CSA things and FDCA Flashcards

Question

What can registration for a pharmacy also include and what dont you have to do?

Answer 1

The issuance of a registration for any pharmacy shall also have the effect of permitting such pharmacy to operate as a retail dealer without requiring such pharmacy to obtain a retail dealer’s permit. On evidence satisfactory to the board: 1. That the pharmacy for which the registration is sought will be conducted in full compliance with the law and the rules and regulations of the board; 2. that the location and appointments of the pharmacy are such that it can be operated and maintained without endangering the public health or safety; and 3. that the pharmacy will be under the supervision of a pharmacist, a registration shall be issued to such persons as the board shall deem qualified to conduct such a pharmacy.

Answer 2

* 7 members from BOP and Board of Healing Arts * Purpose: promote consistent regulation and enhance coordination among boards with jurisdiction over licensees involved in collaborative drug therapy management. * advise and make recommendations to the Board of Pharmacy and Board of Healing Arts on matters relating to collaborative drug therapy management

Answer 3

3.6 g (base)

Answer 4

* Enter board and licensee may enter into stipulations * A hearing can be scheduled * A formal hearing can be scheduled

Answer 5

* maintain the system * Assuring the stocking, accounting and dispensing is accurate * Assuring confidentiality * Limit loading and unloading to R.PH, intern or tech * Security maintanence * Inspected for accuracy at least monthly and it is the PIC responsibility

Answer 6

5 x or 6 months whichever comes first

Answer 7

* Adequate drug information references * Supervision and training of technicians * P & P for preparation of IV’s * 7-day “after-the-fact” review of medication orders (68-7-11(l)) -Each medication order shall be reviewed by a pharmacist within seven days of the date it was written * Security * Tech-check-Tech requirements (68-7- 11(q)) • Note the technician requirements---- * Except with regard to drugs that have not been checked for accuracy by a pharmacist after having been repackaged, prepackaged, or compounded in a medical care facility pharmacy, a pharmacy technician in a medical care facility may check the work of another pharmacy technician in filled floor stock, a crash cart tray, a unit dose cart, or an automated dispensing machine if the checking pharmacy technician meets each of the following criteria: (1) Has a current certification issued by the pharmacy technician certification board or a current certification issued by any other pharmacy technician certification organization approved by the board. Any pharmacy technician certification organization may be approved by the board if the board determines that the organization has a standard for pharmacy technician certification and recertification not below that of the pharmacy technician certification board; (2) has either of the following experience levels: (A) **One year** of experience working as a pharmacy technician plus at least **six months** **experience working as a pharmacy technician in the medical care facility at which the checking will be performed;** or (B) one year of experience working as a pharmacy technician in the medical care facility at which the checking will be performed; and (3) has successfully completed a written training program and related examination designed by the pharmacist-in-charge of the medical care facility pharmacy to demonstrate competency in accurately checking whether floo

Answer 8

Within 72 hours of the first partial fill

Answer 9

The confidential communications between a licensed pharmacist and the pharmacist's patient and records of prescription orders filled by the pharmacist are placed on the same basis of confidentiality as provided by law for communications between a physician and the physician's patient and records of prescriptions dispensed by a physician. Nothing in this subsection shall limit the authority of the board or other persons, as provided by law, from inspecting the book or file of prescription orders kept by a pharmacy or firm performing any duty or exercising any authority as otherwise provided by law.

Answer 10

* **Thirty clock-hours** of continuing education shall be required for renewal of a pharmacist license during each licensure period. Continuing education clock-hours may be prorated for licensure periods that are less than biennial at a rate of 1.25 clock-hours per month. * Continuing education programs shall not include in-service programs, on-the-job training, orientation for a job, an education program open to the general public, a cardiopulmonary resuscitation (CPR) course, a basic cardiac life support (BCLS) course, emergency or disaster training or direct experience at a healthcare facility under a code blue, testing out of a course, and medical school courses * Each provider shall furnish a certificate of completion to the licensee for each continuing education program that the licensee has successfully completed. Each certificate shall be in a format approved by the board and shall include the following: (A) The licensee’s name; (B) the title and date of the approved continuing education program; (C) the name of the provider, D) the number of continuing education clock-hours approved by the board; (E) the number of continuing education clock-hours completed by the licensee; (F) the approved program number issued by the board; and (G) the provider’s dated signature, certifying program completion * Within 30 days of completion, each licensee shall submit to the board proof of completion of any approved continuing education program not reported to the ACPE-NABP CPE monitor service. No credit shall be given for any certificate of completion received by the board after the June 30 expiration date of each licensure period. * A licensee shall not be allowed to carry forward excess clock-hours earned in one licensure period into the next licensure period * The required continuing education shall be obtained in the two-year licensure period ending on the June 30 expiration date of each license.

Answer 11

* Equipment and supplies to compound in good repair and available in sufficient quanitity to meet the needs of practice * Note this requirement is for **other** than medical care facility pharmacy

Answer 12

* Must register with the board * Must display registration at work * Must get 1740 preceptor supervised hours * Once registered have to get them within 6 years * Preceptor can only supervise 2 interns * Within 30 days of getting a new job need to tell the board * Must tell board within 30 days of moving, changing email, or legal name.

Answer 13

DEA form 41

Answer 14

1. Pt name and address 2. Prescriber name 3. Initial date of dispensing Rx number 4. Drug name, strength and quantity dispensed 5. Name of dispensing pharmacist 6. Drug allergies or sensitivities 7. **Retain 5 years from date of last entry**

Answer 15

* Retail pharmacy non-resident pharmacies and hospital pharmacies (termed medical care facility pharmacies) * Renew with the board of pharmacy annually (expires on june 30th) * Display the registration * Have a pharmacist on duty when open * Designate a PIC

Answer 16

* Rx cannot be refilled more than authorized or after one year following the date of issuance whichever is first * Except: 1. Providing a 3 monts supple of rx drug that is not a CS or psychotherapeutic drug **if sufficient number of refills to do so** 2. Dispense a **7 day** emergency refilling 3. Exercise brand substitution brand exchange if in compliance with the orange book 4. Exercise biologic exchange if in compliance with the purple book

Answer 17

Within one business day

Answer 18

* CS must be between two licenses pharmacists * Interns can transfer non CSs

Answer 19

3 days, one day at a time

Answer 20

Within 24 hours of being dispensed unless exempted or filling a zero report

Answer 21

Differentiation between OTC from prescription (legend) drugs - Required prescription drugs to Carry "Caution federal law prohibits dispensing without a prescription or RX only - This was in order to comply with adequate directions for use.

Answer 22

5 x or 6 months whichever is first

Answer 23

* Assure the tech course of training addressess specific topics designed for the pharmacy * Training course is annually review * Documentation of training must be provided for inpection * PIC tells the board when the effective date of tech employement is * 2:1 or 3:1 if two have current certification by the pharm tech certification board.

Answer 24

May handle and store specific drugs identified by written protocol with a pharmacy and approved by the PIC. • Quarterly checks required by PIC • Allowable drugs: • Sterile water and saline for injection or irrigation • Heparin flush • diphenhydramine injection • epinephrine injection

Answer 25

* Pharmacists aware of an incident must report it to PIC as soon as practical * Involved pharmacist and PIC are responsible for preparing the report * Complainant's name, address, age, phone number * Name of each employee involved & license number * Date of incident & date of report * Pharmacist’s description of incident * Prescriber’s name and whether contacted * Signatures of all involved employees * Report retained for 5 years and available to board within 3 business days, if requested * Reports non-discoverable except by the board of pharmacy

Answer 26

1. Daily back up is performed 2. Maintain a written rx on file 3. Have a numerical system for rx ID 4. Maintain a written or electronic daily log 5. Store each active pt profile 6. Document that pharmacist is responsible for each authorization refill 1. ID on a daily basis the pharmacist fill Rxs 7. Able to reproduce all information in the system in written form within 72 hours of being requested

Answer 27

- Structure/function claims- * But the manufacturer needs to be able to substantiate these claims are truthful and not misleading * Need to notify FDA within 30 days of making the claim * But must conatin disclaimer that it isnt evaluated by the FDA - - Health Claims * relationship of DS to a disease or condition * this is generally not permitted unless the FDA has promulgated a regulation re: conditions and labeling Nutritional Support Claims- highlight nutritional attributes of a product.

Answer 28

* 18 years old * Board approved school * Once year of preceptor supervised 1740 * Pass NAPLEX and MPJE with 75 * May need to get finger printed and criminal background check * Notify board within 30 days of changing residential address or email address

Answer 29

means a person selling at retail non-prescription drugs which are prepackaged, fully prepared by the manuf. for use by the consumer. Shall NOT include: • controlled substances • legend drugs • drugs administered by injection

Answer 30

* Written physician approved policies and procedures for record keeping, reporting and adminitering vaccines * No greater than 2 year validity.

Answer 31

* To make available unused medications to medically indigent (voluntary) * Donating: * LTCF, mail service pharmacies, hospital pharmacies * Qualifying center or clinic mean indigent health clinic federally qualified health center, or community mental health center. * Donating meds are not considered resold

Answer 32

• Supervised by PIC • RN or PA approved by the PIC shall be in charge of distribution and control of drugs • No regulations yet

Answer 33

Required proof of efficacy prior to marketing - Established current GMP requirements - Increased controls over clinical investigations (informed consent) - Gave FDA authority over Rx drug advertising.

Answer 34

* Function of all personell * Control and accountability of drugs in compliance with fed/state law * Documentation of reportable incidents * Maintenance of records of dispensing, prepackaging, and compounding

Answer 35

1 year at least 8 months after the previous inventory

Answer 36

“Electronic supervision” means pharmacist supervision in real-time of a tech or pharmacy student working in a KS medical care facility pharmacy. • Application to the board required • Pharmacist may be electronically connected to multiple hospital pharmacies at one time • Pharmacist may supervise only one student or tech in a hospital pharmacy at one time. • Only one student or tech may work in the remote hospital pharmacy site at one time. • Pharmacist must verify each order before dispensing

Answer 37

* Notify within 5 days * Do a CS inventory * Do a CS Inventory within 72 hours of becoming the PIC * If there is a change in majority ownership must tell board within 5 days after change

Answer 38

• Under supervision of a PIC • Responsible for • P & P • Storage, maintenance of prescription meds • Packaging, distribution, adequate safety

Answer 39

1. Product name, additives, quantity 2. Expiration date 3. flow rate 4. Storage conditions if applicable

Answer 40

* State concept * All pharmacies need a PIC * Operating for more than 30 days without one is a violation of the practice act * Responsible for compliance with laws but does not relieve other pharmacists from compliance * Must pass and exam within 30 days of becoming a PIC, score an 85 or better * Responsible for ensuring that a licensed pharmacist is on duty at all times that the pharmacy is open * May not be the PIC in more than 1 full time pharmacy operation * Full time site is where on premises pharmacist services total 30 hours or more/week

Answer 41

II, III, IVs

Answer 42

There is no limit in federal or Kansas law

Answer 43

90 day supply

Answer 44

* May package, do manipulative, repetitive or nondiscretionary tasks related to Rx processing . . . But does NOT perform duties restricted to a pharmacist. * Register with the Board; Registrations expire every two years * Pass one or more exams within time specified by the Board and pay registration fee * Successfully complete employment-specific training * Notify the Board of new employer within 30 days of changing jobs * Display registration in part of business where engaging in tech. activities (65-1663) * Wear nametag

Answer 45

* Brand or Generic name * **Manufacturer** * Drug Strength and quantity * **Lot number, date repackaged and person responsible** * BUD * AUX labels if needed **Pharmacist/intern initials**

Answer 46

* Identify in the record what pharmacist verified the accuracy of the prescription * Make a reasonable effort to ensure the Rx is for a liegitamate medical purpose by an authorized prescriber. * Only pharmacist or pharm intern can receive a new script order. * A pharmccy tech can get a refill if authorized * First and last name of transferring agent

Answer 47

Shared services in Kansas includes: • Shared order filling and • Shared order processing • See study guide on BB • How do these regulations compare to central fill regulations in federal CSA?

Answer 48

• Requires consulting pharmacist • Develop policies and procedures • Assure proper control and accountability for emergency kit • Methods of drug distribution • Dispensed via a prescription • Traditional, unit-dosed, and/or automated drug delivery system • Emergency kit • Supplied by pharmacy • Drugs identified by P & T Committee • (Recall CSA requirements if automated dispensing machine used for CS) • Locked and sealed • Expiration date • No greater than 1 year from date of filling

Answer 49

* Pharmacist must submit signed protocol (statewide or individual if desired) to the board w/in 5 days of signing; notify board within 30 days if stopping * Must counsel or you cant dispense * Must docume each dispensing * Record as the prescriber either the pharmacist or protocol physician * Retain the record within the pharmacy for at least 5 years

Answer 50

Within 60 days of the date of issuance

Answer 51

For purposes of this regulation, "reportable incident" and "incident" shall mean a preventable medication error involving a prescription drug and resulting in any of the following: 1. (1) The patient receiving the wrong drug; 2. the patient receiving an incorrect drug strength 3. the patient receiving an incorrect dosage form; 4. the drug being received by the wrong patient; 5. inadequate or incorrect packaging, labeling, or directions; or 6. the dispensing of a drug to a patient in a situation that results in or has the potential to result in serious harm to the patient.

Answer 52

Cannot be picked up at a location other than a registered pharmacy

Answer 53

* Must detail methods, procedures, decision criteria the pharmacist uses to perform, document, and communicate witht he physician regarding CDTM * May NOT authorize a pharmacist to administer and flu vaccine except pursuant to the vaccine statue/regulations * Must be signed and dated by each physician and pharmacist * Signing pharmacist must send a copy to the board within 5 business days * Review and update at least every 2 years

Answer 54

* May include internet sources, annually updated * Current KS law * Texts * Toxicolgy * Pharmacology * drug interactions * pt focused drug reference * Drug equivalence * Medical dictionary

Answer 55

“Except for prescription drugs in unit-dose systems that contain only one medication and in which the drug has not reached the patient and is still intact, prescription drugs that have been dispensed to the final consumer shall not be resold, re-dispensed or distributed by a licensed pharmacist.” (68-12-2)

Answer 56

• Definition: Site where prescription-only drugs are stored & from where they are dispensed or administered. • e.g. providing drug needs of jail, juvenile detention center inmates, college students, inpatient hospice • Must be supervised by pharmacist or practitioner • Must develop/approve training and supervision of personnel in providing drugs and controlling drugs • Maintain at least quarterly review of drug records, storage conditions for all drugs • Develop P & P for documenting reportable incidents • Assure drugs dispensing for use outside the institution are adequately labeled.

Answer 57

120 mL or 24 doses in 48 hours

Answer 58

* Select drug products * Interpret pt records, perform drug regimen reviews * Encourage proper drug utilization by **personally** offering to counsel on each new Rx, annually for maintenance and refills when appropriate * Offer supplemental information but that does not replace verbal counseling * and delegate non-judgemental functions

Answer 59

* Complete 20 documented hours of continuing education each registration year q 2 years * Registration end october 31st * Must pass PTCB or ExCPT exam before renewal * Board can suspend revoke or deny renewal of tech registration on same grounds as those of pharmacists- may also require physical or mental exam

Answer 60

* Dispensing from prescription copies is not permitted * It is state law that prohibits a pharmacist from dispensing a generic product that is not considered bioequivalent according to the FDA (orange book) * Interchangable biologics * Inform the patient of the interchange * Maintain a record of biological product dispensed * Communicate to the presciber within 5 business days following dispensing the product name and manufacturer dispensed unless * There is no interchangeable produt for the one prescribed or * A refill is not changed from the prior dispensed * Board will maintain a link on the website to the FDA interchangeable product list.

Answer 61

* License expires every 2 years * Date is established by regulation June 30th * If you keep practicing and dont renew you get fined * License renewal * Completion of board furnished application * Payment of fee * Completion and documentation of continuing education * ACPE-NABP online CPE monitoring * Kansas BOP approved CE programs

Answer 62

Primary agency that enforces FDCA through regulation and issuance of guidance documents

Answer 63

* Agents or Employees of a registrant acting within their scope of practice * Individual practicioners employed in a hospital, use internal code and DEA # * Pharmacists

Answer 64

Community pharmacies, hospital pharmacies, teaching institutions * 224 * 224b * Valid for 3 years * Registration can be denie revoked * Costs 731 bucks lasts for 3 years

Answer 65

* 224 * lasts for 3 years

Answer 66

A pharmacy registered as a dispenser may manufacture or distribute to other practitioners an aqueous or oleaginous soln. or solid dosage form containing a narcotic substance in a preparation NOT exceeding 20% of the complete product AS a dispenser

Answer 67

A pharmacy registered as a dispenser may sell to other registrants without registering as a distributor as long as the total number of dosage units distributed does not exceed **5%** of the total units of **CS** distributed and dispensed in **one calendar year**.

Answer 68

Can request on line or on paper Then DEA will issue a new one.

Answer 69

* Notify nearest DEA office * Return DEA certification of registration and Unused voided 222 forms and explanation of disposal or transfer of all CSs

Answer 70

* Notify area DEA Special Agent at least **14 days** prior to transfer with specifics via certified mail (receipt requested) or in person

Answer 71

* Pharmacies (including hospital pharmacies) must store CII‐CVs in a securely locked, substantially constructed cabinet OR may disperse CII‐CVs among non‐CS stock * Physicians dont have this choice.

Answer 72

* Convicted of a felony related to a CS * had a DEA registration denied or revoked * Has surrendered a DEA registration for "cause" Regestrant can try to get a waiver: which is based on a bunhc of factors listed in the pharmacy manual, and this must be granted before hiring.

Answer 73

QUOTAS for the amount of CIs and CIIs that can be produced giving them a ceiling and is published in the FR.

Answer 74

Objective to achieve and opioid drug free state through use of decreasing does

Answer 75

Objective to treat an opioid dependent individual with stable opioid agonist therapy for a period in excess of 21 days these are inforced by substance abuse and mental health services

Answer 76

* Can be used for detox or maintenance IF the pt is entrolled in an OTP * **But pharmacists can other dispense methadone for pain** not for detox or maintenance * Prescribers not entrolled in an OTP: MAY administer methadone for a maximum of 3 days – one day at a time – to maintain patient while enrolling in OTP (3‐day rule); • Administer to hospital inpatient while the patient is being treated for an illness or diagnosis outside of detox or maintenance

Answer 77

Need Special education and DEA Number Buprenorphine SL Bup/Naloxone is the prescriber qualified? Additional registrations and X number, Use of drugs for off label purposes? 3 day rule

Answer 78

* Ephedrine, PSE, and phenylpropanolamine are considered scheduled listed chemical products * Regulated sellers must follow requirements for OTC sales * Exception of a single sale of 60 mg or less of PSE * Products must be behind the counter or in locked cabinet * Employer must self certify annually on DEA website and maintain documentation that each employee is trained *

Answer 79

Logbook * Written or electonic and photo ID required for Sales Identifies: * Products purchased by name * Quantity Sold * Name, Address, signature of purchaser * Date and time of sale * Seller must determine that signature and ID match * Logbook has to give notice that false or misleading information may lead to criminal penalties..

Answer 80

3.6 grams of product base per day regardless of transactions number 9 g per 30 days 7.5 g if purchased by mail Must be 18 in KS

Answer 81

* Prescriber name and address * Pts full name and address * date issued * Drug name, strength, dosage form, quantity and directions for use * Refill info * Prescriber name manually signed * DEA number

Answer 82

CIII CIV and CVs Need prescriber auth cant change pts name drug (except generic) and prescribers signature CIIs• A pharmacist may add a date if it is not written with consultation with the prescriber. A pharmacist may also change a drug strength, quantity, and directions for use after consulting with the prescriber. The patient’s address, prescriber’s DEA number may also be added. A dosage form may be selected if one is not written. **All information added/changed must be initialed dated and timed.**

Answer 83

No refills Valid for 6 months from date of issue (kansas)

Answer 84

No more than 5 x or 6 months after the date of issue whichever is first Refill record on back or other appropriate document date refilled quanitity pharmacist initials Total number of refills must be retrievable

Answer 85

Fed: May refill as Authorized Kansas: No more than 5 times or 6 months after the date issue which ever come first Refill record documented like above

Answer 86

* Yes * You must record the partials the same way as you record refills on the back of the paper Rx or however else its done * Quantity dispensed for ALL partials fills cannot exceed quantity prescribed (face quantity + refill) * No dispensing can occur beyond 6 months of the date of issuance * Partial fill doesnt = refill

Answer 87

Yes Quantity, date of the partial and name of pharmacist filled on the face of the paper Rx No dispensing can occur beyond 72 hours of the partial filling If remaining portion is not able to be filled within 72 hours notify prescriber

Answer 88

Pts in LTCF Terminally ill * Requirements * On Prescription Face: terminally ill or LTCF * On back or where appropriate: Date quantitiy dispensed, remaining quanitity, to be dispensed, ID of dispensing pharmacist * Limitation: 60 days from issue date

Answer 89

* Need to take Immediately * No alt available * Not reasonably possible for prescriber to give written script

Answer 90

* You cant refill a single CII * But you can issue multiple scripts if: * Each Script is issued for a actual medical reasons * Provider provides written insturctions on each scriptexcept for the first one indicatin when they can be filled * Issuance is permissible under state law * The quantity of all doesnt exceed a 90 day supply * You cant fill it before the earliest day

Answer 91

**Objective:** To prevent illicit sales of CS over the Internet by “rogue” Web sites, while allowing the use of electronic communications for prescribing and dispensing CS for legitimate medical purposes. * Valid prescription: issued for legitimate purpose by practitioner who has conducted at least one in‐person patient evaluation. * Pharmacies that meet the definition of “online pharmacy” must obtain modification of their DEA registration for all Internet business

Answer 92

ONce Except if they share a real time data base then they can be refilled however many times its says up to 5 has to be a real pharmacist doing the transferr

Answer 93

Purchased • Dispensed • Distributed • Returned • Destroyed • Lost or Stolen • Inventoried (CS on hand)

Answer 94

DEA 222 Forms • Executed & unexecuted • Power of Attorney forms • DEA Registration certificate • Self‐certification certificate and PSE sales logbook • Logbook for sales of C‐V OTC products

Answer 95

2 years fed 5 years kanasasfrom date of last entry

Answer 96

CIs and CIIs

Answer 97

CIII-CV Executed paper DEA 222 forms • Prescriptions (paper) • Inventory records These can be kept centrally: Financial and shipping records, if DEA notified • Electronic refill records

Answer 98

1. Electronically searchable file(s) 2. Manual filing: 3 methods * 3‐file method * 2‐file methods (Note: p. 278 of text) 1. All CS together & all non‐CS together (“C” stamped on III, IV, & V) 2. All CII together & all other CS + non‐CS together (“C” stamped on III, IV, & V) Need red C but waived for electronic

Answer 99

* Pt must be 18 * Must have ID if unknown to pharmacist * Must document sale * Name/Address of purchaser • Name/Quantity of drug • Date of purchase • Name/initials of dispensing pharmacist * Dispensing must be done my pharmacist but non pharm can do the payment

Answer 100

Can be used as an alternative to hard copy but need to have thee requirements * Pharmacists verification of accuracy on hard copy or print out or bounf book or file * Date signed must be within 72 hours * Can print out any refill data to user pharmacy within 48 hours if kept central * Back up system

Answer 101

Form 222 hard copy or electronic with a CSOS Currently a triplicate form however proposed single sheet format Signed and dated by person authorized to sign a registration application Know manual procedure for completing DEA 222 form

Answer 102

Lost In Translation * Execute new form, execute statement noting serial number of lost form, date of lost form, list of drugs and fact drugs werent recieved * Retain copy number 3 with statement Stolen Order Forms * Report to nearest DEA office stating the serial numbers of stolen and or date of issuance * Must Notify DEA if found

Answer 103

1. Returning CII drugs to a wholesaler (distributor) manufacturer or reverse distributor 2. Selling a pharmacy business requires the seller to 1. Inform the DEA 14 days prior to sale 2. Transfer all CII drugs by use of DEA 222 form 3. Distributing CII drugs between DEA registrants

Answer 104

A physician must use a DEA Form 222 in order to obtain C‐II drugs for office use from another registrant – usually pharmacy. A physician may NOT write a prescription to acquire C‐II drugs from a pharmacy for this purpose.

Answer 105

The invoice or packing slip you do not need a DEA form but you have to file it separately and it must be readily retrievable

Answer 106

* Initial: Right when they start dispensing * Biennial at least every 2 years, kansas is annual * Separate inventories for each registered site * Inventory CS on hand * Opening or closing of business * Newly controlled substances on effective date of scheduling published in the FR

Answer 107

Exact count of CIIs CIIIs and CIV CV in containers more than 1000 doses Estimate of CIII, CIV, CV in containers of 1000 or less

Answer 108

* 1 Registrant requests permission from the DEA * Complete form 41 listing everything * DEA will direct the method * 2 Registrant uses a reverse distributor * CIIs are transferred to the reverse via the Reverse distribu DEA form 222 * CIII through V drugs must also be documented and record retained by the registrant * Reverse distibu must submit form 41 for the DEA disosal and destruction

Answer 109

Purpose: Disposal of CS returned from ultimate users or long term care facilities (LTCF) on behalf of their patients * retail pharmacies and hospitals or clinics pharmacies may voluntarily become authorized collectors and: * Administer mail back programs or * Maintain collection receptacles within the pharmacy * Or manage a collection receptacle at a LTCF * DEA requires modification of registration to become an authorized collector * Pharmacies May not co-mingle their inventory disposal/destruction w/these returns

Answer 110

Must tell DEA in writing within one day Submit Form 106 What Tell police

Answer 111

• Peyote (CI, psychoactive alkaloid, hallucinogen) is exempt from control when used in bona fide religious activities by the Native American Church. (Persons that manufacture and distribute must register, however.)

Answer 112

CSA authorized inspection of controlled premises Inspections are usually drug accountability / compliance audits- so every ones knows the records are being kept correctly * DEA may inspect, copy, and verify records, reports, required forms, equipment, and CS * Cannot inspect financial, sales, pricing data, or personal records unless registrant provides written consent * • Cannot review patient charts * No right to interview witnesses, including registrant or employees * • May collect samples (usually will leave receipt)

Answer 113

* DEA investigators should present their DEA credentials and a Notice of Inspection (Form 82). * Consent must be **informed and voluntary**. * Registrant may withhold consent or withdraw it at any time. * • Anything incriminating said by registrant may be used against them

Answer 114

* Administrative Inspection Warrant differs from a Notice of Inspection * • DEA may obtain a warrant if registrant consent was withheld or withdrawn from an inspection * • Allows DEA to inspect during regular business hours – which does NOT mean at the convenience of the owner • * Entry/inspection must be permitted by the registrant * Refusal can carry fine and jail sentence

Answer 115

* Proactively prepare. Maintain, review, and regularly update CS policies and procedures for compliance with DEA requirements * Share an audit plan with employees and conduct a practice drill * Examine agent(s)’ credentials, obtain their business cards, and ascertain the purpose. * Take detailed notes of what was said, done, and suggested by agents during the inspection. * Answer questions asked, but do not speculate. Silence is preferable to incriminating statements. * Everything said during an audit may be introduced in an administrative, civil, or criminal proceeding * Request a final discussion or exit interview with inspectors

CSA things and FDCA Flashcards

(158 cards)