Pure Food and Drug Act of 1906 (Wiley Act)
Prevents adulteration and misbranding
Drugs met standard of strength/quality/purity according to
... [Show More] USP/NF
Food, Drug, and Cosmetic Act of 1938
Required manufacturer to prove drug safety prior to marketing it
Also defined/regulated: adulteration, misbranding, interstate commerce
Durham Humphrey Amendment of 1951
Divided medications into OTC and prescription (legend) drugs
Kefauver-Harris Amendment of 1962
Manufacturer's must prove that a drug is both safe and effective
Poison Prevention and Packaging Act of 1970
Required child-resistant (C-R) packaging for drugs and dangerous household substances
Exempt for C-R packaging: SL nitroglycerin
Must record request for non C-R packaging on prescription or patient's profile
Prescription Drug Marketing Act of 1987
Laws prohibiting reimportation of drugs
Patients can not buy drugs in other countries and bring to US unless:
1. It is for a 90 day supply or less and for that specific patient (not resold)
2. Effective treatment not available in the US, the condition is serious, and drug has no unreasonable risk
Omnibus Budget Reconciliation Act of 1990
Required counseling and patient profiles for all Medicaid patients
Dietary Supplement Health And Education Act of 1994
Defined dietary supplements as food products
MD Board of Pharmacy Members
Total of 12 members:
10 pharmacists (must have 5 years of practice) representing:
Chain
Independent
Acute care
At large
Long term care
Home infusion
2 consumers, appointed by the governor
MD Board of Pharmacy Term Length and Removal
4 years, may serve 2 consecutive terms
Member may be removed if they miss 2 consecutive meetings without being excused (and for incompetence, misconduct)
MD Pharmacist Licensure Requirements
1. Good moral character
2. At least 18 y/o
3. Graduate of ACPE pharmacy
school
4. Completed professional
experience program
-1000 hours in ACPE school or
-1560 hours of work training
under direct supervision of
pharmacist (typically for
foreign grad)
5. Pass NAPLEX
6. Pass MPJE
MD Pharmacist License Renewal Time and Requirements
Biennial (every 2 years), renewal due by last day of birth month
30 hours of CE (must keep documentation of completing CEs for 4 years after date of renewal)
-2 hours must be live
-1 hour must be in med errors
-4 hours related to vaccines if vaccine certified
-can earn 2 hours from attending BOP meeting, max of 4 hours per renewal
Changes that must be Reported to the MD BOP
Pharmacist'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
Requirements for Reciprocating a License to MD
Apply to the BOP
Completion of 520 hours of practice after graduation
Pass MD MPJE
Maybe english competency? (unless already passed an equivalent exam in another state)
Requirement for Reinstating an Expired License Based on Time Frame
2-5 years: retake and pass the MPJE
5-10 years: retake and pass MPJE and evidence of 1000 hours of pharmacy work experience
>10 years: all of the above and must retake and pass NAPLEX
Pharmacy Technician Registration Requirements
Pass PTCB or ExCPT or:
Complete training program approved by board that is no longer than 6 months in duration and includes 160 hours of work experience
Pass an exam approved by the board
17 years or older
High school grad or GED or currently enrolled in good standing
State criminal history check (fingerprinting)
Pharmacy Technician Registration Renewal
Biennial renewal, expires on the last day of birth month
Must complete 20 hours of CE
Tasks that a Pharmacist may NOT Delegate to a Technician
1. Provide final verification
2. Make decisions that require pharmacist professional judgement
3. Clinically evaluate patient profile
4. Counsel patients
5. Accept or transcribe new prescriptions
6. Accept transferred prescriptions
7. Give or accept transferred rx for a CDS (which means they can give a transfer for a non-CDS)
8. Independently compound (but they can compound under direct supervision)
9. Administer medications
10. Accept the return of prescription drugs/devices from a patient
Pharmacy Intern Registration Requirements
Currently enrolled in and completed 1 year of pharmacy education or graduated from a pharmacy program
Pharmacy Intern Registration Renewal
Intern registration is good for 2 years
May be renewed one time only
Tasks that a pharmacy intern is NOT allowed to perform
1. Final verification
2. Delegating pharmacy acts
3. Any act not authorized by supervising pharmacist
4. Represent as a pharmacist
5. Dispense medications when Rph not in pharmacy
6. Be present in pharmacy when Rph is not on-site
7. Independently compound
8. Accept return of prescription drugs/devices from a patient
9. Act within the parameters of a therapy management contract
Pharmacy Permit Expiration Dates
Renewed every 2 years
Expires May 31st on even years
Facilities that Require Pharmacy Permit
1. 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
Opening Requirements for a MD Pharmacy
1. Class A prescription balance or equivalent
2. Refrigerator with thermometer
3. Equipment sufficient for scope of practice
4. Hot and cold water
5. Reference material sufficient for scope of practice
6. Current MD Law book
7. Security system and means of securing pharmacy if hours differ from front store
8. Name of main pharmacist
9. Pharmacy must be operational within 60 days of permit (or permit will be rescinded)
Permit Holder Requirements for Permanent Pharmacy Closure
1. Must notify the board at least 14 days prior in writing
2. Board will inspect within 72 hours of closure
3. Any indication that the store was once a pharmacy but be covered/removed within 30 days of closure
4. Notify drug suppliers prior to closure
5. Notify public of closure date, where records will be transferred, how old records will be maintained and how they may access their records
5. On the day of closure, must have/surrender: copy of CDS inventory, unused/voided DEA Form 222s, MD permit, MD CDS registration, name/address/phone/DEA registration where drugs or records were transferred
Establishments that may be Granted a Pharmacy Waiver Permit
Specialized services, ie:
Home infusion
Inpatient hospital
Non-sterile compounding
Sterile compounding
Nuclear pharmacy
Veterinary care
Prescription Expiration Dates
Rx must be dated to be valid
Rx must be filled within 120 days from written date
MD Medicaid requires rx to be filled within 30 days from written date
Prescription Refills
Non-control: PRN refills up to 1 year from written date (not an actual law, but good practice)
C3-C5: 5 refills within 6 months
C2: no refills
Drug Expiration Date on Prescription Label
1 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
Generic Substitution
Rph 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 [Show Less]