Controlled Substances Flashcards
1
Q
Dispensers (practitioners and pharmacies) of CS must register with the DEA…
A
initially and reregister every 3 years (does not apply to pharmacists, interns)
2
Q
Pharmacies secure their DEA # using…
A
a DEA 224 form
3
Q
CS inventories are performed…
A
every 2 years (biennially)
4
Q
Controlled Substances Inventory- records for CS must contain…
A
- date and time inventory was taken
- form and strength of CS
- Schedule II CS requires an exact count or measure (keep a separate inventory record)
5
Q
Schedule III, IV, and V- records- an exact count must be taken if…
A
the container holds more than 1000 tabs or caps. Otherwise, can take an estimated count.
6
Q
CS records must be kept for at least…
A
2 years form the date of the inventory
7
Q
Newly introduced CS or changes in scheduling of a substance must be taken on the…
A
effective “date of” the schedule change (only for this CS, complete inventory is not required)
8
Q
Schedule II controlled substances must be obtained from a supplier by using…
A
DEA Form 222 (triplicate format signed designee does not need to be a pharmacist)
9
Q
Form 222 is the vehicle for moving…
A
Schedule II drugs
10
Q
Form 222 are serially numbered and issued by the DEA with…
A
name, address, registration #, authorized activity, and schedules of the registrants
11
Q
Each DEA 222 form contains an…
A
original, duplicate, and triplicate copies (written on upon receipt of drugs)
12
Q
The DEA 222 form is valid for…
A
not more than 60 days after its execution by the purchaser
13
Q
The DEA 22 form must be signed either by the…
A
person who signed the most recent application for registration or reregistration, or by a person authorized to obtain and executive order forms by a power of attorney
14
Q
Copy 3 must be retained by…
A
the purchaser. Upon receipt of Schedule II CS by the pharmacy must be recorded (on the retained Copy 3): the # of commercial or bulk containers furnished on each item and date on which the containers are received
15
Q
DEA 222 forms must be maintained at the registered location for at least…
A
2 years from their execution
16
Q
Loss or theft of DEA 222 forms must be…
A
reported immediately to the DEA (must include the serial numbers on each form lost or stolen)
17
Q
Theft or Loss of CS must be filed using….
A
DEA Form 106
18
Q
Disposal of CS must be accomplished by…
A
submitted DEA Form 41
19
Q
Transfer records of CS must be…
A
kept for at least 2 years and a record of transaction should be delivered to an agent of the DEA or the nearest office of the DEA
20
Q
Transfer records of CS must contain:
A
- name, dosage form, and strength
- number of commercial containers of each finished form transferred
- date of the transfer of CS
- name, address, and registration number of the transferee
21
Q
methadone 5 and 10 mg are for…
A
treatment of pain
22
Q
methadone 40 mg is…
A
only available at hospitals and facilities authorized for detoxification and maintenance treatment of opioid addiction
23
Q
Schedule III prescriptions may be orally…
A
ordered by the practitioner (follow up with the postmarked within the 7-day period). If practitioner fails to deliver the written Rx required, the dispensing pharmacist must notify the regional office of the DEA.
24
Q
Faxed prescriptions for CS must have:
A
- ID number of fax machine used to send Rx
- date and time of transmission
- name, address, phone and fax # of pharmacy
- full name and title of agent authorized to transmit fax is not prescriber himself
25
Schedule II CS may b sent via fax to a dispensing pharmacy to...
facilitate dispensing of the Rx
26
A schedule II CS faxed Rx may serve as the original, signed Rx when:
* the narcotic Rx calling for the compounding of an IV solution for direct administration to a patient in a private residence, long-term care facility, or hospice setting
* the narcotic Rx issued for a patient enrolled in a hospice care program certified and/or paid for by Medicare under Title XVIII (18) or licensed by state law may serve as the original Rx. The prescriber, or his or her agent, must write on the Rx that the patient is a hospice patient.
27
CS- Required info. on the Rx:
* name of the CS
* finished form of the CS (dosage form and strength)
* name and address of the person to whom it was dispensed
* date of dispensing
* # of units or quantity dispensed
* written or typewritten name or initials who dispensed CS
* serial # of the Rx
28
CS Label Requirements:
* name and address of the pharmacy
* serial # assigned to the Rx
* date of the initial filling of the Rx (fore refills, the date originally filled)
* name of the patient
* name of the prescribing practitioner
* directions for use, and cautionary statements
* Schedule II, III, and IV CS the transfer warning: "Caution: federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed"
29
Schedule II Rx must be dispensed within...
72 hours of the first partial filling. If, for any reason, the balance is not dispensed within the 72-hr period, the pharmacist must notify the prescribing practitioner (exception: up to 60 days for terminally ill or LTCF patient)
30
Transferring Pharmacy must write "VOID" on the face of the Rx. Transferring pharmacy must write on back of Rx:
* name, address, and DEA # of pharmacy receiving the Rx
| * the name of pharmacist receiving Rx info., the date of the transfer, and the name of the pharmacist transferring info
31
Receiving pharmacy must write "transfer" on face of the Rx. Receiving pharmacy must write...
* the date of issuance of original Rx
* original # of refills
* # of refills remaining
* date of last refill
* name and address
* DEA #
* original Rx #
* the name of the transferring pharmacist
32
Dispensing CS without a Rx (only by a pharmacist and must be done in good faith). May not give more than...
8 oz. of any substance containing opium, 4 oz of any other CS, 48 dosage units of any substance containing opium, or 24 dosage units of any other CS may be dispensed to the same purchaser in any 48-hr period
33
Purchasers of CS (w/o a Rx) must be...
* at least 18 y/o
* must show ID (if unknown to pharmacist)
* a bound record book must be maintained for 2 yrs
34
Bound record book of CS must contain...
* name and address of the purchaser
* name and quantity of CS purchased
* date of each purchased
* name or initials of the pharmacist who dispensed the substance
35
Drug samples may only be distributed upon written request of a practitioner. Manufacturers must maintain records of each every sample distribution for...
a period of 3 years
36
All Rx medications, including CS and narcotics in Schedules II-V, may be mailed...
from a physician or pharmacist pursuant to a Rx. No markings of any kind may be on the outside wrapper or container indicating the nature of the contents.
37
Flammable substances (eg. acetone) and alcoholic beverages may not...
be sent to a patient through the U.S. mail
38
When methadone or any CII is used for detoxification and maintenance of narcotic addiction, then...
the practitioners must obtain a separator DEA registration as a narcotic tx program and register with the SAMHSA of the DHHS
39
Manufacturers of controlled dangerous substances shall...
pay an annual fee of $400.00 at the time of application for registration or for renewal of registration
40
Distributors and reverse distributors of controlled dangerous substances shall...
pay an annual fee of $200.00 at the time of application for registration or for renewal of registration.
41
Dispensers of controlled dangerous substances or practitioners registered to conduct research with controlled dangerous substances shall:
pay an annual fee of $40.00 at the time of application for registration or for renewal of registration.
42
Incorporated humane societies or licensed animal control facilities registered to purchase
and administer sodium pentobarbital for the purpose of animal euthanasia shall pay...
an annual fee of $40.00 for registration or renewal of registration as a Dispenser in the category
of hospital/clinic.
43
A separate fee shall be paid...
for each separate place of business or professional practice for which registration is required.
44
The following persons shall be exempt from payment of a fee for registration or renewal of registration:
1) Any hospital, clinic, institution, or other facility operated by any department of the State
of New Jersey;
2) Any other agency, excluding individual State employees, for which the State of New
Jersey would be responsible for payment of the fee, provided that such exemption is
approved by the Director of the Division of Consumer Affairs in the Department of Law
and Public Safety; and
3) Hospitals and other facilities operated by any department of the United States of
America.
45
Exemption from payment of a fee for registration or renewal of registration does not relieve the person of the requirement to:
obtain a registration or of any other requirements or duties prescribed by law.
46
“Reverse distributor” means a person who receives controlled dangerous substances acquired from another person registered under this chapter for the purpose of:
1) Returning unwanted, unusable, or outdated controlled substances to the manufacturer or
the manufacturer’s agent; or
2) Where necessary, processing such substances or arranging for processing such substances for disposal.
47
Every person who manufactures or proposes to manufacture a controlled dangerous substance or substances, unless specifically exempted by statute or specifically waived by the Director, shall...
obtain registration and shall obtain a renewal of the registration every year thereafter.
48
Every person who dispenses (including prescribing, administering, compounding, or delivering) or proposes to dispense a controlled dangerous substance or substances, unless specifically exempted by statute or specifically waived by the Director, shall...
obtain registration and shall obtain a renewal of the registration every year thereafter.
49
Every person who conducts research or proposes to conduct research with a controlled dangerous substance or substances, unless specifically exempted by statute or specifically waived by the Director, shall:
obtain registration and shall obtain a renewal of the
| registration every year thereafter.
50
A person desiring to obtain a registration or a renewal of registration as provided in (a) through (d) above shall:
prepare and file an application in accordance with the procedure set forth in N.J.A.C. 13:45H-1.4, accompanied by the annual registration fee as set forth in N.J.A.C. 13:45H-1.1.
51
Every person or duly authorized agent who dispenses or proposes to dispense sodium pentobarbital for purposes of animal euthanasia, unless specifically exempted by statute or specifically waived by the Director, shall apply...
for registration and shall obtain a renewal of registration every year thereafter.
52
A separate application shall be made and a separate registration obtained for each place of business or professional practice, where the applicant manufactures, distributes, acts as a reverse distributor or dispenses controlled dangerous substances. A separate application shall be made and a separate registration obtained for:
each separate and distinct business entity, affiliated corporation, or subsidiary corporation that engages in such activities, but a single entity doing business at one location under more than one business name or trade name may obtain a single registration provided that all such business names or trade names are stated in the application.
53
Applications for registration to use sodium pentobarbital for animal euthanasia may be
obtained from the Drug Control Unit. Upon receipt of said application by this Unit, the security, safeguards, recordkeeping requirement and personnel training requirements shall be:
inspected and/or reviewed, and upon satisfactory compliance with the statute and regulations, a registration certificate shall be issued to the applicant.
54
Every person or duly authorized agent required to register pursuant to (g) above shall:
specify the controlled dangerous substances or the Schedules for which he wishes to obtain a registration in his application and may manufacture, distribute or act as a reverse distributor of, only those controlled dangerous substances authorized in his registration.
55
Raw materials, bulk materials awaiting further processing, and finished products which are
controlled substances listed in Schedule I or II shall be stored in one of the following secure storage areas:
Where small quantities permit, a safe or steel cabinet:
i. Which safe or steel cabinet shall have the following specifications or the equivalent; 30 man-minutes against surreptitious entry, 10 man-minutes against forced entry, 20 man-hours against lock manipulation, and 20 man-hours against radiological
techniques;
ii. Which safe or steel cabinet, if it weighs less than 750 pounds, is bolted or cemented to the floor or wall in such a way that it cannot be readily removed; and
iii. Which safe or steel cabinet, if necessary, depending upon the quantities and type of controlled substances stored, is equipped with an alarm system, which upon
attempted unauthorized entry, shall transmit a signal directly to a central protection company or a local or State police agency which has a legal duty to respond, or a 24-hour control station operated by the registrant, or such other protection as the Division may approve.
56
A vault constructed after September 1, 1971:
i. The walls, floors and ceilings of which vault are constructed of at least 8 inches of reinforced concrete or other substantial masonry, reinforced vertically and
horizontally with 1/2 inch steel rods tied six inches on center, or the structural equivalent to such reinforced walls, floors and ceilings;
ii. The door and frame unit of which vault shall conform to the following specifications or the equivalent; 30 man-minutes against surreptitious entry, ten man-minutes against forced entry, 20 man-hours against lock manipulation, and 20 man-hours against radiological techniques;
iii. Which vault, if operations require it to remain open for frequent access, is equipped
with a “day-gate” which is self-closing and self-locking, or the equivalent, for use during the hours of operation in which the vault door is open;
iv. The walls or perimeter of which vault are equipped with an alarm, which upon
unauthorized entry shall transmit a signal directly to a central station protection company, or a local or State police agency which has a legal duty to respond, or a 24-hour control station operated by the registrant, or such other protection as the Division may approve, and, if necessary, holdup buttons at strategic points of entry to the perimeter area of the vault;
v. The door of which vault is equipped with contact switches; and
vi. Which vault has one of the following; complete electrical lacing of the walls, floor and ceilings; sensitive ultrasonic equipment within the vault; a sensitive sound accumulator system; or such other device designed to detect illegal entry as may
be approved by the Division.
57
Raw materials, bulk materials awaiting further processing, and finished products which are
controlled substances listed in Schedules III, IV, and V shall be stored in one of the following secure storage areas:
1) Where small quantities permit, a safe which complies with the requirements set forth in
(a)1 above;
2) A vault which complies with the requirements set forth in either (a)2 or 3 above; or
3) A building or areas located within a building, which building or area:
i. Has walls or perimeter fences of sufficient height and construction to provide
security from burglary;
ii. Has substantial doors which may be securely locked during non-working hours by a multiple position combination or key lock;
iii. Is equipped with an alarm which, upon unauthorized entry, shall transmit a signal directly to a central station protection company, or local or State police agency
which has a legal duty to respond, or a 24-hour control station operated by the registrant, or such other protection as the Division may approve; and
iv. In which all controlled substances are segregated from all other merchandise and kept under constant surveillance during normal business hours.
58
The controlled substances storage areas shall be:
be accessible only to an absolute minimum number of specifically authorized employees. When it is necessary for employee maintenance personnel, nonemployee maintenance personnel, business guests or visitors to be present in or pass through controlled substances storage areas, the registrant shall provide for adequate observation of the area by an employee specifically authorized in writing.
59
The registrant shall:
design and operate a system to disclose suspicious orders of controlled substances. The registrant shall inform the Drug Control Unit of suspicious orders when discovered by the registrant. Suspicious orders include orders of unusual size, orders deviating substantially from a normal pattern, and orders of unusual frequency.
60
The registrant shall notify the Drug Control Unit of any theft or loss of any controlled substances upon discovery of such theft or loss. The supplier shall be...
be responsible for reporting in-transit losses of controlled substances by the common or contract carrier selected pursuant to (e) below upon discovery of such theft or loss. The registrant shall also
complete DDC-52 form 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.
61
The registrant shall not distribute any controlled substance listed in Schedules II through V as a complimentary sample to any potential or current customer without the prior written request of the customer, to be used only for satisfying the legitimate medical needs of patients of the customer, and only in reasonable quantities. Such request must contain:
the name, address and registration number of the customer and the name and quantity of the
specific controlled substance desired. The request shall be preserved by the registrant with other records of the distribution of controlled substances. In addition, the requirements of N.J.A.C. 13:45H-6 shall be complied with for any distribution of a controlled substance listed in Schedule II. For purposes of this paragraph, the term “customer” includes a registrant to whom a complimentary sample of a substance is given in order to encourage the prescribing or recommending of the substance by the registrant.
62
When shipping controlled substances, a registrant is responsible for selecting common or contract carriers that provide adequate security to guard against in-transit losses. When storing controlled substances in a public warehouse, a registrant is responsible for:
selecting a warehouseman which will provide adequate security to guard against storage losses;
wherever possible, the registrant shall store controlled substances in a public warehouse which complies with the requirements set forth in N.J.A.C. 13:45H-2.2. In addition, the registrant shall employ precautions (for example assuring that shipping containers do not
indicate that contents are controlled substances) to guard against storage or in-transit losses.
63
When distributing controlled substances through agents (for example, detailmen), a registrant is responsible for:
providing and requiring adequate security to guard against theft and diversion while the substances are being stored or handled by the agent or agents.
64
Before the initial distribution of carfentanil, etorphine hydrochloride, and/or diprenorphine to any person, the registrant must:
verify that the person is authorized to handle the
| substance(s) by contacting the Drug Enforcement Administration.
65
Controlled substances listed in Schedule I shall be:
stored in a securely locked, substantially constructed cabinet.
66
Controlled substances listed in Schedules II, III, IV and V shall be:
stored in a securely locked, substantially constructed cabinet. However, pharmacies may disperse such
substances throughout the stock of non-controlled substances in such a manner as to obstruct the theft or diversion of the controlled substances.
67
This section shall also apply to non-practitioners authorized to conduct research or chemical
analysis under another registration. The registrant shall not:
employ as an agent or employee who has access to controlled substances any person who has had an application for registration denied, or has had his registration revoked, at any time.
68
The registrant shall notify the Drug Control Unit of the theft or loss of any controlled substances upon discovery of such loss or theft. The registrant shall also:
complete DDC-52 form regarding such loss or theft.
69
Carfentanil, etorphine hydrochloride and diprenorphine shall be:
stored in a safe or steel cabinet equivalent to a U.S. Government Class V security container.
70
A person or duly authorized agent registered to use sodium pentobarbital for purposes of animal euthanasia shall:
maintain records and inventories and shall file the reports required by this subchapter.
71
Each commercial container of a controlled substance (except for a controlled substance excepted by the Division pursuant to N.J.S.A. 24:218d) shall have:
printed on the label the symbol designating the schedule in which such controlled substance is listed. Each such commercial container, if it otherwise has no label, must bear a label complying with the requirement of this part.
72
Each manufacturer shall:
print upon the labeling of each controlled substance distributed by him the symbol designating the schedule in which such controlled substance is listed.
73
The symbol shall be prominently located on the right upper comer of the principal panel of the label of the commercial container and/or the panel of the commercial container normally displayed to dispensers of any controlled substance listed in Schedules I through V. The symbol must be:
at least two times as large as the largest type otherwise printed on the label
74
In lieu of locating the symbol in the comer of the label, as prescribed in (a) above, the symbol may be:
overprinted on the label, in which case the symbol must be printed at least one-half the height of the label and in a contrasting color providing clear visibility against the background color of the label.
75
On each bottle, multiple dose vial, or other commercial container of any controlled substance listed in Schedule I or II or of any narcotic controlled substance listed in Schedule III or IV, there shall be:
securely affixed to the stopper, cap, lid covering or wrapper of such container a seal to disclose upon inspection any tampering or opening of the container.
76
A registered individual practitioner is not required to keep records with respect to narcotic controlled substances listed in Schedules II through V, which he or she prescribes in the lawful course of his or her professional practice; he or she shall keep records, however, with respect to:
such substances that he or she administers and dispenses.
77
A registered individual practitioner is required to keep records with respect to nonnarcotic controlled substances listed in Schedules II through V, which:
he or she dispenses or administers.
78
A registered person using any controlled substance in research conducted in conformity with
an exemption granted under Section 505(i) or 512(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i) or 360b(j)) at a registered establishment which maintains records in accordance with either of these sections is not required to keep records if he:
notifies the Bureau of the name, address, and registration number of the establishment maintaining such records.
79
A registered person using any controlled substance in preclinical research or in teaching at a registered establishment which maintains records with respect to such substances is not required to keep records if he:
notifies the Drug Enforcement Administration and the Drug Control Unit of the name, address, and registration number of the establishment maintaining
such records.
80
Every inventory and other record required to be kept under this subchapter shall be kept by the registrant and be available, for at least:
2 years from the date of such inventory of
records or pursuant to recordkeeping provisions of the State professional licensing board governing the registrant, whichever is longer, for inspecting and copying by authorized employees of the Drug Enforcement Administration and the Drug Control Unit, except that financial and shipping records (such as invoices and packing slips but not executed order
forms subject to 21 CFR 1305.17) may be kept at a central location rather than at the registered location in accordance with 21 CFR 1304.04, which is incorporated herein by reference.
81
Each registered manufacturer, distributor, reverse distributor, importer, and exporter shall
maintain inventories and records and controlled substances as follows:
1) Inventories and records of controlled substances listed in schedules I and II shall be
maintained separately from all of the records of the registrant; and
2) Inventories and records of controlled substances listed in schedules III, IV, and V shall be maintained either separately from all other records of the registrant or in such form that the information required is readily retrievable from the ordinary business records of the registrant.
82
Each registered pharmacy shall maintain the inventories and records of controlled substances as follows:
1) Inventories and records of all controlled substances listed in schedules I and II shall be maintained separately from all other records of the pharmacy, and prescriptions for such substances shall be maintained in a separate prescription file; and
2) Inventories and records of controlled substances listed in schedules III, IV, and V shall be maintained either separately from all other records of the pharmacy or in such form that the information required is readily retrievable from ordinary business records of the pharmacy, and prescriptions for such substances shall be maintained either in separate prescription file for controlled substances listed in schedules III, IV, and V only or in such form that they are readily retrievable from other prescription records of the pharmacy.
Prescriptions will be deemed readily retrievable if, at the time they are initially filed, the the face of the prescription is stamped in red ink in the lower right comer with the letter “C” no less than one-inch high and filed either in the prescription file for controlled
substances listed in schedules I and 11 or in the usual consecutively numbered prescription file for non-controlled substances.
83
Each inventory shall contain a complete and accurate record of all controlled substances on hand on the date the inventory is taken. Controlled substances shall be deemed to be “on hand” if:
they are in the possession of or under the control of the registrant, including substances returned by a customer, substances ordered by a customer but not yet invoiced, substances stored in a warehouse on behalf of the registrant, and substances in the
possession of employees of the registrant and intended for distribution as complimentary
samples.
84
A separate inventory shall be made by a registrant for each registered location. In the event controlled substances in the possession or under the control of the registrant at a location for which he is not registered, the substances shall be:
included in the inventory of the registered
location to which they are subject to control or to which the person possessing the substance
is responsible. Each inventory for a registered location shall be kept at the registered location.
85
A separate inventory shall be:
made by a registrant for each independent activity for which he is registered, except as provided in N.J.A.C. 13:45H-5.12
86
A registrant may take an inventory on a date that is within:
4 days of the registrant’s biennial inventory date pursuant to N.J.A.C. 13:45H-5.7 if, as part of the registrant’s CDS registration renewal, the registrant provides the Drug Control Unit with the date the inventory was taken. A registrant may take an inventory either as of the opening of business or as of
the close of business on the inventory date. The registrant shall indicate on the inventory
records whether the inventory is taken as of the opening or as of the close of business and
the date the inventory was taken.
87
An inventory must be maintained in a written, typewritten or printed form. An inventory taken
by use of an oral recording device must be:
promptly transcribed.
88
Every person required to keep records shall take an:
inventory of all stocks of controlled substances on hand on the date he or she first engages in the manufacture, distribution, or dispensing of controlled substances, in accordance with 21 CFR 1304.11(b), which is incorporated herein by reference.
89
On the effective date of a rule by the Drug Enforcement Administration Administrator
pursuant to 308.48, 308.49 or 308.50 of the Act or the Division pursuant to N.J.S.A. 24:21-3 adding a substance to any schedule of controlled substances, which substance was, immediately prior to that date, not listed on any such schedule, every registrant required to keep records who possesses that substance shall:
take an inventory of all stocks of the substance on
hand. Thereafter such substances shall be included in each inventory made by the registrant
pursuant to N.J.A.C. 13:45H-5.7.
90
A person or duly authorized agent registered to use sodium pentobarbital for purposes of animal euthanasia and required to keep records shall:
maintain a quarterly inventory (last day of
March, June, September, and December) on forms provided by the Drug Control Unit in the manner prescribed in N.J.A.C. 13:45H-5.9. A copy of such inventory shall be received in the Drug Control Unit within 7 days after such required report is completed.
91
All prescriptions for controlled substances shall be dated as of, and signed on, the day when issued and shall bear the:
1) full name and address of the patient
2) the drug name, strength, dosage form
3) quantity prescribed
4) directions for use
5) the full name, address, proper academic degree or other definitive identification of the professional practice for which he or she is licensed
6) registration # of the practitioner
92
An intern, resident, or foreign-trained physician, or physician on the staff of a Veterans’ Administration facility, exempted from registration under 21 CFR 1301.22(c) shall:
include on all prescriptions issued by him or her the:
1) registration number of the hospital or other
institution
2) the special internal code number assigned to him or her by the hospital or other institution as provided in 21 CFR 1301.22(c), in lieu of the registration number of the practitioner required by this section.
3) Each written prescription shall have the name of the physician stamped, typed, or hand-printed on it, as well as the signature of the physician.
93
An official exempted from registration under 21 CFR 1301.23(a) shall include:
on all prescriptions issued by him or her, his or her branch of service or agency (for example, “U.S.
Army” or “Public Health Service”) and his or her service identification number, in lieu of the
registration number of the practitioner required by this section. The service ID number for a Public Health Service employee is his or her Social Security identification number. Each prescription shall have the name of the officer stamped, or hand-printed on it,
as well as the signature of the officer
94
A prescription for a Schedule III, IV, or V narcotic drug approved by the Food and Drug Administration specifically for “detoxification treatment” or “maintenance treatment” as defined in N.J.A.C. 13:45H-11.1 must include:
the ID number issued by the Administrator under 21 CFR 1301.28(d) or a written notice stating that the practitioner is acting under the good-faith exception under 21 CFR 1301.28(e)
95
No prescription for a controlled substance listed in Schedule III or IV shall be:
filled or refilled more than 6 months after the date on which such prescription was issued and no such
prescription authorized to be refilled may be refilled more than 5 times.
96
A prescription for a controlled substance listed in Schedule V may be refilled only as:
expressly authorized by the prescribing individual practitioner on the prescription. If no such
authorization is given, the prescription may not be refilled.
97
Each refilling of a prescription shall be entered on the back of the prescription or on the electronic prescription record (or on another appropriate uniformly maintained, readily retrievable record, such as medication records), which indicates by the number of the prescription the following information:
1) The name and dosage of the controlled substance;
2) The date of each refilling;
3) The quantity dispensed;
4) The identity or initials of the dispensing pharmacist in each refilling; and
5) The total number of refills for that prescription, initialed, and dated by the pharmacist as of the date of dispensing, and shall state the amount dispensed.
98
If the pharmacist merely initials and dates the back of the prescription or annotates the electronic prescription record he or she shall be:
deemed to have dispensed a refill for the full face amount of the prescription.
99
The partial filling of a prescription for a controlled substance listed in Schedule III, IV, or V is
permissible, provided that:
1) Each partial filling is recorded in the same manner as a refilling;
2) The total quantity dispensed in all partial fillings does not exceed the total quantity
prescribed; and
3) No dispensing occurs after 6 months after the date on which the prescription was issued.
100
As an incident to a distribution under N.J.A.C. 13:45H-8.4 a pharmacist may manufacture (without being registered to manufacture) an aqueous or oleaginous solution or solid dosage form containing a narcotic controlled substance in a proportion not exceeding...
20% of the completed solution, compound or mixture.
101
Any person lawfully in possession of a controlled substance listed in any Schedule may distribute (without being registered to distribute) that substance to the person from whom he or she obtained it or to the manufacturer of the substance, or, if designated, to the manufacturer’s registered agent for accepting returns, provided that a written record is maintained, which indicates:
the date of transaction, the name, form and quantity of the substance, the name, address, and registration number, if known, of the supplier or manufacturer.
102
In the case of returning a controlled substance listed in Schedule I or II, an order form shall be used in the manner prescribed in Part 305 of the Act and N.J.A.C. 13:45H-6 and be maintained as the written record of the transaction. An electronic order may also be used to return a Schedule I or II controlled substance in accordance with this chapter and 21 CFR
1305.05. Any person not required to register pursuant to 21 U.S.C. §§822(c), 957(b)1 or N.J.A.C. 13:4511-1.3 shall be:
exempt from maintaining the records required by this section.
103
A registrant shall notify the Drug Control Unit in writing no less than 14 days prior to the discontinuance or transfer of business activities with respect to controlled substances as set forth in (a) above, unless the Drug Control Unit waives this time limit in individual instances, and shall return for the cancellation to the Drug Control Unit, within 10 days of the discontinuance or transfer of business activities, the State Certification of Registration. Such notification shall include but not be limited to:
1) Name, address, State CDS and Federal DEA registration numbers of the registrant
discontinuing or transferring his controlled substances activities;
2) Name, address, State CDS and Federal DEA registration numbers of the registrant, or
proof of application for same, of registrant to whom the controlled substances are to be
transferred;
3) Name, address, State CDS and Federal DEA registration numbers, or proof of
application for same of the registrant receiving the records, which include prescription
files, or patient orders of practitioners of the discontinued business;
4) Name, and address of the person or firm who will maintain records, such as invoices,
purchase records and executed order forms of the discontinued or transferred business
for a period of not less than two years; and
5) The date on which the discontinuance or transfer of the business activity will take place.
104
Every registrant shall notify:
the Drug Control Unit within 5 days of the Drug Enforcement Administration authorizing the registrant to be an authorized collector of controlled substances as set forth in 21 CFR Part 1317 Subpart C.
b) Every registrant shall notify the Drug Control Unit whenever there is any change to its status
as an authorized collector within 5 days of such change.
105
“Detoxification treatment” means:
the administration or dispensing for a period not in excess of 21 days, of a narcotic drug or narcotic drugs in decreasing doses to an individual in order to
alleviate adverse physiological or psychological effects incident to withdrawal from the
continuous or sustained use of a narcotic drug and as a method of bringing the individual to a
narcotic drug-free state within such period of time
106
“Maintenance treatment” means:
the dispensing for a period in excess of 21 days, of a
| narcotic drug or narcotic drugs in the treatment of an individual for dependence upon heroin or other morphine-like drug
107
Every person who engages in a narcotic treatment program, including a compounder, shall:
obtain a registration, and shall obtain a renewal of the registration each year thereafter.
108
In conducting a narcotic treatment program using any narcotic drug listed in Schedules II, III, IV and V, employees, agents, or affiliated practitioners in programs, need not:
register separately.
109
Each program site located away from the principal location and at which place narcotic drugs are stored or dispensed must be:
separately registered and obtain narcotic drugs by use of order forms pursuant to N.J.A.C. 13:45H-5.6
110
For each registration or reregistration to engage in a narcotic treatment program, including a compounder, the applicant shall:
pay an annual fee of $20.00 at the time of application for registration or for renewal of registration.
111
The acceptance of delivery of narcotic substances by a narcotic treatment program shall be made only by:
a licensed practitioner employed at the facility or other authorized individuals designated in writing. At the time of delivery, the licensed practitioner or another authorized individual in writing (excluding persons currently or previously dependent on narcotic drugs), shall sign for the narcotics and place his specific title (if any) on any invoice. Copies of these signed invoices shall be kept by the distributor.
112
Narcotics dispensed or administered at a narcotic treatment program will be:
dispensed or administered directly to the patient by either the licensed practitioner or a registered
nurse under direction of the licensed practitioner, a licensed practical nurse under the direction of the licensed practitioner, or a pharmacist under the direction of the licensed practitioner.
113
Persons enrolled in a narcotic treatment program will be:
required to wait in an area physically separated from the narcotic storage and dispensing area.
114
All narcotic treatment programs must comply with:
the provisions of N.J.S.A. 26:2G-21 through 30; and with standards established by the Secretary of the Federal Department of Health and Human Services (after consultation with the Drug Enforcement
Administration) respecting the quantities of narcotic drugs which may be provided to persons enrolled in a narcotic treatment program for unsupervised use.
115
In addition to the record-keeping requirements required in (a) above, each person registered or authorized to maintain/or detoxify controlled substance users in a narcotic treatment the program shall maintain records with the following information for each controlled substance:
1) Name of substance;
2) Strength of substance;
3) Dosage form;
4) Date dispensed;
5) Adequate identification of patient (consumer);
6) Amount consumed;
7) Amount and dosage form taken home by patient;
8) Dispenser’s initials.
116
All sites which compound a bulk narcotic solution from bulk narcotic powder to liquid for onsite use must:
keep a separate batch record of the compounding.
117
Records of identity, diagnosis, prognosis, or treatment of any patients which are maintained in connection with the performance of a narcotic treatment program shall be:
confidential, except that such records may be disclosed for purposes and under the circumstances authorized by Part 310 and Part 1401 of 21 U.S.C.
