Maryland Board of Pharmacy Proposes Two Compounding Rules
Comments Open Until August 7, 2017
IACP Maryland Members:
The Maryland Board of Pharmacy is proposing two rules pertaining to compounding.
The first concerns changes to pharmacy permit holder requirements. One of the proposed changes under COMAR 10.34.37 would require pharmacists who dispense sterile compounded preparations to patients in the state to comply with USP standards, which would appear to include the new USP Chapter <800>.
The second proposal, COMAR 10.09.03, concerns changes to dispensing fees; includes compounded prescriptions.
Please note - Comments for both proposed rules are due by August 7, 2017.
Comments can be directed to
Michele Phinney
, Director, Office of the 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
[email protected]
, or fax to 410-767-6483. Comments will be accepted through August 7, 2017. A public hearing has not been scheduled.
Maryland
Pharmacy Permit Holder Requirements - Wholesale Distribution and Nonresident Pharmacy Operations
Citation: COMAR 10.34.37
Comments/Briefs Due: 8/7/2017
Published
Summary: 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.
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.
History: Comment deadline: 08/07/17
Notice of Proposed Action published on 07/07/17
Maryland
Pharmacy Services
Citation: COMAR 10.09.03
Comments/Briefs Due: 8/7/2017
Published
Summary
: The Secretary of Health proposes to amend Regulations .01 and .03-.07 under COMAR 10.09.03 Pharmacy Services.
The purpose of this action is to update the Department's reimbursement methodology to pharmacy providers as required by the CMS Covered Outpatient Drug final rule (CMS-2345-FC), which mandates the transition from an estimated acquisition cost to an actual acquisition cost as the basis for the State Medicaid pharmacy ingredient cost reimbursement. The proposed action also removes unnecessary references to the Primary Adult Care Program.
History: Comment deadline: 08/07/17
Notice of Proposed Action published on 07/07/17
