chapter 18 controlled substances
TRANSCRIPT
18.1
CHAPTER 18
CONTROLLED SUBSTANCES
18.2
Hospital CONTROLLED SUBSTANCES
DEA
DEA assigned to facility (vs. the pharmacy)
Registrant is entity vs. individual
Renewal every 3 years, can renew & manage registration online
Director of Pharmacy responsible for oversight
Large number of individuals handle controlled substances (CS)
Sound P&P to ensure accountability, minimize opportunity for diversion Ordering Schedule II-V
DEA form 222 required for ordering CIIs
Can request order form books on DEA website; will receive the maximum number of order form books allowed for your business activity (7 forms per book, typically max 6 books per request)
Registrant may authorize power of attorney (POA) for individuals responsible for signing schedule II orders (sample form page 18.9). Must be signed by the person who signed most recent application for registration or renewal plus the individual being authorized.
All executed 222 order forms must be dated on or after POA authorization date (should not have 222 orders signed by individuals that don’t have an active POA on file).
Maintain POA forms as part of CS records
Keep POA records up to date o If renewal application signed by a different person (new DOP), must update POA
files o Revoke POA when employee leaves or responsibilities change; maintain record of
revoked POA in files
CSOS – electronic schedule II ordering (can also use for II-V ordering)
Registrant and POAs can order via CSOS once registered and digital certificate activated (registrant designates a CSOS coordinator)
CSOS certificates expire when registration expires
Individual enrollment; must have active POA on file prior to enrolling in CSOS
Individual must enroll under each DEA license if ordering for multiple sites
CSOS certificate valid for all vendors; separate set up for each
No line item limit for ordering, faster than paper 222, accurate
Can separate tasks of ordering and signing (added accountability)
Schedule III-V - order from wholesaler or vendors
ADC system interfacing tracks pars at the cabinet level and communicates to CS vault for inventory management/reordering
Receiving Schedule II-V
CS totes delivered directly to vault; separate from non-controlled inventory
18.3
Ensure not delivered to loading docks or other general areas
Best practice – validate inventory received against invoices before signing for driver and taking custody of shipment (in transit loss is responsibility of supplier; after take custody, responsibility of pharmacy and requires reconciliation with supplier and/or DEA 106 for loss)
Confirm receipt of each line item on invoice for all II-V
Date/initial each line on 222 form
Delegate ordering and receiving to different individuals
A third individual should audit receiving records to validate what was ordered to what was received and then stocked into inventory.
Compare DEA 222 form (or printed CSOS) to wholesaler invoice
Compare wholesaler invoice to vault receipt records Storage & Security
Locked in a secure area as defined by hospital policy
MM 03.01.01 “in a secure area to prevent diversion”
Many organizations use automated dispensing cabinets (ADC) to secure controlled substances
Require individual login
Cabinet access restricted to authorized users
Can restrict based on role (respiratory therapists can access cabinet and specific bins but cannot access CS or other drugs they don’t administer)
Maintains perpetual inventory and transaction record, provides discrepancy notifications at the cabinet and system level, maintains audit trail
Accessing CS pocket requires a “blind count” by users (unlike non-controlled substances, the system doesn’t tell the user what the count should be in the pocket)
User notified if count entered is wrong, prompted to recount or create discrepancy
May choose to classify other drugs with potential for abuse or diversion as a “control” for tightened security, blind counts, discrepancy tracking and audit trails (propofol, sildenafil)
CS only stored in lock lidded bins vs. open matrix, limited access, auditable
Pharmacy vault restricted to those with CS responsibilities
Users must protect passwords; Bio-ID preferred over password if possible
Ensure terminated employees’ access to ADCs is revoked promptly
Always log out of machine; auto log-off after set time period with no activity
Hospitals without ADCs utilize med carts or locked cabinets on the unit, difficult to maintain security of keys when large number of nurses
Emergency kits and code cart trays – ideally don’t contain controlled substances, too easy to access or transport out of unit/facility unnoticed
Other considerations
Securing IV controlled substances in patient rooms, consider lock boxes
18.4
PCA and epidural pump key accountability and security
Secure delivery of CS to patient care areas Waste
With witness as defined by hospital policy
Document all CS waste
Witness login/password required at the ADC
Manual (paper log, anesthesia records) requires signature of witness
Reinforce witness needs to actually witness/visualize waste
Reconcile waste transactions (administered + wasted = dispensed), follow up on discrepancies
Consider handling of fentanyl patch waste Disposal/Destruction
Reverse Distributor – remove expired CS from site
Schedule II transferred via DEA 222
III-V invoiced, maintain records
DEA form 41 for destruction
CS for immediate administration in an institutional setting remains under the control of the institution even if the substance is not fully exhausted (such as partial vial, considered pharmaceutical waste vs. requiring disposal/destruction)
64B16-28.303 Destruction of Controlled Substances All Permittees (Excluding Institutional Class I Nursing
Homes).
(1) Controlled substances that cannot be retained as usable shall be securely stored in the
pharmacy/prescription department of the permittee pharmacy until destroyed.
(2) Permittees are required to complete a United States Drug Enforcement Administration (D.E.A.) Form DEA-
41 “Registrants Inventory of Drugs Surrendered” (effective 8/31/2014), herein incorporated by reference,
available at http://www.flrules.org/Gateway/reference.asp?No=Ref-03998 or
http://www.deadiversion.usdoj.gov/21cfr_reports/surrend/. This form, at the time of destruction, shall be
witnessed and signed by the prescription department manager or the consultant pharmacist of record and
D.E.A. agent, or a Department inspector. This method of destruction requires that a copy of the completed
and witnessed Form DEA 41 be mailed to the D.E.A. office in his/her area within one (1) business day after the
destruction.
18.5
(3) Another method of destruction shall be conducted by at least two persons: One will be the prescription
department manager or the consultant pharmacist of record. The other will be one of the following: medical
director or his/her physician designee, director of nursing or his/her licensed nurse designee, or a sworn law
enforcement officer. These persons shall serve as the witnesses for the Form DEA-41 and the destruction. This
method of destruction requires that a copy of the completed and witnessed Form DEA-41 be mailed to the
D.E.A. office in the permittee’s area within one (1) business day after destruction.
(4) In lieu of destruction on the premises as outlined in subsections (2) and (3) above, controlled substances
may also be shipped to reverse distributors for destruction in conformity with federal guidelines.
(5) For patient specific controlled substance prescriptions in a Modified Institutional Class II B pharmacy, the
destruction method in subsection 64B16-28.301(2), F.A.C., must be followed.
Rulemaking Authority 465.005, 465.022 FS. Law Implemented 465.022, 465.018 FS. History–New 4-21-87,
Formerly 21S-19.003, Amended 7-31-91, Formerly 21S-28.303, 61F10-28.303, Amended 1-30-96, Formerly 59X-
28.303, Amended 2-5-07, 10-27-09, 2-1-12, 4-20-14.
Also refer to pages 18.12-15 FAQ: DEA Rule on Disposal of Controlled Substances
Accountability
Must be able to account for CS through entire system (closed system); maintain audit trail
Outside of Pharmacy - Discrepancy monitoring by pharmacy and nursing
Policies establishing expectations for surveillance (who, how often, resolution process), see sample table page 18.10
Discrepancies between expected and actual quantity on hand should be resolved in a timely manner with proper documentation of reason by person creating the discrepancy and a witness
Unresolved discrepancies monitored by pharmacy and nurse manager or designee (charge nurse)
Pharmacy should review discrepancy resolutions for appropriateness
Establish an escalation pathway to nursing leadership for discrepancies not resolved within certain time period or with inappropriate reason
Empty return bins regularly, monitor for inventory discrepancies (establish who is responsible for emptying, monitoring)
Nursing should have process to ensure what dispensed is documented as administered, wasted, or returned
May be on MAR, flowsheets in patient chart
For CS stored in lockbox or non-automated storage location, requires manual process to validate logged inventory against actual, typically every shift or at least daily
Patient specific dispensing of CS, ensure delivery and administration records returned and reconciled
Nursing controlled drug records
One sheet lists all drugs (example page 18.11)
End of shift counts (confirmation bias)
Patient specific administration record - nurse records each dose administered, waste, and remaining quantity. Completed sheet and any non-administered CS returned to pharmacy. Retain with CS records.
18.6
Monitor anesthesia records for complete documentation, trend by user, partner with anesthesia and OR leadership
If possible, incorporate data analytics software for monitoring. Otherwise, this is a manual process
Trend discrepancies by unit and user level (inventory and waste transaction discrepancies)
Compare user CS transactions to users on same unit, assess for outliers (utilize standard deviation)
Pharmacy – internal monitoring
Vault blind count inventory on scheduled basis; completed by two techs
Biennial inventory of all schedule II-V (every two years)
Restock audit report to confirm quantity of CS dispensed from vault is received into ADC on unit (system alerts after defined period of time, giving tech time to deliver)
Monitor waste documentation (used for compounding)
Consider cameras or other security measures
Monitor for diversion and tampering, inspect tamper seals, consider refractive index
Don’t be complacent or too trusting; diverters typically don’t look the part Prescribing considerations
Interns, residents, housestaff may prescribe CS under the registration of the hospital. Hospital must maintain list of internal codes for agent prescribers
Example:
ARNPs can write orders for CS for inpatients within their scope of practice and pursuant
to medical staff protocols
Florida law does not allow ARNPs to prescribe controlled substances. All prescriptions for controlled substances must be written and signed by a licensed physician.
PAs cannot prescribe or dispense CS; however, a PA can order CS for inpatients
A supervising physician may delegate to a PA the authority to order medications for the supervising physician’s patient during his/her care in a facility licensed under Chapter 395, Florida Statutes, notwithstanding any provisions in Chapter 465 or 893, Florida Statutes. An order is not considered a prescription in this instance.
Theft or Significant Loss
Notify local DEA Diversion Field Office within one business day of discovery of theft or significant loss
Notify law enforcement (recommended but not required by federal law)
Complete DEA Form 106 (available as online form; can amend)
18.7
Notify Board of Pharmacy within 1 business day after discovery of theft or loss (465.022)
TJC MM.01.01.03 “abuses and losses are reported to the Director of Pharmacy and the Chief Executive Officer”
Collaborate with HR and Occupational Health. Be familiar with HR policies related to drug free workplace, for cause drug testing, management of suspected diversion, coordination with PRN (Professionals Resource Network), etc.
Collaborate with nursing and anesthesia – recognition of impaired professional Policies and Procedures
Consider policies for:
Inventory management including ordering and receiving, tracking, scheduling of inventory counts
Scope of services (especially if multiple DEA licenses, offsite offices, EDs or ambulatory surgery centers – who is responsible for what?)
Access levels of personnel
Surveillance and monitoring
Discrepancy resolution
Handling and documentation of waste
Disposal and destruction Recordkeeping
All records including purchasing, receiving, storage, distribution, dispensing, disposal
CS records must be maintained for 4 years
Schedule II separate from III-V
Executed 222 forms separate from other documents (although can attach to matched invoice)
Records to be maintained
DEA 222 (executed and unexecuted forms) or CSOS
Power of Attorney authorization to sign forms
Receipts and invoices for schedule III, IV and V controlled substances
All inventory records including the initial and biennial inventories, dated as of beginning or close of business
Records of controlled substances distributed or dispensed
DEA 106
Inventory of Drugs Surrendered for disposal (DEA form-41 or Reverse Distributor)
Records of transfers of controlled substances between pharmacies
DEA registration certificate
Other issues Updated record of doctor DEA numbers Prescription pad control
18.8
Medicare COP standards: 42 CFR Ch. IV (10–1–11 Edition) §482.25(a)(3) - Current and accurate records must be kept of the receipt and disposition of all scheduled drugs.
18.9
SAMPLE POWER OF ATTORNEY FORM
Power of Attorney for DEA Forms 222 and Electronic Orders
(Name of registrant)
(Address of registrant)
(DEA registration number)
I, ___________________ (name of person granting power), the undersigned, who am authorized
to sign the current application for registration of the above-named registrant under the Controlled
Substances Act or Controlled Substances Import and Export Act, have made, constituted, and
appointed, and by these presents, do make, constitute, and appoint ____________________
(name of attorney-in-fact), my true and lawful attorney for me in my name, place, and stead, to
execute applications for Forms 222 and to sign orders for Schedule I and II controlled substances,
whether these orders be on Form 222 or electronic, in accordance with 21 U.S.C. 828 and Part
1305 of Title 21 of the Code of Federal Regulations. I hereby ratify and confirm all that said
attorney must lawfully do or cause to be done by virtue hereof.
_________________________________
(Signature of person granting power)
I, _________________ (name of attorney-in-fact), hereby affirm that I am the person named
herein as attorney-in-fact and that the signature affixed hereto is my signature.
_________________________________
(signature of attorney-in-fact)
Witnesses:
1. _________________
2. _________________
Signed and dated on the ____ day of ____, (year), at ____ .
Notice of Revocation
The foregoing power of attorney is hereby revoked by the undersigned, who is authorized to sign
the current application for registration of the above-named registrant under the Controlled
Substances Act or the Controlled Substances Import and Export Act. Written notice of this
revocation has been given to the attorney-in-fact ____ this same day.
______________________________
(Signature of person revoking power)
Witnesses:
1. ____________________
2. ____________________
Signed and dated on the ____ day of ____, (year), at ____.
18.10
SAMPLE SURVEILLANCE TABLE REPORT NAME FREQUENCY REVIEWER SCOPE UNRESOLVED DISCREPANCIES
DAILY CONTROLLED SUBSTANCE PHARMACY TECHNICIAN (CST)
This report identifies any discrepancies noted by nursing that have not been resolved. Discrepancies that have not been resolved within 24 hours of their inception will be communicated to the appropriate nurse manager. The Controlled Substance Technician will run additional Omnicell reports, gather the necessary information, and discuss the resolution of the discrepancy with the Pharmacy manager for the Vault area. When needed the Assistant Director, IP Pharmacy Operations will arrange to discuss unresolved discrepancies with the appropriate nursing manager. Discrepancies that have not been resolved will be recorded by the Controlled Substance Technician. A monthly report by nursing area will be generated and distributed to the nursing and pharmacy managers.
RESOLVED DISCREPANCIES DAILY CST This report is used to monitor the resolution of controlled substance discrepancies. The analysis should include appropriateness of resolution reason and the identification of patterns related to individual users. Acceptable resolutions will be filed. Unacceptable resolutions will investigated jointly by nursing and pharmacy management and corrective
VAULT INVENTORY DAILY CST Blind, manual count of all items involved in any Secure Vault transaction since previous End of Cycle Report
VAULT INVENTORY WEEKLY CST Blind, manual count of ALL Secure Vault inventory items.
DISPENSE/RETURN/WASTE DAILY AS NEEDED DEA requirement to document transactions for all scheduled medications. Report generated automatically and stored electronically, available as reference if needed.
RESTOCK AUDIT DAILY CST DESTOCK/RESTOCK matching: identify discrepancies between controlled substances ISSUED from Secure Vault and RESTOCKED at the designated cabinet.
NON-VAULT SUPPLEMENTAL RESTOCK
DAILY CST Two-Fold purpose: 1. Evaluate cabinet inventory (pars and reorder points) 2. DESTOCK/RESTOCK matching for off hours dispensing.
EXPIRED MED REPORT DAILY CST Monitor expired controlled substances stocked in ADCs. Report looks for past one year and 14 days in advance.
EMPTY DRAWER RETURN WEEKLY CST AND AUTOMATION TECHS
END OF CYCLE DAILY CST
CABINET CYCLE COUNT QUARTERLY CST AND AUTOMATION TECHS The cycle count assignments will be rotated to ensure no single person counts the same cabinet twice in 2 consecutive months.
18.11
SAMPLE FORM Controlled Drug Record Proof of Use Form NOTE: Top of box is the transaction amount.
ORAL CONTROLLED DRUGS Bottom of box is the final count.
Date Signature #1
Unit sheet verified by: Signature #2 Page ____ of ____T
ime
Pa
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Alp
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Clo
nazepam
0.5
MG
tab
Clo
nazepam
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Dia
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5 M
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Hydro
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10/5
00 M
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Hydro
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PA
P 2
.5/5
00 M
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Hydro
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5/5
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Hydro
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7.5
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Hydro
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MG
tab
Lora
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0.5
MG
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Lora
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1 M
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thadone 1
0 M
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RECORD ALL WASTE WITH SIGNATURE ON BACK OF FORM
BALANCE from previous
Dosage
GIVEN WASTED
18.12
18.13
18.14
18.15
18.16
18.17
18.18
NURSING HOME
Controlled Drugs in the Nursing Home
I. Regulatory Overview
1. Board of Pharmacy Regulations 64BB16-28.301 Destruction of Controlled Substances –
Class I (Institutional Pharmacies – Nursing Homes)
2. Controlled Substances Act 10D-46
3. Nursing Home Regulations 59A-4.112 Pharmacy Services
(1) The consultant pharmacist shall establish a system to accurately record the receipt and
disposition of all controlled drugs in sufficient detail to enable an accurate
reconciliation.
(2) The pharmacist shall determine that drug records are in order and that an account of all
controlled drugs is maintained and periodically reconciled.
(3) All controlled substances shall be disposed of in accordance with State and federal laws.
All non-controlled substances may be destroyed in accordance with the facility’s
policies and procedures. Records of the disposition of all substances shall be maintained
in sufficient detail to enable an accurate reconciliation.
4. Federal Survey Manual
F431 MEDICATION STORAGE, LABELING, AND CONTROLLED SUBSTANCES GUIDANCE
(Excerpts)
INTENT (F431) 42 CFR 483.60(b)(2)(3)(d)(e)
The intent of this requirement is that the facility has in place a functioning medication system that includes the
services of a licensed pharmacist and provides for:
• Safe and secure storage (including proper temperature controls and limited access) and safe handling
(including disposition) of all medication;
• Accurate labeling to facilitate consideration of precautions and safe administration of medications;
• Accurate and timely medication records and periodic reconciliation and accounting of all controlled
substances; and
• Prompt identification of loss or diversion of controlled substances so as to minimize the time between actual loss or
diversion and the detection and determination of the extent of loss or diversion.
CONTROLLED SUBSTANCES The facility should have a system to account for the receipt and disposition of all controlled substances. This system
includes, but is not limited to:
• Record of receipt of all Schedule II medications specifying the name and strength of the medication, the quantity
received, and designating the name of the resident or the emergency medication supply (consistent with state law);
NOTE: The facility may store some controlled medications in an emergency medication supply in accordance with
state law. The system must address the reconciliation and monitoring of this supply as well as the supply for
individual residents.
• Documentation of usage, which may include for example, the medication administration record, proof-of-
use sheets, or declining inventory sheets;
• Documentation of disposition including destruction, wastage, return to the pharmacy/manufacturer, or
disposal in accordance with applicable state law, and
• Periodic reconciliation of the records (generally, at least monthly or more frequently as defined by facility
procedures).
18.19
The pharmacist is not required by these regulations to complete the reconciliation, but rather to determine that there
is an effective system to do so and that the facility has completed the reconciliation according to its procedures and/or
state laws and regulations. Although this regulation does not set a time frame for reconciliation, this system should
identify how often, how, when, and by whom the reconciliation will be done. The system should be capable of
readily identifying loss or diversion of controlled substances so as to minimize the time frame between the actual loss
or diversion and the time of detection and follow-up to determine the extent of loss. Because diversion can occur at
any time, the reconciliation should be done often enough to identify problems. (Some state or other federal laws or
regulations may specify the frequency of reconciliation, which may be reflected in the facility’s procedure and
practices.) If the systems have not been effective in preventing or identifying diversion or abuse, the pharmacist and
the facility should review and revise the monitoring procedures, as necessary, such as increasing the frequency of
reconciliation efforts.
II. Tamper Proof Prescriptions and E-Forcse in Long Term Care (Florida Statute 456.42)
1) Schedule III – V prescriptions can still be faxed from the prescriber to the pharmacy without
the use of a tamper proof prescription
2) Verbal prescriptions for Schedule III – V can still be called in from the prescriber’s office
to the long term care pharmacy without a follow-up hard copy
3) Schedule II prescriptions can still be faxed from the prescriber to the pharmacy for a nursing
home resident. In an ALF, DEA regulations do not allow a faxed prescription to serve as an
original prescription. Therefore, A tamper proof prescription blank should be used.
4) A verbal “emergency” prescription can still be called in from the prescriber to the LTC
pharmacy for Schedule II drugs.
5) All controlled substance prescriptions in Schedules II – IV need to be reported to E-Forsce
within 7 days of dispensing.
6) Closed door pharmacies are not required to re-register for dispensing of controlled substances
by July 2012 as required for retail pharmacies.
III. DEA’s view of the facility nurse as an agent of the prescriber (Page 18.39 – 18.46)
In most LTC facilities the nurse will accept a verbal order from the prescriber, prepare a
telephone order and fax that order to the vendor pharmacy. While a nursing home nurse is
generally considered an agent of the prescriber by state Boards of Pharmacy, the DEA requires
a written agreement between the nurse and prescriber in order to act as an agent for Schedule
III – V controlled substances. CII “Emergency prescriptions” MUST be verbally communicated
between the prescriber and the pharmacist.
IV. Chart Order vs Prescription Order
DEA – “… a drug order written on a patient’s chart in a long term care facility is not an
“effective” controlled substances prescription, unless it contains all necessary information as
described in “Manner of Issuance of Prescriptions” in the DEA code. This includes:
a. Date
b. Patient Name
c. Patient Address (not facility name)
d. Drug Name, Strength and Dosage Form
e. Quantity to be dispensed
f. Prescriber’s Signature
g. Prescriber’s Address
h. DEA Number
i. Directions for use
18.20
V. Proper Procedures for Obtaining a Hard Copy Prescription
a. DEA Opinion Letter ( see page 18.34 & 18.35 )
b. Appropriate Form Use for Obtaining CII Hard Copy RX’s (see page 18.36)
VI. Audit Trail - Security, Accountability, Disposal
a. Drugs received into the facility
1) By patient
2) By pharmacy
3) Name, date, quantity received
b. Drugs administered to the resident
1) Medication administration record (MAR)
2) Proof of use sheets - required for Schedule II, desirable for the rest
c. Drugs not administered to the resident
1) Wastage, contamination (witness)
2) Pilferage
3) Sent home with the resident
4) Destroyed in the facility
VII. Change of Shift Inventory Count (see Page 18.33)
a. Date, hour, signature of on-coming and off-going nurses
b. Discrepancy
c. Monitoring
VIII. The Process for removing Controlled Substances from the floor
a. End of shift
b. When the D.O.N. is not available (ex. Weekends)
IX. Reconciliation of Controls in the Facility
Once this system is established, the consultant can “determine that reconciliation is done”
by either:
1. Reviewing internal audits done by the facility
2. Spot checking documentation at the nursing station
3. Monitoring shift counts
4. Doing a complete audit of all controlled substances records in the facility.
This option may be reserved for those cases when the facility identifies
multiple discrepancies or suspected diversion.
18.21
X. Destruction of Controlled Substances (by Facility Type)
1. Class I Institutional Pharmacy (Nursing Homes & ICF-DD’s)
Option One - Facility may destroy drugs on the premises
Witnessed by the consultant pharmacist, the director of nursing,
and the administrator or designee.
Option Two - A Pharmacy licensed as a "Collector" with DEA may place a collection
receptacle with an inner liner within the facility (in a secure area). Both controls
and non-controls can be collected. When the liner is full it is sealed and
transferred off site for destruction (sent to a reverse distributor). Once the inner
liner is removed it must be sent within 3 days for destruction
64B16-28.301 Destruction of Controlled Substances – Institutional Class I Pharmacies (Nursing Homes).
(1) Controlled substances that have been dispensed and not used by the patient shall not be returned to the
pharmacy and shall be securely stored by the nursing home until destroyed.
(2) A document must be completed showing the name and quantity of the drug, strength and dosage form,
patient’s name, prescription number and name of the institution. This documentation, at the time of destruction, shall
be witnessed and signed by the consultant pharmacist, director of nursing, and the administrator or his/her designee,
which may include a licensed physician, mid-level practitioner, nurse, another pharmacist, or a sworn law
enforcement officer.
Rulemaking Authority 465.005, 465.022 FS. Law Implemented 465.022, 465.019 FS. History–New 4-21-87, Formerly 21S-19.001,
Amended 7-31-91, Formerly 21S-28.301, 61F10-28.301, Amended 1-30-96, Formerly 59X-28.301, Amended 7-21-09, 2-10-14.
2. Class II Institutional Pharmacy including Modified IIA, B and C
A. FOR CONTROLED SUBSTANCES UNDER THE DEA PERMIT
Option One - The Controlled Substances may be sent to an approved reverse distributor.
Option Two - Send a completed DEA Form 41 (Registrants Inventory of Drugs Surrendered)
Signed by the consultant pharmacist or Pharmacy Manager, a DEA agent or a
Dept Inspector witnessing the destruction. The completed DEA Form 41 must
be mailed to the local DEA office within ONE day of destruction
Option Three - The destruction must be completed by 2 people including the Prescription
Department Manager or Consultant Pharmacist. The other could be the Medical
Director (or a Physician designee), the D.O.N (or a licensed nurse designee) or
a sworn law Enforcement Officer. The completed DEA Form 41 must be
mailed to the local DEA office within ONE day of destruction
B. FOR PATIENT SPECIFIC CONTROLLED SUBSTANCES A document must be completed showing the name and quantity of the drug, strength and dosage form, patient’s
name, prescription number and name of the institution. This documentation, at the time of destruction, shall be
witnessed and signed by the consultant pharmacist, director of nursing, and the administrator or his/her designee,
which may include a licensed physician, mid-level practitioner, nurse, another pharmacist, or a sworn law
enforcement officer.
64B16-28.303 Destruction of Controlled Substances All Permittees (Excluding Institutional Class I Nursing
Homes).
(1) Controlled substances that cannot be retained as usable shall be securely stored in the pharmacy/prescription
department of the permittee pharmacy until destroyed.
(2) Permittees are required to complete a United States Drug Enforcement Administration (D.E.A.) Form DEA-41
“Registrants Inventory of Drugs Surrendered” (effective 8/31/2014), herein incorporated by reference, available at
18.22
http://www.flrules.org/Gateway/reference.asp?No=Ref-03998 or
http://www.deadiversion.usdoj.gov/21cfr_reports/surrend/. This form, at the time of destruction, shall be witnessed
and signed by the prescription department manager or the consultant pharmacist of record and D.E.A. agent, or a
Department inspector. This method of destruction requires that a copy of the completed and witnessed Form DEA 41
be mailed to the D.E.A. office in his/her area within one (1) business day after the destruction.
(3) Another method of destruction shall be conducted by at least two persons: One will be the prescription
department manager or the consultant pharmacist of record. The other will be one of the following: medical director
or his/her physician designee, director of nursing or his/her licensed nurse designee, or a sworn law enforcement
officer. These persons shall serve as the witnesses for the Form DEA-41 and the destruction. This method of
destruction requires that a copy of the completed and witnessed Form DEA-41 be mailed to the D.E.A. office in the
permittee’s area within one (1) business day after destruction.
(4) In lieu of destruction on the premises as outlined in subsections (2) and (3) above, controlled substances may
also be shipped to reverse distributors for destruction in conformity with federal guidelines.
(5) For patient specific controlled substance prescriptions in a Modified Institutional Class II B pharmacy, the
destruction method in subsection 64B16-28.301(2), F.A.C., must be followed.
Rulemaking Authority 465.005, 465.022 FS. Law Implemented 465.022, 465.018 FS. History–New 4-21-87, Formerly 21S-19.003,
Amended 7-31-91, Formerly 21S-28.303, 61F10-28.303, Amended 1-30-96, Formerly 59X-28.303, Amended 2-5-07, 10-27-09, 2-
1-12, 4-20-14.
3. Florida ALF’s
WITH PHARMACY PERMIT
Follow the same procedures spelled out for Modified II permits
WITHOUT PHARMACY PERMIT
The facility may destroy on-site without the assistance of a consultant pharmacist. This type
of destruction should always be documented on a form of some type and witnessed by a
minimum of two people
18.23
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR PARTS 1300, 1301, 1304, 1305, 1307, and 1317
[Docket No. DEA-316]
RIN 1117-AB18
Disposal of Controlled Substances
FACILITIES OTHER THAN NURSING HOMES (page 100-101)
Issue: Commenters asked the DEA to clarify how hospitals, schools, summer camps, or
other entities may dispose of controlled substances that unintentionally end up in their possession
(e.g., when persons abandon controlled substances and return is not possible). Also, several
commenters asked the DEA to explain how controlled substances may be disposed of when the
ultimate user or other authorized person is unable to dispose of them due to death or
incapacitation.
Response: The DEA has limited authority regarding who may deliver pharmaceutical controlled
substances for the purpose of disposal. Pursuant to the Disposal Act, Congress granted the DEA
authority to authorize three groups of people to deliver controlled substances for the purpose of
disposal. First, an “ultimate user” who has lawfully obtained a pharmaceutical controlled
substance may deliver the substance to another person who is authorized to accept it for the
purpose of disposal. The CSA defines “ultimate user” as “a person who has lawfully obtained,
and who possesses, a controlled substance for his own use or for the use of a member of his
household or for an animal owned by him or by a member of his household.” 21 U.S.C. 802(27).
Second, if a person dies while lawfully in possession of a pharmaceutical controlled substance,
any person lawfully entitled to dispose of the decedent’s property may deliver the substance to
another person for the purpose of disposal. 21 CFR 1317.30. Third, LTCFs may dispose of
pharmaceutical controlled substances on behalf of ultimate users who reside or have resided at
such facilities. 21 U.S.C. 822(g). The DEA has no authority to expand the types of individuals
and entities lawfully permitted to deliver pharmaceutical controlled substances for the purpose of
disposal. The DEA has carefully considered its statutory authority, diversion risks, public safety,
convenience for ultimate users, and the interests of the public. The DEA believes that this rule
provides safe and convenient disposal options for ultimate users and other authorized persons.
The DEA understands that there may be circumstances where there is no authorized person to
dispose of the controlled substances, such as when controlled substances are abandoned at a
school or summer camp, and return to the ultimate user is not feasible. In such instances, the
affected entities should contact local law enforcement or their local DEA office for guidance on
proper disposal procedures.
18.24
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR PARTS 1300, 1301, 1304, 1305, 1307, and 1317
[Docket No. DEA-316]
RIN 1117-AB18
Disposal of Controlled Substances
CONTROL SUBSTANCE DESTRUCTION - FINAL RULE
NON-RETRIEVABLE STANDARD (Page 10)
Existing DEA regulations do not specify a standard to which controlled substances must
be destroyed. With this final rule, the DEA is implementing a standard of destruction—
nonretrievable— for registrants that destroy controlled substances, and procedures for the
destruction of controlled substances. 21 CFR 1300.05 (“non-retrievable”), 1317.90, and 1317.95.
The DEA is not requiring a particular method of destruction, so long as the desired result is
achieved. This standard is intended to allow public and private entities to develop a variety of
destruction methods that are secure, convenient, and responsible, consistent with preventing the
diversion of such substances. Destruction of controlled substances must also meet all other
applicable Federal, State, tribal, and local laws and regulations. Once a controlled substance is
rendered “non-retrievable,” it is no longer subject to the requirements of the DEA regulations.
Page 106
the DEA indicated that incineration and chemical digestion are some
examples of current technology that may be utilized to achieve the non-retrievable standard. The
preamble of the NPRM states that sewering (disposal by flushing down a toilet or sink) and
landfill disposal (mixing controlled substances with undesirable items such as kitty litter or coffee
grounds and depositing in a garbage collection) are examples of current methods of disposal that
do not meet the non-retrievable standard.
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18.26
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XI. PHARMACY OPERATIONAL ISSUES
1. Emergency CII orders – must get “original” within 7 days
2. Faxed C-II medications as original II – in the LTCF and Hospice.
“The term Long Term Care Facility (LTCF) means a nursing home, retirement care,
mental care or other facility or institution which provides extended health care to
resident patients.”
3. Partial Fills of a CII – may be partially filled for up to 60 days
Requirements:
1) Patient must be a resident of a Long Term Care Facility OR a terminally ill patient
2) The Pharmacist must record on the original prescription either “LTCF patient” or
“terminally ill”
3) For each partial filling, the dispensing pharmacist:
Must record on the back of the prescription or on another appropriate record, uniformly
maintained, and readily retrievable
(1) The date of the partial filling
(2) Quantity dispensed
(3) remaining quantity
(4) identification of the dispensing pharmacist
XII. Theft or Diversion
1. Report to administrator and director of nursing
2. If substantiated:
a. Submit DEA form 106 (available at http://www.deadiversion.usdoj.gov)
or may be submitted on line on an electronic version of Form 106
b. Report to AHCA
c. Report to local police
3. Types of Diversion in the nursing home
a. Removal of controlled substances and documentation
b. Reordering Controls when not needed
c. Ordering new Controls without a valid order
d. Diverting discontinued controls
e. Documenting Administration for orders not administered
f. Diversion from the Emergency Kit
g. Tampering with the dosage form ( ex. removing the contents of a capsule)
h. Diversion of used dosage Forms (used Duragesic patches)
XIII. Biennial Inventories
1. Facilities that are DEA registrants must do a complete inventory at least every other
year even if they maintain perpetual inventories
2. Nursing Homes are not required to do Biennial inventories since they are not DEA
registrants
3. The vendor Pharmacy is required to do biennial inventories and must include any
controlled substances in the Emergency Kits
18.28
XIII. Summary of Consultant Responsibilities
1. Oversight of the audit trail to ensure that controls can not diverted without the system
identifying the loss.
2. Ensure that “reconciliation” is occurring in the facility
3. Review of shift count procedures at each nursing unit
4. Review of security of Controlled Substances in the Emergency Kits
Suggestions:
1. Destroy discontinued controls frequently to prevent large supplies being stored in the facility
2. Destroy controls prior to any change in D.O.N. or consultant
18.29
NURSING HOME
SAMPLE POLICY & METHODS
DISPOSITION OF CONTROL DRUGS
POLICY:
It is the policy of this facility to dispose of control drugs in accordance with all state and
federal laws.
METHOD:
All control drugs which have been discontinued or control drugs not being sent home with
discharged patients will be returned to the drug enforcement agency for destruction.
When control drugs are to be removed from the nursing unit, the nurse in charge will
prepare a disposal of medication form, indicating the name of the patient, prescription
number, name of the drug, quantity of drug, and signature of the nurse in charge. This
form along with the medication and the proof of use sheet will be returned promptly to the
director of nursing office. The director of nursing and the consultant pharmacist will
certify as to the accuracy of the disposal of medication form and both will sign this form if
correct. This form and the proof of use sheet will be maintained in the patient medical
record or as a separate file.
The consultant pharmacist with the other two witnesses will prepare DEA Form 41. Each
entry will indicate the patient name, RX number, name of the control drug, strength, and
the quantity.
The DEA Form 41 will be mailed to DEA within one day f the destruction.
18.30
NURSING HOME
SAMPLE POLICY & METHODS
PROOF OF USE FORMS
POLICY:
It is the policy of this facility that the administration of all control substances shall be
properly recorded on a proof of use form and retained in the patient records as required by
law.
METHODS:
1. When receiving a control substance (II through V), a proof of use form shall be
properly completed listing the name of the patient, the name, strength, and quantity
of the drug.
2. When administering a control drug this proof of use form will be properly
completed listing the drug given, the time of administration, and the signature of
the licensed person administering the drug.
3. If any control drug is wasted for any reason, an explanation shall be promptly
recorded on the back of this form and witnessed by another licensed person.
4. When this form is completed is shall be retained on the patients chart.
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18.32
CONTROLLED SUBSTANCES
AUDIT
FACILITY:
_________________________________
DATE: ___________
Resident's Name Drug & Strength Control Log Count
Doses on MAR/PRN Notes
18.33
NARCOTIC SHIFT COUNT
UNIT: MONTH YEAR
DATE E.D.K.
LOCK
* G or Y
NURSE
OFFGOING
7AM
NURSE
ONCOMING
7AM
E.D.K.
LOCK
* G or Y
NURSE
OFFGOING
3PM
NURSE
ONCOMING
3PM
E.D.K.
LOCK
* G or Y
NURSE
OFFGOING 11PM
NURSE ONCOMING
11PM
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
* G = Green Lock
L= Yellow Lock
Nursing: If Yellow lock Present, please Document lock Number And contact Pharmacy To replace kit
18.34
18.35
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18.37
IIB14: TRANSDERMAL DRUG DELIVERY SYSTEM (PATCH) APPLICATION
Purpose
To administer medication through the skin for continuous absorption while the patch is in place, through proper
placement of the patch and care of the application sites.
Equipment Required
1. Medication patch
2. Alcohol wipes
3. Medication Administration Record (MAR)
Procedures
A. Identify the location on the body for patch placement.
B. Remove old patch from body.
C. Cleanse area of old patch with alcohol wipe.
D. Remove new patch from package and envelope.
E. Label patch with date and nurse’s initials.
F. Apply new patch firmly against skin.
G. Wash your hands.
H. Document placement site on MAR as follows:
SITE CODE
Left upper arm LA
Right upper arm RA
Left upper thigh LT
Right upper thigh RT
Left chest LC
Right chest RC
Left upper back LB
Right upper back RB
For transdermal scopolamine:
Behind left ear LE
Behind right ear RE
I. Fentanyl patches maintain up to 84% of the Fentanyl when replaced. To prevent diversion
each used patch should be documented on a Fentanyl Destruction Log and destroyed by flushing.
The destruction should be witnessed by a second nurse with both signatures appearing on the
Destruction Log.
18.38
FENTANYL PATCH DESTRUCTION LOG
{affix pharmacy label here}
MONTH: _______________________
DAY OF MONTH TIME OF REMOVAL
SIGNATURE OF NURSE DESTROYING PATCH SIGNATURE OF NURSE WITNESS
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
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18.40
18.41
18.42
18.43
18.44
Designating Agent of Practitioner For
Communicating Controlled Substance
Prescriptions to Pharmacies
_______________________________________ (Name of registered individual practitioner)
__________________________________________________________________________ (Address as it appears on certificate of registration)
__________________________
(DEA registration number)
I, _______________________ (name of registrant), the undersigned, who is authorized to dispense (including
prescribe) controlled substances in Schedules II, III, IV, and V under the Controlled Substances Act, hereby authorize _______________________ (name of agent), to act as my agent only for the
following limited purposes:
1. To prepare, for my signature, written prescriptions for controlled substances in those instances where I
have expressly directed the agent to do so and where I have specified to the agent the required elements of the
prescription (set forth in 21 CFR 1306.05).
2. To convey to a pharmacist by telephone oral prescriptions for controlled substances in Schedules III,
IV, and V in those instances where I have expressly directed the agent to do so and where I have specified to the
agent the required elements of the prescription (set forth in 21 CFR 1306.05).
3. To transmit by facsimile to a pharmacy prescriptions for controlled substances in those instances where I
have expressly directed the agent to do so and where I have specified to the agent the required elements of the
prescription (set forth in 21 CFR 1306.05) and I have signed the prescription.
This authorization is not subject to further delegation to other persons. Both the undersigned DEA-registered
individual practitioner and the undersigned agent understand and agree that the practitioner is solely responsible for
making all medical determinations relating to prescriptions for controlled substances communicated by the agent
pursuant to this agreement, and for ensuring that all such prescriptions conform in all other essential respects to the
law and regulations.
The undersigned agent understands he or she does not have authority to make any medical determinations. The
undersigned DEA-registered prescribing practitioner further understands that the prescribing practitioner must
personally communicate all Schedule II emergency oral prescriptions to the pharmacist.
Both the undersigned practitioner and agent understand that the agent may not call in an emergency oral prescription
for a Schedule II controlled substance on behalf of the practitioner.
This agency agreement shall be terminated immediately if and when any of the following occur:
1. The undersigned practitioner no longer possesses the active DEA registration specified in this agreement.
2. The undersigned agent is no longer employed in the manner described in this agreement.
3. The practitioner or the agent revokes this agency agreement by completing the revocation section at the
end of this document or by executing a written document that is substantially similar to the revocation
section at the end of this document.
________________________ (Signature of practitioner)
18.45
AGENT
I, _________________________ (name of agent), hereby affirm that I am the person named herein as agent and
that the signature affixed hereto is my signature. I further affirm that I am a ____________(title), licensed in the State of Florida, and (if applicable) am employed by/under contract with
___________________________ (name of employer or contracting entity). I agree to abide by
all the terms of this agreement and to comply with all applicable laws and regulations relating to controlled
substances.
______________________________ _______________________________________
(Signature of agent) (State license number of agent where applicable)
________________________________________________ (Name of employer/contracting entity where applicable)
________________________________________________
(Address of employer/contracting entity where applicable)
Witnesses:
1. ___________________________________ 2. _______________________________________
Signed and dated on the _____ day of ______ (month), ____________ (year), at _______________.
Revocation
The foregoing agency agreement is hereby revoked by the undersigned. The agent is no longer authorized to
communicate Schedule III, IV and V controlled substance prescriptions to a pharmacy on my behalf. A copy of this
revocation has been given to the agent this same day.
__________________________________________
(Signature of registered practitioner revoking power)
Witnesses:
1. ___________________________ 2. ___________________________
Signed and dated on the ______day of ___________ (month) ____________ (year), at _____________.
Note: DEA recommends that the original signed agency agreement be kept by the practitioner during the term of the
agency relationship and for a reasonable period after termination or revocation. Suggested retention policy is 2 years.
18.46
PREPARING FOR FACILITY NURSES ACTING AS PRESCRIBER AGENTS
ACTION STEPS:
1. Contact prescribers to see if they are willing to use facility nurses as agents
2. Identify which nurses will act as prescriber agents
3. Complete DEA written agreements between willing prescribers and facility nurses
4. Facility will need to maintain a database of these agreements so that staff changes are carried
through. This includes revoking agreements for employees that leave, adding new nurses and
new prescribers
5. Prepare procedures which need to be incorporated into the pharmacy P&P manual
6. Train nursing staff on necessary elements for a controlled prescription
NOTES:
1. This agreement does not affect Schedule II drugs. These must still be handled by the
prescriber.
2. A controlled substance prescription must include:
1) patient name
2) patient address (must be address of facility not facility name)
3) drug name and strength
4) quantity
5) refill instructions
6) Doctor’s address
7) Doctor’s DEA number
3. I would suggest that the nurse document “Agent” next to his/her name on the telephone
order to reflect a current agreement with the prescriber.
18.47
U. S. Department of Justice
Drug Enforcement Administration
8701 Morrisette Drive
Springfield, Virginia 22152
www.dea.gov
OCT 1.5 2008 Dear Colleague:
On November 19, 2007, the Drug Enforcement Administration (DEA) published in the
Federal Register (FR) the Final Rule entitled Issuance of Multiple Prescriptions for Schedule 11
Controlled Substances (72 FR 64921). In the preamble to that Rule, DEA stated that "the
essential elements of the [schedule 11] prescription written by the practitioner (such as the name
of the controlled substance, strength, dosage form, and quantity prescribed) . , . may not be modified orally."
The instructions contained in the Rule's preamble are in opposition to policy posted on the
DEA Diversion website regarding changes a pharmacist may make to a schedule II prescription
after oral consultation with the prescriber, In a Question and Answer section, the website
instructed that a "pharmacist may change or add the dosage form, drug strength, drug
quantity, directions for use, or issue date only after consultation with and agreement of the
prescribing practitioner."
DEA recognizes the resultant confusion regarding this conflict and plans to resolve this
matter through a future rulemaking. Until that time, pharmacists are instructed to adhere to
state regulations or policy regarding those changes that a pharmacist may make to a schedule
II prescription after oral consultation with the prescriber.
Questions regarding this correspondence may be directed to the Liaison and Policy Section,
Office of Diversion Control, DEA at (202) 307.7297.
18.48
18.49
18.50
18.51
18.52
FEDERAL CODE REGARDING CONTROLLED SUBSTANCES IN LONG TERM CARE
§ 1301.27 Separate registration by retail pharmacies for installation and operation of automated dispensing systems at long term care facilities.
(a) A retail pharmacy may install and operate automated dispensing systems, as defined in §1300.01 of this chapter, at long term care facilities, under the requirements of §1301.17. No person other than a registered retail pharmacy may install and operate an automated dispensing system at a long term care facility.
(b) Retail pharmacies installing and operating automated dispensing systems at long term care facilities must maintain a separate registration at the location of each long term care facility at which automated dispensing systems are located. If more than one registered retail pharmacy operates automated dispensing systems at the same long term care facility, each retail pharmacy must maintain a registration at the long term care facility.
(c) A registered retail pharmacy applying for a separate registration to operate an automated dispensing system for the dispensing of controlled substances at a long term care facility is exempt from application fees for any such additional registrations.
[70 FR 25465, May 13, 2005]
****************************************************************************************************
Section 1306.11 Requirement of prescription.
(a) A pharmacist may dispense directly a controlled substance listed in Schedule II, which is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act, only pursuant to a written prescription signed by the practitioner, except as provided in paragraph (d) of this section. A prescription for a Schedule II controlled substance may be transmitted by the practitioner or the practitioner's agent to a pharmacy via facsimile equipment, provided that the original written, signed prescription is presented to the pharmacist for review prior to the actual dispensing of the controlled substance, except as noted in paragraph (e), (f), or (g) of this section. The original prescription shall be maintained in accordance with Sec. 1304.04(h) of this chapter.
(b) An individual practitioner may administer or dispense directly a controlled substance listed in Schedule II in the course of his professional practice without a prescription, subject to Sec. 1306.07.
(c) An institutional practitioner may administer or dispense directly (but not prescribe) a controlled substance listed in Schedule II only pursuant to a written prescription signed by the prescribing individual practitioner or to an order for medication made by an individual practitioner which is dispensed for immediate administration to the ultimate user.
18.53
(d) In the case of an emergency situation, as defined by the Secretary in Sec. 290.10 of this title, a pharmacist may dispense a controlled substance listed in Schedule II upon receiving oral authorization of a prescribing individual practitioner, provided that:
(1) The quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period (dispensing beyond the emergency period must be pursuant to a written prescription signed by the prescribing individual practitioner);
(2) The prescription shall be immediately reduced to writing by the pharmacist and shall contain all information required in Sec. 1306.05, except for the signature of the prescribing individual practitioner;
(3) If the prescribing individual practitioner is not known to the pharmacist, he must make a reasonable effort to determine that the oral authorization came from a registered individual practitioner, which may include a callback to the prescribing individual practitioner using his phone number as listed in the telephone directory and/or other good faith efforts to insure his identity; and
(4) Within 7 days after authorizing an emergency oral prescription, the prescribing individual practitioner shall cause a written prescription for the emergency quantity prescribed to be delivered to the dispensing pharmacist. In addition to conforming to the requirements of Sec. 1306.05, the prescription shall have written on its face "Authorization for Emergency Dispensing," and the date of the oral order. The written prescription may be delivered to the pharmacist in person or by mail, but if delivered by mail it must be postmarked within the 7 day period. Upon receipt, the dispensing pharmacist shall attach this prescription to the oral emergency prescription which had earlier been reduced to writing. The pharmacist shall notify the nearest office of the Administration if the prescribing individual practitioner fails to deliver a written prescription to him; failure of the pharmacist to do so shall void the authority conferred by this paragraph to dispense without a written prescription of a prescribing individual practitioner.
(5) Central fill pharmacies shall not be authorized under this paragraph to prepare prescriptions for a controlled substance listed in Schedule II upon receiving an oral authorization from a retail pharmacist or an individual practitioner.
(e) A prescription prepared in accordance with Sec. 1306.05 written for a Schedule II narcotic substance to be compounded for the direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous or intraspinal infusion may be transmitted by the practitioner or the practitioner's agent to the pharmacy by facsimile. The facsimile serves as the original written prescription for purposes of this paragraph (e) and it shall be maintained in accordance with Sec. 1304.04(h) of this chapter.
(f) A prescription prepared in accordance with Sec. 1306.05 written for Schedule II substance for a resident of a Long Term Care Facility may be transmitted by the practitioner or the practitioner's agent to the dispensing pharmacy by facsimile. The facsimile serves as the original written prescription for purposes of this paragraph (f) and it shall be maintained in accordance with Sec. 1304.04(h).
(g) A prescription prepared in accordance with Sec. 1306.05 written for a Schedule II narcotic substance for a patient enrolled in a hospice care program certified and/or paid for by Medicare under Title XVIII or a hospice program which is licensed by the state may be transmitted by the practitioner or the practitioner's agent to the dispensing
18.54
pharmacy by facsimile. The practitioner or the practitioner's agent will note on the prescription that the patient is a hospice patient. The facsimile serves as the original written prescription for purposes of this paragraph (g) and it shall be maintained in accordance with § 1304.04(h) of this chapter.
[36 FR 7799, Apr. 24, 1971, as amended at 36 FR 18733, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973 and amended at 53 FR 4964, Feb. 19, 1988; 59 FR 26111, May 19, 1994; 59 FR 30832, June 15, 1994; 62 FR 13964, Mar. 24, 1997; 65 FR 45713 July 25, 2000; 68 FR 37410, June 24, 2003]
18.55
NURSING HOME
SAMPLE POLICY & METHODS
CONTROLLED DRUG POLICY AND PROCEDURE
OBJECTIVE:
1. To provide physical facilities and method of operation for the administration and
control of Schedule II-V drugs, which will meet the requirements of state and
federal narcotic enforcement agencies.
2. To ensure maximum safety for residents and nursing personnel.
THE NARCOTIC BOX:
A separate locked compartment for control drugs is provided within a locked cart. The
compartment has a special lock and key and must be kept locked at all times.
THE NARCOTIC KEY:
1. The narcotic key shall be in the possession of the charge nurse, or a nurse
especially designated by her during her hours of duty.
2. Upon being relieved from duty, the nurse shall transfer the key to the nurse taking
her place.
3. The nurse shall have the key in his/her possession at all times while on duty. The
key shall not be left lying around loose.
4. The narcotic key is not to be given to private duty nurses, or any other nurse not
responsible, or to doctors, nurses aides, or practical nurses who are not permitted
to give medications.
THE NARCOTIC COUNT AND INVENTORY:
1. Control drugs are counted every 8 hour tour by the nurse reporting on duty with
the nurse reporting off duty.
2. The inventory of the control drugs must be recorded on the narcotic records and
signed for correctness of count.
3. The controlled drug check list must be signed by the nurse coming on duty and
going off duty to verify that the count of all control drugs is correct.
18.56
4. If a discrepancy is found, check the resident’s order sheets and chart to see if a
narcotic has been administered and not recorded. Check previous recording on the
control sheets for mistakes in arithmetic. If the cause of the discrepancy cannot be
located and/or the count does not balance, report the matter to the supervisor and
director of nursing.
5. In counting control drugs, the nurse must be alert for any evidence of a
substitution. Inspect tablets and solutions closely, noting any defects in drug
container. Any suspicion of substitution or tampering with controlled drugs must
be reported to the supervisor immediately.
6. All control drug discrepancies require the initiation of an incident report. This
incident report shall be reviewed by the consultant pharmacist, medical director,
and administrator and reported at the next pharmacy services committee meeting.
18.57
Code of Federal Regulations for
Controlled Substances Ordering System (CSOS)
_________________________________________________________
Section 1305.21 Requirements for electronic orders.
(a) To be valid, the purchaser must sign an electronic order for a Schedule I or II controlled substance with a digital signature issued to the purchaser, or the purchaser's agent, by DEA as provided in part 1311 of this chapter.
(b) The following data fields must be included on an electronic order for Schedule I and II controlled substances:
(1) A unique number the purchaser assigns to track the order. The number must be in the following 9-character format: the last two digits of the year, X, and six characters as selected by the purchaser.
(2) The purchaser's DEA registration number.
(3) The name of the supplier.
(4) The complete address of the supplier (may be completed by either the purchaser or the supplier).
(5) The supplier's DEA registration number (may be completed by either the purchaser or the supplier).
(6) The date the order is signed.
(7) The name (including strength where appropriate) of the controlled substance product or the National Drug Code (NDC) number (the NDC number may be completed by either the purchaser or the supplier).
(8) The quantity in a single package or container.
(9) The number of packages or containers of each item ordered.
(c) An electronic order may include controlled substances that are not in schedules I and II and non-controlled substances.
Section 1305.22 Procedure for filling electronic orders.
(a) A purchaser must submit the order to a specific supplier. The supplier may initially process
the order (e.g., entry of the order into the computer system, billing functions, inventory
identification, etc.) centrally at any location, regardless of the location's registration with DEA.
Following centralized processing, the supplier may distribute the order to one or more registered
locations maintained by the supplier for filling. The registrant must maintain control of the
processing of the order at all times.
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(b) A supplier may fill the order for a Schedule I or II controlled substance, if possible and if the
supplier desires to do so and is authorized to do so under §1305.06.
(c) A supplier must do the following before filling the order:
(1) Verify the integrity of the signature and the order by using software that complies with Part
1311 of this chapter to validate the order.
(2) Verify that the digital certificate has not expired.
(3) Check the validity of the certificate holder's certificate by checking the Certificate Revocation
List. The supplier may cache the Certificate Revocation List until it expires.
(4) Verify the registrant's eligibility to order the controlled substances by checking the certificate
extension data.
(d) The supplier must retain an electronic record of every order, and, linked to each order, a
record of the number of commercial or bulk containers furnished on each item and the date on
which the supplier shipped the containers to the purchaser. The linked record must also include
any data on the original order that the supplier completes. Software used to handle digitally
signed orders must comply with part 1311 of this chapter.
(e) If an order cannot be filled in its entirety, a supplier may fill it in part and supply the balance
by additional shipments within 60 days following the date of the order. No order is valid more
than 60 days after its execution by the purchaser, except as specified in paragraph (h) of this
section.
(f) A supplier must ship the controlled substances to the registered location associated with the
digital certificate used to sign the order, except as specified in paragraph (h) of this section.
(g) When a purchaser receives a shipment, the purchaser must create a record of the quantity of
each item received and the date received. The record must be electronically linked to the original
order and archived.
(h) Registered procurement officers of the Defense Supply Center of the Defense Logistics
Agency may order controlled substances for delivery to armed services establishments within the
United States. These orders may be shipped to locations other than the registered location, and in
partial shipments at different times not to exceed six months from the date of the order, as
designated by the procurement officer when submitting the order.
Section 1305.23 Endorsing electronic orders.
A supplier may not endorse an electronic order to another supplier to fill.
Section 1305.24 Central processing of orders.
(a) A supplier that has one or more registered locations and maintains a central processing computer system in which orders are stored may have one or more of the supplier's registered locations fill an electronic order if the supplier does the following:
(1) Assigns each item on the order to a specific registered location for filling.
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(2) Creates a record linked to the central file noting both which items a location filled and the location identity.
(3) Ensures that no item is filled by more than one location.
(4) Maintains the original order with all linked records on the central computer system.
(b) A company that has central processing of orders must assign responsibility for filling parts of orders only to registered locations that the company owns and operates.
Section 1305.25 Unaccepted and defective electronic orders.
(a) No electronic order may be filled if:
(1) The required data fields have not been completed.
(2) The order is not signed using a digital certificate issued by DEA.
(3) The digital certificate used had expired or had been revoked prior to signature.
(4) The purchaser's public key will not validate the digital signature.
(5) The validation of the order shows that the order is invalid for any reason.
(b) If an order cannot be filled for any reason under this section, the supplier must notify the purchaser and provide a statement as to the reason (e.g., improperly prepared or altered). A supplier may, for any reason, refuse to accept any order, and if a supplier refuses to accept the order, a statement that the order is not accepted is sufficient for purposes of this paragraph.
(c) When a purchaser receives an unaccepted electronic order from the supplier, the purchaser must electronically link the statement of nonacceptance to the original order. The original order and the statement must be retained in accordance with §1305.27.
(d) Neither a purchaser nor a supplier may correct a defective order; the purchaser must issue a new order for the order to be filled.
Section 1305.26 Lost electronic orders.
(a) If a purchaser determines that an unfilled electronic order has been lost before or after receipt, the purchaser must provide, to the supplier, a signed statement containing the unique tracking number and date of the lost order and stating that the goods covered by the first order were not received through loss of that order.
(b) If the purchaser executes an order to replace the lost order, the purchaser must electronically link an electronic record of the second order and a copy of the statement with the record of the first order and retain them.
(c) If the supplier to whom the order was directed subsequently receives the first order, the supplier must indicate that it is “Not Accepted” and return it to the purchaser. The purchaser must link the returned order to the record of that order and the statement.
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Section 1305.27 Preservation of electronic orders.
(a) A purchaser must, for each order filled, retain the original signed order and all linked records for that order for two years. The purchaser must also retain all copies of each unaccepted or defective order and each linked statement.
(b) A supplier must retain each original order filled and the linked records for two years.
(c) If electronic order records are maintained on a central server, the records must be readily retrievable at the registered location.
Section 1305.28 Canceling and voiding electronic orders.
(a) 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 copy of the order, indicate on the copy “Void,” and return it to the purchaser. The supplier is not required to retain a record of orders that are not filled.
(b) The purchaser must retain an electronic copy of the voided order.
(c) To partially void an order, the supplier must indicate in the linked record that nothing was shipped for each item voided.
Section 1305.29 Reporting to DEA.
A supplier must, for each electronic order filled, forward either a copy of the electronic order or an electronic report of the order in a format that DEA specifies to DEA within two business days.
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1306 [Docket No. DEA–287F] RIN 1117–AB01
Issuance of Multiple Prescriptions for Schedule II Controlled Substances
AGENCY: Drug Enforcement Administration (DEA), Department of Justice
ACTION: Final rule.
SUMMARY: The Drug Enforcement Administration (DEA) is finalizing a Notice of Proposed Rulemaking published on
September 6, 2006 (71 FR 52724). In that document, DEA proposed to amend its regulations to allow practitioners to provide
individual patients with multiple prescriptions, to be filled sequentially, for the same schedule II controlled substance, with such
multiple prescriptions having the combined effect of allowing a patient to receive over time up to a 90-day supply of that
controlled substance.
DATES: Effective Date: This rule is effective December 19, 2007.
64930 Federal Register / Vol. 72, No. 222 / Monday, November 19, 2007 / Rules and Regulations (b)(1) An individual practitioner may issue multiple prescriptions authorizing the patient to receive a total of up to a 90-day
supply of a Schedule II controlled substance provided the following conditions are met:
(i) Each separate prescription is issued for a legitimate medical purpose by an individual practitioner acting in the usual
course of professional practice;
(ii) The individual practitioner provides written instructions on each prescription (other than the first prescription, if the
prescribing practitioner intends for that prescription to be filled immediately) indicating the earliest date on which a
pharmacy may fill each prescription;
(iii) The individual practitioner concludes that providing the patient with multiple prescriptions in this manner does not
create an undue risk of diversion or abuse;
(iv) The issuance of multiple prescriptions as described in this section is permissible under the applicable state laws; and
(v) The individual practitioner complies fully with all other applicable requirements under the Act and these regulations
as well as any additional requirements under state law.
(2) Nothing in this paragraph (b) shall be construed as mandating or encouraging individual practitioners to issue
multiple prescriptions or to see their patients only once every 90 days when prescribing Schedule II controlled
substances. Rather, individual practitioners must determine on their own, based on sound medical judgment, and in
accordance with established medical standards, whether it is appropriate to issue multiple prescriptions and how
often to see their patients when doing so.
■ 3. Section 1306.14 is amended by adding a new paragraph (e) to read as follows:
§ 1306.14 Labeling of substances and filling of prescriptions.
* * * * *
(e) Where a prescription that has been prepared in accordance with section 1306.12(b) contains instructions from the prescribing
practitioner indicating that the prescription shall not be filled until a certain date, no pharmacist may fill the prescription before
that date.
Dated: November 7, 2007.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E7–22558 Filed 11–16–07; 8:45 am]
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64B16-27.831 Standards of Practice for the Dispensing of Controlled Substances for Treatment of Pain. (1) An order purporting to be a prescription that is not issued for a legitimate medical purpose is not a
prescription and the pharmacist knowingly filling such a purported prescription shall be subject to
penalties for violations of the law.
(2) The following criteria shall cause a pharmacist to question whether a prescription was issued for a
legitimate medical purpose:
(a) Frequent loss of controlled substance medications,
(b) Only controlled substance medications are prescribed for a patient,
(c) One person presents controlled substance prescriptions with different patient names,
(d) Same or similar controlled substance medication is prescribed by two or more prescribers at same time,
(e) Patient always pays cash and always insists on brand name product.
(3) If any of the criteria in (2) is met, the pharmacist shall:
(a) Require that the person to whom medication is dispensed provide picture identification and the
pharmacist should photocopy such picture identification for the pharmacist’s records. If a photocopier is
not available, the pharmacist should document on the back of the prescription complete descriptive
information from the picture identification. If the person to whom medication is dispensed has no picture
identification, the pharmacist should confirm the person’s identity and document on the back of the
prescription complete information on which the confirmation is based.
(b) Verify the prescription with the prescriber. A pharmacist who believes a prescription for a controlled
substance medication to be valid, but who has not been able to verify it with the prescriber, may
determine not to supply the full quantity and may dispense a partial supply, not to exceed a 72 hour
supply. After verification by the prescriber, the pharmacist may dispense the balance of the prescription
within a 72 hour time period following the initial partial filling, unless otherwise prohibited by law.
(4) Every pharmacy permit holder shall maintain a computerized record of controlled substance
prescriptions dispensed. A hard copy printout summary of such record, covering the previous 60 day
period, shall be made available within 72 hours following a request for it by any law enforcement
personnel entitled to request such summary under authority of Section 465.017(2), F.S. Such summary
shall include information from which it is possible to determine the volume and identity of controlled
substance medications being dispensed under the prescription of a specific prescriber, and the volume
and identity of controlled substance medications being dispensed to a specific patient.
(5) Any pharmacist who has reason to believe that a prescriber of controlled substances is involved in the
diversion of controlled substances shall report such prescriber to the Department of Health.
(6) Any pharmacist that dispenses a controlled substance subject to the requirements of this rule when
dispensed by mail shall be exempt from the requirements to obtain suitable identification.
Specific Authority 465.005, 465.0155 FS. Law Implemented 456.072(1)(i), 465.0155, 465.016(1)(i), (o), 465.017(2) FS.
History–New 8-29-02, Amended 2-24-03, 11-18-07.
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Rules - 2003
FR Doc 03-17127 [Federal Register: July 8, 2003 (Volume 68, Number 130)] [Proposed Rules] [Page 40576-40579] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr08jy03-20]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1301
[Docket No. DEA-196P] RIN 1117-AA73
Reports by Registrants of Theft or Significant Loss of Controlled Substances
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice of proposed rulemaking; guidance.
SUMMARY: DEA is proposing the amendment of its regulations to clarify its policy regarding reports by registrants of theft or significant loss of controlled substances. There has been some confusion as to what constitutes a significant loss, and when and how initial notice of a theft or loss should be provided to DEA. This Notice of Proposed Rulemaking proposes the clarification of DEA regulations and provides guidance to registrants regarding the theft, significant loss and explained loss of controlled substances.
DATES: Written comments must be postmarked on or before September 8, 2003.
ADDRESSES: Comments should be sent to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537, Attention: DEA Federal Register Representative/CCR.
FOR FURTHER INFORMATION CONTACT: Patricia M. Good, Chief, Liaison and Policy Section, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537, Telephone (202) 307-7297.
SUPPLEMENTARY INFORMATION:
Background
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DEA is publishing this Notice of Proposed Rulemaking (NPRM) to propose the clarification of its policies and procedures regarding the reporting by registrants of the theft or significant loss of controlled substances.
Title 21, Code of Federal Regulations, Sec. 1301.74(c) "Other security controls for non-practitioners; narcotic treatment programs and compounders for narcotic treatment programs.'' requires that: "The registrant shall notify the Field Division Office of the Administration in his area of any theft or significant loss of any controlled substances upon discovery of such theft or loss. The supplier shall be responsible for reporting in-transit losses of controlled substances by the common or contract carrier selected pursuant to Sec. 1301.74(e), upon discovery of such theft or loss. The registrant shall also complete DEA Form 106 regarding such theft or loss. Thefts must be reported whether or not the controlled substances are subsequently recovered and/or the responsible parties are identified and action taken against them.''
Title 21, Code of Federal Regulations, Sec. 1301.76(b) "Other security controls for practitioners.'' further requires that: "The registrant shall notify the Field Division Office of the Administration in his area of the theft or significant loss of any controlled substances upon discovery of such loss or theft. The registrant shall also complete DEA (or BND) Form 106 regarding such loss or theft.''
A number of questions have arisen regarding the meaning of certain terms in these paragraphs. Specifically, there seems to be confusion within the regulated industry as to the exact meaning of the phrase "upon discovery''. Therefore, as further discussed below, DEA is proposing the amendment of the regulations to insert the word "immediately'' before the phrase "upon discovery'' to clarify this point. Further, DEA is proposing the amendment of its regulations to list certain factors which registrants should consider when determining whether a loss of controlled substances is significant. Finally, this document provides guidance to registrants on the reporting of breakage, spillage or other explained losses of controlled substances. No regulatory amendments are being proposed regarding this guidance.
Theft or Other Unexplained Significant Loss of Controlled Substances
What Is a DEA Registrant Required To Do When a Theft or Significant Loss Is Discovered?
Every DEA registrant is required to notify the DEA field office in their area of any theft or significant loss of controlled substances upon its discovery. DEA has always viewed "upon discovery'' to mean that notification should occur immediately and without delay. Every DEA registrant (practitioner, pharmacy, hospital/clinic, manufacturer, distributor, etc.) must comply with this requirement, and such compliance cannot be overridden by an internal corporate policy that is contrary to the notification requirement. For example, a DEA-registered pharmacy must provide notice to the local DEA field office when a theft or significant loss is discovered. This requirement is not satisfied by the reporting of the theft or significant loss internally to individuals in corporate management. DEA must be notified directly and immediately of the theft or significant loss of the controlled substances. A corporation that owns/operates multiple registered sites and wishes to channel all notifications through
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a central point such as corporate loss prevention, corporate security, or other corporate entity may do so but must still fulfill the requirement to provide notice to DEA immediately upon discovery by the actual registrant. However, this immediate notification does not always occur. Therefore, DEA is proposing the amendment of its regulations to insert the word "immediately'' before the phrase "upon discovery'' to clarify this point.
The purpose of immediate notification is to provide an opportunity for DEA, state, or local participation in the investigative process when warranted, and to create a record that the theft or significant loss was properly reported. It also alerts law enforcement to more broadly based circumstances and patterns of which the individual registrant may be unaware. This notification is considered part of a good-faith effort on the part of the regulated industries to maintain effective controls against the diversion of controlled substances, as required by 21 CFR 1301.71(a). Lack of prompt notification could prevent effective investigation and prosecution of individuals involved in the diversion of controlled substances. Withholding or failing to provide information is a violation of the law and regulations (21 U.S.C. 821, 21 U.S.C. 842(a)(5), 21 CFR 1301.74(c), 1301.76(b)).
How Should Notice of a Theft or Significant Loss Be Provided?
The regulations require that notice of a theft or significant loss must be reported to DEA upon its discovery. As noted above, DEA has always viewed "upon discovery'' to mean that
[[Page 40577]]
notification should occur immediately and without delay. Where circumstances of the theft or significant loss are immediately known, a DEA Form 106, Report of Theft or Loss of Controlled Substances, should be used to detail the circumstances of that theft or significant loss. When details concerning the specific circumstances surrounding the theft or loss are unknown at the time of discovery, DEA recommends initial notice be provided by faxing a short statement to DEA advising of the theft or significant loss. While such initial notice may alternatively be mailed, delays occuring due to the mailing process may hinder investigative efforts by DEA. A DEA Form 106, Report of Theft or Loss of Controlled Substances, is not immediately necessary. The registrant may then make efforts to determine the facts involved by conducting inventories, internal audits, and/or investigations using internal or law enforcement resources, as appropriate. The DEA Form 106 should be submitted once the circumstances surrounding the theft or significant loss are clear. The DEA Form 106 must document the circumstances of the theft or significant loss and the quantities of controlled substances involved. DEA recognizes that some time may elapse between the time initial notice of a theft or loss is provided and the conclusion of the investigation. DEA suggests that if an investigation takes more than two months to complete, registrants provide updates regarding the investigation to DEA. The conduct of an investigation does not obviate the need for immediate notification of the theft or significant loss by the registrant to the local DEA field office. If, after an investigation of the circumstances surrounding the disappearance of the material, it is determined that no theft or significant loss occurred, no DEA Form 106 need be filed.
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However, DEA recommends the registrant advise DEA that a DEA Form 106 is not needed or will not be filed regarding the incident.
What Other Actions Should a Registrant Take When a Theft or Significant Loss Occurs?
The theft of controlled substances from a registrant is a criminal act, and a source of controlled substances diversion requiring notification of DEA. Although not specifically required by DEA law or regulations, the registrant should also notify local law enforcement and state regulatory agencies. Prompt notification of law enforcement agencies will allow them to investigate the incident and prosecute those responsible for the diversion.
Complete accountability by a registrant for all controlled substances handled is a fundamental requirement of the closed distribution system mandated by the Controlled Substances Act (CSA). The CSA requires: "* * * every registrant under this title manufacturing, distributing, or dispensing a controlled substance or substances shall maintain, on a current basis, a complete and accurate record of each such substance manufactured, received, sold, delivered, or otherwise disposed of by him,* * *.'' (21 U.S.C. 827(a)(3)). No registrant should disregard any unexplained shortage of controlled substances. Registrants should treat an individual theft or significant loss seriously and should monitor occurrences so that patterns do not remain undetected. Record keeping must be accurate and complete so as to serve as a reliable reporting and recording device.
DEA has become aware of instances in which registrants have used a DEA Form 106 to document or explain minor inventory discrepancies, thereby "balancing the books.'' DEA wishes to stress that the DEA Form 106 should be used only to document thefts or significant losses of controlled substances. Minor inventory discrepancies, not attributable to theft, should not be reported to DEA or recorded on a DEA Form 106. Rather, registrants should make appropriate notations of minor inventory discrepancies in their records, indicating the amount of variance between the physical count and the amount accounted for through records. Such discrepancies need not be reported to DEA if they are not significant or actual losses. If a registrant is unsure of the significance of a loss after considering the factors described below, the registrant should file the report. Any continuing pattern of loss of seemingly insignificant quantities should always be considered significant.
What Specific Regulations Does This Rulemaking Propose To Amend?
Specifically, this rulemaking proposes the amendment of 21 CFR 1301.74(c) and 1301.76(b) to insert the word "immediately'' before the phrase "upon discovery'' to clarify the points raised in the previous discussion. Although not specifically mentioned in the previous discussion, such reports include the report by a supplier of in-transit thefts or losses of controlled substances by the common or contract carrier selected by the supplier pursuant to 21 CFR 1301.74(e). Further, this rulemaking proposes a minor technical correction to Sec. 1301.76(b) to remove the reference to BND Form 106, as this form is no longer used.
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Significant Loss of Controlled Substances
What Constitutes a Significant Loss?
Questions have arisen as to exactly what constitutes a "significant loss.'' There is no single objective standard which can be established and applied to all registrants to determine whether a loss is significant. Any unexplained loss or discrepancy should be reviewed within the context of a registrant's business activity and environment. What constitutes a significant loss for one registrant may be construed as comparatively insignificant for another. For example, the loss by a pharmacy of a 100-count bottle of controlled substance tablets would be viewed as significant, whereas the same loss by a full line distributor may be viewed differently, particularly if the loss is an unexplained inventory discrepancy that may have resulted from a picking error. A manufacturer may experience continuous losses in the manufacturing process due to atmospheric changes, mixing procedures, etc. Such losses may not be deemed by the registrant to be significant, and may be recorded in batch records. Conversely, for registrants other than manufacturers, the repeated loss of small quantities of controlled substances over a period of time may indicate a significant aggregate problem which must be reported to DEA, even though the individual quantity of each occurrence is not significant.
When determining whether a loss is significant, a registrant should consider, among others, the following factors: (1) The actual quantity of controlled substances lost in relation to the type of business; (2) A pattern of such losses, and the results of efforts taken to resolve them; and, if known, (3) Local trends and other indicators of the diversion potential of the missing material.
Specific questions which a registrant should ask to identify whether a loss is significant include, but are not limited to: (1) Has a pattern of loss been identified? Would this pattern result in a substantial loss of controlled substances over that period of time? (2) Are specific controlled substances being lost, and do the losses appear to be random? (3) Are the specific controlled substances likely candidates for diversion? (4) Can losses of controlled substances be associated with access to those
[[Page 40578]]
controlled substances by specific individuals? Can losses be attributed to unique activities which may take place involving the controlled substances?
Individual registrants should examine both their business activities and the external environment in which those business activities are conducted to determine whether unexplained losses of controlled substances are significant. When in doubt, registrants should err on the side of caution in alerting the appropriate law enforcement authorities, including DEA, of thefts and losses of controlled substances.
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What Specific Regulations Does This Rulemaking Propose To Amend?
Specifically, this rulemaking proposes the amendment of 21 CFR 1301.74(c) and 1301.76(b) to include the factors listed above as factors which a registrant should consider when determining whether a loss is significant and, thus, must be reported to DEA. DEA encourages registrants to use other criteria, as well as those factors listed above, which they have found to be useful in the evaluation of losses of controlled substances when determining whether such losses are significant, but is proposing the provision of these factors as the minimum which registrants should consider.
Guidance Regarding Breakage, Spillage and Other Explained Loss of Controlled Substances
What Is Required of a DEA Registrant When Breakage or Spillage Occurs?
DEA has encountered instances in which registrants have attempted to report spillages or explained losses of controlled substances on a DEA Form 106. The breakage, spillage or other witnessed controlled substance losses do not require the immediate notification of DEA. If controlled substance containers are broken or damaged, or controlled substances spilled, the substances are not considered "lost'' because they can be accounted for. When breakage, spillage or damage of controlled substances occurs, the affected controlled substances must be disposed of according to DEA requirements.
If there is breakage, spillage or other damage to controlled substances, but the controlled substances are still recoverable, then the registrant has two options for disposing of the controlled substances. The registrant may dispose of the controlled substances by either (1) Contacting their local DEA field office and receiving permission from that office to dispose of the controlled substances pursuant to 21 CFR 1307.21, or (2) the registrant may send those controlled substances to a firm registered with DEA to handle returns/ disposals.
If the registrant receives permission from DEA to dispose of the controlled substances pursuant to 21 CFR 1307.21, then that registrant must complete a DEA Form 41, Registrants Inventory of Drugs Surrendered, explaining the circumstances of the breakage. Two individuals who witnessed the breakage, spillage or damage must sign the DEA Form 41, indicating what they witnessed. Registrants must submit three copies of the DEA Form 41 to their local DEA field office (21 CFR 1307.21(a)(1)). Registrants are also required to maintain a copy of the DEA Form 41 in their records.
If the registrant sends the controlled substances to a DEA registered disposer, then the registrant must complete the necessary paperwork showing the distribution of the damaged controlled substances to the registered disposer.
If the breakage or spillage is clearly observed but the controlled substances are not recoverable, then the registrant must document the circumstances of the breakage in their inventory records. Two individuals who witnessed the breakage must sign the inventory records, indicating what they witnessed. These records must be maintained in the registrant's files.
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Regulatory Certifications
Regulatory Flexibility Act
The Deputy Assistant Administrator hereby certifies that this rulemaking has been drafted in accordance with the Regulatory Flexibility Act (5 U.S.C. 605(b)), has reviewed this regulation, and by approving it certifies that this regulation will not have a significant economic impact on a substantial number of small entities. This regulation seeks to clarify existing DEA regulations regarding the reporting of thefts and losses of controlled substances. No new recordkeeping or reporting requirements are proposed in this rulemaking.
Executive Order 12866
The Deputy Assistant Administrator further certifies that this rulemaking has been drafted in accordance with the principles in Executive Order 12866 Section 1(b). DEA has determined that this is not a significant rulemaking action. Therefore, this action has not been reviewed by the Office of Management and Budget. This rulemaking merely seeks to clarify existing DEA regulations, policies and procedures.
Executive Order 12988
This regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform.
Executive Order 13132
This rulemaking does not preempt or modify any provision of state law; nor does it impose enforcement responsibilities on any state; nor does it diminish the power of any state to enforce its own laws. Accordingly, this rulemaking does not have federalism implications warranting the application of Executive Order 13132.
Unfunded Mandates Reform Act of 1995
This rule will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more in any one year, and will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.
Small Business Regulatory Enforcement Fairness Act of 1996
This rule is not a major rule as defined by section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996. This rule will not result in an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets.
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List of Subjects in 21 CFR Part 1301
Administrative practice and procedure, Drug traffic control, Security measures.
For the reasons set out above, 21 CFR part 1301 is proposed to be amended as follows:
PART 1301--REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES
1. The authority citation for part 1301 continues to read as follows:
Authority: 21 U.S.C. 821, 822, 823, 824, 871(b), 875, 877.
2. Section 1301.74 is amended by revising paragraph (c) to read as follows:
[[Page 40579]]
Sec. 1301.74 Other security controls for non-practitioners; narcotic treatment programs and compounders for narcotic treatment programs.
* * * * *
(c) The registrant shall notify the Field Division Office of the Administration in his area of any theft or significant loss of any controlled substances immediately upon discovery of such theft or loss. The supplier shall be responsible for reporting in-transit losses of controlled substances by the common or contract carrier selected pursuant to Sec. 1301.74(e), immediately upon discovery of such theft or loss. The registrant shall also complete DEA Form 106 regarding such theft or loss. Thefts must be reported whether or not the controlled substances are subsequently recovered and/or the responsible parties are identified and action taken against them. When determining whether a loss is significant, a registrant should consider, among others, the following factors: (1) The actual quantity of controlled substances lost in relation to the type of business; (2) The specific controlled substances lost; (3) Whether the loss of the controlled substances can be associated with access to those controlled substances by specific individuals, or whether the loss can be attributed to unique activities which may take place involving the controlled substances; (4) A pattern of such 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, (5) Whether the specific controlled substances are likely candidates for diversion; (6) Local trends and other indicators of the diversion potential of the missing material.
* * * * *
3. Section 1301.76 is amended by revising paragraph (b) to read as follows:
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Sec. 1301.76 Other security controls for practitioners.
* * * * *
(b) The registrant shall notify the Field Division Office of the Administration in his area of the theft or significant loss of any controlled substances immediately upon discovery of such loss or theft. The registrant shall also complete DEA Form 106 regarding such loss or theft. When determining whether a loss is significant, a registrant should consider, among others, the following factors: (1) The actual quantity of controlled substances lost in relation to the type of business; (2) The specific controlled substances lost; (3) Whether the loss of the controlled substances can be associated with access to those controlled substances by specific individuals, or whether the loss can be attributed to unique activities which may take place involving the controlled substances; (4) A pattern of such 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, (5) Whether the specific controlled substances are likely candidates for diversion; (6) Local trends and other indicators of the diversion potential of the missing material.
* * * * *
Dated: June 25, 2003.
Laura M. Nagel, Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. 03-17127 Filed 7-7-03; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an unofficial version. An official version of this publication may be obtained directly from the Government Printing Office (GPO).