Random Numbers- Time Requirements, Refills, etc.

The *2018 Farm Bill* made hemp and hemp derivatives including cannabidiol (CBD) containing no more than ___% tetrahydrocannabinol (THC) non-controlled substances.

*0.3%* NOTE: However, FDA-approved cannabidiol derived from cannabis containing no more than 0.1% THC, such as Epidiolex®, were originally placed into Schedule V. In 2020, DEA removed these products from Schedule V, so they are no longer controlled substances under federal law. As of the date of publication of this book, Florida had not yet removed Epidiolex® from Schedule V, but was expected to do that to match the federal law. *IT STILL HASN'T*

The Centers for Medicare and Medicaid Services (CMS) limits PRN orders for psychotropic drugs to how many days?

*14 days*, unless the practitioner documents the rationale for extending an order beyond 14 days. NOTE: PRN orders for psychotropic drugs cannot be renewed unless the attending physician evaluates the resident for appropriateness of that drug.

How long does an outsourcing facility have to report serious adverse event experiences?

*15 days*; must also conduct follow-up investigation and report similar to current drug manufacturers

What is the minimum age to be a pharmacy technician in Florida?

*17* years old

For licensure by endorsement (aka reciprocity), if licensed in another state for more than 2 years, must submit proof of ____ hours of continuing education (CE) for the ____ years preceding application.

If licensed in another state for more than 2 years, must submit proof of *30 hours* of continuing education (CE) for the *2 years* preceding application.

In order to serve as a consultant pharmacist preceptor, a person must be a consultant pharmacist of record at an institutional pharmacy, have at least ___ year(s) of experience as a consultant pharmacist of record, and not serve as a preceptor to more than ___ applicants at one time.

In order to serve as a consultant pharmacist preceptor, a person must be a consultant pharmacist of record at an institutional pharmacy, have *at least 1 year* of experience as a consultant pharmacist of record, and not serve as a preceptor to more than *2 applicants* at one time.

How often must pharmacist licenses be renewed?

Licenses renew *biennially (every 2 years)* on *September 30th of odd-number years* NOTE: Person licensed for 50 years or more is exempt from payment of renewal or delinquent fee and is given a lifetime license

Long-term detoxification (e.g., Methadone from a addiction clinic) means dispensing of a narcotic drug to a narcotic-dependent person in decreasing doses in excess of 30 days but not in excess of ___ days.

Long-term detoxification (e.g., Methadone from a addiction clinic) means dispensing of a narcotic drug to a narcotic-dependent person in decreasing doses in excess of 30 days but not in excess of *180 days.*

What is the maximum number of refills allowed for C3 to C5 prescriptions?

May be refilled as indicated on the original prescription *up to 5 times or 6 months.* STUDY TIP: There is no limit on the number of partial fills that can be provided, so long as the total amount dispensed does not exceed the total number of dosage units authorized and it is within the 6-month time period .Some pharmacy computer systems count each partial fill as a refill and invalidate the prescription after 5 partial fills, but this is not legally accurate. These prescriptions are still valid if the full quantities for all refills authorized have not been dispensed within 6 months.

Modified Class II pharmacies must have a Pharmacy Services Committee that meets at least how often?

Modified Class II pharmacies must have a Pharmacy Services Committee that meets *at least annually*.

The consultant pharmacist must review all controlled substance destruction documentation how often to ensure compliance in Institutional Class I (Nursing Home) pharmacies?

Monthly STUDY TIP: Notice that a DEA Form 41 is not required for destruction by a Class I Institutional Pharmacy (nursing home) because these drugs have already been dispensed to the patients. They are accounted for in the dispensing records of the pharmacy servicing that nursing home.

What is the requirement for hospitalized or institutionalized patients regarding PPIs?

Must be given to patients *b4 first administration of drug* and *every 30 days thereafter* NOTE: This probably does not happen in practice, but you need to know that it is technically required.

To become licensed by examination, one must submit proof of completion of internship program approved by the Board that shall not exceed _____ hours

Must submit proof of completion of internship program approved by the Board that shall not exceed *2,080 hours*

How many refills are allowed for Thalomide?

No automatic refills or telephone prescriptions are permitted. Also, subsequent prescriptions may be dispensed only if there are 7 days or less remaining on the existing prescription.

When are on-site inspections required for pharmacies?

Passing an on-site inspection is required before the issuance of a new pharmacy permit, for a change of ownership, a change of address, or a change of location.

How long does pharmacy have to dispense Thalomide after obtaining a confirmation number?

Pharmacy must obtain a confirmation number prior to dispensing via toll-free number or online. The confirmation number is valid for *24 hours* and must be entered on the prescription. This means the prescription must be dispensed within *24 hours* of obtaining the confirmation number.

How long do patients have to fill prescriptions for C2s after written?

There is *no time limit under Federal law* as to when a *Schedule Il prescription* must be filled after being issued by the practitioner. However, under *Florida law*, all prescriptions (*including Schedule II controlled substances*) must be filled *within 1 year after the date issued or the first date authorized to fill.* STUDY TIP: This creates the odd situation where *Schedule II prescriptions* are technically valid for up to *1 year*, but *Schedule III-V prescriptions* are valid for *only 6 months*. Even though a Schedule II prescription may be technically valid for 1 year, pharmacists must use professional judgment and exercise their corresponding responsibility before dispensing a controlled substance prescription to ensure it is valid NOTE: PAs and APRNs may only prescribe up to a 7-day supply of Schedule II controlled substance. There is an exception for psychiatric nurses.

What must a purchaser do when they have received notification of an unaccepted electronic order for controlled substances from the supplier? How long must the original statement be kept?

The purchaser must electronically link the statement of nonacceptance to the original order. The original statement must be retained for *two years*. Neither a purchaser nor a supplier may correct a defective order. The purchaser must issue a new order for the order to be filled.

Is there a maximum allowable intern to pharmacist ratio? Is there exceptions to this?

There is no maximum ratio of interns to pharmacists except when an intern is *performing immunizations* and for *foreign pharmacy* graduate interns when a 1:1 ratio applies.

LTCF staff may dispose of a patient's controlled substances into an authorized collection receptacle. Disposal into a collection receptacle must occur within how many business days after the discontinuation of use by the patient?

within *3 days* after the discontinuation of use by the patient

OTC Drugs for Minor Sore Throat max days to self-treat?

2 days

*Methods of Obtaining CE:* 3. How many CE hours can be obtained by performing volunteer services?

3. Up to *5 hours (10 real hours)* of CE credit may be obtained by performing volunteer services to the indigent or to underserved populations or in areas of critical need within the state. One hour is awarded for every 2 hours of volunteer work.

For pseudoephedrine HCL, what is the daily limit of of base product for OTC purchasers?

3.6 g; which equals: 1. 146 30 mg tabs 2. 73 60 mg tabs 3. 36 120 mg tabs

What is the maximum days supply for Isotretinoin, as restricted by iPLEDGE?

30 days

Pharmacies must comply with request for patient to obtain a copy of their PHI within how many days?

30 days (may extend to no more than 30 days if patient given reason why)

In Florida, the 7 members that must be licensed pharmacists also must be residents of Florida and must have been engaged in the practice of pharmacy in Florida for at least how long?

4 years

How long are the terms for members of the Florida BOP?

4 years; however, if a Board member's term ends, they may continue to serve until a new Board member has been appointed. NOTE: A Board member may not serve more than two full terms; however, if a member's term expires, they may remain on the Board until a new appointment is made by the Governor.

*Methods of Obtaining CE:* 4. How many CE hours can be obtained for completing courses from post-professional degree programs from accredited colleges or schools of pharmacy?

4. Completion of post-professional degree programs from accredited colleges or schools of pharmacy: *5 hours* of CE *per semester hour* may be claimed for courses completed during the renewal period.

A pharmacy does NOT have to register with the DEA as a *distributor* as long as total quantities of controlled substances distributed during a 12-month period in which the pharmacy is registered do not exceed ____% of the total quantity of all controlled substances dispensed and distributed during that same 12 month period.

5%

*Methods of Obtaining CE:* 5. How many CE hours can be obtained for a *volunteer expert witness* providing expert witness opinions for cases being reviewed by the Department of Health?

5. A volunteer expert witness providing expert witness opinions for cases being reviewed by the Department of Health shall receive *5 hours* of CE in the subject matter of risk management. The maximum CE allowable by this method is *10 hours*.

For the Cancer Drug Donation Program (under the Florida Food Drug and Cosmetic Act), a cancer drug may not be accepted or dispensed under the program if the drug bears an expiration date that is less than ____ months after the date the drug was donated or if the drug appears to have been tampered with or mislabeled

6 months

*Methods of Obtaining CE:* 6. How many hours can a presenter of a live seminar, a live video teleconference, or through an interactive computer-based application obtain?

6. The presenter of a live seminar, a live video teleconference, or through an interactive computer-based application may receive *1 credit for each course hour presented*, but may not receive additional credit for presenting the same course on multiple occasions.

For PAs, Schedule II controlled substances limited to ___ days.

7 days

For APRNs, Schedule II controlled substances are limited to a ____ day supply (unless for psychiatric medications prescribed by psychiatric nurses).

7 days NOTE: ONLY psychiatric nurse ARPNs can prescribe mental health controlled substances for children younger than 18 years of age.

*Methods of Obtaining CE:* 7. Can any out-of-state CE hours be approved in Florida?

7. *Yes.* A pharmacist who earns general CE in another state that is not ACPE approved but is approved by the Board of Pharmacy in the other state *can apply* that CE to the Florida CE requirements.

How long does one have to reactivate a delinquent license?

A delinquent license may only be reactivated *within 2 years*; after that, the license is void. NOTE: This rule applies to pharmacist licenses, consultant pharmacist licenses, nuclear pharmacist licenses, and pharmacy technician registrations.

A pharmacy can request an exemption from the electronic recordkeeping system for Pseudoephedrine if it maintains a sales volume of less than _____ of base product in a 30-day period. See FLCSA § 893.1495(5)b)

A pharmacy can request an exemption from the electronic recordkeeping system for Pseudoephedrine if it maintains a sales volume of less than *72 g of base product* in a *30-day period*. See FLCSA § 893.1495(5)b)

Consultant pharmacists who wish to order and evaluate laboratory tests under §465.0125 must complete a ____-hour initial certification course meeting the requirements of Rule 64B16-26.320. This certification course may apply to the 24 hours of consultant pharmacist CE required to renew a consultant pharmacist license.

Consultant pharmacists who wish to order and evaluate laboratory tests under §465.0125 must complete a *3-hour* initial certification course meeting the requirements of Rule 64B16-26.320. This 3 hour certification course may apply to the *24 hours* of consultant pharmacist CE required to renew a consultant pharmacist license.

What are the federal and state laws for the requirements and reporting for thefts or significant losses of controlled substances?

Federal: *DEA* must be notified in writing *within 1 business day of discovery*; also recommends notifying local police. A DEA *Form 106* (Theft or Loss of Controlled Substances) should be filled out on the DEA website. NOTE: Submitting DEA Form 106 immediately is not necessary if the pharmacy needs time to investigate the facts, but an initial notification must be provided in writing to DEA within 1 business day of discovery. If the investigation lasts longer than 2 months, the pharmacy needs to provide an update to DEA. Florida law: Requires notification of a theft or significant loss of controlled substances to the *county sheriff within 24 hours upon discovery*. Failure to do so is a first degree misdemeanor. See FLCSA § 893.07(5)(b). FPA § 465.022(11)(b) requires the prescription department manager (*PDM*) of a pharmacy to notify the Florida Board of Pharmacy of any theft or significant loss of any controlled substances within one business day after discovery of the theft or loss.

How long does a woman have to fill a prescription for Isotretinoin?

*7 days* from the day of *pregnancy test* (NOT the results)

Mail Service Limitations for Pseudoephedrine: Mail service companies must confirm the identity of purchasers. Sales are limited to how much in 30 days?

*7.5 g* per 30-day period.

What is the maximum days supply an *optometrist* can prescribe the oral anti-glaucoma agents or their generic or therapeutic equivalents of Acetazolamide and Methazolamide?

*72 hours (3 days)*

What is the time window to fill Thalomide via Celgene REMS for females of reproductive potential and other patients?

*7 days* from date of *last pregnancy test* for females of reproductive potential; *30 days for other patients* (24 hours for pharmacists to dispense after receiving confirmation #) EXP: Because specific authorization numbers are valid for 7 days from the date of the last pregnancy test for female of reproductive potential and 30 days from the date issued for other patients.

How many hours of CE are required for Opioid and Controlled Substance validation and counseling?

*2 hours* Must include: 1. Ensuring access to controlled substances for all patients with a valid prescription 2. Use of the Prescription Drug Monitoring Program's (PDMP) Database 3. Assessment of prescriptions for appropriate therapeutic value 4. Detection of prescriptions not based on a legitimate medical purpose 5. The laws and rules related to the prescribing and dispensing of controlled substances 6. Proper patient storage and disposal of controlled substances 7. Protocols for addressing and resolving problems recognized during the drug utilization review 8. Education on the provision of Florida Statute § 381.887 on Emergency Treatment for Suspected Opioid Overdoses and on the State Surgeon General's Statewide Standing Order for Naloxone (eff. May 19,2017) for as long as the Order is valid and effective 9. Pharmacist-initiated counseling of patients with opioid prescriptions 10. Available treatment resources for opioid physical dependence, addiction, misuse, or abuse.

A pharmacy may compound narcotic controlled substances pursuant to a prescription as long as the concentration is not greater than ___%.

*20%* NOTE: This 20% concentration limit applies to aqueous or oleaginous solutions or solid oral dosage forms. See chart of coincident activities allowed at 21 CFR 1301.13. DEA may consider compounding a narcotic prescription greater than 20% to be manufacturing, which would require the pharmacy to be registered with DEA as a manufacturer.

A prescriber or dispenser, or their designee, who does not consult the PDMP for a legitimate reason shall document the reason and shall not prescribe or dispense greater than how many days supply of a controlled substance to the patient?

*3-day supply*

What is the maximum days supply for verbal C-III prescriptions?

*30 days* NOTE: Florida does not allow a pharmacist to dispense more than a *30-day* supply for a Schedule III controlled substance from a verbal prescription. See FLCSA § 893.05(2)(e) STUDY TIP: This law was put into place when hydrocodone combination products were still Schedule III drugs. Since then, they have been rescheduled into *Schedule II and therefore cannot be verbal except in an emergency*, but the law is still in place. This is a law that is unique to Florida and could easily be the subject of an MPJE question.

*Medication Assisted Treatment (MAT) for Opiate Dependence:* A DATA-waived physician may be allowed to treat up to how many patients?

*30, 100, or 275 patients*, depending on his or her authorization. A DATA waived APRN or PA may initially treat up to 30 patients. After one year, a DATA-waived APRN or PA may apply for authorization to treat up to 100 patients. STUDY TIP: A DATA-waived practitioner can treat opioid addiction and prescribe MAT drugs (buprenorphine and buprenorphine/naloxone) from his or her office. They do not need to work at or be registered as a Narcotic Treatment Program. Likewise, a practitioner that is part of a Narcotic Treatment Program cannot automatically prescribe MAT drugs to be filled at a pharmacy. They would also need to be a DATA-waived practitioner. Subutex®=buprenorphine and Suboxone®=buprenorphine/naloxone combination

When buying a pharmacy, if the previous owner agrees that the controlled substance activities of the pharmacy may be carried out under his or her DEA registration and shall remain in effect, this limit for this is no more than ___ days after the purchase date.

*45 days after purchase date (longer in some situations)* NOTE: This temporary use procedure is not in a DEA rule. It was authorized many years ago in a policy letter from DEA. It is a practical policy to allow the new owner time to obtain a DEA registration after a change in ownership while still allowing patients to obtain refills and get prescriptions filled. An owner cannot apply for a DEA registration until they have their state pharmacy license and state controlled substance license if applicable. The 45-day limitation was in the original guidance from DEA, but some local DEA offices may permit a longer time period if needed.

To become licensed by examination, if graduated from a school or college of pharmacy outside the United States and passed TOEFL, TSE, and FPGEE, they must also have how many hours of supervised work in an activity program?

*500 hours* See Rule 64B16-26.2031

Under the HITECH Act to amend HIPAA, covered entities (including pharmacies) must notify individuals of a breach of their "unsecured" PHI within how many days?

*60 days after discovery of breach* NOTE 1: BAs (Business Associates- person or entities, other than members of a pharmacy's workforce, who perform a function or service on behalf of the pharmacy that requires the use or disclosure of PHI) must report any breaches of unsecured PHI to the covered entity and provide the identities of each affected individual. NOTE 2: A "breach" is defined as unauthorized acquisition, access, use, or disclosure of PHI that compromises its security or privacy. It does not include instances in which there has been an inadvertent disclosure from an authorized individual to another person authorized to access PHI within the same organization. A breach also does not include instances in which the covered entity or BA has a good faith belief that the PHI is not further acquired, accessed, retained, used, or disclosed.

If a supplier sends a partial quantity for the requested amount of a C-2, how long do they have to provide the rest before the order becomes void?

*60 days* EXP: A supplier may provide a partial quantity for the requested amount, but the remaining quantity must be sent within 60 days or the order becomes void. With the exception of certain Department of Defense orders, *no DEA Form 222 is valid more than 60 days after its execution by the purchaser*.

Patients have a right to amend their PHI records and request an accounting of disclosures of their PHI made by a pharmacy under certain circumstances. Pharmacies must comply with a request to amend or request for an accounting of disclosures within how many days?

*60 days* (but may extend it by no more than *30 additional days* if they notify the individual of the reason for the delay)

What is the days supply limit for PAs to write scripts for C2s?

*7 days* NOTE: May not prescribe psychiatric mental health controlled substances for children younger than 18; general, spinal, or epidural anesthetics; radiographic contrast materials; or controlled substances may not be prescribed in a pain management clinic.

What is the days supply limit for APRNs to write scripts for C2s?

*7 days* NOTE: This limitation does not apply to controlled substances that are psychiatric medication prescribed by *psychiatric nurses* (e.g., Adderall). NOTE2: Except for psychiatric nurse, APRNs may not prescribe psychiatric mental health controlled substances for children younger than 18

Every pharmacy must maintain a computerized record of controlled substances dispensed. A hard-copy printout summary of such record covering the previous 60-day period shall be made available within how many hours of request by any authorized law enforcement personnel?

*72 hours* NOTE1: The summary record must include information to be able to determine the volume (probably should say "quantity") and identity of controlled substances being dispensed under the prescription of a specific prescriber, and the volume (probably should say "quantity") and identity of controlled substances being dispensed to a specific patient. NOTE2: This is a curious requirement because all this information is reported to and is available in the PDMP. While law enforcement agencies do not have direct access to the PDMP, they may request information from the PDMP for an active investigation from the Department of Health if they have entered into a user agreement with the department. Since this language is still in the rule, pharmacies need to be able to provide this summary report from their computer within 72 hours upon request from authorized law enforcement personnel. Also note, a separate rule requires pharmacies to produce records of dispensing from the computer system for all prescriptions dispensed (not just controlled substances) upon request from an authorized agent of the Department of Health within 48 hours. See Rule 64B16-28.140

Optometrists are limited to prescribing Tramadol hydrochloride, Acetaminophen 300 mg with No. 3 codeine phosphate 30 mg, Amoxicillin with or without clavulanic acid, Azithromycin, Erythromycin, Dicloxacillin, Doxycycline/Tetracycline, Keflex, Minocycline, Acyclovir, Famciclovir, and Valacyclovir for how long?

*72 hours* without consultation with a physician licensed under Chapter 458 or Chapter 459 and who is skilled in diseases of the eye

The quantity prescribed and dispensed is limited to the amount needed to treat the patient during the emergency period. Florida law is stricter and specifies that the quantity for an emergency verbal Schedule II prescription is limited what hours/days supply limit?

*72-hour supply.* See FLCSA § 893.04(1)(f) NOTE: The prescription order must be immediately reduced to writing by the pharmacist and contain all information except the practitioner's signature. If the prescriber is not known to the pharmacist, the pharmacist must make a reasonable effort to determine that the phone authorization came from a valid practitioner.

What is the maximum days supply limit for multiple C-IIs at once?

*90 days* EXP: Multiple Prescriptions for Schedule II Drugs. (DEA Rule 21 CFR 1306.12(b) (1)) 1. DEA permits an individual practitioner to issue multiple Schedule II prescriptions on the same day, authorizing the patient to receive a total of no more than a 90-day supply of a Schedule II controlled substance. Instructions indicating the earliest fill date on which the prescriptions can be filled must be on each prescription 2. This 90-day limit only applies when the prescriber is issuing multiple prescriptions for a Schedule II controlled substance on the same day, with instructions that some of the prescriptions are not to be filled until a later date. NOTE: Logically, if there is no quantity limit for a single Schedule II prescription, then there is no reason for this rule. Technically, that is correct, but in this case DEA realized that because many insurance plans don't cover more than a 30-day supply of controlled substances, patients would need to go to the prescriber every month to get a new written prescription for any Schedule II controlled substance since they could not be called in. This was before electronic prescriptions were more prevalent. Rather than having prescribers postdate a prescription, which DEA has never allowed and still does not allow, this rule was adopted. When it adopted this rule, DEA limited the total quantity to 90 days, but it has still not placed a days' supply limit on a single controlled substance prescription. STUDY TIP: The rules for issuing multiple Schedule Il prescriptions seem to cause much confusion with pharmacy students and pharmacists. Be sure you understand this concept. These are not considered refills.

How often must dispensers (pharmacies and practitioners) register with the DEA?

*Every 3 years*

The Centers for Medicare and Medicaid Services (CMS) requires Medication Regimen reviews to be conducted how often for ALL long-term care patients?

*Every 30 days* NOTE: The pharmacist must report any irregularities to the attending physician, the facility's medical director, and the facility's director of nursing, and these reports must be acted upon.

The Poison Prevention Act of 1970 (PPPA): 1. Requires what type of packaging? 2. This is required for what drugs?

*IMPORTANT* 1. *Child-resistant* containers 2. *All Rx drugs* and for the *following non-Rx drugs, drug classes, preparations, or dietary supplements*: *I. Aspirin*: Any aspirin-containing preparation for human use in dosage form intended for *oral administration*. *II. Methyl salicylate (oil of wintergreen)*: *Liquid preps containing more than 5% by weight* of methyl salicylate *unless packaged in pressurized spray* containers. *III. Controlled drugs*: Any prep for human use in a dosage form intended for *oral administration* that consists in whole or in part of any substance subject to control under the Federal Controlled Substances Act. NOTE: Bc there are *some Schedule V* controlled substances available without a prescription under federal law. *IV. Methyl alcohol (methanol)*: Household substances in *liquid form containing 4% or more* by weight of methyl alcohol *unless packaged in a pressurized spray container*. *V. Iron-containing drugs* (with the exception of animal feeds used as vehicles for the administration of drugs): Non-injectable animal and human drugs providing iron for therapeutic or prophylactic purposes, which contain a *total amount of elemental iron equivalent to 250 mg*. *VI. Dietary supplements containing iron* (with the exception of those preps in which iron is present solely as a colorant): Dietary supplements that contain an *equivalent of 250 mg or more of elemental iron* in a single package. *VII. Acetaminophen*: Preps for human use in a dosage form intended for *oral* administration and containing *more than 1 g* of acetaminophen in a *single package.* *NOTE: APAP Exemptions:* a. Acetaminophen-containing *effervescent tablets or granules containing <10% acetaminophen* w/ a median lethal dose greater than *5 g/kg of body* weight and that release at least *85 ml of carbon dioxide per grain* of acetaminophen when placed in water. b. *Unflavored* acetaminophen-containing preparations in *powder form*, other than those intended for pediatric use, that are packaged in unit doses with *no more than 13 grains* of acetaminophen per unit dose and that contain no other substance subject to the special packaging requirements. *VIII. Diphenhydramine HCl*: Preps for human use in oral dosage forms containing more than the equivalent of *66 mg* of diphenhydramine base in a single package. *IX. Ibuprofen*: Preps for human use in oral dosage forms containing *1 gram or more* of ibuprofen in a single package. *X. Loperamide*: Preps for human use in oral dosage forms containing *more than 0.045 mg* of loperamide in a single package. *XI. Lidocaine*: Products containing *more than 5 mg* of lidocaine in a single package *XII. Dibucaine*: Products containing *more than 0.5 mg* of dibucaine in a single package (includes all dosage forms, including creams, sprays, and transdermal patches). *XIII. Naproxen*: Preps for human use in oral dosage forms *containing 250 mg or more* of naproxen in a single package. *XIV. Ketoprofen*: Preps for human use in oral dosage forms containing *more than 50 mg* of ketoprofen in a single package. *XV. Fluoride*: Products containing *more than 50 mg of elemental* fluoride and *more than 0.5% fluoride* in a single package. *XVI. Minoxidil*: Preps for human use containing *more than 14 mg* of minoxidil in a single package (includes topical products that must continue to meet requirements once applicator is installed by consumer). *XVII. Imidazolines*: Products containing *0.08 mg or more* in a single package. Imidazolines are a drug class that includes tetrahydrozoline, naphazoline, oxymetazoline, and xylometazoline often found in ophthalmic & nasal products. *XVIII. Any drug switched from Rx to OTC status.*

What is the maximum number of refills for Isotretinoin?

0 refills allowed

Legislation passed in 2019 required most healthcare professionals (including pharmacists) to complete a board-approved, ___-hour continuing education course on human trafficking by January 1, 2021. The course must address both sex trafficking and labor trafficking, how to identify individuals who may be victims of human trafficking, how to report cases of human trafficking, and resources available to victims.

1 hour NOTE: This was a onetime requirement and does not have to be completed with every two-year renewal. The law also requires posting a sign regarding human trafficking. See Chapter 4, Section II. The Board has not adopted any rules on this.

For Veterinary Prescription Drug Retailers, an order may not be valid for more than how long?

1 year

All requirements for pharmacist licensure by examination must be met within what timeframe of receipt of application or else have to be reapplied?

1 year NOTE: Successful examination scores may be used upon reapplication only if completed within *3 years of reapplication*.

What is the max days supply/refill limits for Thalomide?

The prescriber writes no more than a *4-week (28-day) supply*, with no automatic refills or telephone prescriptions. REMS!

Partial fills for C-IIs: 1. What is the rule for partial fills for C-IIs if the pharmacist is unable to provide the entire quantity? 2. What is the rule for fulfilling partial fills for C-IIs via written or electronic prescriptions if requested by the patient of the prescriber? 3. What is the rule for the terminally ill and LTCF patients?

1. *72-Hour Rule*: If a pharmacist is unable to fill the entire quantity on a Schedule II controlled substance prescription, a partial quantity may be provided so long as the remaining quantity is provided within 72 hours. If the remaining quantity cannot be provided, the pharmacist must notify the prescriber. 2. *30-Day Rule*: Under the Comprehensive Addiction and Recovery Act (CARA) of 2016, federal law was modified in 2016 to allow partial fills of Schedule II controlled substances for up to 30 days if requested by the patient of the prescriber. The total quantity dispensed may not exceed the original quantity prescribed. This applies to written and electronic prescriptions, but not to emergency verbal C-II controlled substance prescriptions. NOTE: DEA has yet to update their partial fill regulations or Pharmacist Manual to reflect this change. 3. *60-Day Rule*: For terminally ill and LTCF patients, both federal and Florida law allow partial fills of Schedule II prescriptions as many times as needed as long as the partial fillings are recorded on the prescription or maintained in the pharmacy's computer system. All partial fills for terminally ill and LTCF patients must be completed within 60 days. STUDY TIP: Be sure to understand the difference between a partial fill and a refill. Partial fills are NOT considered a full refill. Remember, there are no refills on a C-II substance prescription.

*Licensure by endorsement (aka reciprocity):* 1. For licensure by endorsement (aka reciprocity), along with the other requirements, a pharmacist must submit evidence of being licensed and actively practicing pharmacy in another jurisdiction for at least how many years? OR 2. They must submit evidence of successful completion of Board-approved postgraduate training or Board-approved clinical competency examination within the year preceding application, or have completed internship requirements within the preceding ____ years

1. *At least 2* of the immediately preceding 5 years 2. *2 years*

Renewal of Consultant Pharmacist License: 1. How many hours are required specifically for Consultant Pharmacists? 2. Can these hours be used toward the general required 30-hours of CE? 3. How many hours must a Consultant Pharmacist complete if they wish to continue ordering and evaluating lab tests? 4. Can these hours be applied to the general requirements for Consultant Pharmacists?

1. A consultant pharmacist must complete *24 hours* of consultant pharmacist CE that meets the requirements of Board Rule 64B16-26.302. See rule for details 2. *No.* The 24 hours of CE required for consultant pharmacist recertification may not be used toward the general 30-hour CE requirements for a pharmacist license. STUDY TIP: You should be familiar with the consultant pharmacist licensure requirements, as these requirements are unique to Florida. 3. Consultant pharmacists that wish to continue to order and evaluate laboratory tests must complete at least *one hour* of CE on ordering and evaluating laboratory tests in order to renew their license. 4. *Yes.* This one hour may apply to the 24 hours of consultant pharmacist CE required to renew a consultant pharmacist license.

*Methods of Obtaining CE:* 1. Programs must be approved by whom to be accepted for CE requirements? 2. Can CE hours be obtained by attending Board meetings for disciplinary hearings? If so, is there a maximum amount of hours that can be obtained by this method?

1. All programs approved by the Accreditation Council for Pharmacy Education (ACPE) are deemed approved for general CE for pharmacists. STUDY TIP: Do not get mixed up between continuing education (CE) hours and continuing education units (CEU). Nearly everyone tracks CE by hours, but ACPE tracks continuing education units or CEUs, which means a one-hour CE course will be accredited as 0.1 CEUs. If you see an ACPE course accredited for 0.3 CEUs, that equals 3 CE hours. 2. Licensees may obtain *5 hours* of CE in subject matter of Risk Management by attending one full day of a Board meeting at which disciplinary hearings are conducted. The maximum CE allowable by this method is *10 hours*. NOTE: You cannot receive CE for attendance at a Board meeting if you are required to appear before the Board.

Psychiatric Nurses: 1. What is the definition? *2. What is the day limit for C-IIs?* 3. What is the age limitations for prescribing psychiatric controlled substances?

1. An Advanced Practice Registered Nurse (APRN) licensed under §464.012 who has a master's or doctoral degree in psychiatric nursing, holds a national advanced practice certification as a psychiatric mental health advanced practice nurse, and has 2 years of post-master's clinical experience under the supervision of a physician. *2. Not subject to the 7-day limitation for C-IIs* like regular APRNs, *as long as they are psychiatric medications* *NOTE: This makes sense to allow for ADHD C-IIs for more than 7 days* 3. They may prescribe psychiatric controlled substances to patients under the age of 18 (unlike regular APRNs) NOTE: The additional requirements and restrictions on the treatment of pain that apply to all other prescribers of controlled substances are also applicable.

1. When are initial inventories required to be taken? 2. How often must inventory be taken for controlled substances? 3. When drugs are newly schedule or re-scheduled, when must the inventory take place?

1. An initial inventory is required on the *first day* the pharmacy is *open* for business. 2. Both federal and Florida law require a controlled substance inventory *biennially (every 2 years)* and that inventory must be maintained in the pharmacy. The inventory may be done on the pharmacy's regular physical inventory date, which is nearest to, and does not *vary by more than 6 months* from, the biennial date that would apply. 3. Newly scheduled drugs or drugs moved from one schedule to another must be inventoried *on the day* scheduled or moved to a new schedule.

*E-FORCSE™: The Florida Prescription Drug Monitoring Program (PDMP): C. Reporting Requirements* 1. How long does a pharmacy have to report (through the PDMP) each time a controlled substance is dispensed? 2. Extensions of time to report the dispensing of a controlled substance may be granted for no more than how many days (upon request to the program by any dispenser unable to submit data by electronic means, if the dispenser provides evidence of having suffered a mechanical or electronic failure or cannot report for reasons beyond the control of the dispenser or if the system is unable to receive submissions)? 3. What are the exemptions for reporting? 4. What if zero controlled substances are dispensed in the preceding business day? 5. Dispensing information with errors or omissions shall be corrected and resubmitted by the reporting dispenser within what time frame? 6. What specific information must be reported by the pharmacy for each controlled substance dispensed to the PDMP?

1. As soon thereafter as possible, but *no later than the close of the next business day after the day the controlled substance is dispensed*, unless an extension is approved by the department for cause as determined by rule. See FLCSA § 893.055(3) 2. *30 days* 3. Exemptions: a. All acts of administration. b. The dispensing of a controlled substance in the healthcare system of the Department of Corrections. c. The dispensing of a controlled substance to a person under the age of 16. d. Pharmacies and registered dispensing practitioners that do not dispense controlled substances in or into this state must submit a "Notification of Exemption From Reporting," and must renew the exemption every two years when renewing their pharmacy permit. 4. A dispenser that has no dispensing transactions to report for the preceding business day must submit a zero activity report as described in the "Data Submission Dispenser Guide." 5. One business day of receiving electronic or written notice from the program manager or support staff of the error or omission 6. Must be reported by the pharmacy: (1) Name of the prescribing practitioner (2) Practitioner's DEA number (3) Practitioner's National Provider Identification (NPI number) (4) Date prescription was issued (5) Date prescription was filled (6) Method of payment (cash, insurance, etc.) (7) Name, address, telephone number, and date of birth of person for whom the prescription was written (8) Name, NDC number, quantity, and strength of the controlled substance dispensed (9) Name, DEA number, pharmacy permit number, and address of the pharmacy (10) Whether prescription was an initial or refill and the number of refills ordered (11) Name of the individual picking up the controlled substance prescription and type of identification provided STUDY TIP: This information is reported electronically, but you should know what is required to be reported and when it is required to be reported for purposes of the MPJE.

*Board-Ordered Disciplinary Continuing Education Courses (Rule 64B16-26.6012):* 1. What methods can pharmacists obtain CE hours that are required by disciplinary order? 2. How long must CE Courses on Laws and Rules be? 3. How long must CE Courses on Quality Related Events be?

1. CE Courses being taken as part of a disciplinary order, unless otherwise ordered by the Board, may be conducted by any method, including live, correspondence, or distance education. 2. CE Courses on Laws and Rules shall be *at least 12 hours* in length and must cover specific topics as outlined in the rule. 3. CE Courses on Quality Related Events shall be *at least 8 hours* in length and cover specific topics as outlined in the rule. NOTE: This type of CE is often required after a *dispensing error.*

What are the requirements for reporting losses of "listed chemicals", primarily pseudoephedrine products in the pharmacy?

1. DEA requires any unusual or excessive loss or disappearance (this would include a theft) of a listed chemical to be reported to DEA at the earliest practicable opportunity. 2. A written report must be provided within *15 days* and must include a description of the circumstances of the loss (in-transit, theft from premises, etc.).

*Pharmacy Technician Ratio (Rule 64B16-27.410):* 1. What is the general rule for the pharmacist to technician ratio? 2. In reality, what is the maximum ratio allowed for pharmacist to technicians if the pharmacy is NOT engaged in sterile compounding? 3. In reality, what is the maximum ratio allowed for pharmacist to technicians if the pharmacy is engaged in sterile compounding? 4. In reality, what is the maximum ratio allowed for pharmacist to technicians if the pharmacy is a non-dispensing pharmacy or if it is a dispensing pharmacy but the area in question is physically separate (by a permanent wall or barrier) from the area in which drugs are dispensed and there is no sterile compounding taking place?

1. General Rule (*1 to 1*): A pharmacist shall not supervise more than one registered pharmacy technician; nor shall a pharmacy allow a supervision ratio of more than one registered pharmacy technician to one pharmacist unless specifically authorized to do so under this rule. *STUDY TIP: This language is inexplicably still in the rule, so it is included in this book, but the rule later specifically authorizes a 3:1, 6:1, or 8:1 ratio. So despite this language, it is incorrect to state that the ratio of registered pharmacy technicians to pharmacists is 1:1.* 2. Six to One (*6:1*) Ratio: Any pharmacy or pharmacist may allow a supervision ratio of up to 6 registered pharmacy technicians to one pharmacist as long as the pharmacist or registered pharmacy technicians are not engaged in sterile compounding. 3. Three to One (*3:1*) Ratio: Any pharmacy or pharmacist engaged in sterile compounding shall not exceed a ratio of 3 registered pharmacy technicians to one pharmacist. STUDY TIP: This ratio only applies to pharmacists and technicians engaged in sterile compounding and does not affect the technician ratios for other activities not involving sterile compounding in areas of the pharmacy separated from the sterile compounding area. In other words, a pharmacy could have 3 technicians involved in sterile compounding supervised by a single pharmacist and 6 additional technicians in a separate area involved in other dispensing being supervised by another pharmacist. 4. Eight-to-One (*8:1*) Ratio: A pharmacy may allow a supervision ratio of 8 registered pharmacy technicians to 1 pharmacist if the pharmacy is a non dispensing pharmacy or, if it is a dispensing pharmacy, it may utilize an 8:1 ratio in any area physically separate (by a permanent wall or barrier) from the area where drugs are dispensed and there is no sterile compounding taking place. STUDY TIP: This would apply to a call center pharmacy or remote order processing pharmacy that does not dispense medication.

Explain the Duty to Report (§ 465.015(3)) for fraudulent prescriptions for controlled substances and the time period for which a pharmacist must report it.

1. It is unlawful for any pharmacist to knowingly fail to report to the sheriff or other chief law enforcement agency of the county where the pharmacy is located of any instance that the pharmacist knew or believed a person obtained or attempted to obtain a controlled substance through fraudulent methods or representations. 2. This report must be made *within 24 hours* after learning of the fraud or attempted fraud or at the close of the next business day, whichever is later.

*HITECH Act (Amendment of HIPAA):* 1. For breaches of PHI affecting fewer than 500 individuals, covered entities must do what? 2. If more than 500 individuals are affected, the Secretary of HHS (Health & Human Services) and prominent local media must be notified in addition to the affected individuals within how many days?

1. Maintain a log of these breaches and notify HHS of these breaches *annually.* 2. Within *60 days* after the breach is discovered

Registration of Pharmacy Interns (§ 465.013 and Rules 64B16-26.2032, 64B16-26.2033, and 64B16-26.400): 1. Do Pharmacist Interns have to register? 2. Can a Pharmacist Intern perform any duties unsupervised? 3. Within how many days must a termination of enrollment in an intern program, or withdrawal of registration or attendance in an accredited school or college of pharmacy be reported to the Board? 4. What pharmacist:intern ratio is required for foreign pharmacy graduate interns? 5. What are the requirements for Pharmacists that are serving as preceptors of pharmacy interns? 6. How many hours of internship are required to become a pharmacist? What are the specifics?

1. Pharmacist interns in the state must be registered before being employed. NOTE: Interns must be enrolled in an internship program at an accredited college or school of pharmacy or have graduated from one and not yet be licensed in the state. 2. An intern may not perform any acts relating to the filling, compounding, or dispensing of medicinal drugs unless it is done under the direct and immediate personal supervision of a licensed pharmacist. 3. Within *30 days* of termination in enrollment in an intern program, or withdrawal of registration or attendance in an accredited school or college of pharmacy, all registered interns shall report such change in enrollment, registration, or attendance to the Board. 4. Foreign pharmacy graduate interns must be supervised at a ratio of *one pharmacist to one intern*. 5. Pharmacists serving as preceptors of pharmacy interns: (1) Shall accept responsibility for professional guidance and training of the intern and be able to devote time to preceptor training sessions and instruction of the intern (2) Must hold current licensure in the state in which pharmacy is practiced (3) May not have a license revoked, suspended, on probation, or subject to payment of an unpaid fine, or be subject of ongoing disciplinary proceedings (4) Must agree to assist the college or school of pharmacy in achievement of the educational objectives, and provide documentation of the pharmacist's continued professional education and of active involvement in a patient-centered practice. 6. A total of *2,080 hours* of internship are required to be licensed as a pharmacist. (1) All internship hours may be obtained prior to the applicant's graduation. (2) Hours worked in excess of 50 hours per week prior to an applicant's graduation, or in excess of 60 hours per week after an applicant's graduation, will not be credited.

The total quantity of codeine (Robitussin AC= Guaifenesin/Codeine) that may be sold OTC to any one purchaser within a 48-hour time period may not exceed what limit?

120 mg of Codeine Federal= 120 cc (4 oz)

*Renewal of Pharmacy Technician Registration:* 1. How many CE hours must be completed for renewal? 2. How many hours must be completed on Medication Errors? Can these be applied to the general hours? 3. How many hours must be live? 4. How many hours must be completed on HIV/AIDS? 5. Do they have to complete the same training on Human Trafficking? 6. Can Pharmacy Technicians earn hours for attending Board meetings for disciplinary hearings? How many hours can they earn if so?

1. Pharmacy technicians must complete *no less than 20 hours* of Board-approved CE in order to renew a registration. 2. Pharmacy technicians must complete a *2-hour* Board-approved course on medication errors. Yes, these hours may be part of the required 20 hours. 3. At least *4 hours* of the 20 hours must be obtained at a live seminar, live video teleconference, or through an interactive computer-based application. 4. Upon *first renewal*, pharmacy technicians must complete *1 contact hour* of a Board-approved course on HIV/AIDS. 5. Yes. Legislation passed in 2019 required most healthcare licensees, including pharmacy technicians, to complete a Board-approved, *1-hour* continuing education course on human trafficking by January 1, 2021. NOTE: All programs approved by the Accreditation Council for Pharmacy Education (ACPE) are deemed approved for general CE for pharmacy technicians. 6. *Yes.* Pharmacy technicians may obtain *5 hours* of CE in subject matter of Risk Management by attending one full day of a Board meeting at which disciplinary hearings are conducted. The maximum CE allowable by this method is *10 hours.* NOTE: You cannot receive CE for attendance at a Board meeting if you are required to appear before the Board.

Mobile Retail Vendors ("flea markets") for Pseudoephedrine: 1. How must it be stored? 2. What is the limit for sales per 30 days?

1. Product must be placed in a locked cabinet. 2. Sales are limited to no more than *7.5 g of base* product per customer per 30 days.

VII. Florida Food Drug and Cosmetic Act- Chapter 499 *B. Selected Permits* *(1) Retail Pharmacy Wholesale Distributor:* 1. This type of permit is require for whom? 2. The wholesale distribution activity cannot exceed ____ of the total annual purchases of prescription drugs. 3. What if it exceeds this %? 4. The transfer (i.e., distribution) must be between whom?

1. Required for a retail (community) pharmacy that engages in wholesale distribution of prescription drugs. 2. The wholesale distribution activity does not exceed *30%* of the total annual purchases of prescription drugs. 3. If the wholesale distribution activity exceeds the 30% maximum, the pharmacy must obtain a *prescription drug wholesale distributor permit.* 4. The transfer (i.e., distribution) must be between a retail pharmacy and either: (1) Another retail pharmacy; or (2) A Modified Class II institutional pharmacy; or (3) A healthcare practitioner licensed in this state and authorized by law to dispense or prescribe prescription drugs.

Continuing Education (CE) Requirements (S 465.009 and Rule 64B16-26.103(1): 1. How many hours are required for CE for pharmacists? 2. How many of these hours are required to be on Medication Errors? 3. How many of these hours are required to be on the Validation of Prescriptions for Controlled Substances? 4. How many of these hours must be live? 5. How many hours must be completed on the safe and effective administration of vaccines and auto-injectors if certified to administer vaccines or epinephrine auto-injectors? 6. What are the specific requirements if this is the initial renewal?

1. To renew a pharmacist license, a pharmacist must obtain *30 hours* of continuing education (CE) in courses approved by the Board during the 24 months prior to expiration of the license. 2. Pharmacists must complete *2 hours* of a Board-approved course on medication errors. These hours may be part of the required 30 hours of CE. 3. Pharmacists must complete *2 hours* of Board approved CE on Validation of Prescriptions for Controlled Substances as required in Rule 64B16-27.831. See Chapter 2 4. At least *10 hours* must be from live seminars, video tele-conferences, or interactive computer-based applications. 5. A pharmacist certified to administer vaccines or epinephrine auto-injectors must complete a *3-hour* CE course on the safe and effective administration of vaccines and epinephrine auto-injection as part of the required 30 hours of CE. 6. Initial Renewal: (1) A *1 hour* HIV/AIDS CE course is required as part of the initial renewal of a license. (2) If you are renewing your license for the first time and your initial renewal occurs *12 months or more* after initial licensure date, you are required to complete *15 hours* of CE (of which *5 hours must be live*), including 2 hours of medication errors, 2 hours of controlled substances, and *1 hour in HIV/AIDS*. (3) If your initial renewal occurs *less than 12 months* from your initial licensure date, you are required to complete *1 hour in HIV/AIDS, 2 hours of medication errors, and 2 hours* of controlled substances (*5 total hours*).

A pharmacy cannot provide information from the PDMP to a law enforcement officer. A law enforcement agency would have to request information directly from the PDMP program at the Department of Health and only for an active investigation. Although it is similar information, a law enforcement officer can request a pharmacy to produce a *summary record of controlled substances* dispensed in the last ____ days from a specific prescriber or to a specific patient from a pharmacy pursuant to Rule 64B16-27.831(8).

A pharmacy cannot provide information from the PDMP to a law enforcement officer. A law enforcement agency would have to request information directly from the PDMP program at the Department of Health and only for an active investigation. Although it is similar information, a law enforcement officer can request a pharmacy to produce a summary record of controlled substances dispensed in the last *60 days* from a specific prescriber or to a specific patient from a pharmacy pursuant to Rule 64B16-27.831(8).

Can a physician who is not part of a narcotic treatment program administer (not prescribe) narcotic drugs (e.g., methadone) to an addicted individual? If so, is there a limit of days supply?

A physician who is not part of a narcotic treatment program may administer (not prescribe) narcotic drugs (e.g., methadone) to an addicted individual for *not more than a 3-day period* until the individual can be enrolled in a narcotic treatment program.

All Modified Class II institutional pharmacies must have a consultant pharmacist who provides on-site consultations at least how often?

All Modified Class II institutional pharmacies must have a consultant pharmacist who provides on-site consultations *at least once per month.*

What are the C-V and C-III concentration limits for Opium?

C-*V* limit = *100 mg/100 ml* *NOTE: Anything above by Florida Law= C2 since stricter law applies* C-*III* limit (Federal law) = *500 mg/100 ml* and *25 mg/dosage unit* C-*III* limit (Florida law)- *None listed.* NOTE: It is difficult to say if this was done intentionally or is simply an oversight in the Florida law, but the Florida controlled substance schedules do not have the federal Schedule III limit of 500 mg/100 ml for opium products compounded with another pharmaceutical ingredient. The Florida law does contain a limit for opium for Schedule V of 100mg/100ml. This means that under *Florida law*, any compounded opium product *greater than 100mg/100ml* goes from Schedule V straight to *Schedule II.*

What are the C-V and C-III concentration limits for Codeine?

C-V limit = *200 mg/100 ml* C-III limit = *1.8 g/100 ml* and *90 mg/dosage unit* (so from 201 mg/100 mL to 1.79 g/100 mL is C-III) NOTE1: Anything above this limit would be Schedule II. NOTE2: Products such as Cheracol and Robitussin AC contain the maximum amount of codeine allowed for Schedule V. If you add any amount of codeine to these products, they would then be Schedule III.

What is the days supply limit for an opioid C-II for acute pain?

For acute pain, a prescription for an opioid drug listed in Schedule II may not exceed a *3-day supply* Can prescribe a 7-day supply if: (1) The prescriber, in his or her professional judgment, believes that more than a 3-day supply of such an opioid is medically necessary to treat the patient's pain (2) The prescriber indicates *"Acute Pain Exception"* on the prescription NOTE: This is different than what is written on prescriptions for opioids for non-acute pain. For the treatment of pain other than acute pain, a prescriber must write *"Non-acute Pain"* on a prescription for an opioid drug listed in Schedule II. (3) The prescriber adequately documents in the patient's medical records the acute medical condition and lack of alternative treatment options that justify deviation from the 3-day supply limit. STUDY TIP 1: This 3-day/7-day limit only applies to Schedule Il opioids for the treatment of acute pain. It does not apply to all Schedule II drugs, nor does it apply to opioids not being prescribed for acute pain. STUDY TIP 2: "Acute Pain Exception" is only required on the prescription to increase the quantity from a 3-day supply to a 7-day supply for acute pain. "Non-acute Pain" is required on the prescription when treating other than acute pain so that neither the 3-day nor 7-day limits would apply. NOTE2: For the treatment of pain related to a traumatic injury with an Injury Severity Score of 9 or greater, a prescriber who prescribes a Schedule II controlled substance must concurrently prescribe an *emergency opioid antagonist*. NOTE 3: If a prescriber forgets to write "Acute Pain Exception" or "Non-acute Pain" on a prescription for a Schedule II opioid, the pharmacist may confirm with the prescriber and annotate the prescription. Any changes should be promptly reduced to writing.

How long must records for controlled substances be maintained?

Records of controlled substances must be maintained for *2 years* under both the federal and Florida controlled substances acts. STUDY TIP: Although federal and state law are consistent on this, there are certain records that may be required to be kept longer under other laws or rules, and these can sometimes include controlled substance records. For instance, Florida rules require that *original prescription records be kept 4 years from the date of last dispensing*, and that would include controlled substance prescriptions. RECORDS TO BE KEPT: C-IIs: Copy 3 of DEA Form 222 or copy of original single page DEA Form 222 (with the number of containers and date received filled in) C-III to C-Vs: Supplier's invoice IF ELECTRONIC: Most pharmacies maintain records of dispensing in an electronic system (i.e., computer system). The DEA has specific requirements for electronic records of prescriptions as follows: 1. The electronic system must provide online retrieval of original prescription info and current refill history for those prescriptions which are currently authorized for refill. 2. The pharmacist must verify and document that the refill data entered into the system is correct. 3. The system must be able to produce a hard-copy printout of each day's controlled substance prescription refills, and each pharmacist who refilled those prescriptions must verify his/her accuracy by signing and dating the printout as he/she would sign a check or legal document. This daily printout must be printed *within 72 hours* of the date refills were dispensed.

What are the Retail Sales Limits of base product per day and per 30 days for Pseudoephedrine?

Sales of covered products to an individual are limited to *3.6 g* of the base product *per day* and *9 g* of the base product *per 30 days*. Many states have sales limits per transaction.

Short-term detoxification (e.g., Methadone from a addiction clinic) means dispensing of a narcotic drug in decreasing doses for a period not to exceed ___ days.

Short-term detoxification (e.g., Methadone from a addiction clinic) means dispensing of a narcotic drug in decreasing doses for a period not to exceed *30 days*.

How many lines per form on the DEA 222 single form and the triplicate form?

Single= 20 Triplicate= 10

To become a Consultant Pharmacist, along with the other requirements, one must successfully complete a period of assessment and evaluation under the supervision of a preceptor within one year of completion of the consultant pharmacist course. This must be completed over no more than ____ consecutive months and shall include at least ___ hours of training in specific areas. See rule details for specific areas.

To become a Consultant Pharmacist, along with the other requirements, one must successfully complete a period of assessment and evaluation under the supervision of a preceptor within one year of completion of the consultant pharmacist course. This must be completed over no more than *3 consecutive months* and shall include *at least 40 hours* of training in specific areas. See rule details for specific areas. NOTE: At the time of publication of this book, the Board had proposed, but not finalized, changes to Rule 64B16-26.300 to eliminate this requirement.

To become a Consultant Pharmacist, along with the other requirements, one must successfully complete a consultant pharmacist course of no fewer than ____ hours sponsored by an accredited college of pharmacy and approved by the Tripartite Committee.

To become a Consultant Pharmacist, along with the other requirements, one successfully complete a consultant pharmacist course of no fewer than *20 hours* sponsored by an accredited college of pharmacy and approved by the Tripartite Committee. NOTE: Used to be 12 hours; 24 hours for CE renewals

How much/what type training does a pharmacist need to complete to be certified to administer vaccines (i.e. CEs) for initial and each 2-year renewal period?

To obtain initial certification, a pharmacist (or registered intern) must complete *at least 20 hours* of continuing education (CE) concerning the safe and effective administration of vaccines, including cardiopulmonary resuscitation (CPR) training. See Rules 64B16-26.1031 and 64B16-26.1032 for details on certification application and training program. To maintain immunization certification, a pharmacist must complete *3 hours* of CE during each two-year renewal period. See § 465.009(6)

After request to DEA, when can the pharmacy start storing the records at a central location other than the main pharmacy?

Unless the pharmacy is notified by DEA that permission to keep the central records is denied, the pharmacy may begin maintaining central records *14 days after notifying DEA.* NOTE: Central records *shall not include* executed (i.e., completed) *DEA order forms (Copy 3 of DEA Form 222 or the copy made by the pharmacy of a single copy DEA Form 222), prescriptions, or inventories.* These must be kept at the pharmacy. STUDY TIP: Notice that *unused* DEA Form 222s *may be kept at a central location*, but once they have been *executed (i.e., completed), they must be kept at the pharmacy.* This is because the used DEA order form is the official record of the Schedule II controlled substances received. Be sure to know the records that cannot be kept at a central location.

If a verbal emergency prescription for a C-II is filled, how many days after authorizing must the prescriber furnish the pharmacist with a signed or valid electronic prescription?

Within *7 days* after authorizing emergency telephone script NOTE: If mailed, must be post-marked within 7 days NOTE2: Must be marked on prescription with "Authorization for Emergency Dispensing" STUDY TIP: Remember, the quantity of a C-II prescription that may be prescribed verbally in an emergency is limited to a 72-hour supply under Florida Law. That is different from federal law. NOTE3: Must contact local DEA office if the prescriber fails to deliver a written or electronic prescription for the emergency telephone prescription