Maryland Pharmacy Law (MPJE)
requirements for dispensing of prescription drugs by physicians, dentists or podiatrists
DF-CLIMB
Dispensing permit from board
Biennial inventory
Label the drug according to pharmacy act
Follow poison prevention act
Inspected by drug control divison
Must purchase drugs from licensed wholesaler or pharmacy
Must complete 10 contact hours of ACPE approved CE on preparing and dispensing
prescription drugs
Composition of the board of pharmacy
12 total = 2 consumers + 10 pharmacists
2 pharm chain
2 independent retail pharm
2 acute care hospitals
1 LTC
1 home infusion/home based care
2 pharmacists at large
How long is pharmacist license good for?
2 years
Number of CE required to renew license
30 CE hours
True/False: Separate pharmacy permits are not required for different locations, as long as
they are under the same company
False, you need permit for each separate geographic location
If there are multiple pharmacies within the same hospital does each pharmacy require a
separate permit?
,No
How long must prescriptions be kept for?
5 years from the date of last refill
Retail pharmacies may conduct wholesale distributions with ________ as long as it doesn't
exceed ______ of total prescriptions per year
other retail pharmacies; 5%
Pharmacy permits are good for ______ and expired when?
May 31st every two years
True/False: agents of the board may enter the pharmacy during normal business hours and
inspect for compliance with Federal and State laws/regulations
True
Can a pharmacist refuse to fill a prescription? What are the requirements?
Yes based upon professional or scientific judgement. Must notify prescriber within 72 hours
of refusal to fill rx
A prescription should not be filled after ______ days unless authorized by the prescriber
120 days
Generic Substitution
-Prescribers orders brand name drug
-FDA has approved generic available
-Prescribers does NOT prohibit substitution
-The prescription is NOT reimbursed by a third-party payer
Within ____ business days after dispensing a biological product, the pharmacist SHALL
communicate the specific biological product dispensed to the prescriber
5
Prescription label requirements
DE(NI)^3S^2
, Date of filling
Expiration date of the lesser of 1 year from date of dispensing or manufacturer's expiration
date
Special handling or storage requirements
Name and strength of the drug
Must contain same name as used by the prescriber on the prescription (avoid misbranding)
If a generic drug is substituted, must also add generic name (to avoid misbranding) and the
name of the manufacturer or distributor of the drug
A pharmacist may refill a prescription
without refill authorization IF:
-The drug is essential to the maintenance of life and to the continuation of therapy in a
chronic condition
-The pharmacist believes it would be detrimental to the patient's health if the drug was not
provided
-The pharmacist attempts to obtain authorization but is unsuccessful
-The drug is NOT a controlled substance
If a pharmacist provides an emergency
refill without authorization:
Must record date, quantity, and sign or initial the record
May provide only 1 refill of a 14-day supply (or unit-of-use)
Must notify the prescriber within 72 hours
If a state of emergency is declared, a pharmacist may refill without authorization IF:
The pharmacist is unable to obtain authorization
The drug is not a controlled substance
requirements for dispensing of prescription drugs by physicians, dentists or podiatrists
DF-CLIMB
Dispensing permit from board
Biennial inventory
Label the drug according to pharmacy act
Follow poison prevention act
Inspected by drug control divison
Must purchase drugs from licensed wholesaler or pharmacy
Must complete 10 contact hours of ACPE approved CE on preparing and dispensing
prescription drugs
Composition of the board of pharmacy
12 total = 2 consumers + 10 pharmacists
2 pharm chain
2 independent retail pharm
2 acute care hospitals
1 LTC
1 home infusion/home based care
2 pharmacists at large
How long is pharmacist license good for?
2 years
Number of CE required to renew license
30 CE hours
True/False: Separate pharmacy permits are not required for different locations, as long as
they are under the same company
False, you need permit for each separate geographic location
If there are multiple pharmacies within the same hospital does each pharmacy require a
separate permit?
,No
How long must prescriptions be kept for?
5 years from the date of last refill
Retail pharmacies may conduct wholesale distributions with ________ as long as it doesn't
exceed ______ of total prescriptions per year
other retail pharmacies; 5%
Pharmacy permits are good for ______ and expired when?
May 31st every two years
True/False: agents of the board may enter the pharmacy during normal business hours and
inspect for compliance with Federal and State laws/regulations
True
Can a pharmacist refuse to fill a prescription? What are the requirements?
Yes based upon professional or scientific judgement. Must notify prescriber within 72 hours
of refusal to fill rx
A prescription should not be filled after ______ days unless authorized by the prescriber
120 days
Generic Substitution
-Prescribers orders brand name drug
-FDA has approved generic available
-Prescribers does NOT prohibit substitution
-The prescription is NOT reimbursed by a third-party payer
Within ____ business days after dispensing a biological product, the pharmacist SHALL
communicate the specific biological product dispensed to the prescriber
5
Prescription label requirements
DE(NI)^3S^2
, Date of filling
Expiration date of the lesser of 1 year from date of dispensing or manufacturer's expiration
date
Special handling or storage requirements
Name and strength of the drug
Must contain same name as used by the prescriber on the prescription (avoid misbranding)
If a generic drug is substituted, must also add generic name (to avoid misbranding) and the
name of the manufacturer or distributor of the drug
A pharmacist may refill a prescription
without refill authorization IF:
-The drug is essential to the maintenance of life and to the continuation of therapy in a
chronic condition
-The pharmacist believes it would be detrimental to the patient's health if the drug was not
provided
-The pharmacist attempts to obtain authorization but is unsuccessful
-The drug is NOT a controlled substance
If a pharmacist provides an emergency
refill without authorization:
Must record date, quantity, and sign or initial the record
May provide only 1 refill of a 14-day supply (or unit-of-use)
Must notify the prescriber within 72 hours
If a state of emergency is declared, a pharmacist may refill without authorization IF:
The pharmacist is unable to obtain authorization
The drug is not a controlled substance
