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ing a hearing shall, within 30 days after suant to section 303 (a) of the Act (21 the date of receipt of the order to show U.S.C. 823(a)) are satisfied. Any other cause (or the date of publication of person participating in the hearing purnotice of the application for registration suant to $ 301.43 shall have the burden in the FEDERAL REGISTER in the case of of proving any propositions of fact or $ 301.43), file with the Director a written law asserted by him in the hearing. request for a hearing in the form pre (b) At any other hearing for the scribed in § 316.47 of this chapter. denial of a registration, the Bureau shall
(b) Any person entitled to participate have the burden of proving that the rein a hearing pursuant to $ 301.43 and de quirements for such registration pursusiring to do so shall, within 30 days of ant to section 303 of the Act (21 U.S.C. the date of publication of notice of the 823) are not satisfied. hearing in the FEDERAL REGISTER, file (c) At any hearing for the revocation with the Director a written notice of his or suspension of a registration, the Buintention to participate in such hearing reau shall have the burden of proving in the form prescribed in § 316.48 of this that the requirements for such revocachapter. Any person filing a request for tion or suspension to section 304(a) of a hearing need not also file a notice of the Act (21 U.S.C. 824(a)) are satisfied. appearance.
§ 301.56 Time and place of hearing. (c) Any person entitled to a hearing or to participate in a hearing pur
The hearing will commence at the suant to $$ 301.42-301.45 may, within place and time designated in the order to the period permitted for filing a request
show cause or notice of hearing published for a hearing or a notice of appearance,
in the FEDERAL REGISTER (unless exfile with the Director a waiver of an op
pedited pursuant to $ 301.46(c)) but portunity for a hearing or to participate
thereafter it may be moved to a different in a hearing, together with a written place and may be continued from day to statement regarding his position on the
day or recessed to a later day without matters of fact and law involved in such notice other than announcement thereof hearing. Such statement, if admissible, by the presiding officer at the hearing. shall be made a part of the record and
$ 301.57 Final order. shall be considered in light of the lack of opportunity for cross-examination in
As soon as practicable after the presiddetermining the weight to be attached
ing officer has certified the record to the to matters of fact asserted therein.
Director, the Director shall issue his (d) If any person entitled to a hear
order on the granting, denial, revocation, ing or to participate in a hearing pur
or suspension of registration. In the suant to $$ 301.42-301.45 fails to file a
event that an application for registrarequest for a hearing or a notice of
tion to manufacture in bulk a basic class appearance, or if he so files and fails to
of any controlled substance listed in appear at the hearing, he shall be
schedule I or II is granted, or any apdeemed to have waived his opportunity
plication for registration is denied, or for the hearing or to participate in the
any registration is revoked or suspended, hearing, unless he shows good cause for
the order shall include the findings of such failure.
fact and conclusions of law upon which (e) If all persons entitled to a hear
the order is based. The order shall ing or to participate in a hearing waive
specify the date on which it shall take or are deemed to waive their opportunity
effect. The Director shall serve one copy for the hearing or to participate in the
of his order upon each party in the hearing, the Director may cancel the
hearing. hearing, if scheduled, and issue his final MODIFICATION, TRANSFER AND TERMINATION order pursuant to $ 301.57 without a
OF REGISTRATION hearing. [36 F.R. 7778, Apr. 24, 1971, as amended at
§ 301.61 Modification in registration. 36 F.R. 13386, July 21, 1971]
Any registrant may apply to modify § 301.55 Burden of proof.
his registration to authorize the handling
of additional controlled substances by (a) At any hearing on an application submitting a letter of request to the Regto manufacture any controlled substance istration Branch, Bureau of Narcotics listed in schedule I or II, the applicant and Dangerous Drugs, Department of shall have the burden of proving that the Justice, Post Office Box 28083, Central requirements for such registration pur- Station, Washington, D.C. 20005. The let
ter shall contain the registrant's name,
SECURITY REQUIREMENTS address, registration number, and the substances and/or schedules to be added 3
$ 301.71 Security requirements gener
ally. to his registration, and shall be signed in accordance with $ 301.22(f). If the regis (a) All applicants and registrants shall trant is seeking to handle additional provide effective controls and procedures controlled substances listed in schedule I to guard against theft and diversion of for the purpose of research or instruc controlled substances. In order to detertional activities, he shall attach three mine whether a registrant has provided copies of a research protocol describing effective controls against diversion, the each research project involving the ad Director shall use the security requireditional substances, or two copies of a ments set forth in $$ 301.72-301.76 as statement describing the nature, extent, standards for the physical security conand duration of such instructional ac
trols and operating procedures necessary tivities, as appropriate. No fee shall be to prevent diversion. Materials and conrequired to be paid for the modification.
struction which will provide a structural The request for modification shall be equivalent to the physical security conhandled in the same manner as an ap
trols set forth in $$ 301.72, 301.73 and plication for registration.
301.75 may be used in lieu of the ma[36 F.R. 18729, Sept. 21, 1971]
terials and construction described in
those sections. $ 301.62 Termination of registration. (b) Substantial compliance with the The registration of any person shall
standards set forth in $$ 301.72-301.76 terminate if and when such person dies,
may be deemed sufficient by the Director ceases legal existence, discontinues busi
after evaluation of the overall security ness or professional practice, or changes
system and needs of the applicant or his name or address as shown on the
registrant. In evaluating the overall se
curity system of a registrant or applicertificate of registration. Any registrant who ceases legal existence, discontinues
cant, the Director may consider any of business or professional practice, or
the following factors as he may deem
relevant to the need for strict complichanges his name or address as shown on the Certificate of Registration shall
ance with security requirements: notify the Director promptly of such
(1) The type of activity conducted fact. In the event of a change in name
(e.g., processing of bulk chemicals, preor address, the person may apply for a
paring dosage forms, packaging, labeling, new Certificate of Registration in ad
cooperative buying, etc.); vance of the effective date of such
(2) The type and form of controllea change by filing an application and pay
substances handled (e.g., bulk liquids or ing the appropriate fee in the same man
dosage units, usable powders or nonusuaner as an application for new registra
ble powders); tion. The application shall be handled in
(3) The quantity of controlled sub
stancu handled; the same manner as an application for
(4) The location of the premises and registration.
the relationship such location bears on § 301.63 Transfer of registration.
security needs; No registration or any authority con
(5) The type of building construction ferred thereby shall be assigned or other
comprising the facility and the general wise transferred except upon such con
characteristics of the building or build
ings; ditions as the Director may specifically
(6) The type of vault, safe, and secure designate and then only pursuant to his
enclosures or other storage system (e.g., written consent.
automatic storage and retrieval system) & 301.64 Termination of provisional
(7) The type of closures on vaults,
safes, and secure enclosures; The registration of any person who is (8) The adequacy of key control sysprovisionally registered under section tems and/or combination lock control 702(a) of the Act (21 U.S.C. 822 note) systems; and who have not been assigned a date (9) The adequacy of electric detecfor registration by August 31, 1971, shall tion and alarm systems, if any including terminate on October 1, 1971.
use of supervised transmittal lines and [36 F.R. 18729, Sept. 21, 1971]
standby power sources;
(10) The extent of unsupervised public access to the facility, including the presence and characteristics of perimeter fencing, if any;
(11) The adequacy of supervision over employees having access to manufacturing and storage areas;
(12) The procedures for handling business guests, visitors, maintenance personnel, and nonemployee service personnel;
(13) The availability of local police protection or of the registrant's or applicant's security personnel, and;
(14) The adequacy of the registrant's or applicant's system for monitoring the receipt, manufacture, distribution, and disposition of controlled substances in its operations.
(c) When physical security controls become inadequate as a result of a controlled substance being transferred to a different schedule, or as a result of a noncontrolled substance being listed on any schedule, or as 6 result of a significant increase in the quantity of controlled substances in the possession of the registrant during normal business operations, the physical security controls shall be expanded and extended accordingly. A registrant may adjust physical security controls within the requirements set forth in 88 301.72–301.76 when the need for such controls decreases as a result of a controlled substance being transferred to a different schedule, or a result of a controlled substance being removed from control, or as a result of a significant decrease in the quantity of controlled substances in the possession of the registrant during normal business operations.
(d) Any registrant or applicant desiring to determine whether a proposed security system susbtantially complies with, or is the structural equivalent of. the requirements set forth in $$ 301.72301.76 may submit any plans, blueprints, sketches or other materials regarding the proposed security system either to the Regional Director in the region in which the system will be used, or to the Compliance Investigations Division, Bureau of Narcotics and Dangerous Drugs, Department of Justice, Washington, D.C. 20537.
(e) Physical security controls of locations registered under the Harrison Narcotic Act or the Narcotics Manufacturing Act of 1960 on April 30, 1971, shall be deemed to comply substantially with the standards set forth in $$ 301.72, 301.73 and 301.75. Any new facilities or
work or storage areas constructed or utilized for controlled substances, which facilities or work or storage areas have not been previously approved by the Bureau, shall not necessarily be deemed to comply substantially with the standards set forth in $$ 301.72, 301.73 and 301.75, notwithstanding that such facilities or work or storage areas have physical security controls similar to those previously approved by the Bureau. [36 F.R. 18729, Sept. 21, 1971) 8 301.72 Physical security controls for
nonpractitioners: storage areas. (a) Schedules I and II. 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:
(1) Where small quantities permit, a safe:
(i) Which safe has an Underwriters' Laboratories Burglary Rating of T-20, E or better, or the equivalent of such a safe;
(ii) Which safe, 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, if necessary, depending upon the quantities and type of controlled substances stored, is equipped with an alarm system which, upon 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 Director may approve.
(2) A vault constructed before, or under construction on, September 1, 1971, which is of substantial construction with a steel door, combination or key lock, and an alarm system; or
(3) 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 12-inch steel rods tied 6 inches on center, or the structural equivalent to such reinforced walls, floors, and ceilings;
(ii) The door of which vault contains a multiple-position combination lock or the equivalent, a relocking device or the equivalent, and steel plate with a thick
ness of at least 12 inch or with a 2-hour (iv) In which all controlled subfire rating or the equivalent;
stances are segregated from all other (iii) Which vault, if operations re- merchandise and kept under constant quire it to remain open for frequent ac surveillance during normal business cess, is equipped with a"day-gate" which hours. is self-closing and self-locking, or the (c) Multiple storage areas. Where seyequivalent, for use during the hours of eral types or classes of controlled suboperation in which the vault door is stances are handled separately by the open;
registrant or applicant for different pur(iv) The walls or perimeter of which poses (e.g., returned goods, or goods in vault are equipped with an alarm, which process), the controlled substances may upon unauthorized entry shall transmit be stored separately, provided that each a signal directly to a central station pro storage area complies with the requiretection company, or a local or State po- ments set forth in this section. lice agency which has a legal duty to (d) Accessibility to storage areas. The respond, or a 24-hour control station op- controlled substances storage areas shall erated by the registrant, or such other be accessible only to an absolute miniprotection as the Bureau may approve, mum number of specifically authorized and, if necessary, holdup buttons at employees. When it is necessary for emstrategic points of entry to the perimeter ployee maintenance personnel, nonemarea of the vault;
ployee maintenance personnel, business (v) The door of which vault is equip guests, or visitors to be present in or pass ped with contact switches; and
through controlled substances storage (vi) Which vault has one of the fol areas, the registrant shall provide for lowing: complete electrical lacing of the adequate observation of the area by an walls, floor and ceilings; sensitive ultra employee specifically authorized in sonic equipment within the vault; a sen writing. sitive sound accumulator system; or such
[36 F.R. 18730, Sept. 21, 1971] other device designed to detect illegal
EFFECTIVE DATE: March 1, 1972. entry as may be approved by the Bureau.
(b) Schedules III, IV, and V. Raw § 301.73 Physical security controls for materials, bulk materials awaiting fur
nonpractitioners: Manufacturing ther processing, and finished products
areas. which are controlled substances listed in All manufacturing activities (including schedules III, IV, and V shall be stored
processing, packaging, and labeling) inin one of the following secure storage volving controlled substances listed in areas:
any schedule shall be conducted in (1) Where small quantities permit, a accordance with the following: safe which complies with the require (a) All in-process substances shall be ments set forth in paragraph (a) (1) of returned to the controlled substances this section;
storage area at the termination of the (2) A vault which complies with the
process. If the process is not terminated requirements set forth in either para at the end of a workday (except where graph (a) (2) or (3) of this section; or a continuous process or other normal
(3) A building or area located within manufacturing operation should not be a building, which building or area:
interrupted), the processing area or (i) Has walls or perimeter fences of
tanks, vessels, bins or bulk containers sufficient height and construction to
containing such substances shall be seprovide security from burglary;
curely locked, with adequate security for (ii) Has substantial doors which may
the area or building. If such security rebe securely locked during nonworking
quires an alarm, such alarm, upon unhours by a multiple-position combina authorized entry, shall transmit a signal tion or key lock;
directly to a central station protection (iii) Is equipped with an alarm which,
company, or local or state police agency upon unauthorized entry, shall transmit which has a legal duty to respond, or a a signal directly to a central station 24-hour control station operated by the protection company, or local or State
registrant. police agency which has a legal duty
(b) Manufacturing activities with conto respond, or a 24-hour control station trolled substances shall be conducted operated by the registrant, or such
an area or areas of clearly defined limited other protection as the Bureau may ap access which is under surveillance by an prove; and
employee or employees designated in
writing as responsible for the area. “Lim. (d) The registrant shall not distribute ited access" may be provided, in the ab- any controlled substance listed in schedsence of physical dividers such as walls ules II through V as a complimentary or partitions, by traffic control lines or sample to any potential or current cusrestricted space designation. The em tomer (1) without the prior written reployee designated as responsible for the quest of the customer, (2) to be used only area may be engaged in the particular for satisfying the legitimate medical manufacturing operation being con needs of patients of the customer, and ducted: Provided, That he is able to pro (3) only in reasonable quantities. Such vide continuous surveillance of the area request must contain the name, address, in order that unauthorized persons may and registration number of the customer not enter or leave the area without his and the name and quantity of the knowledge.
specific controlled substance desired. The (c) During the production of controlled request shall be preserved by the regissubstances, the manufacturing areas trant with other records of distribution shall be accessible to only those employ of controlled substances. In addition, the ees required for efficient operation. When requirements of Part 305 of the chapter it is necessary for employee maintenance shall be complied with for any distribupersonnel, nonemployee maintenance tion of a controlled substance listed in personnel, business guests, or visitors to Schedule II. For purposes of this parabe present in or pass through manufac graph, the term 'customer' includes a turing areas during production of con person to whom a complimentary sample trolled substances, the registrant shall of a substance is given in order to enprovide for adequate observation of the courage the prescribing or recommending area by an employee specifically author of the substance by the person. ized in writing.
(e) When shipping controlled sub[36 F.R. 18731, Sept. 21, 1971)
stances, a registrant is responsible for EFFECTIVE DATE: March 1, 1972.
selecting common or contract carriers
which provide adequate security to guard $ 301.74 Other security controls for against in-transit losses. When storing nonpractitioners.
controlled substances in a public ware(a) Before distributing a controlled
house, a registrant is responsible for sesubstance to any person who the regis
lecting a warehouseman which will pro
vide adequate security to guard against trant does not know to be registered to possess the controlled substance, the reg
storage losses; wherever possible, the istrant shall make a good faith inquiry
registrant shall store controlled subeither with the Bureau or with the
stances in a public warehouse which appropriate State controlled substances
complies with the requirements set forth registration agency, if any, to determine
in $ 301.72. In addition, the registrant that the person is registered to possess shall employ precautions (e.g., assuring the controlled substance.
that shipping containers do not indicate (b) The registrant shall design and that contents are controlled substances) operate a system to disclose to the reg to guard against storage or in-transit istrant suspicious orders of controlled
losses. substances. The registrant shall inform
(f) When distributing controlled subthe Regional Office of the Bureau in his
stances through agents (e.g., detailmen), region of suspicious orders when discov
a registrant is responsible for providing ered by the registrant. Suspicious orders include orders of unusual size, orders de
and requiring adequate security to guard viating substantially from a normal pat
against theft and diversion while the subtern, and orders of unusual frequency. stances are being stored or handled by the
(c) The registrant shall notify the agent or agents. Regional Office of the Bureau in his re- [36 F.R. 7778, Apr. 24, 1971; 36 F.R. 13386, gion of any theft or significant loss of
July 21, 1971, as amended at 36 F.R. 18731, any controlled substances upon discovery Sept. 21, 1971] of such theft or loss. The registrant shall § 301.75 Physical security controls for also complete BND Form 106 regarding
practitioners. such theft or loss. Thefts must be reported whether or not the controlled sub
(a) Controlled substances listed in stances are subsequently recovered and/ schedules I and II shall be stored in a or the responsible parties are identified securely locked, substantially constructed and action taken against them.