FLORIDA PHARMACY LAW REVIEW 2012. www.doh.state.fl.us/mqa/pharmacy. FLORIDA PHARMACY LAWS. TITLE XXXII CHAPTER 456 (HEALTH PROFESSIONS) CHAPTER 465 (PHARMACY ACT) TITLE XLVI (CRIMES) CHAPTER 893 (DRUG ABUSE PREVENTION & CONTROL) FLORIDA PHARMACY REGULATIONS
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FLORIDA PHARMACY REGULATIONS
FLORIDA ADMINISTRATIVE CODE CHAPTER 64B16
Pharmacist must notify the sheriff within 24 hours or close of next business day if a person obtains or attempts to obtain a controlled substance by fraud or misrepresentation.
As of July 1, 2012 all community pharmacies that wish to dispense Schedule II or III C.S. must obtain a permit from the Board.
1.The prescriber writes “MEDICALLY NECESSARY” in his or her own handwriting on the face of the prescription
2.On an oral prescription the prescriber expressly indicates that the brand name drug is medially necessary
3.On an electronic prescription the presriber makes an overt act indicating that the brand name drug is medically necessary
4.The drug is listed on the negative formulary of the Boards of Pharmacy and Medicine
1. advise the patient and the transferring pharmacist that the prescription must be canceled at the original pharmacy
2. must verify that the prescription may be validly filled or refilled in accordance with the prescriber’s intent.
3. record all relevant information from the original prescription
4. obtain the consent of the prescriber if in the pharmacist’s professional judgment such consent is required
1. convey all the required prescription information accurately and completely
2. record the requesting pharmacy and pharmacist’s names
3. cancel the prescription. (No further prescription information shall be given or medication dispensed on the original prescription)
4. If the requesting pharmacy is out-of-state, verify that the requesting individual is a licensed pharmacist and that the pharmacy is licensed
1. Must create and maintain a prescription containing all the information required by law
2. Must be the only person permitted to fill the prescription
3. May not refill the prescription
4. May not order another medicinal drug for the same condition
5. Must affix a label with all required information including the pharmacist’s name and a statement that the prescription may not be refilled
1. Maintain at least $200,000 of liability insurance
2. Complete training in influenza virus immunizations
3. Create and maintain patient records for a least 5 years
4. Forward immunization records to the department for inclusion in the state registry of immunization information
5. Be certified pursuant to a program approved by the Board, and the program must require at least 20 hours of CE classes approved by the Board
6. Submit a copy of the protocol to the Board
FLORIDA BOARD OF PHARMACY RULES AND REGULATIONS (Chapter 64B16)
1. complete a Board approved course of not less than 12 hours at an accredited college of pharmacy, and pass a cognitive test to demonstrate competency.
2. Successfully complete an assessment and evaluation under the supervision of a preceptor within 1 year of completion of the approved course of study. The assessment must include at least 40 hours of training with at least 60% of such training occurring on-site at an institution that holds a pharmacy permit, and must completed over no more than 3 consecutive months. The preceptor must be a consultant pharmacist with at least 1 year of experience and working in an institutional pharmacy which is required to have a consultant pharmacist.
Must be at least 17 years of age
Must complete a training program from either an approved provider or the employer. If employer based, must be approved by the Board, must have 160 hours of training during a period not to exceed 6 months. All clinical training must be supervised by a registered pharmacist .
3. If self-directed study is utilized, an exam of at least 100 questions must be given to assure participant’s knowledge
4. All program records must be kept for 3 years
1. Supervise the controlled substance inventory
2. Receive verbal prescriptions
3. Interpret and identify prescription contents
4. Engage in professional communication or consultation with a practitioner, nurse, or other health professionals
5. Advise or consult with a patient as to prescriptions and patient profiles
1. Interpret all orders for parenteral and bulk solutions
2. Physically exam the final product or completed prescription
3. Be directly available to the patient or the patient’s agent for consultation
4. Be personally available whenever a prescription is dispensed
1. If a sign has been posted indicating the specific hours when the pharmacist may be on a meal break and assuring patients that a pharmacist is available on the premises for consultation during the meal break.
2. If the pharmacist is available for consultation regarding emergency matters
3. Only prescriptions with a final certification by the pharmacist may be delivered
4. Technicians may continue to work during the meal break, and the pharmacist must certify all prescriptions prepared by registered pharmacy technicians during the meal break.
1. accept an oral prescription
2. Prepare a copy of a prescription. When a copy is given, a notation shall be made on the prescription that a copy has been given, the date given, and to whom given.
3. Read a prescription to any person for purposes of providing reference concerning treatment of the patient
1. Injectable products shall not be ordered
2. No oral medications may be ordered for a pregnant patient or a nursing mother
3. The quantity of drug prescribed/dispensed shall not exceed a 34-day supply
4. The dosing directions shall not exceed the manufacturer’s recommended dosage.
5. The pharmacist shall create a prescription and maintain the prescription on the prescription files of the pharmacy
6. The pharmacist shall place on the prescription label the name of the drug and the quantity dispensed in addition to all other required items.
7. The pharmacist shall create and maintain for 2 years patient profiles for all patients for whom the pharmacist prescribes prescription medications, and shall initial and date all entries in the profiles
8. Only prescription drugs may be prescribed by a pharmacist. OTC drugs may not be prescribed
9. Interns and technicians may not be involved in the prescribing of drugs
10. Refer to 64B16-27.220 and 64B16-27.230 for a full list of the drugs a pharmacist may prescribe and specific limitations and requirements
11. Oral analgesics are limited to 6 day supply; urinary analgesics to a 2 day supply, and fluoride products are limited by the patient’s age and the fluoride content of the patient’s drinking water
1. A sign with letters at least 2 inches high shall be prominently displayed in the prescription department stating “Prescription Department Closed”.
2. The prescription department shall be physically separated from the rest of the establishment by a partition or other means of enclosure, and locked
3. Only a pharmacist shall have the keys or other means to gain access to the department
4. No person other than a pharmacist may enter or be present in the prescription department
This law primarily covers controlled substances, and the most important sections for pharmacists are:
893.04 PHARMACIST AND PRACTITIONER
893.055 Prescription Drug Monitoring Program
893.065 Counterfeit-resistant prescription blanks for
Controlled Substances in Sch. II – V
893.1495 Retail sales of Pseudoephedrine
1. full name and address of patient
2. full name and address of prescriber and his/her DEA number
3. name of the drug, strength, quantity and directions for use
4. serial number assigned by the pharmacy
5. initials of the pharmacist filling the prescription
6. date the prescription is filled
1. name and address of the pharmacy’s
2. date the prescription was filled
3. serial number of the prescriptions
4. name of the prescriber
5. name of patient
6. directions for use
7. a warning that it is illegal to transfer the drug to any person other than the patient