Code of Maryland Regulations
Title 10 - MARYLAND DEPARTMENT OF HEALTH
Part 4
Subtitle 34 - BOARD OF PHARMACY
Chapter 10.34.03 - Inpatient Institutional Pharmacy
Section 10.34.03.13 - Controlled Dangerous Substances
Universal Citation: MD Code Reg 10.34.03.13
Current through Register Vol. 51, No. 19, September 20, 2024
A. Drug Accountability.
(1) The director of
pharmacy is responsible for establishing procedures and maintaining adequate
written or electronic records regarding dispensing and accountability of
controlled dangerous substances which specify at least the following:
(a) Name and strength of the drug;
(b) Dose;
(c) Dosage form;
(d) Prescriber;
(e) Patient name with second
identifier;
(f) Date and time of
administration; and
(g) Individual
administering the drug;
(2) The director of pharmacy shall be
responsible for establishing and maintaining adequate procedures for
documentation of:
(a) Recording of receipt of
delivery to the pharmacy;
(b)
Entering into pharmacy inventory;
(c) Receiving into Schedule II inventory;
and
(d) Dispensing of controlled
dangerous substances, Schedule II - Schedule V.
(3) The director of pharmacy or designee
shall be responsible for establishing and maintaining adequate procedures for
documenting partially administered controlled dangerous substances:
(a) For disposal by hospital policy;
and
(b) Return of unused drugs to
the pharmacy.
(4) The
director of pharmacy or designee shall establish procedures to ensure that
controlled dangerous substance records include the handwritten or electronic
signature of the individual authorized:
(a) By
the institution to dispose of drugs or to return them to the pharmacy;
and
(b) To witness the disposal, as
defined by the institution's policies and procedures.
B. Storage and Security in the Institutional pharmacy.
(1) On at least a
monthly basis, a pharmacist or registered pharmacy technician shall perform a
physical count of each Schedule II controlled dangerous substance in the
pharmacy and shall then compare that count with the perpetual inventory
maintained by the pharmacy with reference to each drug;
(2) On at least a monthly basis, the director
of pharmacy or designee shall:
(a) Investigate
discrepancies within the pharmacy;
(b) Report losses as required by law;
and
(c) Take appropriate action;
and
(3) The director of
pharmacy or designee shall establish a procedure by which previously dispensed
controlled dangerous substances that are no longer necessary for medical
reasons are returned to the pharmacy.
C. Storage and Security in the Institution. The director of pharmacy shall develop policies that only permit the dispensing of controlled dangerous substances when the following security precautions exist in the institution and the pharmacy:
(1)
Access to controlled dangerous substances outside the pharmacy is restricted to
authorized personnel approved by institutional policy;
(2) Controlled dangerous substances stored
outside the pharmacy are accounted for at least at the change of each shift by
licensed personnel authorized by the institution, unless a controlled access
automated dispensing system provides an on-demand report of a perpetual
inventory; and
(3) A pharmacist
reviews the discrepancies in counts of controlled dangerous substances
previously reported by other professional personnel.
Disclaimer: These regulations may not be the most recent version. Maryland may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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