Term
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Definition
| pharmacy packages drugs from manufacturer’s container to a customized unit dose or other type of unique dispensing systems for direct patient use |
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Term
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Definition
| placing any drug from a manufacturer’s original container into different packaging |
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Term
| Time length for repackaging records |
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Definition
| Records must be maintained for one year or until the expiration date of the product, whichever is greater |
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Term
| Requirements for determining expiration date |
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Definition
| Current guidelines: 6 months or one year if packaged in containers “better than PVC” |
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Term
| FDA Risk Evaluation & Management Strategies (REMS) |
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Definition
| implemented by FDA in 2008 to establish formal protocols to communicate information about safety and efficacy concerns with certain medications |
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Term
| REMS include at least one of the following elements designed to ensure safety of use: |
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Definition
Practitioners must be certified or have training to prescribe medication;
Pharmacies and other dispensers or those who administer must have special certification;
Drug distribution is limited to only certain settings such as clinics or hospitals;
Patients who receive the medication must receive special information regarding safe use, including required lab testing;
Patients must be monitored when using the medication;
Patients must be enrolled in a registry to use drug |
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Term
| closed distribution system |
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Definition
| System for regulating controlled drugs |
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Term
| Attorney General of the United States(Dept of Justice) |
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Definition
| has authority under CSA to classify drugs into Schedules I-V |
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Term
| Controlled Substances Act (CSA) |
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Definition
| defines drugs necessary for control based upon narcotic and nonnarcotic; schedule I-V |
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Term
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Definition
| natural or synthetic opium or opiate derivative including poppy straw, coca leaves, cocaine |
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Term
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Definition
| has a high potential for abuse and addiction based on studies and or chemical properties but does not contain a narcotic substance |
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Term
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Definition
| no currently accepted medical use in US |
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Term
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Definition
| Commonly prescribed drugs include: Ritalin and other amphetamines for ADHD; Percocet and its generic equivalents; Oxycodone and generic equivalents; Dilaudid and generic equivalents; cocaine |
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Term
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Definition
| abuse may lead to moderate or low physical dependence or high psychological dependence; Categories include: barbiturates; APAP/ASA with codeine; weight loss agents with amphetamine; anabolic steroids; GHB; paregoric |
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Term
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Definition
| Categories include: drugs with NMT 1 mg difenoxin and not less than 25 mcg of atropine sulfate per dosage unit; benzodiazepines; barbital; chloral hydrate; certain stimulants such as diethylpropion and phentermine |
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Term
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Definition
In many states, including VA, SV drugs can be sold by a pharmacist without a prescription *** (however, limits; pharmacist has the right to reject);
Common agents include Robitussin with codeine and generic versions |
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Term
| Exclusions from Federal Scheduling |
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Definition
| A manufacturer or other entity (FDA) may petition DEA for exclusion of a substance under any of the federal schedules; DEA must issue a public notice with details of the final order in the Federal Register open for public comment for at least 60 days |
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Term
| Who has authority to Add or Deschedule Controlled Substances? |
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Definition
| Virginia Board of Pharmacy |
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Term
| Timeline for federal controlled substance provisions |
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Definition
| Any change in federal controlled substance scheduling provisions may be enacted by state Board after 120 days of the final publication in the Federal Register without public notice |
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Term
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Definition
| Virginia officially classifies prescription drugs not otherwise deemed controlled by DEA into this category (va law - cannot make otc into controlled) |
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Term
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Definition
| Schedule V controlled substance considered may be dispensed by a pharmacist without a prescription |
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Term
| Manufacturer Labeling & Packing Requirements |
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Definition
Commercial containers of controlled substances must be labeled with the designated schedule by placing the C-I, C-II, C-III, C-IV, C-V or;
Symbol may be a C with the schedule number inside of it |
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Term
| Closed Loop Distribution Process |
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Definition
| Every entity involved in DEA manufacture, distribution, purchase or dispensing must be registered with DEA except ultimate consumer; Not every INDIVIDUAL health care practitioner must be registered but employer or affiliated health care setting must be registered |
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Term
| Activities Requiring Registration |
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Definition
Manufacturing, dispensing, researching, narcotic treatment programs, chemical analysis, and import and export of controlled substances;
Each entity must provide separate registrations for each site where it conducts business |
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Term
| Registration and Reregistration Procedures |
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Definition
DEA issues renewal notices 60 days prior to expiration;
Registrants not receiving renewal notices must notify DEA within 45 days of expiration |
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Term
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Definition
Dispensers: Form 224;
Manufacturers, distributors, and narcotic treatment programs: Form 225 |
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Term
| Distribution of Controlled Substances on Discontinuance of Business |
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Definition
| Must return the Certificate of Registration and executed 222 Forms to the Washington, DC office*** |
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Term
| Pharmacy closings; going out of business; change of ownership |
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Definition
Must notify Board of Pharmacy at least 14 days in advance of closure or change in ownership;
Must provide the Board with information related to the disposition of all controlled substances in SII-VI |
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Term
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Definition
Manufacturers and distributors (wholesalers) register each year at the end of the month assigned by DEA for the registration year (21 CFR 1301.13©);
Pharmacies, hospitals/clinics, teaching institutions must register once every three years in the month assigned by DEA (21 CFR 1301.13(d));
Most entities can reapply for reregistration within 60 days of expiration except importers/exporters that permits 120 day timeframe (21 CFR 1301.13(b)) |
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Term
| VA practitioners authorized to prescribe for controlled substances |
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Definition
| MD, OD, podiatrists, dentists, veterinarians, licensed nurse practitioner --II-VI; Licensed physician assistant (CIII-VI only); TPA-certified optometrist may only prescribe oral analgesics listed in Schedules III-VI appropriate to relieve ocular pain |
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Term
| DEA Rule for Multiple CII Prescriptions |
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Definition
| Allows prescribers to issue multiple prescriptions for CII controlled substances for up to a 90 day supply |
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Term
| Label for CII Controlled Substance Prescriptions in VA |
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Definition
Serial number or name of drug
Date of initial filling
Name and address of pharmacy or pharmacist (no phone number required)
Name of patient (address not required)
Name of prescriber
Directions for use |
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Term
| VA Requirements for Drug Repackagers |
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Definition
Drug name;
Strength;
Date repackaged;
Quantity prepared;
Initials of pharmacist verifying process;
Assigned lot or control number;
Manufacturer or distributor’s name and lot or control number;
Expiration date |
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Term
| VA Requirements for Drugs Placed into Automated Counting Devices or Dispensers |
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Definition
Drug name and strength;
Name of manufacturer or distributor;
Manufacturer’s control or lot number for all lots placed into bin at time of filling;
Expiration date |
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Term
| FDA Requirements for Generic Substitution |
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Definition
Compares bioavailability of the drug in 24-36 healthy volunteers;
Looks for a variation of AUC and CMax of between 20%-25% above or below brand name product |
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Term
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Definition
| substitution of different drug, same class |
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Term
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Definition
| substitution of different drug, same class |
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Term
| Who develops and approves REMs? |
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Definition
| by manufacturers and the FDA |
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Term
| Only entities and persons registered with DEA may dispense, administer, manufacture, purchase, sell, or otherwise acquire controlled substances including |
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Definition
Pharmacies but not pharmacists;
Prescribers;
Manufacturers;
Distributors/wholesalers;
Researchers;
Hospitals but not long-term care facilities |
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Term
| Who must consult with the Department of Health and Human Services for a clinical and medical evaluation of the drug? |
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Definition
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Term
| Virginia Definition: Controlled Substance |
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Definition
Drug, substance or immediate precursor to substances listed in SI-V by the CSA or by the state Board of Pharmacy;
Excludes distilled spirits, wine, malt beverages, or tobacco |
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Term
| Where should transfer proposals be sent when going out of business? |
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Definition
| DEA requires transfer proposal to be sent by registered or certified mail to the special agent in charge of the DEA region*** of the registrant |
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Term
| DEA Definition of Dispensing |
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Definition
Delivering a controlled substance to an ultimate user or research subject or
Pursuant to the lawful order of a practitioner including:
Prescribing and administration of a controlled substance and the packaging, labeling, or compounding necessary to prepare the substance for such delivery;
Dispenser is the entity that delivers the controlled substance to the ultimately user or research subject;
Under this section, a pharmacy is a practitioner;
DEA recognizes pharmacists as individual practitioners if authorized by state law;
A hospital is also a practitioner |
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Term
| Dispensing CII Controlled Substance Prescriptions in VA |
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Definition
Written prescription from prescriber
Meets minimum DEA requirements of drug name, strength, dosage form, quantity prescribed, and directions for use AND Dated and signed by practitioner/prescriber on date written--post dated or undated prescriptions not acceptable; Full name and address of patient or owner of animal for vet rxes (may be added by pharmacist);
Full name, address, and DEA number of prescriber |
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Term
| Dispensing CIII-VI Controlled Substance Prescriptions in VA |
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Definition
Written prescription from prescriber;
Meets minimum DEA requirements of drug name, strength, dosage form, quantity prescribed, and directions for use (21 CFR 1306.05);
May also be filled pursuant to an oral prescription;
Dated and signed by practitioner/prescriber on date written--post dated or undated prescriptions not acceptable;
Oral prescriptions must contain the same information except no prescriber signature required |
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Term
| Which schedule does not require an address? |
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Definition
| For SVI drugs: no address needed if the information is readily-retrievable in the pharmacy’s records |
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Term
| Label for CII Controlled Substance Prescriptions in VA |
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Definition
Serial number or name of drug;
Date of initial filling;
Name and address of pharmacy or pharmacist (no phone number required);
Name of patient (address not required);
Name of prescriber;
Directions for use |
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