SCHEDULE

DEA ________ form is issued as the CS registration (CII-CV) if application approved by DEA

223

beyond-use-date for *medium risk sterile* compounding at room temperature, refrigerated, and frozen

30 hours (room temperature), 9 days (refrigerated), 45 days (frozen)

If pharmacy is located within a state that DOES sign the MOU, distribution of *compounded* products in interstate commerce may not exceed _________________ of the total prescription orders dispensed / distributed by the pharmacy (i.e. greater than _________________ will be deemed "inordinate amounts")

50%

Which part of the USP covers Non-Sterile Compounding?

795

True or False: In Massachusetts, outsourcing facilities must receive patient specific prescriptions in order to distribute

False (May receive patient specific prescriptions but do not have to in order to distribute)

A hazardous drug is any drug identified as hazardous or potentially hazardous by the National Institute for Occupational Safety and Health (____________) on the basis of at least one of the following six criteria: a. ____________, b. teratogenicity or developmental toxicity, c. ____________ toxicity in humans d. organ toxicity at ____________ doses in humans or animals, e. ____________, and f. new drugs that ____________ existing hazardous drugs in structure or toxicity.

NIOSH; carcinogenicity; teratogenicity; low; reproductive; genotoxicity; mimic

True or False: Gabapentin is an example of a med that must be reported to PDMP due to its potential for abuse

True (Gabapentin is a drug in flux - not federally scheduled, it is a schedule VI in MA - scooped up into reporting requirements at state level, etc.)

An area where the primary engineering control (PEC) is physically located. Activities that occur in this area include the preparation and staging of components and supplies used when compounding

buffer area

Hazard Communication Standard: right to ____________ and right to ____________

know, understand

a compounded drug is _________________ if its advertising or promotion is false or misleading in any particular.

misbranded

Out of state of MA, *CII NARCOTIC* can be prescribed by _________ who is licensed to practice medicine and registered in __________ or in a state __________ with the Commonwealth wherein such physician resides or practices the filling of prescriptions within the commonwealth, issued within the preceding __________

physician (again like CII non-narcotics out of state, cannot be mid-level practitioner like NP, but must be physician); Maine, contiguous; 5 days

Factors for determining Schedule of Controlled Substances: (1) Its actual or relative _____________ for abuse; (2) Scientific _____________ of its pharmacological effect, if known; (3) The state of current scientific knowledge regarding the drug or other substance; (4) Its history and current _____________ of abuse; (5) The scope, duration, and _____________ of abuse; (6) What, if any, _____________ there is to the public health; (7) Its psychic or _____________ dependence liability; and (8) Whether the substance is an immediate _____________ of a substance already controlled under this subchapter.

potential; evidence; pattern; significance; risks; physiological; precursor

A sterile drug or nutrient compounded in a licensed pharmacy or other healthcare related facility pursuant to the order of a licensed prescriber; the article may or may not contain sterile products.

preparation

Controlled Substances _________________ are used to prevent diversion and keep system controlled

security requirements

*Product Tracing/Transaction Information*: - Includes transaction information, history, and statement - Must be passed, received, and maintained for _________________ years by each trading partner including _________________ - Any method (paper or electronic) of passing the information is permissible until November 2023, at which time only _______________ is permissible. - there are some Important exceptions for pharmacies

six, pharmacies; electronic

Title I Drug Compounding - Compounding Quality Act Sec. 105: requires HHS to receive submissions from _________________ of pharmacy: (1) describing any _________________ actions taken against compounding pharmacies or any recall of a compounded drug, and (2) expressing concerns that a compounding pharmacy may be _________________ the FDCA.

state boards; disciplinary; violating

NIOSH provides some guidance for possible scenarios: a. Gloves, gowns, head, hair, shoe covers required for ____________ and ____________ compounding b. Gloves required for administering ____________ HD c. ____________ required for administering injectable antineoplastic HD

sterile, nonsterile; antineoplastic; gowns

An airflow moving in a single direction in a robust and uniform manner and at sufficient speed to reproducibly sweep particles away from the critical processing or testing area.

unidirectional airflow

If deemed appropriate in the pharmacist's professional judgement, the days' supply dispensed (e.g. 30-day supply with 11 refills vs. 90-day supply with 3 refills) may be changed __________ consultation only for drugs that do not require _______________.

without, PMP reporting

beyond-use-date for *low risk sterile* compounding with *12 hours or less* at room temperature, refrigerated, and frozen

12 hours (room temperature), 12 hour (refrigerated), N/A (frozen)

Controlled substances in schedules I and II are ordered on a DEA form ____________

222

To register with the DEA as a distributor or manufacturer or Narcotic Treatment Program under the Controlled Substance Act, you would complete a form _________

225

beyond-use-date for *high risk sterile* compounding at room temperature, refrigerated, and frozen

24 hours (room temperature), 3 days (refrigerated), 45 days (frozen)

In absence of stability data, the BUD of a water-containing topical/dermal or mucosal liquid or semi-solid formulation (non-sterile compounding) would be _______________

30 days

In Massachusetts, a written prescription for a controlled substance in Schedule II shall become invalid __________ after the date of issuance.

30 days (it is 5 days for out of state MD)

Short-term detoxification = not in excess of ____________ days Long-term = more than 30 days but not in excess of ____________ days

30 days; 180 days

beyond-use-date for *low risk sterile* compounding at room temperature, refrigerated, and frozen

48 hours (room temperature), 14 days (refrigerated), 45 days (frozen)

If pharmacy is located within a state that does NOT sign the MOU, distribution of *compounded* products in interstate commerce is restricted to not more than _________________ of the total prescription orders dispensed / distributed by the pharmacy.

5%

Which part of the USP covers Sterile Compounding?

797

How does the FDA determine compounded product are essentially copies? FDA intends to consider a *compounded drug product to be essentially a copy* of a commercially available drug product if: - the compounded drug product has the same active pharmaceutical ingredient(s) (_________________) as the commercially available drug product - the API(s) have the same, similar, or an easily substitutable dosage _________________; AND - the commercially available drug product can be used by the same _________________ as prescribed for the compounded drug,

API; strength; route of administration

> 10 CFU/ cubic meter of air per plate

ISO Class 7

_________________- Established GMP requirement

Kefauver Harris Amendment of 1962

Three situations the fax may serve as the original for a CII prescription: 1. CII narcotic to be compounded for IV, IM, SC, Intraspinal, parenteral administration 2. CII drug for residents of __________ facilities 3. CII narcotic patients of __________certified by/or paid for by __________

LTC; hospice care program, Medicare

To address the inordinate amounts of compounded products, FDA has established a method to collaborate with the States through a _________________

Memorandum of Understanding (MOU)

Who has authority to oversee Opioid Treatment Programs (OTP)?

Substance Abuse and Mental Health Services Administration (SAMSHA)

True or False: Attorney General must make rules pursuant to the rulemaking procedures on the record and after opportunity for a hearing

True

True or False: CII-V could be locked in substantially constructed cabinet, but it is also okay for it to be dispersed throughout CVI stock if it is in a manner designed to reduce risk of diversion

True

True or False: In Massachusetts, outsourcing facilities MUST register with FDA and MUST be inspected by FDA prior to distributing compounded drugs

True

True or False: Ketamine is an example of an anesthetic that is scheduled as a CS CIII

True

True or False: MA, gabapentin also needs to be reported to Prescription Drug Monitoring Program

True

True or False: No food, drinks, or cardboard boxes are allowed within ISO classified areas (and no Cardboard boxes or particulate producing materials in any areas adjacent to an ISO classified area either)

True

True or False: Safety Data Sheets, documents that provide information on a hazardous chemical and its characteristics, should be readily accessible for every hazardous chemical used

True

Many state laws and regulations follow _________________ standards

USP

These are the general principles of __________ - Aseptic Technique - Compounding Processes and Beyond-Use Dating (BUD) - General Facility Design and Layout or Primary/Secondary Engineering Controls including proper airflow, interlocking requirements, doors, etc. - Personnel Monitoring · Glove Fingertip Sampling · Media Fill Testing - Environmental Monitoring · Non-viable air sampling · Viable air sampling · Surface sampling · Temperature and Humidity Monitoring · Airflows and Pressure Differential Monitoring

USP 797 (Sterile Compounding)

Special DEA # for prescribing buprenorphine under DATA 2000: - "X" DEA Number - A DEA number that is in ____________ to the prescriber's DEA registration number - Pharmacies need ____________ for record keeping requirements under Controlled Substance Act

addition; both

*Individual practitioners* (physician, dentist, veterinarian, etc.) who are agents of or employees of another practitioner, OTHER than a mid-level practitioner (nurse practitioner, nurse midwife, physician assistant) who is registered to dispense controlled substances may, when acting in the normal course of their employment, _____________, or ____________- but not ____________- using the registration of the employer in accordance with state law 21 CFR 1301.22(b).

administer, dispense; prescribe

Manufacturers and Distributors: _______________ renewal of registration with CSA

annual

An ISO Class 8 or better area where personnel hand hygiene and garbing procedures and staging of components is performed

ante-area

____________ must be ISO 7 if proceeding Hazardous Drug Buffer Area ISO 7 ____________ area must be ____________ Pressure if for hazardous Drugs

anteroom; buffer, negative

A location that includes any component or fluid pathway surfaces (e.g. vial septa, injection port, beakers) or opening (e.g. opened ampules, needle hubs) exposed and at risk of direct contact with air (e.g. ambient room or HEPA filtered), moisture (e.g. oral and mucosal secretions) or touch contamination. Risk of microbial particulate contamination of the critical site increase with the size of the opening and exposure time.

critical site

Controlled substance inventory must include: - the ____________ of the inventory, - when inventory was taken (i.e. the beginning or close of business), - the ____________ of each controlled substance inventoried, - the finished ____________ of each of the substances (e.g., 10 milligram tablet), - the number of dosage ____________ of each finished form in the commercial container (e.g., 100 tablet bottle), - the ____________ of commercial ____________ of each finished form (e.g., four 100 tablet bottles), and - a ____________ of the substance

date, name, form, units, number, containers, count

With each change to a controlled substance prescription, the following information *must be documented* in the computerized pharmacy system or on the written prescription: A. the _______________ B. _______________ changed or added C. name of the authorizing _______________, if applicable D. name of the _______________ accepting / making the change

date; item; prescriber; pharmacist

*Maintenance*: The dispensing for a period in ____________ of ____________ days of a narcotic drug or narcotic drugs in the *treatment of an individual for dependence* upon heroin or other morphine-like drug.

excess, 21

The air exiting the HEPA filter in a unidirectional air stream that is essentially particle free

first air

Poison Prevention and Packaging Act (PPPA) 1970: - "special packaging" of _______________ products and _______________ to protect children from serious injury or illness. - _______________ packaging - Manufacturers may market one size of an _______________ product for the elderly or handicapped in noncompliant containers, provided that the package states, "This Package for Households Without Young Children."

household, drugs; child-resistant; OTC

Glove Fingertip Monitoring- _______________ plate per hand - Results should be reported separately per employee per hand (cfu/hand) - Action level is based on both hands - Directly after hand hygiene and garbing process - Must pass before compounding CSPs for human use - Initial Gloving Competency - _______________ cfu, no less than 3 times - Re‐evaluation - Every _______________ for Low/Medium Risk - Every _______________ months for _______________ Risk

one; 0; year, 6, high

A room that is at a higher pressure than the adjacent spaces, and therefore, the net airflow is out of the room.

positive pressure room

Trading partners must have a system to _________________, _________________, and _________________ the FDA and other partners of "suspect" and "illegitimate" prescription drug products.

quarantine, investigate, and notify

*Partial Fill: CIII-V* Partial refills of Schedule III, IV, and V controlled substance prescriptions are permissible under federal regulations provided that: - each partial filling is dispensed and _________ in the same manner as a refilling (i.e., date refilled, amount dispensed, initials of dispensing pharmacist, etc.) - the total quantity dispensed in all partial fillings does not _________ the total quantity prescribed, and - no _________ occurs after _________ past the date of issue

recorded; exceed; dispensing, 6 months

PDMA generally prohibits _______________ of Rx drugs

reimportation

Is this considered simple, moderate, or complex non-sterile compounding? • Making a preparation that has a United States Pharmacopeia (USP) compounding *monograph* or that appears in a *peer-reviewed journal article*; • The source contains specific quantities of all components, compounding procedure and equipment and *stability data for that formulation with appropriate BUDs*; • *Reconstituting* or manipulating commercial products* that may require the addition of one or more ingredients as directed by the manufacturer. NOTE Massachusetts distinctions- MA does not consider reconstitution of non-sterile commercially available product (e.g. Amoxicillin suspension) to be compounding - *in MA, reconstitution is not considered compounding (EX: adding 50 ml to amoxicillin for example)*

simple

Massachusetts practitioners must use __________ prescription pads for all written (i.e. paper) prescriptions, for all drug schedules, including Schedule VI

tamper-resistant

In absence of stability data, the BUD of a non-aqueous formulation (non-sterile compounding) would be _______________

6 months (* Or the earliest expiration date of any of the API or components (if shorter)

Which part of the USP covers Handling of Hazardous Drugs (pending implementation)?

800 (informational only right now, will come out officially later)

An ISO Class 5 Environment

Critical area

All of the following activities require _________________ Manufacturing Distributing Reverse Distributing (even waste streams of controlled substances are heavily controlled by DEA) Dispensing or instructing (includes Practitioner, Hospital/ Clinic, Retail Pharmacy, Central fill pharmacy, Teaching Institution) Research (CI - CV) Narcotic Treatment Program (including compounder) Importing Exporting Chemical Analysis

DEA CS Registration (to keep it a closed process of distribution; all of these activities need to be registered by the DEA)

How do pharmacies recognize qualifying physicians for DATA 2000 buprenorphine prescribing?

DEA number that starts with X

True or False: Hydrocodone is a CIII drug

False (Hydrocodone was CIII but was rescheduled to CII in October 2014)

True or False: If needed, POA can be passed off to someone else when POA was given to you

False (POA can only be given by the registrant - can't pass off the POA to someone else when POA was given to you)

> 1 CFU/ cubic meter of air per plate

ISO class 5

> 100 CFU/ cubic meter of air per plate

ISO class 8 (or worse)

CII Narcotic out-of-state prescribing: what counts as a contiguous state that physician can be from to prescribe? (6 states total)

NH, VT, CT, RI, NY (+ ME)

What schedule of controlled substances? - High abuse potential - No current acceptable medical treatment in U.S. - No acceptable information regarding safety- even under medical supervision

Schedule I

Long acting barbiturates, hypnotics, benzodiazepines, such as zolpidem (*Ambien*) *clonazepam (Klonopin)* triazolam (*Halcion*) *diazepam (Valium)* *alprazolam (Xanax)* *chloral hydrate (Noctec)* phenobarbital (Solfoton) chlordiazepoxide (Librium) elprazolam (Prosom) clorazepate (Tranxene) carisoprodol (*Soma*) eszopiclone (*Lunesta*)

Schedule IV

True or False: federal law does not limit amount prescribed for CII's

True

True or False: CII prescriptions must be written and signed by prescriber

True (but there are exceptions for emergency CII prescription by phone)

A room in which the concentration of airborne particles is controlled to meet a specified airborne particulate cleanliness class. Microorganisms in the environment are monitored so that the microbial level of air, surface and personnel gear are not exceeded for a specified cleanliness class

clean room

What does the FDA consider *insanitary conditions*? - Cleaning and Disinfecting · Improper selection of _________________ agents · Improper _________________ of cleaning agents or supplies (dedicated supplies) · No disinfection of equipment or supplies at each _________________ from areas of lower quality of air Pharmacies don't use ready-to-use formula - do own dilution --> can mix wrong things, mix wrong amounts; cleaning agents are not effective because not done properly and per directions

cleaning; use; transition

CSA created a _______________ system for manufacturing, distributing and dispensing federally controlled substances

closed (So there is no diversion - DEA requires system to remain closed when transferring hands)

Federal law is primary law; however, states can regulate controlled substances under their police powers State Law cannot __________ with federal law State Law can be ____________ than federal law

conflict; stricter

floors, counters, and easily cleanable surfaces should be cleaned at least ____________ for sterile compounding

daily

The dispensing for a period of time of a narcotic drug or narcotic drugs in *decreasing* doses to an individual to alleviate adverse physiological or psychological effects incident to *withdrawal* from continuous or sustained use of a narcotic drug and as a method of bringing the individual to a narcotic-free state within such period of time

detoxification

_____________ - q 3 years renewal of registration of CSA

dispensers

Cleaning of sterile areas is performed from "____________ clean" to "____________" areas and from ____________ to bottom All of the surfaces of the sterile compounding areas must be cleaned regularly and frequently ISO class 5 critical sites need to be cleaned ____________

less, cleanest; top; continually

the production of FDA approved drug products pursuant to current good manufacturing practices (CGMP).

manufacturing

*CIII to CV prescriptions* · CIII-CV prescriptions may be ___________, ___________, written or e-prescribed · Refills are allowed- CIII or CIV- no more than ___________ times within ___________ months · CIII or CIV prescriptions expire ___________ after the date written. · Authorized refills may be transferred from one pharmacy to another ___________ within that 6-month period.

oral, fax; 5, 6; 6 months; once

A beyond-use date (BUD) is assigned by the _______________ for a preparation that they compound. Determined by _______________ of preparation; _______________ of ingredients and _______________ information of the compounded preparation.

pharmacy; type, expiration date, stability

CII inventory must be by an actual ____________ count

physical

Controlled substances have a closed System of Distribution- only _____________ may engage in manufacturing, distribution or dispensing

registrants

Title I Drug Compounding - Compounding Quality Act Sec. 103: prohibits the _________________ of a compounded drug labeled "not for resale," or the intentional _________________ of a prescription for a compounded drug (came from NECC - giving false names to the prescriptions)

resale; falsification

A defective sterile drug preparation log documenting the recalled drug preparation shall be kept by the pharmacy (_______________ year record retention requirement); and _______________ drug preparation shall be kept by the pharmacy.

10; recalled

In absence of stability data, the BUD of a water-containing oral formulation (non-sterile compounding) would be _______________

14 days refrigerated

Schedule V drug cannot contain more than: · ____________ mg of *codeine* per 100mL or 100 g · 100mg of dihydrocodeine, ethylmorphine, or ____________ per 100mL or 100g · 2.5mg of ____________ and not less than 25mcg of atropine per dosage unit · 0.5mg of difenoxin and not less than 25mch of atropine sulfate per dosage unit

200; opium; diphenoxylate

Regarding destruction and disposal of controlled substances: - pharmacy may transfer controlled substances to a DEA registered reverse distributor who handles the disposal of controlled substances. - When a pharmacy transfers schedule II controlled substances to a reverse distributor for destruction, the reverse distributor must issue an official order form (DEA Form _____) or the electronic equivalent to the pharmacy. - When schedules III-V controlled substances are transferred to a reverse distributor for destruction, the pharmacy must maintain a record of distribution that lists the drug name, dosage form, strength, quantity, and date transferred. - The authorized reverse distributor completes and files the DEA Form _____

222; 41

After one year at the 100-patient limit for treating pts with buprenorphine under DATA, qualifying practitioners who meet the "qualifying practicioner" criteria can apply to increase their patient limit to ____________. Qualifying practitioners may also request a temporary increase to treat up to 275 patients to address ____________ situations.

275; emergency

*Combat Methamphetamine Epidemic Act (CMEA) of 2005 and Methamphetamine Act of 2008* OTC sale of products containing ephedrine, pseudoephedrine, PPA now classified as schedule list chemical products. Placed limits on purchase. (because people were stealing or buying lots of these chemical products to create meth) What is the limit on retail sales? *Retail purchases* - no more than ____________ grams/day or 9 grams/____________ What is the limit on mail order? No more than ____________ grams/month (of the 9 gram/month retail limit) can be imported by private or commercial carrier or the Postal Service

3.6; month; 7.5

Title I of DQSA - Compounding Quality Act (reinstated _________________ of FD&C Act) - Prompted by the _________________ (NECC) tragedy- a MA pharmacy compounded and shipped large batches of contaminated sterile injectables across the country- killing 64 and injuring over 700 patients. - Exempts compounded drugs from _________________ requirements, manufacturing _________________ requirements with adequate directions for use, and _________________ requirements if the drug is compounded by or under the direct supervision of a licensed _________________ in a registered outsourcing facility* and meets applicable requirements.

503A exemption; New England Compounding Center; new drug, labeling, track and trace, pharmacist

CSPs are compounded using aseptic technique within an ISO Class ____________ PEC (e.g., LAFW, BSC, CAI, or CACI) that is located within an ISO Class 7 ____________ area with an ISO Class ____________ ante area.

5; buffer; 8

What does the FDA consider *insanitary conditions*? - Equipment and Facilities - Actionable microbial contamination in ISO _________________ area or adjacent - Unsealed _________________ tiles - Ante room and buffer room door open at the _________________ - HEPA filters not sealed around the _________________ to support frame (all relating back to proper DESIGN in guidance, USP, and draft pharmacy regulations in MA) - Construction in an area adjacent to compounding without _________________ controls

5; ceiling; same time; adequate

Under the Combat Methamphetamine Epidemic Act (CMEA) of 2005 and Methamphetamine Act of 2008, sales of more than ____________ PSE must be recorded by the retail establishment. · What must be recorded: - ____________ by name - ____________ sold - ____________ and ____________ of purchaser - ____________ and time of sale - Purchaser's ____________

60 mg; product, quantity, name and address, date, signature

In MA, *schedule II or III* prescriptions shall not be filled for more than a *30-day supply* of such substance upon any single filling, but there are exceptions such as: - EXCEPTION: *dextroamphetamine sulphate (aka Dexedrine Spansule, Zenzedi, ProCentra) and methylphenidate hydrochloride (aka Ritalin, Quillivant XR, etc.)* may be filled for up to a __________ of such substance upon any single filling if for the treatment of minimal __________ or __________; - EXCEPTION: *__________ consisting of Schedule II or Schedule III controlled substances may be filled for a maximum of __________ days. Note: *MUST FOLLOW USP <797> BUD* - if compounded rx is not sterile or stable for 90 days, you can't fill 90 days

60-day-supply, brain dysfunction, narcolepsy; implantable infusion pumps, 90

SAME DRUG, SAME PATIENT - MULTIPLE PRESCRIPTIONS - A practitioner may provide individual patients with multiple prescriptions for the same schedule II controlled substance to be filled sequentially. - The combined effect of these multiple prescriptions is to allow the patient to receive, over time, up to a ___________ supply of that controlled substance. - All RXs must be dated with the ___________________________ (i.e. date written) - Subsequent RXs must contain a "___________________________ date"

90-day; date of issuance; do not dispense before

What is the difference between prescribing CII narcotic vs. non-narcotic when they are both being prescribed out of state?

CII narcotic - needs to be from a physician from Maine or contiguous state (but ALWAY for out-of-state, regardless of CII narcotic or non-narcotic, it can only be prescribed by a physician and becomes invalid after 5 days from date of issuance)

If a loss or theft of any controlled substance occurs, what form do you have to fill out and submit to the Field Division Office in the area?

DEA Form 106

Only schedules I and II controlled substances are ordered with _______________ or the electronic equivalent Controlled Substance Ordering System (_______________)

DEA Form 222, CSOS

For destruction or disposal of controlled substances, what form needs to be filled out?

DEA Form 41

_______________ administers all parts of Controlled Substance Act (CSA)

Drug Enforcement Agency (DEA)

Amended the Food, Drug, and Cosmetic Act with respect to human drug compounding and drug supply chain security.

Drug Quality and Security Act (DQSA) of 2013

True or False: While on duty at Barnes Pharmacy, a local independent pharmacy, you may dispense a prescription brought into the pharmacy by Karyn Taylor for Ritalin written by a NP licensed and practicing in RI

FALSE (it is a CII non-narcotic, but must be written by an MD, not by NP)

True or False: A hospital registered with the DEA may assign a medical resident working in the normal course of business a specific internal code in the form of a prefix to the hospital's DEA number

FALSE (needs to be suffix like AN27512635-*123*)

A hospital registered with the DEA may assign a medical resident working in the normal course of business a specific internal code in the form of a prefix to the hospital's DEA number

FALSE (suffix, not prefix)

True or False: CII controlled substances are limited to 1 refill.

False (Authorization of refills for a CII's is prohibited- a new prescription must be issued.)

True or False: To register with the DEA as a dispenser under the Controlled Substance Act, you would complete a form 225

False (DEA *224* form is used to apply for CS registration for dispensers)

True or False: providers may in the usual course of professional practice prescribe controlled substances to an addict in order to maintain or detoxify the addict

False (Providers may not in the usual course of professional practice prescribe controlled substances to an addict in order to maintain or detoxify the addict)

True or False: mixing two or more manufactured cream products when the stability of the mixture is not known is considered complex non-sterile compounding

False (considered "moderate" non-sterile compounding)

True or False: Making Magic Mouthwash or combining two creams when stability data for that formulation with beyond use date (BUD) is known is considered moderate non-sterile compounding

False (considered "simple" non-sterile compounding)

True or False: In Massachusetts, registrants are required to report the loss of any controlled substances upon discovery to the Drug Control Program within 48 hours of discovery.

False (must report within 24 hours)

True or False: Pharmacies are requirement to submit a copy of their controlled substance inventory to the DEA

False (no requirement to submit a copy of the inventory to DEA whether it is initial inventory or biennial inventory)

True or False: PDMA of 1987 prohibits community pharmacies from reselling drug samples

False (prohibits they from RECEIVING drug samples)

True or False: Medical Surveillance is a required practice in USP 800 for hazardous drugs

False (recommended, not required)

True or False: Controlled Substances in CIV may be stored in pharmacy area or in a clean room adjacent to pharmacy area

False (this would be true of CVI substances; however all Controlled Substances in CII-V must be stored in pharmacy area only)

*For Hazardous Drugs: ____________ must be:* • Tested to American Society for Testing and Materials (____________) standard D6978 (or successor) • ____________-free • Inspected for physical defects before use • Must be changed every ____________ minutes or when torn, punctured, or contaminated

Gloves, ASTM, powder(-free), 30

Examples of Schedule I drugs

Heroin, Marijuana (* State Distinction w/ various States passing Medical Marijuana - as well as recreational marijuana statutes - despite marijuana remaining a CS Schedule I substance federally)

All commercial containers of drugs in schedule _______ must bear a symbol of CS schedule it has been assigned to (i.e. a "C" w/ roman numeral (II-V)

I to V

Occupational Safety and Health Administration (OSHA) OSHA is an agency of the United States Department of ____________ - The ____________ for OSHA is the Assistant Secretary of Labor for Occupational Safety and Health. - OSHA's administrator answers to the ____________ of Labor, who is a member of the cabinet of the President of the United States. - Occupational Safety and Health Act of 1970 - Enacted by Congress in 1970 - To *assure safe and healthful ____________ conditions for working men and women*; by authorizing enforcement of the standards developed under the Act; by assisting and encouraging the States in their efforts to assure safe and healthful working conditions; by providing for research, information, education, and training in the field of occupational safety and health; and for other purposes.

Labor; administrator; Secretary; working

Which Schedule II Controlled Substance is used for both the treatment of severe pain and in the detoxification and maintenance of narcotic addicts in Opioid Treatment Programs (OTPs)? A. Suboxone B. Methadone C. Oxycodone

Methadone

Under the Combat Methamphetamine Epidemic Act (CMEA) of 2005 and Methamphetamine Act of 2008, how do ephedrine, pseudoephedrine, and PPA need to be secured?

Must be kept behind the counter or locked cabinet where customers do not have access (It isn't required to be sold in pharmacies, does NOT need to be sold by prescription - can be OTC)

A. Personal protective equipment (PPE) is equipment worn to minimize exposure to hazards that cause serious workplace injuries and illnesses. Examples of PPE in Handling Hazardous Drugs: - ____________ Mask - ____________ gown (ASTM F739-12 testing) - Face Shield - ____________ Gloves - ____________ (fit-tested for the employee)

N-95; non-permeable; nitrile; respirator

*503 B Exemptions*: FDA registration (voluntary unless required by Resident State (247 CMR 21 for MA) § Describes conditions under which certain human drug products compounded at a facility registered as an outsourcing facility are entitled to exemptions from two (2) provisions of the FD&C Act: - 505: FDA approval prior to marketing (_________________); and - 502(f)(1): adequate _________________ for use labeling requirement

NDA, directions

National Institute of Occupational Safety and Health (____________) - under OSHA, there is NIOSH, which is an organization; subsection of OSHA that deals with alerts related to ____________ drugs 1. NIOSH is part of the Centers for Disease Control and Prevention (____________) within the U.S. Department of Health and Human Services. 2. The National Institute for Occupational Safety and Health is the United States federal agency *responsible for conducting research and making recommendations for the ____________ of ____________ injury and illness.* 3. The *Occupational Safety and Health Act*, signed by President Richard M. Nixon, on December 29, 1970, *created both NIOSH and the Occupational Safety and Health Administration* (OSHA). NIOSH was established to help *ensure safe and healthful working* conditions by providing research, information, education, and training in the field of occupational safety and health. *NIOSH provides national and world leadership to prevent work-related illness, injury, disability, and death by gathering information, conducting scientific research, and translating the knowledge gained into products and services*

NIOSH; hazardous; CDC; prevention, work-related

In an emergency, the prescriber may give an ________ prescription (i.e. telephoned) for a ___________________________ drug if: - the pharmacist makes a reasonable effort to __________ the prescriber; - the amount is __________ to what is necessary to treat the patient during the emergency; - *use professional discretion* - the prescriber must deliver an original prescription to the __________ within __________ days*; - the prescriber writes "Authorization for Emergency Dispensing" on the prescription; - the prescriber __________ how the situation met the criteria for emergency treatment

ORAL, Schedule II; identify, limited; dispensing pharmacist, 7 days; documents

Narcotics, amphetamines, barbiturates, such as: opium morphine (MS Contin) fentanyl (*Fentora*) *methadone* meperidine (Demerol) secobarbital (Seconal) pentobarbital (Nembutal) *amphetamine (Adderall)* hydrocodone *codeine sulfate (but note: combination products w/ Codeine Phosphate CIII and CV)* hydromorphone (*Dilaudid*) Oxycodone (*Percocet*) methylphenidate (*Ritalin*)

Schedule II

What schedule of controlled substances? - High abuse potential - Acceptable medical use (although it may have severe restrictions) - Abuse may lead to severe physical / psychological dependence

Schedule II

Narcotic‐analgesic combinations, Narcotic cough medications, Intermediate acting barbiturates, Anabolic steroids, such as butalbital (*Fiorinal* ) *ketamine* (Ketalar) *dronabinol* (Marinol) testosterone (*Androgel 1%*) *Tylenol #4, Tylenol #3* *buprenorphine* (Suboxone)

Schedule III

What schedule of controlled substances? - Potential of abuse less than CI and CII controlled substances - Currently acceptable medical treatment in the U.S. - Abuse may lead to moderate or low physical dependence or high psychological dependence

Schedule III

What schedule of controlled substances? - Low potential of abuse relative to CIII controlled substances - Current acceptable medical treatment in the U.S. - Abuse may lead to limited physical dependence or high psychological dependence relative to CIII controlled substances

Schedule IV

Cough syrups w/codeine, antispasmodics, neurologics, such as: diphenoxylate/atropine (Lomotil) guafenisin and codeine (Robitussin AC) pregabalin (Lyrica) promethazine HCl and codeine phosphate (Phenergan w/codeine)

Schedule V

What schedule of controlled substances? - Little abuse potential - Current acceptable medical treatment in the U.S. - Abuse may lead to limited physical dependence or high psychological dependence relative to CIV controlled substances

Schedule V

_______________: MA has created a controlled substance schedule for prescription drugs that not otherwise scheduled as CI - CV (all other prescription drugs that aren't federally scheduled)

Schedule VI

*The Attorney General must shall apply the provisions of this subchapter to the controlled substances listed in the schedules established by 21 USC § 812 and must: - include recommendations regarding scientific and medical matters from _______ of Health and Human Services (HHS) - can make a decision about controlled substance w/o HHS approval when done to avoid an "______________ to public safety"

Secretary; imminent hazard

• Title I of DQSA: Drug Compounding - Compounding Quality Act • Title II of DQSA: Drug _________________ Security Act (DSCSA)

Supply Chain

True or False: in non-sterile compounding, only authorized personnel are allowed in the immediate vicinity of the drug compounding operations.

True

True or False: By federal law, making Morphine Sulfate Suppositories or diphenhydramine hydrochloride troches is considered "moderate non-sterile compounding," but according to Massachusetts draft regulations, it would be considered "complex"

True (MA state distinction- making suppositories and troches would be considered COMPLEX compounding according to draft regulations but federally would be "moderate")

True or False: The FDA's prohibition of copying a commercially available drug extends to essential copies, not just exact copies (aka compounding copies of an approved drugs that are prepared by manufacturers is illegal except for certain circumstances, like if it's out of stock)

True (because compounded solutions are exempted from cGMP, it is obviously safer to get something from manufacturer that must follow cGMP)

A mode of processing pharmaceutical and medical products that involves the separate sterilization of the product and of the package and the transfer of the product into the container and its closure under at least ISO Class 5 conditions.

aseptic process

ISO 5 area needs to be cleaned at the ____________ of the work shift, prior to ____________, ____________ compounded preparations, every ____________ minutes, and after spills or suspected contamination of ISO class 5 critical area

beginning, compounding, between, 30

The date or time after which a CSP shall not be used, stored, or transported. The date is determined from the date of time the preparation is compounded.

beyond-use-date

The date or time after which a CSP shall not be used, stored, or transported. The date is determined form the date of time the preparation is compounded.

beyond-use-date (BUD)

a ventilated cabinet for CSPs, personnel, product and environmental protection having an open front with inward airflow for personnel protection, downward high efficiency particulate air HEPA filtered laminar airflow for product protection and HEPA-filtered exhausted air for environmental protection

biological safety cabinet

Drug Addiction Treatment Act (DATA) 2000 To receive a waiver to practice opioid dependency treatment with approved ____________ medications, a practitioner must notify the SAMHSA Center for Substance Abuse Treatment (CSAT) of their intent to practice this form of medication-assisted treatment (____________). The notification of intent must be submitted to CSAT before the initial ____________ or ____________ of opioid treatment. Qualifying practitioners can treat up to ____________ patients using buprenorphine for the treatment of opioid use disorder (OUD) in the first year if they possess a waiver under 21 U.S.C. 823 (i.e., a DATA 2000 waiver) and meet certain requirements.

buprenorphine, MAT; dispensing or prescribing; 100

Moderate non-sterile compounding: making a preparation that requires special _______________ or _______________ (such as calibration of dosage unit mold cavities) or per individualized dosage units;* or making a preparation for which _______________ for that specific formulation are not available. *Massachusetts state distinction (considered complex in MA current DRAFT regs): making suppositories and troches are considered COMPLEX compounding

calculations, procedures; stability data

Pharmacist Guidelines and Responsibilities under the PPPA: - The pharmacist is responsible to ensure packaging of required drugs is in _______________ containers - _______________ patients are not required to receive child-resistant containers (i.e. this is for *home-use only*) - _______________ may provide a "blanket" waiver for child-resistant packaging - Pharmacists should obtain patient waiver for child-resistant packaging in writing from the patient or their agent (but not required to) - _______________ may not provide a "blanket" waiver for child-resistant packaging for a patient (i.e. each prescription must direct the use of noncomplying packaging)

child-resistant; institutionalized; patients; provider

_______________ non-sterile compounding: Making a preparation that requires special training, environment, facilities, equipment, and procedures to ensure appropriate therapeutic outcomes.

complex

Media Fill Testing - should be utilizing media fill that mimics is as _______________ as the most challenging thing that you would have to compound (ex: if TPN is something you compound, you have to do a lot of manipulations, rather than just 1) - "A test used to qualify aseptic technique of compounding personnel or processes and to ensure that the processes used are able to produce _______________ product without microbial contamination." - Media‐Fills shall be done on all compounding personnel upon _______________ hire and _______________ for low‐ and medium‐risk, _______________ for high‐risk compounding, thereafter.

complex; sterile, initial; annually, semiannually

Activities Requiring Hazardous PPE • Appropriate PPE worn during: a. Receipt b. Storage c. Transport d. ____________ (sterile and nonsterile) e. Administration f. Deactivation/Decontamination, Cleaning, Disinfecting g. Spill Control

compounding

_________________ is performed by/under the supervision of a licensed pharmacist pursuant to United States Pharmacopeia (USP)

compounding

production of a drug preparation that meets the unique needs of an individual patient when a commercially available drug does not meet those needs

compounding

The responsibility for the proper prescribing and dispensing of ____________ substances is upon the prescribing practitioner, but a ____________ rests with the pharmacist who fills the prescription. A prescription must be issued for a legitimate medical purpose by a practitioner acting within the usual course of professional practice (i.e. provider- patient relationship w/i scope of practice). Legitimate medical purpose- determined by professional judgement based on acceptable treatment in the U.S.

controlled; corresponding responsibility

What does the FDA consider *insanitary conditions*?: Staff Related- Aseptic Practices - Handling beta-lactam, hazardous drugs or hormones without providing _________________ to prevent contamination of the production area (this is considered cross-contamination) - Improper _________________ - Failing to properly disinfect _________________ (must sanitize gloves properly) - Exposed _________________ during compounding (cuff all the way down, tucked into glove) - Moving too _________________ while performing aseptic manipulations - _________________ first pass air (proper air flow through HEPA filtered air; if block, will have insanitary conditions)

controls; gowning; gloves; skin; quickly; blocking

Cancellation and Voiding of Electronic Orders- a supplier may void all (or part) of an electronic order by notifying the purchaser of the voiding. - If the entire order is voided, the supplier must make an electronic _______________ of the order and indicate "Void" on the copy and return it to the _______________. - The supplier is not required to retain a record of orders that are not filled. - The _______________ must retain an electronic copy of the voided order. - Should a supplier partially void an order, the supplier must indicate in the linked record that nothing was _______________ for each item voided.

copy, purchase; purchaser; shipped

Closed System of Distribution- only registrants may engage in manufacturing, distribution or dispensing • Manufacturers and Distributors: annual renewal of registration - each individual pharmacist doesn't have to have their own DEA • Dispensers- q 3 years renewal of registration *Exemptions to Registration:* - Agent or employee of a registered manufacturer, distributor, dispenser acting in the normal _________ of business or employment - Common _________, contract carrier or warehouseman acting in the normal course of business or employment - An ultimate user who possess the _________ for lawful purpose

course; carrier; CS

*Schedule II - V* prescriptions: The following may be changed or added, *after consultation with the prescriber*, unless otherwise noted: a. ________ (date written) *IF IT WAS OMITTED (if it was already there, the date of issuance cannot be changed)* b. prescriber's ________ c. ___________ address i. may be added if omitted without consultation ii. may only be changed after consultation with the prescriber or authorized agent d. _____________ for use e. dosage _________ f. drug ____________ g. ____________ prescribed h. _______________ physician's name of mid-level prescriber i. ____________ information (*Schedule III to V only*) j. The following may be added and the prescriber's office should be notified if the following language is omitted: a. "____________" language and b. "partial fill upon patient request" language (partial fill language is only for Schedule II)

date of issue; address; patient's (only need consultation if you are CHANGING the address, if it was omitted, you can just add it); directions; form; strength; quantity; supervising; refill; no substitution

Things to consider when determining BUD for Non-Sterile Compounded Preparations: - Nature of drug - Dosage form - _______________ mechanism - Components* and components expiration dates** - Potential for microbial proliferation - Container in which packaged - Expected _______________ conditions * Compounded Non-Sterile Preparations containing drugs or chemicals known to be liable to decomposition will require _______________ BUDs. ** the earliest expiration date of any drug, active pharmaceutical ingredient, or component whichever is _______________

degradation; storage; shorter; earliest

Electronic equivalent to DEA Form 222 CSOS order may not be filled if any of the following occurs: 1. The required data fields have not been completed. 2. The order is not signed using a _______________ issued by DEA. 3. The digital certificate used has _______________ or been revoked prior to signature. 4. The purchaser's _______________ will not validate the digital certificate. 5. The validation of the order shows that the order is _______________ for any reason. If the order meets any of the above it is an unaccepted and defective electronic order

digital certificate; expired; public key; invalid

A critical area within the ISO Class 5 primary engineering control (PEC) where critical sites are exposed to unidirectional HEPA‐filtered air, also known as "first air"

direct compounding area (DCA)

Garbing occurs in the ante area and should be sequenced from "_______________" to "_______________": ▪ Don shoe covers, hair and beard covers, and a mask* ▪ Perform hand hygiene ▪ Don gown, fastened securely at the neck and wrists ▪ Sanitize hands using an alcohol‐based hand rub (ABHR) ▪ Enter the buffer area ▪ Don sterile powder‐free gloves ▪ Sanitize the gloves with application of 70% sterile IPA and allow gloves to dry * Some SOPs require donning of shoe covers after hair and face covers so personnel do not touch their faces after touching dirty shoes

dirtiest to cleaning

An agent that frees from infection, usually a chemical agent but sometimes a physical one, and that destroys disease‐causing pathogens or other harmful microorganisms but may not kill bacterial and fungal spores. It refers to substances applies to inanimate objects.

disinfectant

Valid DEA # Consists of 2 letters followed by 7 digits - valid DEA= authorized to ____________ and/or ____________ - the first letter is a code identifying the type of ____________ (i.e. dispenser, distributor, practitioner) A - Deprecated (used by some older entities); B - Hospital/Clinic; C - Practitioner; D - Teaching Institution; E - Manufacturer; F - Distributor G - Researcher; H - Analytical Lab; J - Importer; K - Exporter; L - Reverse Distributor; M - Mid Level Practitioner; N - Military Practitioner; P - Narcotic Treatment Program; T - Narcotic Treatment Program; R - Narcotic Treatment Program S - Narcotic Treatment Program; U - Narcotic Treatment Program; X - Suboxone/Subutex Prescribing Program - the second letter is generally the first letter of the registrant's____________ or ____________ name

dispense, prescribe; registrant; last name, business

A DEA 222 is required for each _______________, _______________, or _______________ of a _______________ controlled substance

distribution, purchase, transfer; Schedule II

Red Flags for Controlled Substances to watch out for as a pharmacist: 1. Prescriptions for "cocktailed" medications 2. Requests for ____________ refills 3. A large portion of prescriptions for controlled substances by ____________ particular prescriber 4. Doctors located 100 ____________ away from pharmacy 5. *Other pharmacists aren't filling prescriptions from the particular prescriber* - all of that prescriber's prescriptions are getting sent to you and they are only for opioids 6. Patients travel in ____________ to the pharmacy 7. Requests to pay ____________ for prescriptions of the opioid :O 8. Patient presents multiple prescriptions for controlled substances from multiple ____________ ("doctor shopping")

early; one; miles; groups; cash; doctors

CIII-CV inventory may be an ____________ count or measure of the contents unless the container holds more than ____________ tablets or capsules in which case an ____________ count is required

estimated; 1,000; exact

_______________ is identified by the product manufacturer. It is placed on the vial and in the package insert and is dependent on the temperature and the appropriate storage of the unopened container.

expiration date

To check the validity of a DEA #: Step 1: add the ____________, ____________, and ____________ digits of the DEA number Step 2: add the second, fourth, and sixth digits of the DEA number and multiply by ____________ Step 3: add the result of Step 1 to the result of Step 2 - the last digit must be the ____________ as the last digit of the DEA number. Example: DEA number AB7258367 Step 1: 7 + 5 + 3 = 15 Step 2: 2 + 8 + 6 = 16 x 2 = 32 Step 3: 15 + 32 = 47

first, third, and fifth; 2; same

*Partial refills of Schedule II* controlled substance prescriptions are permissible under federal regulations however the remaining quantity is void* Exceptions include: - Unable to fill ___________________________ (i.e. out-of-stock) amount so long as remainder can be filled within ___________ hours; - ___________ (i.e. hospice patient); or § Long Term Care Facility (*partial fills* up to ___________ from date of issuance)

full amount, 72 hours; terminally ill; 60 days

*Emergency controlled substance prescribing* is defined by the Secretary of Health and Human Services as situations in which the prescribing practitioner determines that: (1) ___________________________ of a controlled substance is necessary, for proper treatment of the intended ultimate user; (2) that no appropriate ___________________________ is available, including administration of a drug which is not a controlled substance under Schedule II of the Act; and (3) it is not reasonably possible for the prescribing practitioner to provide a ___________________________ to be presented to the person dispensing the substance, prior to dispensing"

immediate administration; alternative treatment; written prescription

the exemptions of 503A do not extend to the provisions of §501(a)(2)(A) _________________

insanitary conditions

In Massachusetts, what additional information is required to be on the controlled substance prescription? Massachusetts- '________________ is mandated unless the practitioner indicates '________________' in accordance with the law''.

interchange; no substitution

CSA requires registrant to maintain inventory, a complete and accurate list of all stocks and forms of controlled substances in the possession of the registrant CSA requires that all ____________ records be maintained at the registered location in a readily retrievable manner for at least ____________ years Inventory records of ____________ must be kept ____________ from all other controlled substances

inventory, two; CII's, separate

*Massachusetts Distinctions: Opioid Schedule II Partial Fill* In Massachusetts, a pharmacist filling a prescription for a schedule II substance shall if requested by the patient dispense the prescribed substance in a ___________________________ than indicated on the prescription The remaining portion may be filled upon patient request in accordance with federal law; provided, however, that only the ___________________________ that originally dispensed the lesser quantity shall dispense the remaining portion. Upon an initial partial dispensing of a prescription or a subsequent dispensing of a remaining portion, the pharmacist or the pharmacist's designee shall make a ___________ in the patient's ___________ maintained by the pharmacy, which shall be accessible to the prescribing practitioner by request, indicating that the prescription was partially filled and the quantity dispensed. The ___________ partial dispensing of a prescription filled pursuant to subsection (d) or (d 1/2) shall be filled not more than ___________ after the prescription issue date. The ___________ portion filled pursuant to this subsection must be filled not later than ___________ after the prescription issue date.

less quantity; same pharmacy; notation, record; initial, 5 days; remaining, 30 days

If requested by the patient, a pharmacist may dispense a _________ quantity than indicated on any _________ prescription. The remaining portion of the partially filled Schedule II prescription may be filled within _________ of the prescription issue date, in accordance with state and federal law. - Only the pharmacy dispensing the original quantity may dispense the remaining portion. - As a reminder, for Schedule II prescriptions issued by prescribers who are licensed in _________ state and do not hold a Massachusetts Controlled Substance Registration, provided they meet the requirements of M.G.L. c. 94C, § 18(d) or § 18(d½), the initial partial dispensing shall be filled within _________ of the prescription issue date, and the remaining portion may be filled within _________ of the prescription issue date.

lesser, Schedule II; 30 days; another, 5 days, 30 days

A visible line on the floor that separates the room into areas for different purposes. For example, in the ante‐area, the line separates the cleaner area from the less clean area of the room.

line of demarcation

For *ALL schedules* (Schedule II - VI) the following prescription information may *NEVER be changed or added* For any of these changes, a new prescription is required A. patient's ________ (i.e. change to different patient), even if it's the wrong maiden name B. controlled ________ prescribed (except generic substitution) C. ________ name D. prescriber's ________ E. earliest ________ to be filled (Schedule II only)

name (even if it's the wrong maiden name); substance; prescriber's; signature; date

I. Ordering Controlled Substances: *Schedules III-V* Receipt (invoice or packing slip) must contain: - the _______________ of each controlled substance; - the finished form; - the number of dosage units of _________ form in each commercial container; and - the number of commercial containers ordered and received. The registrant must keep record on the receipt: - the _______ received - confirm _____________ of the order Receipts must be maintained in a readily _______________ manner for inspection by the DEA.

name; finished; date; accuracy; retrievable

*High* Level Sterile Compounding: _______________ ingredients/components sterilized to produce a _______________ product trying to attain sterility - Prepared from non‐sterile ingredients, including: • Non‐Sterile Active Pharmaceutical Ingredients (API) or • Products not intended for sterile routes of administration - CSPs in this category must be terminally sterilized before administration to patients and are subject to _______________ - _______________ procedures for high‐risk level CSPs, such as weighing and mixing, shall be completed in no worse than an ISO Class _______________ environment. - Examples: customized medications for health care providers; medications in short supply; designer/specialty medications

non-steril, sterile; sterility testing; pre-sterilization, 8

A registrant* may authorize one or more individuals, whether or not located at his or her registered location, to issue __________ for Schedule ____________ controlled substances on the registrant's behalf by executing a *power of attorney* for each such individual

orders; Schedule I and II

_________________ are not exempt from Current Good Manufacturing Practice (CGMP) requirements and will be inspected by FDA according to a risk-based schedule - 503A is exempted from cGMP, but 503B is not! but 503B still has the same other two exemptions

outsourcing facilities

In power of attorney, "registrant" can refer to an individual ___________; a partner of the registrant, if a partnership; or an ______________ of the registrant, if a _____________, corporate division, association, trust or other entity

owner, officer, corporation

*Drug Supply Chain Security Act of 2013 Title II DQSA* - Drug Supply Chain Security (DSCA) - goal is to prevent counterfeits from coming into supply chain - Applies to transactions where prescription drugs change _________________ with some important exceptions (transaction information, history, and statement) - Establishes uniform national _________________ standards for wholesalers and 3PL providers - Establishes requirements to facilitate the _________________ of prescription drug products through the pharmaceutical supply distribution chain (i.e. a track and trace system) - Establishes requirements for drug manufacturers, wholesalers, dispensers, and re-packagers to ensure that all prior _________________ information is provided at each transfer of ownership. - Requires trading partners (manufacturer, wholesale distributor, dispenser, and repackager) in the event of a recall or for the purpose of _________________ a suspect product or an illegitimate product, to provide within a reasonable time, the applicable transaction documentation upon request by the Secretary or other appropriate federal or state official. ( if see something up, you need to investigate it, rather than keep passing it up - all about safety for patient!) - Any method (paper or electronic) of passing the information is permissible until November 2023, at which time only electronic is permissible (A full system _________________ track and trace system must be in place by November 2023).

ownership; licensing; tracing; transaction; investigating; electronic

*Methadone* - CII analgesic used for the treatment of severe ____________ or ____________ and ____________ of narcotic addicts in Opioid Treatment Program (OTP) - Manufacturers voluntarily restricted 40mg tablets to OTPs only and the product is not FDA-approved for the management of pain - Methadone may not be prescribed or dispensed for maintenance or detoxification of addicts in the regular course of medical practice - *retail pharmacies can't dispense a drug for maintenance or detox of addicts* - *Pharmacy dispensing permitted for ____________ indication ONLY*

pain, detoxification, maintenance; analgesic

(processes in place that ensure compounder isn't skirting the system and full and valid pedigree, not counterfeit drugs) The compounded drug product qualifies for the *503A exemption* if the drug product is compounded: - For an identified _________________ (*no office use compounding*) - Based on receipt of a valid _________________ or in *_________________ quantities* _________________ receipt of a valid prescription based on a history of receiving prescriptions (i.e. *Anticipatory Compounding*) - aka *if you anticipate you are going to have to make 50 drugs, then you can make them in advance but you have to have data to support that and have to have prescription before dispensed* - By a licensed pharmacist* in a state licensed pharmacy - In compliance with USP, using drugs with USP monographs or components of FDA approved drugs - Using bulk drug substances that are: • manufactured by _________________ facilities, and • accompanied by a _________________ (COA) - Following the interstate _________________ rules of the Memorandum of Understanding (MOU) between the _________________ and the _________________ where the pharmacy is located

patient; prescription, limited, before; FDA registered; Certificate of Analysis; shipment, FDA and state

All prescriptions for *controlled* substances shall be *dated as of*, and signed on, *the day when issued* and shall bear the: full name and address of the _________________ drug name, _________, and _________ form _________ prescribed _________ for use name, address, and _________ of the practicioner Any prescription issued by a practitioner for an opioid substance contained in Schedule II of section 3 shall include a notation on the prescription that the patient may fill, upon request, the prescription in compliance with subsection (d3/4) of section 18 in an amount not to exceed the recommended full quantity indicated.

patient; strength, dosage; quantity; directions; registration number

*For Hazardous Drugs: Disposable Gowns must be/have*: - Must be shown to be resist ____________ - Made of ____________ or other laminate materials - Close in the back - Long sleeved w/ ____________ cuffs (elastic or knit) - No seams or closures that could allow ____________ to pass through - Changed per manufacturer information for permeation (If no manufacturer information, change every ____________ hours; Change immediately ____________ spill or splash) - Cannot be worn in ____________ areas

permeability; polypropylene; closed; HDs; 2-3, after; other

In Massachusetts, a pharmacist shall keep a ____________ inventory of each controlled substance in Schedules ____________ which the pharmacist has received, dispensed or disposed of in accordance with the law. This inventory must be reconciled at least once every ____________ days

perpetual, II, 10

Out of state of MA, *CII NON-NARCOTICS* can be prescribed only by a ______________ who is licensed to practice medicine and registered in another state where he resides or practices the filling of prescriptions within the commonwealth, issued within the preceding __________

physician (not mid-level practitioner like NP, but it can be physician from anywhere); 5 days

Individual practitioner- ____________, ____________, ____________ or other individual licensed or registered to dispense controlled substances in the jurisdiction in which s/he practices, but the term does NOT include ____________, pharmacy, or institutional practitioner.

physician, dentist, veterinarian; pharmacist

Legal - allowing someone else to act on your behalf (similar to health proxies, etc.) Can issue POA to other individual(s) - don't have to be physically there Can issue 222 or the validated CSOS on the registrant's behalf

power of authroity

*Institutional practitioner*- when acting in the normal course of business or their employment, administer, dispense AND _______________ controlled substances under the registration of the hospital or institution, provided that all of the following conditions are met: · administer, dispense and prescribe controlled substances is done in the usual course of professional practice · the individual practitioner is authorized or permitted to do so by the _______________ in which he is practicing · the hospital or other institution by whom he is employed has _______________ that the individual practitioner is so permitted to dispense, administer, or prescribe drugs within the jurisdiction · such individual practitioner is acting only within the scope of her employment in the hospital or institution · the hospital or institution authorizes the intern, resident, or foreign-trained physician to dispense or prescribe under the hospital registration and designate a specific _______________ number for each intern, resident, or foreign-trained physician so authorize. The code number shall consist of numbers, letters, or a combination thereof and shall be a _______________ to the institution's _______________ registration number, preceded by a hyphen. · A current list of internal codes and the corresponding individual practitioners is kept by the hospital or institution and is made available at all times to other registrants and law enforcement agencies upon request for the purpose of verifying the authority of the prescribing individual practitioner

prescribe; jurisdiction; verified; internal code, suffix, DEA

What can be added to a controlled substance prescription without consultation of the prescriber? (4 things)

prescriber's DEA number, date of issuance (if was omitted; if it was there, you canNOT change it), patient's address (if omitted; if it was there, you can change it WITH CONSULTATION with prescriber/authorized agent); no substitution or partial fill language (but prescriber's office should be notified)

FD&C Act: *503 A Exemption- State Licensed Pharmacy* (patient-specific compounding) Licensed Pharmacy compounding patient specific in accordance with a valid prescription Describes conditions under which certain compounded human drug products are entitled to exemptions from three (3) provisions of the FD&C Act: The 503A exemption says they are exempt from: 1. Needing FDA approval _________________ to marketing (_________________) 2. _________________ requirements - don't have to meet cGMP standards 3. adequate _________________ for use labeling requirement

prior, NDA; cGMP; directions

What does the FDA consider insanitary conditions? - Vermin in _________________ area or adjacent area (must keep things clean) - _________________ microbial contamination (bacterial, mold) - _________________ contamination (rust, dust, hairs, broken glass) in production area (even things that you cannot see - test CFU)

production; visible; non-microbial

DATA 2000 ____________ practitioners include physicians, Nurse Practitioners (NPs), Physician Assistants (PAs), Clinical Nurse Specialists (CNSs), Certified Registered Nurse Anesthetist (CRNAs), and Certified Nurse-Midwifes (CNMs). Qualifying practitioners must satisfy one of the following two conditions to treat 100 patients in their first year: 1) The physician holds a ____________ certification in addiction medicine or addiction psychiatry by the American Board of Preventive Medicine or the American Board of Psychiatry and Neurology 2) The practitioner provides medication-assisted treatment (____________) in a "qualified practice setting." A qualified practice setting is a practice setting that: • provides professional coverage for patient medical emergencies during hours when the practitioner's practice is closed; • provides access to case-management services for patients including referral and follow-up services for programs that provide, or financially support, the provision of services such as medical, behavioral, social, housing, employment, educational, or other related services; • uses health information technology systems such as ____________; • is registered for their State prescription drug monitoring program (____________) where operational and in accordance with Federal and State law; and • accepts ____________ payment for costs in providing health services, including written billing, credit, and collection policies and procedures, or federal health benefits.

qualified; board; MAT; EMRs; PDMP; third-party

Some factors used in evaluating *effective security controls and procedures*: - the type of activity conducted (e.g., processing of bulk chemicals, preparing dosage forms, packaging, labeling, cooperative buying, etc.) - the type and form of controlled substances handled - the _________________ of controlled substance handled - _________________ of the premises - type of building (and general characteristics) - the type of closures on vaults, safes, and secure enclosures - Adequacy of _________________ system (avoid robberies!! Safe should be _________________ to the floor) - Adequacy of _________________

quantity; location; lock control, bolted; alarms

When determining whether a loss is significant, a registrant should consider, among others, the following factors: - The actual _____________ of controlled substances lost in relation to the type of business; - The specific controlled _____________ lost; - Whether the loss of the controlled substances can be associated with access to those controlled substances by specific _____________, or whether the loss can be attributed to unique _____________ that may take place involving the controlled substances; - A _____________ of losses over a specific time period, whether the losses appear to be random, and the results of efforts taken to resolve the losses; and, if known, - Whether the specific controlled substances are likely candidates for _____________; - Local _____________ and other indicators of the diversion potential of the missing controlled substance.

quantity; substances; individuals, activities; pattern; diversion; trends

Types of Controlled Substance Inventories: *Initial Inventory* - taken when issued a DEA ____________, - an actual ____________ count of all controlled substances in registrant's possession - if there are no stocks of controlled substances on hand, the registrant should make a record showing a ____________ inventory. - no requirement to submit a copy of the inventory to the DEA - must be kept on ____________

registration, physical, zero, file

*Medical Surveillance* *Workers who are potentially exposed to chemical hazards should be monitored in a systematic program of medical surveillance intended to prevent occupational injury and disease.* - The purpose of surveillance is to identify the earliest ____________ biologic effects so that exposure can be reduced or eliminated before the employee sustains irreversible damage. - The occurrence of exposure-related disease or other adverse health effects should prompt immediate ____________ of primary ____________ measures (e.g., engineering controls, personal protective equipment). In this manner, medical surveillance acts as a check on the appropriateness of controls already in use. - For detection and control of work-related health effects, job-specific ____________ should be performed, as follows: • before job placement; • periodically during employment; • following acute exposures; and • at the time of job termination or transfer (exit examination). • This information should be collected and analyzed in a systematic fashion to allow ____________ detection of disease patterns in individual workers and groups of workers.

reversible; re-evaluation, preventative; medical evaluations; early

*Prescription Drug Marketing Act (PDMA) of 1987* - Requires state licensing of wholesalers - Bans reimportation of Rx drugs except by manufacturer - Bans sale, trade, or purchase of Rx drug _________________ - Mandates requirements for Rx drug samples • Establishes restrictions to limit misbranding and adulteration situations • Defined as a unit of drug not intended to be sold and intended to promote the sale of the drug • Establishes requirements for _________________ to prescribers • Prohibits community pharmacies from _________________ samples - Prohibits _________________ of Rx drugs purchased by _________________ or _________________ facilities - The FDA granted authority to require secondary wholesalers to maintain pedigrees of drugs. - The 1999 regulation to implement was enjoined on the grounds it would likely cause irreparable harm to secondary wholesalers and violate the equal protection clause. - The FDA Amendments Act (FDAAA) in 2007 mandated that the FDA develop track and trace standards and Standard Numerical Identification (SNI)s, but fell short of developing a true federal pedigree program until the DSCSA of 2013.

samples; distribution, receiving; resale, hospitals, healthcare

Schedule II shall not be refilled and shall be kept in a __________ The pharmacist filling a prescription for Schedule II shall endorse his own __________ on the face thereof.

separate file; signature

The prescriber must determine that the *change made for an identified individual patient produces a _________________ from the commercial product* (to show it is not a copy of a manufactured product) The prescriber's determination must be documented on the _________________. Examples include (but are not limited to): - No dye "X", patient allergy - 6mg dose, patient requires higher dose (only commercially available as 5mg) - patient needs a strength not made by manufacturer - Liquid, Patient cannot swallow tablets (not commercially available as liquid) - formulations Note: the benefit described by the physician must be met by compounding the product

significant difference; prescription

Pharmacies that qualify for the 503A exemptions are primarily regulated and licensed by the _________________, although some Federal requirements still apply

state

These medications do not need to be in child-proof containers (exemptions to PPPA) - _______________ dosage forms of nitroglycerin. - Sublingual and chewable forms of isosorbide _______________ in dosage strengths of _______________ or less. - Oral contraceptives (one or more progestogen or estrogen) in manufacturers' _______________ (memory-aid) dispenser packages - _______________ in tablet form in packages containing not more than _______________ mg - Anhydrous cholestyramine in _______________ form. - All _______________ forms of potassium supplements, including individually-wrapped effervescent tablets, unit dose vials of liquid potassium, and powdered potassium in unit-dose packets, containing not more than _______________ milliequivalents of potassium per unit dose. - Pancrelipase preparations in tablet, capsule, or powder form. - Colestipol in _______________ form in packages containing not more than _______________ of the drug. - Prednisone in tablet form, when dispensed in packages containing no more than _______________. - Methylprednisolone in tablet form in packages containing not more than _______________

sublingual; dinitrate, 10 mg; mneumonic; mebendazole, 600 mg; powder; unit dose, 50; powder, 5 g; 105 mg; 84 mg

Lost or Stolen Order DEA 222 Forms: - Verify with supplier that DEA Form 222 was not received by _______________; - notify DEA in writing with _______________ of the lost or stolen form, date, and statement that CS were never _______________; and - File the statement with copy _______________ of the lost or stolen form

supplier, serial #, received; 3

*Low* Level Sterile Compounding ‐ Simple admixtures involving transfer, measuring, and mixing of _______________ or _______________ commercially manufactured sterile products (including the infusion solution) using aseptic technique in a sterile environment. ▪ Each container, including the final container, may not be entered more than _______________ to prepare the CSP. ▪ Compounding consists of preparation for an _______________ patient (i.e. one CSPs at a time) - make one item at a time ▪ Examples: ▪ IV drug dosages that need to be manipulated (e.g., vial‐to syringe transfer, or transfer to diluent bag; or ▪ Reconstitution and transfer into syringe or diluent bag

three or fewer; twice; individual

*Medium* Level Sterile Compounding ‐ Combining more than _______________ commercially available sterile products in a sterile - it's either batch or anticipatory compounding environment using aseptic technique to produce the compound. - Medium Risk encompasses preparations requiring more complex compounding processes (e.g. _______________) - Examples: ▪ _______________: Many to one (e.g. TPNs, IV pain medication combinations) ▪ _______________: One to Many (e.g. anticipatory compounding a batch of Vancomycin 1gm / 250mL NS) - making 30 different bags!

three; TPN; batch, anticipatory

Examples of "complex" non-sterile compounding _______________ dosage forms, _______________-_______________ preparations, and some inserts and suppositories for systemic effects * Massachusetts distinction: considers all suppositories to be complex based on the way they are prepared

transdermal; modified-release

Types of Controlled Substance Inventories: *Biennial Inventory* - the registrant is required to take a controlled substance inventory every ____________ years (biennial) - same required information as the initial inventory - may be taken on ____________ date which is within two years of the previous inventory date - no requirement to submit a copy of the inventory to DEA - must be kept on ____________ - again must be in retrievable format

two; any; file

*Federal requirements for writing Medicaid prescriptions on tamper-resistant pads* require three characteristics: 1. one or more industry-recognized features designed to prevent __________ of a completed or blank prescription form; 2. one or more industry-recognized features designed to prevent the __________ or __________ of information written on the prescription pad by the prescriber; 3. one or more industry recognized features designed to prevent the use of ___________________________ prescription forms.

unauthorized copying; erasure or modification; counterfeit

Title I Drug Compounding - Compounding Quality Act Section 2 establishes _________________ registration for any outsourcing facility* and requires a registered facility to: - report _________________ to HHS the drugs compounded in the facility; - submit _________________ reports; and - be _________________ (a risk-based inspection schedule) *Note state distinction in Massachusetts; in MA, registration of outsourcing facility is not VOLUNTARY, it is REQUIRED and an FDA inspection is also required!!!*

voluntary; biannually; adverse events; inspected

____________, ____________, and ____________ need to be cleaned at least monthly for sterile compounding

walls, ceilings, and storage shelves

DEA regulations generally permitted faxes for CII but only if RPh receives the original __________ and __________ prescription before actual __________ - however, there are exceptions to this that allow for faxes to be the original

written, signed; dispensing