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32 Cards in this Set
- Front
- Back
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* Define: manufacture |
to make, assemble, process or modify devices, or mix, produce or prepare drugs in dosage forms by encapsulating, entableting or other process, or packaging, repackaging, or otherwise changing the container, wrapper or label of any package containing a drug or device in furtherance of the distribution of the drug or device from the original place of manufacture to the person who makes final delivery or sale to the consumer |
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* Define: manufacturer |
a person licensed or approved by the federal food and drug administration to engage in the manufacture of drugs or devices, consistent with the definition of "manufacturer" under the federal food and drug administration's regulations and interpreted guidances implementing the federal prescription drug marketing act |
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* Define: distribute |
To deliver, other than by administering or dispensing |
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* Define: distributor |
Someone who distributes prescription drugs to a person OTHER THAN A CONSUMER OR PATIENT, but does not include: 1. intra-company sales 2. Emergency preparedness 3. Drug samples (sales reps) 4. Distribution to a practitioner for them to give to their patients... can't be more than 5% of the total dosage forms that the pharmacy sells per year |
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* Define: disciplinary action |
Action by the board in order to reprimand a credential holder |
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* Define: reprimand |
to publicly warn the holder of a credential |
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* Define: limitation |
(when used in reference to limiting a credential) to impose conditions and requirements upon the holder of the credential, to restrict the scope of the holder's practice, or both |
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* Define: suspension |
(when used in reference to suspending a credential) to completely and absolutely withdraw and withhold for a period of time all rights, privileges and authority previously conferred by the credential |
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* Define: revocation |
(when used in reference to revoking a credential) to completely and absolutely terminate the credential and all rights, privileges and authority previously conferred by the credential |
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* Define: stipulation |
a condition or requirement that is specified or demanded as part of an agreement. (definition from online) |
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* Define: summary suspension |
immediate termination of a credential over concerns for the safety of patients, employees, or any other persons in the practice (found online.. not in Blue Book) |
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* Define: administrative warning |
Warning given to a credential holder when it has been determined that no further action is required because the complaint involves a first occurrence of a minor violation and the issuance of an administrative warning adequately protects the public by putting the credential holder on notice that any subsequent violation may result in disciplinary action |
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* Define: unprofessional conduct |
Ch 450.1 Unprofessional conduct includes any of the following but does not include the dispensing of an antimicrobial drug for expedited partner therapy as described in s. 450.11 (not word-for-word) 1. Making any false statement or providing false information regarding application for a license 2. Violating ch. 450 or any federal/state statute that relates to the practice of the licensee 3. Practicing pharmacy while impaired by drugs, alcohol or a mental disease 4. Engaging in false, misleading or deceptive advertising 5. Making a substantial misrepresentation in the course of practice which is relied on by another person 6. Engaging in practice which evidences lack of knowledge or ability to apply professional principles or skills 7. Compensation fraud or deceit 8. Violating any order by the board |
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* Describe the application procedures involved in manufacturer original licensure |
Ch. Phar 12.03 To obtain a license a manufacturer must: 1. submit an application 2. pay a fee 3. meet inspection requirements 4. register with the FDA and DEA, if applicable, and comply with all requirements
NOT transferable to another location or person
PEB must act in 60 days |
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Authorized list of distributors |
A manufacturer shall maintain and update at least once per month a list of the manufacturer's authorized distributors of record |
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Manufacturers who function as distributors |
Ch 450.071(1) Manufacturers that distribute prescription drugs or devices manufactured by the manufacturer are exempt from wholesale distributor licensing requirements |
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* Describe the application procedures involved in manufacturer renewal licensure |
Notice of renewal will be mailed out at least 30 days prior to renewal
Renewal date: June 1 of even-numbered years |
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* Describe the application procedures involved in distributor original licensure |
Ch 450.071 An applicant shall submit a form containing: 1. name, business address, and telephone number of the applicant 2. All trade or business names used by the applicant 3. Names, addresses, and telephone numbers of contact persons for all facilities used by the applicant for the storage, handling and distribution of prescription of drugs 4. The type of ownership or operation 5. Names of any partners or partnerships 6. if applicable, name of sole proprietor and the name of the business entity 7. list of all licenses and permits issued in by any other state that authorizes the purchase or possession of prescription drugs 8. Name, address, and telephone number of a designated representative (including some personal information required in ch 450.071(j) 9. A statement that the facility has been inspected in the 3-year period preceding the application 10. Register with the DEA, if applicable
PEB must act within 60 business days |
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* Describe the application procedures involved in distributor renewal licensure |
Renewal is June 1 of even-numbered years
$128
Renewal will be mailed at least 30 days prior to renewal |
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* Identify requirements for maintaining distributor licensure |
Ch. 450.072 Distribute only to licensed persons or facilities & only to locations listed on the license or authorization |
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Facility requirements for maintaining distributor license |
Ch. Phar 13.09 1. be suitable sized and constructed to facilitate cleaning, maintenance, and proper operations 2. Have storage areas designed to provide adequate lighting, ventilation, temperature, sanitation, humidity, space, equipment, and security conditions 3. Have a quarantine area for storage of prescription drugs that are outdated, damaged, deteriorated, misbranded, or adulterated, or that are in immediate or sealed secondary containers that have been opened 4. Be maintained in a clean and orderly condition 5. Be free from infestation by insects, rodents, birds, or vermin of any kind |
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Storage requirements for maintaining distributor license |
Ch Phar 13.11 1. All prescription drugs stored in a facility shall be stored at appropriate temperatures, and under appropriate conditions in accordance with requirements, if any, in the labeling of such products, or with requirements in the current edition of an official compendium 2. If no storage requirements are established for a prescription drug, the product may be held at a controlled room temperature, as defined in an official compendium, to help ensure that its identity, strength, quality, and purity are not adversely affected 3. Appropriate manual, electromechanical, or electronic temperature and humidity recording equipment, or logs shall be utilized to document proper storage of prescription drugs |
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Security requirements for maintaining distributor license |
Ch. Phar 13.10 1. Access from outside the premises is kept to a minimum and be well controlled 2. The outside perimeter of the premises is well lighted 3. Entry into areas where prescription drugs are held is limited to authorized personnel 4. An alarm system is maintained to detect entry after hours 5. A security system is maintained that will provide suitable protection against theft and diversion, including, when appropriate, a system that provides protection against theft or diversion that is facilitated or hidden by tampering with computers or electronic records |
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Damaged/outdated drugs requirements for maintaining distributor license |
Ch. Phar 13.13 1. Prescription drugs in a facility that are outdated, damaged, deteriorated, misbranded or adulterated shall be quarantined and physically separated from other prescription drugs until they are destroyed or returned to their supplier 2. Any prescription drugs in a facility whose immediate or sealed outer or sealed secondary containers have been opened or used shall be identified as such, and shall be quarantined and physically separated from other prescription drugs until they are destroyed or returned to their supplier 3. If conditions under which a prescription drug has beed returned to a facility cast a doubt then the products must be destroyed to returned to the supplier unless adequate testing can be done to assure safety (not word for word out of BB) 4. The record keeping requirements in s. Phar 13.14 shall have followed for all outdated, damaged, deteriorated, misbranded or adulterated prescription drugs |
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Records requirements for maintaining distributor license |
Ch. Phar 13.14 1. A distributor shall establish and maintain inventories and records of all transactions regarding the receipt and distribution or other disposition of prescription drugs. These records shall include a. the source of the drugs, including the name and principal address of the seller or transferor, and the address of the location from which the drugs were shipped b. the identity and quantity of the drugs received and distributed or disposed of c. the dates of receipt and distribution of other disposition of the drugs 2. Inventories and records shall be made available for inspection and copying by the board, its authorized representatives, and authorized representatives of federal, state and local law enforcement agencies for a period of 3 years following distribution or other disposition of drugs 3. Records described in this section that are kept at the inspection site or that can be immediately retrieved by computer or other electronic means shall be readily available for authorized inspection during the retention period. Records kept at a central location apart from the inspection site and not electronically retrievable shall be made available for inspection within 2 working days of a request by the board of its authorized representative |
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*Identify requirements for maintaining manufacturer licensure |
(not really stated anywhere??) |
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* Discuss the PEB's role in disciplinary actions taken against pharmacists |
1. Board receives complaint 2. Gather facts (division of enforcement) & investigate 3. Action against licensee (stipulations, stipulated agreements 4. Hearings |
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What would cause action against a license? |
-Violations of statutes, rules, regulations - Engaging in practice without a required credential |
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Who may file a complaint against a credential holder? |
Ch 440.20 ANYONE! |
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Possible actions against a license |
Reprimand Deny, revoke, suspend, limit, or combination of, the license Fines/forfeitures |
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Process of administrative warnings: Findings |
Ch. SPS 8.03 Findings: a. there is specific evidence of misconduct by the credential holder b. the misconduct is a first occurrence for the credential holder c. The misconduct is a minor violation of a statute or rule related to the profession or other conduct for discipline may be imposed d. issuance of an administrative warning will adequately protect the public |
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Process of administrative warnings: Review |
A credential holder who has been issued an administrative warning may request the disciplinary authority to review the issuance of the administrative warning by filing a written request with the disciplinary authority within 20 DAYS after the mainly of the administrative warning. The request shall be in writing and set forth: (1)the credential holder's name and address (2) the reason for requesting a review
The board must act within 45 calendar days of receipt of request |
