public: |
NONE |
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III. Assumptions. (Identified by Impact Letter and Number from Section II.) |
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D. The proposed regulation requires the nonresident pharmacy to establish a practice of standard care. It requires the nonresident pharmacy to establish a toll-free number, to establish a library and to maintain records of all dispensing or prescription drugs in Maryland. The pharmacy will incur a minimum operation cost to supply these requirements. The pharmacy may see a decrease in costs related to medication errors, such as additional medical attention and litigation costs. |
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 Michele Phinney, 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 dhmh.regs@maryland.gov, or fax to 410-767-6483. Comments will be accepted through August 7, 2017. A public hearing has not been scheduled.
.01 Scope.
This chapter establishes requirements for a pharmacy licensed by the Maryland Board of Pharmacy that [engages]:
A. Engages in wholesale distribution; or
B. Operates as a nonresident pharmacy.
.04 Requirements for Nonresident Pharmacy Operations.
A. A Maryland licensed pharmacist may not be employed by more than one nonresident pharmacy at a time.
B. A nonresident pharmacy shall:
(1) Hold a pharmacy permit issued by the Board;
(2) Have a pharmacist on staff who is:
(a) Licensed by the Board;
(b) Designated as the pharmacist responsible for providing pharmaceutical services to patients in the State; and
(c) Regularly available on-site as needed to meet Maryland patient’s needs;
(3) Designate another Maryland licensed pharmacist as the pharmacist on staff within 60 days upon the loss of the current designated pharmacist on staff;
(4) Be located and equipped so that the pharmacy may be operated without endangering the public health or safety;
(5) Maintain at all times a current reference library that is appropriate to meet the needs of:
(a) The practice specialty of that pharmacy; and
(b) The consumers the pharmacy serves;
(6) Comply with the regulations adopted by the Board establishing the types of texts required to be included in the reference libraries in each of the various practice specialty pharmacies;
(7) Maintain at all times the minimum professional and technical equipment and sanitary appliances that are necessary in a pharmacy to:
(a) Prepare and dispense prescriptions properly; and
(b) Otherwise operate a pharmacy;
(8) Be equipped with the minimum equipment and appliances specified by the Board under this regulation;
(9) Be kept in a clean and orderly manner;
(10) Store all prescription or nonprescription drugs or devices properly and safely as set forth in COMAR 10.34.22.06;
(11) On an annual basis and within 30 days after a change of office, corporate officer, or pharmacist, disclose to the Board the location, names, and titles of all principal corporate officers and all pharmacists who are dispensing prescriptions for drugs or devices to persons in this State;
(12) Comply with all lawful directions and requests for information from the regulatory or licensing agency of the state in which it is located and all requests for information made by the Board pursuant to this regulation;
(13) Maintain at all times a valid, unexpired permit to conduct a pharmacy in compliance with the laws of the state in which it is located;
(14) Maintain records of prescription drugs or devices dispensed to patients in this State so that the records are readily retrievable;
(15) During the pharmacy’s regular hours of operation, but not less than 6 days a week, and for a minimum of 40 hours per week, provide a toll-free telephone service to facilitate communication between patients in this State and a pharmacist or an individual who:
(a) Has access to the patient’s prescription records; and
(b) Is required to refer patients in the State to the responsible pharmacist licensed in the State, as appropriate;
(16) Disclose the pharmacy’s toll-free telephone number on a label affixed to each container of drugs or devices;
(17) Comply with the laws of this State relating to the confidentiality of prescription records if there are no laws relating to the confidentiality of prescription records in the state in which the nonresident pharmacy is located;
(18) With regard to a prescription drug that is delivered in this State by the United States Postal Service, a common carrier, or a delivery service and is not personally hand delivered directly to a patient or to the agent of the patient at the residence of the patient or at another location designated by the patient:
(a) Provide a general written notice in each shipment of a prescription drug that alerts a consumer that, under certain circumstances, a medication’s effectiveness may be affected by exposure to extremes of heat, cold, or humidity; and
(b) Provide a specific written notice in each shipment of a prescription drug that provides a consumer with a toll-free or local consumer access telephone number accessible during regular hours of operation, which is designed to respond to consumer questions pertaining to medications;
(19) Provide information regarding the process for resolving incorrectly filled prescriptions in accordance with existing regulations by:
(a) Posting a sign that is conspicuously positioned and readable by consumers at the point where prescription drugs are dispensed to consumers; or
(b) Including written information regarding the process with each prescription dispensed; and
(20) If dispensing compounded sterile preparations to patients in the State, comply with:
(a) USP standards; and
(b) COMAR 10.34.19.
C. A nonresident pharmacy may not:
(1) Offer pharmaceutical services under any term or condition that tends to interfere with or impair the free and complete exercise of professional pharmaceutical judgment or skill;
(2) Make any agreement that denies a patient a free choice of pharmacist or pharmacy services;
(3) Participate in any activity that is a ground for Board action against:
(a) A licensed pharmacist under Health Occupations Article, §12–313, Annotated Code of Maryland;
(b) A registered pharmacy technician under Health Occupations Article, §12–6B–09, Annotated Code of Maryland; or
(c) A registered pharmacy intern under Health Occupations Article, §12–6D–11, Annotated Code of Maryland; or
(4) Allow an unauthorized individual to represent that the individual is a pharmacist, a registered pharmacy intern, or registered pharmacy technician.
DENNIS SCHRADER
Secretary of Health
