Term
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Definition
| Entity that provides exemptions for pharmacist compounding and prepacking |
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Term
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Definition
| (concerned with diversion) has a lot broader definition of controlled substance versus FDA |
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Term
| Registration for controlled substances |
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Definition
| Manufacturer must be registered for each class of controlled substance |
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Term
| If pharmacy never sells controlled substances do you need DEA registration? |
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Definition
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Term
| Pharmacies that manufacture (i.e. compound) and distribute to other practitioners may provide without registration an aqueous or oleaginous solution or solid dosage form containing a narcotic substance in a preparation not exceeding what percentage of the complete product amt[for in office use]? |
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Definition
| not exceeding 20% of the complete product [for in office use] |
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Term
| To order and transfer SI&II controlled substances, DEA registrants must execute which form? |
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Definition
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Term
| Who provides initial order DEA 222 forms? |
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Definition
| provided by the Washington, DC headquarters office |
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Term
| Where do you get subsequent order forms? |
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Definition
| obtained from assigned DEA field office |
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Term
| Who orders controlled substances? |
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Definition
Usually in VA, it is pharmacist in charge****
(Power of attorney allows another individual to sign order forms
Must be kept in the pharmacy records
Does NOT have to be provided to DEA) |
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Term
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Definition
Copy 1: original;
Copy 2: duplicate;
Copy 3: triplicate |
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Term
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Definition
Purchaser must complete all 3 copies simultaneously;
Must be typewritten, ink pen, or indelible pencil;
Each line contains a space for ordering one substance with a total of 10 lines;
Must order the quantity of each container ordered;
Full name of product and quantity included;
Pharmacy may enter NDC but wholesaler MUST enter NDC if not provided by pharmacy;
Must enter name and address of supplier of order;
Purchaser must sign and date the order form;
Substantive ERRORS may NOT be corrected
Wholesaler may make corrections if address or contact information of wholesaler incorrect |
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Term
| If pharmacy is returning drugs to wholesaler what is the wholesaler acting as? |
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Definition
purchaser; pharmacy acts as supplier [Distributor retains Copy 3 for its records
Pharmacy maintains Copy 1 and submits Copy 2 to DEA] |
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Term
| Who do you submit Form 222 to? |
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Definition
| Purchaser submits Copy 1 and 2 to supplier and retains Copy 3 for files |
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Term
| Supplier duties of DEA forms |
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Definition
Supplier records on the first and second copies the number of containers furnished on each item and date of shipment;
If supplier cannot provide the entire quantity, can provide a partial shipment and supply the balance within 60 days;
Supplier maintains Copy 1 for its files;
Supplier provides DEA with Copy 2;
Upon receipt of items, purchaser records date and quantity of itmes purchased on Copy 3; |
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Term
| What does the Supplier do if they cannot fulfill the orders or if the order form is illegible, incomplete, altered or erased? |
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Definition
then it returns Copy 1 and 2 to the purchaser with a rationale for not filling the order
Purchaser must maintain Copy 1 and 2 with its Copy 3 in its files |
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Term
| How long do order forms have to be maintained? |
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Definition
| All executed order forms must be maintained by all entities for 2 years |
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Term
| Electronic DEA Order Form 222 |
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Definition
Allows electronic transmission of Form 222 from manufacturers to distributors and distributors to pharmacies; Uses the highest form of secure electronic transmission infrastructure by requiring signatures;
A certification authority ensures that each transaction if verified
Similar to credit card processing; Each individual with authority or power of attorney to execute DEA order forms must be issued a password protected digital signature |
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Term
| Lost or Stolen DEA Form 222 |
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Definition
Must record on new order form the serial number of the lost form, date of loss, and the fact that the controlled substances were not received;
Purchaser maintains Copy 3 of new form and lost form together;
Purchaser must send a copy of the statement to the supplier with Copy 1 and Copy 2 of the second order form;
If the supplier receives the original order form, then it must mark it as “not accepted” and return Copy 1 and Copy 2 to the purchaser who retains these copies with Copy 3 |
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Term
| If all three forms were stolen what do you do? |
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Definition
| must be reported to DEA with serial numbers of stolen forms |
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Term
| Ordering Controlled Substances in Schedules III-VI |
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Definition
| Currently, DEA does not require a special order form for schedules III-V; VA imposes similar requirements but adds CVI products; Requires that records are maintained for a period of 2 years from date of transaction |
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Term
| DEA Form 222 is required for? |
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Definition
| If the drug is a Schedule I or II controlled substance |
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Term
| Distributing Controlled Substances among Registrants as long as dosage units does not exceed what percentage? |
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Definition
| Number of dosage units distributed does not exceed 5% of the total units of controlled substances dispensed in one year; HOWEVER, long-term care pharmacies that distribute controlled substances to long-term care facilities in automated dispensing systems exempt from this requirement |
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Term
| When returning to wholesaler, if the DEA number of the person making the distribution or the supplier is unknown can they still make the transfer for CIII-V and CII? |
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Definition
| Yes for CIII-V; BUT NOT FOR CII |
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Term
| Virginia Requirements for Distribution |
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Definition
Manufacturer or wholesaler may distribute CII drugs via official written order forms (DEA Form 222) to:
Other manufacturers or wholesalers registered by DEA and the state of VA;
Licensed pharmacists, permitted pharmacies, or licensed practitioners including MD, OD, podiatrists, dentists, veterinarians or other prescribers otherwise authorized;
Manufacturer or wholesaler may distribute drugs in CIII-VI without official written order form |
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Term
| Security Requirements for Controlled Substances |
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Definition
Schedule I drugs must be stored and securely locked in a “substantially constructed cabinet,”
May disperse stocks of drugs in CII-V throughout inventory to prevent diversion or theft |
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Term
| VA Security Requirements for Controlled Substances |
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Definition
CII's may either be dispersed with other schedules or shall be maintained within a securely locked cabinet, drawer, or safe;
Cabinet, drawer, or safe may remain unlocked during hours that the prescription department is open and a pharmacist is on duty |
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Term
| Federal Requirements for Controlled Substances Loss or Theft |
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Definition
requires registrants to report significant losses and all thefts in writing of controlled substances to the Field Office of the Administration
; Immediately upon discovery |
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Term
| What form must be completed to document loss of controlled substances? |
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Definition
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Term
| VA Requirements for Controlled Substances Loss or Theft |
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Definition
Must report all thefts and significant losses to Board of Pharmacy immediately upon discovery;
If unable to determine the exact quantity and type of the loss of inventory of drugs in CI-V (not VI), then must immediately take an inventory of these products;
Within 30 days of discovery of loss of drugs must submit report to the Board listing the kind, quantity, and strength of drugs lost |
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Term
| Inspections of DEA Registered Entities |
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Definition
| allows DEA to enter premises of registrants where controlled substances or records are maintained and may; Examine and copy all records related to controlled substance distribution, prescribing or dispensing (not financial records); Inspector must state the purpose for the inspection along with a written notice to which the owner or the pharmacist in charge must consent |
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Term
| VA State Board of Pharmacy Inspections |
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Definition
May enter during business hours;
Report of violations must be provided to Board of Pharmacy and it must take action within 30 days;
Board may have access to and copy records at reasonable times;
May not take original records unless warrant avail., may take drug samples |
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Term
| DEA Definition: Prescription |
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Definition
Order for medications;
Dispensed to or for an ultimate user
(Does not include order for medication dispensed for immediate administration to ultimate user);
Individuals in hospitals receive controlled substances pursuant to medication orders
(Individuals in long-term care facilities receive prescriptions (DEA registration is not required)) |
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Term
| Communicating Controlled Substance Prescription Information |
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Definition
| Employee or agent of prescriber (direct communication with doctor) may communicate information to pharmacy for dispensing |
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Term
| Are electronic prescriptions permitted for any DEA schedule? |
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Definition
| Electronic prescriptions currently not permitted for any product in any DEA schedule |
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Term
| Verifying Controlled Substance Prescriptions |
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Definition
2 letters followed by 7 numbers; Physicians and other “traditional” prescribers begin with letters “A” or “B” followed by first letter of prescribers last name; Second field for businesses could be number or letter depending on the company name; Mid-level practitioners registration numbers begin with “M”;
Distributor numbers begin with “P” or “R” |
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Term
| To verify the correctness of DEA numbers |
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Definition
Add the first, third, fifth digits;
Add the sum of the second, fourth, sixth digits and multiply by 2;
Add the equation (first + third +fifth) + (fourth + sixth X2);
The last number in the full equation should correspond to the last digit in the DEA number |
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Term
| National Provider Identifiers (NPI) |
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Definition
Does not replace DEA registration for controlled substances;
Replaces DEA numbers and other randomly assigned numbers for insurance claim processing and other purposes; Pharmacists can receive NPIs and can use to bill for certain services to insurance companies |
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Term
| In VA, a pharmacist that declines to fill a prescription for reasons other than unavailability of drug shall record on the back of the prescription |
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Definition
the word “declined”;
the name, address, and telephone** number of the pharmacy;
the date filling was declines; and the signature of the pharmacist |
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Term
| Dispensing Controlled Substance Prescriptions - DEA requirements |
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Definition
| DEA permits pharmacy technicians or other ancillary pharmacy personnel to assist pharmacist in dispensing prescriptions for controlled substances pursuant to state law |
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Term
| Dispensing Controlled Substance Prescriptions - VA requirements |
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Definition
In VA, technicians may assist pharmacists in preparing a prescription for dispensing;
Pharmacist must review and approve the dispensing;
Technician must be under supervision of pharmacist on duty;
In VA, pharmacy interns registered with the state may also assist in preparing controlled substance prescriptions under the supervision of a pharmacist;
Pharmacy interns can perform more duties in comparison to technicians |
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Term
| Transferring Controlled Substances to Other Pharmacies/Practitioners |
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Definition
Pharmacist can transfer pursuant to DEA regulations;
Transfers should only occur in limited circumstances;
Physicians should purchase controlled substances from warehouses or distributors |
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Term
| Appropriate prescribing of controlled substances |
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Definition
| Controlled substances prescribed for individuals receiving treatment for narcotic addiction must be prescribed through a treatment program with some exceptions |
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Term
| Can methadone be prescribed for pain management? |
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Definition
| Yes, need to be recorded for pain management NOT for narcotic tx program |
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Term
| Patient Purchasing of Controlled Substances via Internet Pharmacies |
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Definition
| Individuals may receive controlled substances and other prescriptions from legitimate internet and mail order pharmacies pursuant to a prescription from a prescriber; Individuals in the US may not purchase controlled substances or other medications from internet pharmacies not located in the United States |
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Term
| DEA Requirements for Internet Pharmacies |
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Definition
Physical location that purchases, dispenses and stores controlled substances must be registered as a retail pharmacy;
All other DEA and state rules apply;
Registration and state licensing requirements;
Label must reflect where product is dispensed;
Note: at this time, DEA does not permit electronically transmitted prescriptions for ANY controlled substances;
For CIII-V must be pursuant to oral or written prescriptions;
Faxed prescriptions treated like oral rxes and must be printed by pharmacy and verified with prescriber but do not need original rx;
For CII, must receive the original written prescription |
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Term
| Verified Internet Pharmacy Practice Sites (VIPPS) |
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Definition
| National Association of Boards of Pharmacy voluntary certification program called VIPPS that meet both DEA and state board of pharmacy requirements |
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Term
| In most cases, C II's must be dispensed pursuant to an original, written prescription signed by prescriber except: |
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Definition
In emergency situations;
Via facsimile for home infusion, residents of long-term care facilities or hospice patients;
Partial filling in situations where a pharmacy cannot supply the entire prescription amount |
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Term
| In VA, a pharmacy may fill a Schedule II prescription how many months after date written? |
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Definition
| 6 months (no refills under ANY circumstance) |
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Term
| Are duplicate Prescription Forms required in Va? |
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Definition
| VA does not require duplicate prescription forms or any standard prescription form |
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Term
| Emergency Dispensing of CII Drugs |
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Definition
DEA permits emergency dispensing of oral (phone) CII prescriptions in retail pharmacies under the following conditions;
Quantity prescribed and dispensed limited to amount necessary to treat patient for emergency period;
Prescription must be reduced to writing immediately by a pharmacist;
Must contain all the necessary information except prescriber signature |
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Term
| How long does the prescriber have to provide pharmacy of emergency dispensed CII? |
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Definition
within 7 days; Prescription must include statement “Authorization for Emergency Dispensing” and date of oral order;
Pharmacist must attach the prescription to the oral emergency prescription;
If prescriber fails to deliver written prescription within the 7 day period, pharmacist must notify the nearest DEA office;
VA adopts same standard |
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Term
| Facsimile Rxes for CII Drugs |
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Definition
| In retail settings, pharmacies may receive a facsimile prescription for a SII but must receive the original written signed prescription prior to dispensing |
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Term
| Facsimiles as original prescriptions for CIIs |
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Definition
Narcotic substance compounded by pharmacy for direct administration to patient by parenteral, IV, IM, SQ, or in intraspinal infusion;
Residents of long-term care facilities;
Hospice setting certified by the Medicare program or licensed by state
(Individual may be in a home hospice setting, does not have to be institutional) |
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Term
| Facsimile copies must contain: |
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Definition
| all required information on face of rx, including prescriber signature |
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Term
| VA Requirements Facsimile Rxes for CII Drugs |
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Definition
| Essentially adopts federal DEA regulations for original facsimile prescriptions |
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Term
| Partial Filling of CII Controlled Substances |
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Definition
Pharmacies may provide a partial quantity of a SII prescription if it is unable to provide the entire quantity OR if patient cannot afford;
Pharmacist must make a note on face of prescription and fill the balance of the prescription within 72 hours after the partial fill |
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Term
| If pharmacist unable to fill remaining quantity of CII? |
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Definition
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Term
| Partial Filling of CII Controlled Substances for Residents of LTCFs/Terminally Ill |
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Definition
| pharmacies can partially fill quantities of controlled substances; Applies for dosages filled up to 60 days from date of issuance of prescription or until the prescription terminated by prescriber |
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Term
| Information related to the partial filling of C II's in LTCFs/term ill must be recorded each time on the face of the prescription |
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Definition
Date;
Quantity dispensed;
Remaining quantity authorized to be dispensed;
Identification of the dispensing pharmacist |
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Term
| Recordkeeping Requirements of CII Partial Fills for LTCFs/Terminally Ill (Information regarding partial fill may be recorded on back of prescription or in a computer system if:) |
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Definition
The computer can indicate the original prescription number;
Date of issue;
ID of prescriber;
Patient;
Name of LTCF;
Medication including dosage form strength and quantity;
Listing of partial fillings;
Immediate, real-time updating of prescription record each time prescription partially filled |
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