AMENDMENT OF BOARD REGULATION NO. 2-A, SERIES 1985, PRESCRIBING UNIFORM CONDITIONS/REQUIREMENTS FOR EXEMPTED PHARMACEUTICAL PREPARATIONS CONTAINING ANY OF THE BENZODIAZEPINE SUB…

Pursuant to the powers vested in the Dangerous Drugs Board under
Section 36 (a), Article VIII of Republic Act 6425, as amended, Board
Regulation No. 2-A, Series of 1985 is hereby amended as follows:

SECTION 1.       Definition

Preparation means ( i) Any solution or
mixture, in whatever physical state, containing benzodiazepine
substances; (ii) Any benzodiazepine substances in dosage form.

SECTION 2.       Unless specifically classified by
regulations as Regulated Drugs, pharmaceutical preparations in whatever
form containing a quantity of the following benzodiazepine substances
are hereby classified as exempt preparations:

International Non-proprietary Names ( INN)	Chemical Name
a.  Alprazolam	8-chloro-1-methyl-6 phenyl-4H-s triazolo [4,3-a] benzodiazepine
b.  Bromazepam	7-bromo-1, 3-dihydro-5- (pyridil-2H-1, 4-benzo diazepin-2-one
c.  Camazepam	7-chloro-1, 3-dihydro-3 hydroxy-1 methyl-5 phenyl-2H-1, 4-benzodiazepin-2-one dimethylcarbamate (ester)
d.  Chlordiazepoxide	7-chloro-2 (methylamine) 5-phenyl-3H 1, 4-benzodiazepin-4-oxide
e.  Clobazam	7-chloro-1-methyl-5- phenyl-1H-1, 5-benzodiazepine-2,4 (3H, 5H)- dione
f.  Clonazepam	5-(o- chlorophenyl)-1. 3-dihydro-7 nitro-2H-1 ,4-benzodiazepin-2-one
g.  Clorazepate	7-chloro-2, 3-dihydro-2-oxo- 5-phenyl-1-1H 1 ,4-benzodiazepine- 3-carboxylic acid
h.  Clotiazepam	5-( chlorophenyl)-7-ethyl-1, 3-dihydro-1- methyl-2H-thieno [2, 3-e]-1, 4-diazepin-2-one
i.  Clonazolam	10-chloro-11b-(o- chlorophenyl)- 2, 3, 7, 11b-tetrahydrooxazolo-[3, 2-d] [1, 4] benzodiazepin-6 (5H)-one
j.  Delorazepam	7-chloro-5-(o-chlorophenyl)-1, 3-dihydro-2H 1, 4- benzodiazepine- 2-one
k.  Diazepam	7-chloro-1, 3-dihydro-1-methyl- 5-phenyl-2H-1, 4-benzodia- zepin-2-one
l.  Estazolam	8-chloro-6-phenyl-4H-s- triazolo [4, 3-a] [1, 4] benzodiazopine
m.  Ethyl Loflazepate	Ethyl-7-chloro-5-(o-fluorophenyl)- 2, 3-dihydro-2-oxo-1H, 4-benzodia- zepine-3-carboxylate
n.  Fludiazepam	7-chloro-5-(o- fluorophenyl)-1, 3- dihydro-1-methyl-2H-1, 4-benzodiazepine- 2-one
o.  Flurazepam	7-chloro-1-[2-diethylamine) ethyl]-5-(ofluorophenyl)-1, 3-dihydro-2H-1, 4-benzodiazepin-2-one
p.  Helazepam	7-chloro-1, 3-dihydro-5-phenyl-1- (2, 2, 2-trifluoroethyl)-2H-1, 4-benzo- diazepin-2- one
q.  Haloxazolam	10-bromo-11b-tetrahy-drooxazolo [3,2-d]-benzodiazepine-6 [5H]-one
r.  Ketazolam	11-chloro-8, 12b dihydro-2, 8- dimethyl-12b-phenyl-4H [1, 3]- oxazine-[3. 2-d] [1, 4] benzodiazepine-4, 7 (6H)- dione
s.  Loprazolam	6-( chlorophenyl)-2, 4-dihydro-2- [4-methyl-1-piperra-Zinyl) methylene]- 8-nitro-1H-imidazo [1, 2-a) [1,4] benzodia-zepin-1-one
t.  Lorazepam	7-chloro-5-(o- chlorophenyl)- 1, 3-dihydro-3-hydroxy-2H-1, 4- benzodiazepine-2-one
u.  Lormetazepam	7-chloro-5-(o- chlorophenyl)-1,3-dihydro- 3-hydroxy-1-methyl-2H-1, 4-benzdiazepin- 2-one
v.  Medazepam	7-chloro-2, 3-dihydro-1-methyl-5- phenyl-1H-1, 4-benzodiazepine
w.  Nimetazepam	1,3-dihydro-1-methyl-7-nitro-5- phenyl-2H-2, 4-benzodiazepin-2-one
x.  Nordazepam	7-chloro-1,3-dihydro 5-phenyl- 2H-1, 4-benzodiazepin-2-one
y.  Oxazepam	7-chloro-1, 3-dthydro-3-hydroxy- 5-phenyl-2H-1, 4-benzdiazepin-2-one
z.  Oxazolam	10-chloro-2, 3, 7, 11b-tetrahydro- 2-methyl-11b-phenylloxazolo [3, 2-d] [1, 4] benzodiazepin-6 (5H)-one
aa.  Pinazepam	7-chloro-1, 3-dihydro-5-phenyl-1(2- propynyl)-2H-1, 4-benzodiazepin-2-one.
ab.  Prazepam	7-chloro-1, ( cyclopropyl-methyl)-1,3- dihydro-5-phenyl-1 (2-propynyl)- 2H-1, 4-benzodiazepin-2-one
ac.  Temazepam	7-chlaro-1, 3-dihydro 3-hydroxy-1- methyl-5-phenyl-2H 1, 4-benzodiazepin-2- one
ad.  Triazolam	8-chloro-6-(o-chlorophenyl)-1- methyl-4H-S- triazolo [4,3-a] [1,4] Benzodiazepine
ae.  Tetrazepam	7-chloro-5-( cylohexen-1-yl)-1, 3- dihydro-1-methyl-2H 1, 4-benzodiazepin -2 one

Provided, however, that the benzodiazepine substance is not in
association with (a) another benzodiazepine substance, (b) a regulated
drug, (c) a prohibited drug, (d) a psychoactive drug not under
international control with known abuse potential.

SECTION 3.       All exempted benzodiazepine preparations shall be subjected to the following requirements:

a.       Registration (With whom to register and file application): — .

1.    Dangerous Drugs Board — all applications for
registration and for the issuance of a license to deal in dangerous
drugs and exempt preparations shall be filed with the Dangerous Drugs
Board; or with the Board’s authorized representatives if situated
outside of the Metro Manila Area.

2.    Bureau of Food and Drugs — Benzodiazepine drug preparations shall be duly registered with the Bureau of Food and Drugs.

b.       Records to be maintained

Every person or any establishment registered with the DDB and
BFD as Importer, Manufacturer, Producer, Compounder, Distributor at
wholesale or retail, shall maintain a true and accurate record for any
benzodiazepine drug preparations, as defined herein, received by him and
its disposal, in a record book designed for the purpose to be kept for
at least two (2) years after the last entry has been made, and is
subject to inspection and verification at any time of the day at
reasonable hours by authorized officers of the DDB. Each entry of D.D.
/or drug benzodiazepine preparations received shall be made on the date
of receipt of the drugs or preparation.  The following data shall appear
in the record book:

1.  Manufacturer, Compounder, Producer

a.       Date raw materials received.

b.       Name and quantity of raw materials on hand.

c.       Name and total quantity and description of finished product.

d.       Name and address of drug establishment and registry number of the registrant to whom the drug was delivered.

e.       Name and quantity of finished products disposed or sold.

f.        Balance of stock on hand.

2.  Importer, Producer

a.       Date of receipt of the raw materials or preparation imported.

b.       Name and quantity of raw material finished drug product imported.

c.       Number of import permit and the date issued by DDB.

d.       Name and quantity of drug disposed or sold.

e.       Name and address of person or establishment to whom it was delivered.

f.        Date of delivery.

g        Balance of Stock on hand.

3.  Retailer

a.       Date of receipt of benzodiazepine drug preparations.

b.       Name and quantity of drug received or purchased.

c.       Name and address of supplier.

d.       Date and quantity when drug was disposed or sold under prescription.

i.             Date of prescription

ii.            Name and address of prescriber

iii.           Preparation and quantity prescribed

iv.           Name and address of patient.

v.            Privilege Tax Receipt No. of the prescribing physician.

vi.           S-2 (Narcotic license) No. of the prescribing physician.

e.       Balance of stock on hand.

Provided, however, that in the case of records of
benzodiazepine drug preparations dispensed for in-patients in hospitals
and/or similar institution, the following shall be observed:

1.    Each entry of benzodiazepine drug preparations disposed
of shall be recorded in a prescribed format containing the following
information:

Record of Benzodiazepine Drug Preparation In-Patient in Hospital and Similar Institutions
Name of Benzodiazepine				Dispensing
Drug of preparation		___________		Pharmacist ____________		Date _______
Date	Time	Full Name of Patient	Bed No.	Room No.	Quantity:Dispensed	Name of Physician

and thereafter transfered to the additional opium book at the end of the period.

2.    At the end of each prescribed period, an ending balance
for the day of stocks on hand shall be indicated in the record book in
red ink, the quantities of which shall be carried forward to the account
for the following day.

3.    Recording or dispensing of benzodiazepine drug
preparations in the additional opium book shall cover a period of twenty
four (24) hours, i.e., from 8:00 a.m. of the preceding day to 8:00 a.m.
of the following day.

c.       Reporting

Importers, manufacturers, compounders, producers and
distributors (wholesalers) thereof shall render semi-annual and annual
reports of transactions of benzodiazepine drug preparations on or before
the tenth day of the month following the period on which report is
rendered to the DDB, which shall show:

1.       Name of benzodiazepine drug preparation

2.       Size of package

3.       Dosage form and dangerous drug content

4.       Stocks on hand at the beginning of the period

5.       Amount imported

6.       Amount locally purchased

7.       Total of 4, 5 and 6 — amount available

8.       Amount sold to wholesalers

9.       Amount sold to retailers

10.     Amount used in the preparation of benzodiazepine drug preparations

11.     Amount disposed of — totals of 8, 9, 10

12.     Balance on hand at the end of the period

d.       Prescription/Dispensing

1.    In prescribing the exempted benzodiazepine drug
preparations, only one drug per prescription should be made. The
quantity of tablets and/or capsules of exempted benzodiazepines
prescribed should be based on the physician’s judgment but should not
exceed a week’s supply. For ampules, the number should not exceed 3
ampules x 2 ml or 1 ampule x 10 ml per prescription except for hospital
use.

Said preparations shall be dispensed through Ordinary Prescription wherein the following should be indicated:

a)         Date of prescription

b)         Name and address of the prescribing physician

c)         Privilege Tax Receipt No. of the prescribing physician

d)         S-2 (narcotic license) No. of the prescribing physician

e)         Name and address of patient

f)          Benzodiazepine transactions to be supplied, the
number of drugs prescribed in words and enclosed in parenthesis under
the roman numeral to depict the quantity of the drug to be prescribed,
its strength and the total no. of units to be supplied.

g)         Direction for use and the word “non-repetition”.

h)         Signature of the doctor

e.       Inspection. To ensure that Section 25, Article IV, in
relation to Section 36 (1), Article VIII, RA 6425, as amended, is being
complied with, the Executive Director, the Chief, CRID, DRO’s deputized
by the Chairman of the Board, may at all times:

a.    enter and inspect any place or premises occupied by a
person authorized to deal in benzodiazepine substances/preparations.

b.    require the production of any register, record book,
prescription, or other documents relating to dealings/transactions in
benzodiazepine substances/ preparations.

c.    Inspect any stocks of benzodiazepine substances/preparations in possession of such person or drug establishment.

f.        Export/Import/Special Permit

All bulk importations or exportations of any benzodiazepine
drug preparations whether in bulk or in dosage form shall be subject to
Special Permit for the importation of exempt preparations and
requirements of the DDB under Board Regulation No. 3-A, s. 1983
(Procedures to be followed by Importers of Dangerous Drug and Exempt
Preparations in the Philippines).

g.       Samples.         The giving away of physician samples
of benzodiazepine drug preparations is not allowed in conformity with
the provisions of Article 10 of the 1971 Convention on Psychotropic
Substances.

h.       Advertising.     The advertisement of benzodiazepine drug preparations in any form is not allowed.

Warnings or Caution. Packaging or labeling of benzodiazepine drug preparations should conspicuously bear the following information/statements:

1.       Direction for use.

2.       A frank statement of the principal hazard or hazards
involved such as: “Warning — may be habit forming”, for the safety of
the user.

3.       Precautionary measures describing the action to be followed or avoided.

4.       Instructions, when necessary or appropriate, for first-aid-treatment.

5.       Instructions for handling or storage and the statement “Keep out of reach of Children” or its practical equivalent.

SECTION 4.       Benzodiazepine substances other than in
preparation form are classified as dangerous drugs and further
categorized as Regulated Drugs.

SECTION 5.       This Regulation supersedes Board Regulation No. 2-A, Series of 1985.

SECTION 6.       Non-compliance or violation of
any provision of this Regulation shall be subject to the appropriate
provision of RA 3720, as amended, [Sec. 11 (b), Sec. 20b (1) and RA
6425, as amended.

SECTION 7.       This Regulation shall take effect upon
its publication once a week for two (2) consecutive weeks in a newspaper
of general circulation.

Adopted: 19 Feb. 1987

(SGD.) ALFREDO R.A. BENGZON, M.D.
(Secretary of Health)
Chairman