Maryland MPJE 2024 Edition. Questions
and Correct, Verified Answers. Graded
A+
Agencies that can Impound Drugs from a MD Pharmacy - ANSFDA
DEA
DDC
Agencies that Conduct Inspections of Pharmacies - ANSMD BOP (opening and annual
inspection [unannounced])
DDC CDS inspections (closing inspection as board's agent)
DEA
FDA
Changes that must be Reported to the MD BOP - ANSPharmacist's name, mailing
address, primary employment must be reported within 30 days of change
Exception: when primary employment change is within the same chain (but to a different
location) may report upon license renewal
Compounding Requirements for Pharmacy - ANS1. Must be for individual patient
2. May not be a copy of an FDA approved drug
3. The product must be safe and effective (can't compound something that was
removed from market for safety issues)
4. Product is not commercially available or patient requires a different strength/dosage
form
5. Bulk drugs must comply with USP/NF and Rph must comply with USP 795/797
6. Can perform anticipatory compounding, but must not exceed 5% of annual rx volume
Dietary Supplement Health And Education Act of 1994 - ANSDefined dietary
supplements as food products
Disposal of Expired Drugs - ANSMay be returned to manufacturer,
distributor/wholesaler, reverse distributor
CDS returns through a reverse distributor or request DEA to allow on site destruction.
Hospitals can dispose with a witness, comprehensive care can dispose with a witness
or pharmacy maintained receptacle
CDS returns must have records maintained for 3 years
, Drug Expiration Date on Prescription Label - ANS1 year from the date filled or the drugs
actual expiry date, whichever is sooner
May be shorter than 1 year based on Rph experience/reference
Durham Humphrey Amendment of 1951 - ANSDivided medications into OTC and
prescription (legend) drugs
Elements of a CDS Rx that an Rph can NOT change - ANS1. Patient's name
2. Name of medication
3. Prescriber's signature
Establishments that may be Granted a Pharmacy Waiver Permit - ANSSpecialized
services, ie:
Home infusion
Inpatient hospital
Non-sterile compounding
Sterile compounding
Nuclear pharmacy
Veterinary care
Facilities that Require Pharmacy Permit - ANS1. Pharmacies
2. In-state distributors
3. Out-of-state distributors that distribute into MD
4. Non-resident (out of state) pharmacies that provide pharmaceutical care to MD
patients
5. Sterile compounders
6. Manufacturers distributing drugs and devices in MD
Faxed CDS Rx - ANSMay serve as the original rx for home infusion, comprehensive
care, or hospice patient
Food, Drug, and Cosmetic Act of 1938 - ANSRequired manufacturer to prove drug
safety prior to marketing it
Also defined/regulated: adulteration, misbranding, interstate commerce
Generic Substitution - ANSRph may sub. a generic unless the MD writes "brand
medically necessary (BMN), dispense as written (DAW), do not substitute (DNS)" or
patients requests brand
If subbing a generic, Rph must:
1. notify patient in writing
2. charge cheaper price
3. indicate generic name and manufacturer on label
and Correct, Verified Answers. Graded
A+
Agencies that can Impound Drugs from a MD Pharmacy - ANSFDA
DEA
DDC
Agencies that Conduct Inspections of Pharmacies - ANSMD BOP (opening and annual
inspection [unannounced])
DDC CDS inspections (closing inspection as board's agent)
DEA
FDA
Changes that must be Reported to the MD BOP - ANSPharmacist's name, mailing
address, primary employment must be reported within 30 days of change
Exception: when primary employment change is within the same chain (but to a different
location) may report upon license renewal
Compounding Requirements for Pharmacy - ANS1. Must be for individual patient
2. May not be a copy of an FDA approved drug
3. The product must be safe and effective (can't compound something that was
removed from market for safety issues)
4. Product is not commercially available or patient requires a different strength/dosage
form
5. Bulk drugs must comply with USP/NF and Rph must comply with USP 795/797
6. Can perform anticipatory compounding, but must not exceed 5% of annual rx volume
Dietary Supplement Health And Education Act of 1994 - ANSDefined dietary
supplements as food products
Disposal of Expired Drugs - ANSMay be returned to manufacturer,
distributor/wholesaler, reverse distributor
CDS returns through a reverse distributor or request DEA to allow on site destruction.
Hospitals can dispose with a witness, comprehensive care can dispose with a witness
or pharmacy maintained receptacle
CDS returns must have records maintained for 3 years
, Drug Expiration Date on Prescription Label - ANS1 year from the date filled or the drugs
actual expiry date, whichever is sooner
May be shorter than 1 year based on Rph experience/reference
Durham Humphrey Amendment of 1951 - ANSDivided medications into OTC and
prescription (legend) drugs
Elements of a CDS Rx that an Rph can NOT change - ANS1. Patient's name
2. Name of medication
3. Prescriber's signature
Establishments that may be Granted a Pharmacy Waiver Permit - ANSSpecialized
services, ie:
Home infusion
Inpatient hospital
Non-sterile compounding
Sterile compounding
Nuclear pharmacy
Veterinary care
Facilities that Require Pharmacy Permit - ANS1. Pharmacies
2. In-state distributors
3. Out-of-state distributors that distribute into MD
4. Non-resident (out of state) pharmacies that provide pharmaceutical care to MD
patients
5. Sterile compounders
6. Manufacturers distributing drugs and devices in MD
Faxed CDS Rx - ANSMay serve as the original rx for home infusion, comprehensive
care, or hospice patient
Food, Drug, and Cosmetic Act of 1938 - ANSRequired manufacturer to prove drug
safety prior to marketing it
Also defined/regulated: adulteration, misbranding, interstate commerce
Generic Substitution - ANSRph may sub. a generic unless the MD writes "brand
medically necessary (BMN), dispense as written (DAW), do not substitute (DNS)" or
patients requests brand
If subbing a generic, Rph must:
1. notify patient in writing
2. charge cheaper price
3. indicate generic name and manufacturer on label
