Florida Rules on Labeling, Compounding & Drug Samples

what must be included on a prescription from a practitioner to write non-CS prescriptions who is ineligible for a DEA number

their name and professional license number

PAs and ARNPs have been licensed to prescribe CS since _________

2017

PA formulary

negative formulary; CANNOT prescribe general anesthetics and radiographic contrast materials, CIIs are limited to a 7 day supply, restricts prescribing psychiatric mental health CS for minors under 18

ARNP formulary

negative formulary; CANNOT prescribe psychiatric mental health CSs for minors under 18 unless the ARNP is a psychiatric nurse, CS limited to 7 day supple (except psychiatric meds prescribed by psychiatric nurses)

supervising physician may delegate PA authority to prescribe or dispense any medication used in practice if which conditions are followed

unless the drug is listed in the negative formulary, PA must disclose to the patient that they are a PA, must inform the patient of the right to see a physician before any medication is prescribed or dispensed by PA

continuing education PA requirement

10 hours of CME in the specialty in which the PA has prescriptive privileges with each licensure renewal; 3 hours of that ten must be on safe and effective use of CS medications offered

T/F ARNP cannot administer CS on prohibited formulary even if ordered by supervising physician

F; they can ADMINISTER but not prescribe

office use compounding

administration of a compounded drug to a patient in the office or a health care facility or treatment setting (including hospital, ASC, or pharmacy)

a pharmacist may dispense and deliver a quantity of compounded drug to a practitioner for office use if...

the quantity does not exceed the amount the practitioner reasonable anticipates may be used before the expiration date or the pharmacy's capacity to comply with standards for identity, strength, quality, and purity consistent with USP guidelines

office use compounding requires that the compounding drug may only be _____________________ not __________________ to the patient

administered, not dispensed

when compounding for office use, the practitioner must include what on the patient's chart when administering compounded product

lot number and BUD

what must the practitioner request from the patient when administering a drug compounded for office use

report any adverse reaction or complaint to facilitate any recall batches

the pharmacy shall maintain readily retrievable records of all compounded drugs ordered for office use for _______________

4 years

what must be included in records for drugs compounded for office use

1. name, address, and phone number of the practitioner and date of the order

2. name, strength, and quantity of the compounded drug, including the number of containers and quantity of each

3. the date the drug was compounded

4. the date the compounded drug was provided to the practitioner

5. the lot number and BUD

pharmacy label for any drug compounded in office must include

1. name, address, and phone number of compounding pharmacy

2. name, strength of preparation and list of active ingredients and strengths

3. pharmacy's lot number and BUD

4. quantity or amount in the container

5. ancillary instructions

6. statement "For Institutional or Office Use Only - Not For Resale", or if the drug is provided to a veterinarian must include "Compounded Drug"

ancillary instructions included on compounding label must include...

storage instructions, cautionary statements, hazardous drug warning labels, etc.

what statement must be on label for drug compounded for office use

"For Institutional or Office Use Only - Not For Resale"

what statement must be on label for drug compounded for veterinary office use

"Compounded Drug"

all sterile compounding shall comply with...

USP, CGMP

T/F federal law does not require registration as an outsourcing facility, some states do require registration but Florida is not included

F; Florida DOES require registration as an outsourcing facility

drug sample

human prescription drug labeled sample, not to be sold, or complimentary provided to physicians and patient free to promote sale of the drug

starter packs

human drug distributed free by manufacturers or distributors to pharmacies to be sold at retail, not a free sample to customer

T/F a person cannot purchase drug samples but they can offer to trade

F; cannot sell, purchase, trade, or offer to sell, purchase, trade

T/F a drug manufacturer/distributor is subject to criminal liability if an employee sells or offers to sell samples even if they were unaware

F; an officer of a drug manufacturer or distributor is not subject to criminal liability solely because of a violation by other employees who sell or offer to sell drug samples

drug manufacturer or distributor must maintain requests, receipts, and distribution records of samples for ___________

3 years

requirements for drug sample records

must identify the drugs recipients of the distributions; requests, receipts, and records must be made available by the drug manufacturer or distributor to the FL DOH for its review and inspection

drug manufacturer or distributor must ______________ conduct a complete and accurate inventory of all drug samples in the possession of its sale representatives

annually

complimentary drug distributor permit is required by...

manufacturer or distributor to hold, distribute, or dispose of any drug samples in FL

how often is the complimentary drug distributor permit renewed

biennially

out of date drug samples must be...

returned to the manufacturer or distributor of that drug sample

when can the FL DOH suspend or revoke a complimentary drug distributor permit

obtained by misrepresentation, fraud, or mistake; if the permit holder has distributed to an unauthorized person, distributed rx drug outside usual course of business, distributed a misbranded/adulterated rx drug, distributed rx drug without written request; hired someone who has violated any requirements or has been convicted of a felony or any other crime involving moral turpitude or CSs to distribute or dispose drugs

FL DOH can impose fines up to ______________ per violation per day

$5,000

define legitimate possession of samples

a. sample was prescribed to them

b. they are the employee of a drug distributor with a complimentary permit

c. they are a person to whom prescription drug samples may be distributed pursuant to this section

d. they are an officer or employee of a federal, state, or local government acting within the scope of his or her employment

pharmacies may not possess sample drugs except listen in _________________: __________________________________________________

64B16-27.220: medicinal drugs that may be ordered by pharmacists

499.032 phenylalanine statement

phenylalanine restricted formula is declared to be a prescription drug that may be dispensed only upon the prescription of a practitioner authorized by law to prescribe prescription drugs

the FL DOH shall provide the ____________________ names of practitioners who have received an excessive quantity of sample drugs

FL Department of Business & Professional Regulation

T/F out-of-date drug samples can be disposed of since they were distributed for free and will not provide any reimbursement

F; must be returned to manufacturer or distributor of drug sample