How many members make up GA Board?
8
Who commissions members of Board?
Governor
Who approves executive director of Board?
Board of
... [Show More] Community Health
Who serves as Assistant Executive Director if there's no Executive Director of the Board?
Director of GA Drugs & Narcotic Agency
How many intern hours does an applicant need?
1500
How long is an intern license valid?
5 years
What must a school/college submit for the Board's approval for intern hours and how frequently?
Summary of courses & experiences & internship credit hours for each course; list of preceptors
Annually
What does an intern have to do if he wants credit for research/industrial program?
-Submit a request for approval of the program to the Board
-Submit an outline of the program from the individual who will supervise the intern
Where is the application for reciprocity found?
National Association of Boards of Pharmacy (NABP)
Filed with NABP then with board for review & an investigation by GDNA maybe
Reciprocity may still be granted if the following conditions are not met:
Applicant didn't renew his license or obtain required CE in state where applicant was licensed but not practicing pharmacy
When must a pharmacist license be renewed?
December 31 of even numbered years
Late - Jan 31; must pay additional 50% of renewal fee
Term given to what happens to your license when it's not renewed by Jan 31 of the year following the renewal date deadline
Administratively Revoked
If your license is inactive do you have to do CE?
No
How many hours of CE does a pharmacist need for biennial renewal?
30 hours (or 3.0 C.E.Us)
1 hour = 0.1 CEU
CE requirements for newly licensed pharmacists
Licensed before or during the first 6 months of biennium (Jan-June) - 30 h
Licensed during the following 12 months (June-July) - 15 h
Licensed during last 6 months of biennium - 0 h
Can the GDNA assist, audit, or verify a pharmacist's CE certificates?
Yah
How long must a pharmacist maintain certificates of attendance at a CE meeting?
2 years from date of preceding renewal period
Who approves providers/sponsors of CE in GA?
the Board
American Council on Pharmaceutical Education (ACPE) approved providers must submit documentation to the board of such approval every _____ years and have _____
2 years; blanket approval
Non-ACPE approved providers must request approval of CE programs as a provider on the program approval from ______
each time a program is presented
*however, Board and/or GDNA may grant special program approvals so they can utilize them on more than one occasion or whenever the program(s) are presented by the Board or GDNA during a biennium
Who is charged with the responsibility of maintaining the criteria for quality in CE programming for each provider?
Administrative authority
Each approved provider of CE must provide a means of registration of the participants at each program and a record of attendance must be maintained for _____. Each participant must also get adequate documentation of his/her completion of the program
5 years
Acceptable forms of CE include
Institutes, seminars;
Lectures, conferences, workshops;
Correspondence & electronically delivered courses that are ACPE approved
How far in advance must providers submit a program approval form to the Board?
60 days
Acceptable reasons for requesting a duplicate wall certificate and/or pocket license
Lost or destroyed OR legal change in name
What's the max fee the Board can have a licensee pay if he/she is found guilty of a charge involving a violation of any drug laws or rules?
$25,000
If the pharmacist whose name is on the license of a pharmacy must no longer be in charge of the pharmacy, how soon does the board have to be notified?
IMMEDIATELY, an be notified of the successor at the same time
When must a pharmacy license be renewed & when does it expire?
Every 2 years; expires on June 30 of each odd year
Lapses if not renewed by Sept 1; must apply for reinstatement
Any person, pharmacy, or facility located outside this state cannot ship, mail, or deliver prescription drugs orders into this state or to advertise its services, personally or through an in-state third party, UNLESS:
-Holds a pharmacy license
-Holds a nonresident pharmacy permit
For a non-resident pharmacy permit application requirement, if the pharmacy dispenses sterile or nonsterile compounding products for a practitioner to use in patient care in the practitioner's office, how old is a copy of the most recent inspection report allowed to be?
no older than 2 years before the date of application was submitted
When must a nonresident pharmacy permit be renewed?
June 30 of odd numbered year; good for 2 years; if not done by Sept 1, must apply for reinstatement
Nonresident pharmacy permit holders must maintain records of all Rxs shipped, mailed, or delivered to patients or practitioners for how long?
2 years
Nonresident pharmacy permit holders shall notify the Board of each location where the required records are being maintained, and such records must be readily retrievable and produced to the Board within _______, upon written request.
15 business days
Minimum of how long a nonresident pharmacy permit holder must have a toll-free telephone number operational
During regular business hours but not less than 6 days per week for a minimum of 60 hours/week
Nonresident pharmacy permit holders must notify the Board within _____ of the receipt of any final order or decision by any other licensing board or federal agency of the imposition of disciplinary action or restriction by such other licensing board or federal agency
5 business days
Within _____, nonresident permit holders must update the Board of any change in pharmacist-in-charge of shipping into Georgia by completing forms provided by the Board and including such pharmacist licensure information and criminal history
72 hours; up to 15 days to provide criminal history information
How quickly must nonresident pharmacy permit holders respond to the Board's investigation involving Rx drugs distributed or compounding practices?
10 business days - if they don't respond, their permit can be immediately suspended
Manufacturer's permits are renewed how often and when do they expire?
Every 2 years; June 30 of each odd numbered years
If the Board wants, any manufacturer with a permit who makes a dangerous drug or CS must give the state (at no cost) _____ to _____ for testing and analysis
One gram or more of the pure compound of each such product to the GDNA
**substance is considered a "trade secret"
Drug wholesaler distributor's license expires when?
June 30 of each odd numbered year
For drug wholesale distributors - Inventories and all records required under this rule shall be made available for inspection and photocopying by any authorized official of a government agency charged with enforcement of these regulations for a period of ______ following deposition of the drugs; must be made available for inspection in _____
2 years; 2 working days
When are researcher's permits renewed & how long are they good for?
June 30 of EVEN numbered years; good for 2 years
Max fine of a holder of a researcher permit
$500 per violation
Prior to a Reverse Distributor removing or receiving drugs from a registrant, the Reverse Distributor must generate paperwork, a copy of which must be maintained by who and how long?
Registrant & reverse distributor; kept for 2 years
All wholesale drug distributors shall make adequate provisions for the return of outdated prescription drugs, both full and partial containers, for up to _____ after the labeled expiration date for prompt full credit or replacement;
Full credit to the purchases must occur within _______ from when drugs were received by the wholesale drug distributor
If full credit isn't able to be given (not within 6 months of expiring, not consistent with p&p), notification from wholesaler to purchaser in writing must be done within ____ of receipt of the drugs and documents of refusal must be maintained by wholesaler for _____
If a new drug is going to be sent to purchaser to replace the expired drug, it must be sent to original purchaser within ____ from the date of return
6 months; 60 days; 30 days; 2 years; 60 days
When must a listed chemical wholesaler distributor facility undergo an inspection by GDNA agent?
Prior to initial licensure and "periodically" but no less than q3 years
For listed chemical wholesale distributors - Produce and maintain, for a minimum of ______ from the date of the transaction, inventories and records of all transactions regarding the receipt, sale, credit, transfer, disposition, and distribution of all listed chemicals to any firm, person, or retail outlet located in this State
3 years
For listed chemical wholesale distributors - Records kept at central location & not electronically retrievable must be made available for inspection within ______ of request
2 working days
Listed chemical wholesale distributors must report to ______ of shortages or losses of listed chemicals within ______
GDNA; 7 business days
For listed chemical wholesale distributors - Within _____, notify the GDNA of any purchases of a product containing a listed chemical from the listed chemical wholesale distributor which the wholesaler judges to be excessive, or have knowledge or suspicion of said purchases being used in the unlawful manufacture of a controlled substance or file with the GDNA any reportable transaction
7 days [Show Less]