Pharmacy Law Update

What are the requirements for licensure as a pharmacist in Georgia?

•       Applicants for licensure as a pharmacist in GA no longer have to take and pass the Georgia Practical Examination 

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•       Required to make a minimum grade of 75 on NAPLEX and MPJE

What is the requirement for a temporary license if a person is a service member, transition service member, or military spouse in georgia?

\-granted temp. licensure by examination

\-granted temp licensure by reciprocity

How long can a service member, transitioning service member, and military spouse hold a temporary license in Georgia?

\-valid for six month from the date of issuance or upon issuance of permanent licensure, whichever comes first

What are the requirements in Georgia for pharmacy residents to get a temporary license?

\-must be requested; not automatically granted

\-expires at the end of the month following the third board meeting after issuance

If there is one pharmacist and four technicians how many technicians must be certified?

\-two

Every two years a technician has to complete

\-20 hours of CE

There are one pharmacist and one or two technicians in the pharmacy , how many technicians have to be certified?

\-no certification required

In addition to the required number of pharmacist to technician ratio how many interns, externs, and observers can be in the pharmacy

\-1 each

If a hospital pharmacy needs a request for more technicians, how can they get it approved by the BOP?

\-BOP may approve applications to increase the ratio of technicians in the hospital pharmacy , but the request must be made in writing by the director of pharmacy

\-once approved they must display this approval with the pharmacy license for the GDNA

What is required to be on a retail prescription?

\-date of issuance

\-patient’s name and address

\-prescriber’s name, address, and telephone number

\-name, strength, dosage form and quantity prescribed

\-directions for use

\-refill authorized

\-signature of prescriber

\-prescriber’s DEA if it is a controlled substance

any cautionary statements required

What are required to be on an inpatient hospital medical order?

\-patient’s name and room number

\-drug name, strength, and directions for use

prescriber’s signature and date

What is required to be on a outpatient hospital medication order?

\-patient’s name and room number

\-drug name, strength, and directions for use

\-prescriber’s signature and date

\-patient’s address

\-quantity

\-prescriber’s DEA, if applicable

When can a PA/APRN issue a prescription for Schedule III, IV, or V without the co-signature of supervising physician:

\-PA/APRN has their own DEA registration number

\-Drug order must have name, address, and telephone number of supervising/delegating MD and PA/APRN

\-No rx issued by PA/APRN can be used to authorized more than 12 months past the date of the original drug order

Which drugs can an APRN prescribe for 24 months?

\-OC, HRT, PNV

True/False: Patient counseling is not required for refills if appropriate counseling ( in RPH’s professional judgement) has occurred previously or has been declined

\-True

If a prescription is delivered how must a offer for patient counseling be given?

\-verbal or written

\-written offer must provide phone numbers and business hours

Where do all controlled substances/dangerous drugs be purchased from?

\-from entities with a valid permit issued by GA BOP

True/False: RPh on duty must sign invoices upon receipt and verification with legal signature, legible GA RPh license number, and date

\-True

If a controlled substance is stollen or lost , how long due you have to report it to the GDNA ?

\-48 hours

How do you report a loss or theft of controlled substances?

\-written report using DEA form 106 and it must be submitted to the DEA and a copy given to the GDNA

What is the CARA?

\-it permits partial filling of schedule II up to 30 days from initial fill at the request of the patient.

\-partial filling due to supply issues still falls under 72 hour requirement

How can a pharmacy become a low THC pharmacy dispensary?

\-they must be licensed by the BOP and also licensed as a retail pharmacy

\-the low THC pharmacy dispensary certificate must be displayed along with the wall certificate of each fulltime RPh

When does a pharmacy have to renew their low THC pharmacy dispensaries licensed?

\-must be renewed every year by June 30

How long does a pharmacy have to keep records for the low THC dispensary?

\-for two years

What are the space requirements to operate as a low THC dispensary?

\-same as the predicate retail space (150 sq. ft.)

True/False: RPh must be on duty in the low THC pharmacy for the same time as required for operation of predicate retail licensee

\-True

What are the storage requirements for low THC products?

\-Low THC products are stored and secured in the same as any prescription drug

Where can you purchase low THC products?

\-all products must be purchased and returned to a facility with a current Georgia Access to Medical Cannabis Commission permit

What is the equipment requirements that all dispensaries must have?

•Copies of or electronic access to current reference materials appropriate for Low THC Pharmacy Dispensary practice that is authoritative on drug interactions, patient counseling, compounding, calculations, and generic substitution

•Poison Control Center’s telephone number

•**Copies of or electronic access to:** GA pharmacy Practice Act ( Title 26, chapter 4), Access to Medical Cannabis ( Title 16, Chapter , Article 9), GA controlled substance dangerous drugs act ( Title , chapter 13), Board of pharmacy rules and regulations

•Adequate supply of Low THC products most comply prescribed (only after a permit has been issued by the Board)

What is required to dispense Low THC products?

•Low THC products can **ONLY be dispensed** by a BOP licensed Low THC Pharmacy Dispensary

•Can only dispense to registered patients

•Pharmacist must **physically view and inspect** patients ID, registration card, and verify the validity of the registration card prior to dispensing

•Pharmacist **must review label** prior to dispensing to verify compliance



•**All Low THC products must be labeled by the dispensary with the following:**

•Date of dispensing 

•Patient’s first and last name

•**Patient’s date of birth**

•**Patient’s unique registry number**

•Caregiver’s first and name, if applicable

•Name, address, and license number of dispensary

•Directions for use

•Any cautionary statement(s) or symbol(s)

If a low THC product is out of date what do you do with it?

\-must review inventory at least every 6 months for expired product and all out of date and expired product must be returned to the original licensed producer for destruction