卫生部、国家中医药管理局关于印发医院中药房基本标准的通知
卫生部 国家中医药管理局
卫生部、国家中医药管理局关于印发医院中药房基本标准的通知
国中医药发〔2009〕4号
各省、自治区、直辖市卫生厅局、中医药管理局，新疆生产建设兵团卫生局，局各直属单位：
根据《医疗机构管理条例》有关规定，卫生部、国家中医药管理局制定了《医院中药房基本标准》。现印发给你们，请遵照执行。在执行过程中有何问题，请及时反馈卫生部、国家中医药管理局。
本标准自印发之日起施行。
二○○九年三月十六日
医院中药房基本标准
一、医院（含中医医院、中西医结合医院、综合医院，下同）中药房应当按照国家有关规定，提供中药饮片调剂、中成药调剂和中药饮片煎煮等服务。
中药品种、数量应当与医院的规模和业务需求相适应，常用中药饮片品种应在400种左右。
二、部门设置
（一）中药房由药剂部门统一管理，可分中药饮片调剂组、中成药调剂组、库房采购组。
（二）至少设有中药饮片库房、中药饮片调剂室、中成药库房、中成药调剂室、周转库、中药煎药室，有条件的医院可按照有关标准要求设置中药制剂室。
三、人员
（一）中药专业技术人员占药学专业技术人员比例至少达到20%，中医医院中药专业技术人员占药学专业技术人员比例至少达到60%。三级医院具有大专以上学历的中药人员不低于50%，二级医院不低于40%。
（二）中药房主任或副主任中，三级医院应当有副主任中药师以上专业技术职务任职资格的人员；二级医院应当有主管中药师以上专业技术职务任职资格的人员。
（三）中药饮片调剂组、中成药调剂组、库房采购组负责人至少应具备主管中药师以上专业技术职务任职资格。
（四）中药饮片质量验收负责人应为具有中级以上专业技术职务任职资格和中药饮片鉴别经验的人员或具有丰富中药饮片鉴别经验的老药工。中药饮片调剂复核人员应具有主管中药师以上专业技术职务任职资格。煎药室负责人应为具有中药师以上专业技术职务任职资格的人员，煎药人员须为中药学专业人员或经培训取得相应资格的人员。有条件的医院应有临床药学人员。
四、房屋
（一）中药房的面积应当与医院的规模和业务需求相适应。
（二）中药饮片调剂室的面积三级医院不低于100平方米，二级医院不低于80平方米；中成药调剂室的面积三级医院不低于60平方米，二级医院不低于40平方米。
（三）中药房应当远离各种污染源。中药饮片调剂室、中成药调剂室、中药煎药室应当宽敞、明亮，地面、墙面、屋顶应当平整、洁净、无污染、易清洁，应当有有效的通风、除尘、防积水以及消防等设施。
五、设备（器具）
中药房的设备（器具）应当与医院的规模和业务需求相适应。
（一）中药储存设备（器具）
药架、除湿机、通风设备、冷藏柜或冷库。
（二）中药饮片调剂设备（器具）
药斗（架）、调剂台、称量用具（药戥、电子秤等）、粉碎用具（铜缸或小型粉碎机）、冷藏柜、新风除尘设备（可根据实际情况选配）、贵重药品柜、毒麻药品柜。
（三）中成药调剂设备（器具）
药架（药品柜）、调剂台、贵重药品柜、冷藏柜。
（四）中药煎煮设备（器具）
煎药用具（煎药机或煎药锅）、包装机（与煎药机相匹配）、饮片浸泡用具、冷藏柜、储物柜。
（五）临方炮制设备（器具）（可根据实际情况选配）
小型切片机、小型炒药机、小型煅炉烘干机、消毒锅、标准筛。
六、规章制度
（一）制定人员岗位责任制、药品采购制度、药品管理制度、在职教育培训制度等各项规章制度。
（二）执行中医药行业标准规范，有国家制定或认可的中药技术操作规程和管理规范，并成册可用。
七、民族医医院中药房（民族药房）参照本《基本标准》执行。
MERCHANT SHIPPING (PREVENTION AND CONTROL OF POLLUTION) ORDINANCE ——附加英文版
Hong Kong
MERCHANT SHIPPING (PREVENTION AND CONTROL OF POLLUTION) ORDINANCE
(CHAPTER 413)
ARRANGEMENT OF SECTIONS
ion
I PRELIMINARY
hort title
nterpretation
II REGULATIONS FOR THE PREVENTION AND CONTROL OF POLLUTION
egulations for the prevention and control of pollution
enalty for taking detained ship to sea
III SHIPPING CASUALTIES INVOLVING A RISK OF POLLUTION
pplication of Part III
hipping casualties
irections; right to recover in respect of unreasonable loss or
damage
ffences in relation to section 6
ervice of directions under section 6
Enforcement of fines
Saving of rights of action, etc.
IV SAVINGS, AMENDMENTS AND REPEALS
Savings, amendments and repeals
dule. (Omitted)
rdinance to provide for the prevention and control of pollution
from
s and for incidental or related matters.
January 1991] L. N. 14 of 1991
PART I PRELIMINARY
hort title
Ordinance may be cited as the Merchant Shipping
(Prevention and
rol of Pollution) Ordinance.
nterpretation
his Ordinance, unless the context otherwise requires--
trol" includes contain and reduce;
ector" means the Director of Marine;
charge" means any release, howsoever caused, from a ship and
includes
escape, disposal, spilling, leaking, pumping, emitting or
emptying;
does not include--
dumping within the meaning of the Convention on the
Prevention of
ne Pollution by Dumping of Wastes and Other Matter signed in
London on
ovember 1972; or
any release directly arising from the exploration,
exploitation and
ciated off-shore processing of sea-bed mineral resources; or
any release for the purposes of legitimate scientific research
into
ution abatement or control;
g Kong ship" means--
a ship registered in Hong Kong; and
a vessel required to be licensed under Part IV of the Shipping
and
Control Ordinance (Cap. 313);
" means oil of any description and includes spirit produced from
oil
ny description and also includes coal tar;
p" means a vessel of any type whatsoever operating in the
marine
ronment and includes a hydrofoil, hovercraft, submersible or
floating
t and a fixed or floating platform.
PART II REGULATIONS FOR THE PREVENTION AND CONTROL OF POLLUTION
egulations for the prevention and control of pollution
In this section--
vention" means the International Convention for the
Prevention of
ution from Ships (including its protocols, annexes and
appendices)
h constitutes Attachment 1 to the Final Act of the
International
erence on Marine Pollution signed in London on 2 November
1973, as
fied by any international agreement referred to in subsection (2)
(b)
);
tocol" means the Protocol (including the annex thereto)
relating to
Convention which constitutes Attachment 2 to the Final Act
of the
rnational Conference on Tanker Safety and Pollution Prevention
signed
ondon on 17 February 1978, as modified by any international
agreement
rred to in subsection (2) (b) (iii); "substance other
than oil"
udes sewage and garbage of any kind.
The Governor in Council may make regulations--
relating to the prevention or control of pollution of the sea or
other
rs by oil, or any substance other than oil, from ships; and
for giving effect to--
the Convention;
the Protocol; and
) any other international agreement (whether made by
resolution or
rwise) which relates to the prevention or control of pollution
of the
or other waters by oil, or any substance other than oil, from
ships
which applies to Hong Kong, including any agreement which
modifies any
r such agreement.
Regulations made under this section may be expressed to apply--
to Hong Kong ships, wherever they may be; and
to other ships while they are within the waters of Hong Kong.
Regulations made under this section may provide that the
regulations,
ny provisions thereof, shall come into force on a date
specified in
regulations which is earlier than the date on which the
international
ement to which the regulations relate comes into force.
Without limiting the generality of subsection (2),
regulations made
r this section may include provisions--
for the approval of documents, the appointment of
surveyors, the
ying out of surveys and inspections and the rendering
of other
ices for the purposes of the regulations, whether in Hong
Kong or
where, and for the issue, duration, effect and
recognition of
ificates for those purposes;
for the keeping, carriage and inspection of record books and
other
rds of operations involving oil, or any substance other than oil,
on
d ships;
for the prohibition, regulation and control of the
loading and
iage on board ships, and the unloading or discharge from ships,
of oil
ny substance other than oil and for procedures relating thereto;
for the design and construction of, and the equipment and fittings
on
d, ships carrying oil or any substance other than oil;
for the compulsory reporting of incidents involving pollution
or the
at of pollution for the purpose of giving effect to Protocol I
visions concerning reports on incidents involving harmful
substances)
he Convention;
for the payment of fees (whether prescribed under this Ordinance,
the
hant Shipping Ordinance (Cap. 281) or otherwise) in respect
of any
ey, inspection, certificate, service or other matter provided
for by
regulations;
that contraventions of the regulations shall be offences
punishable by
lties not exceeding--
on conviction upon indictment, a fine of $5,000,000 and, in the
case
n individual, imprisonment for 2 years;
on summary conviction, a fine of $500,000;
that in the case of any such contravention an offence is committed
by-
the master and the owner of the ship concerned; and
where the contravention is due to the act or omission of
another
on, that person;
for denying entry of any ship to the waters of Hong Kong in respect
of
h any such contravention is believed to have occurred;
for detaining any ship in respect of which any such
contravention is
eved to have occurred and for notifying the relevant consular
officer
any) of the detention and of any proceedings against the ship;
and
for the admission of prescribed or specified documents and
certified
es of documents as evidence in legal proceedings,
the regulations may--
make different provisions for different circumstances or in
relation
ifferent classes or descriptions of ships;
provide for exemptions from any provisions of the
regulations in
ect of different classes or descriptions of ships;
) provide for the granting by the Director, on such terms (if any)
as
ay specify, of exemptions from any provisions of the
regulations in
ect of any ship, or class or description of ships, and
for the
ration or cancellation of any such exemption;
provide for the approval by the Director of equivalent
fittings,
pment or procedures as alternatives to those prescribed;
provide for the delegation of powers exercisable and
functions
ormable by virtue of the regulations;
provide for the application of the regulations to the Crown; and
) include such incidental, supplemental and transitional
provisions as
ar to the Governor in Council to be expedient for the purposes
of the
lations.
Any fees prescribed under this Ordinance--
may be fixed at levels which provide for the recovery of
expenditure
rred or likely to be incurred by the Government or other authority
in
tion generally to the administration, regulation and control of
Hong
ships and of ports, ships and navigation in the waters of Hong
Kong,
shall not be limited by reference to the amount of
administrative or
r costs incurred or likely to be incurred in the provision
of any
icular service, facility or matter; and
may, without prejudice to the generality of paragraph (a), be
fixed at
erent amounts in relation to different sizes of ship, whether
measured
onnage, length or otherwise, or in relation to different
classes,
s or descriptions of service, facility or ship.
enalty for taking detained ship to sea
Where a ship is authorized or ordered to be detained under
regulations
under this Part, and after such detention or after service on
the
er of any notice of or order for such detention, the ship proceeds
or
mpts to proceed to sea before having been released by a
competent
ority, the master of the ship commits an offence and is liable
to a
of $500,000 and to imprisonment for 2 years; and if the
owner or
t or any person who sends the ship to sea is party or privy to
the
nce he also commits an offence and is liable to the same
punishment.
Where a ship proceeds to sea in contravention of subsection (1)
whilst
ng on board a public officer who is acting in the execution of
his
, the master and owner of the ship--
in addition to any punishment to which they may be liable
under
ection (1), both commit an offence against this subsection
and are
liable to imprisonment for 6 months and to a fine of $20,000 and
an
tional fine of $1,000 for each day during the period from the date
on
h the ship proceeded to sea until the date on which the
officer
rns to Hong Kong or, if he does not return directly to Hong
Kong,
d have returned if he had travelled by the quickest practicable
route;
are jointly and severally liable to pay to the Government all
expenses
dental to the taking of the officer to sea and to securing his
return
ong Kong.
Expenses referred to in subsection (2) (b) may be recovered as
if they
a fine imposed by a magistrate.
PART III SHIPPING CASUALTIES INVOLVING A RISK OF POLLUTION
pplication of Part III
Subject to subsections (2) and (3), this Part shall apply in
relation
ll ships whether within or outside the waters of Hong Kong.
As respects a ship which--
is not a Hong Kong ship; and
is for the time being outside the waters of Hong Kong,
power conferred on the governor by section 6 (2) to give
directions
only be exercised in relation to--
an individual who is a British citizen, a British
Dependent
itories citizen, a British Overseas citizen or who under the Hong
Kong
tish Nationality) Order 1986 (App. III, p. EG1) is a British
National
rseas); or
a body corporate which is established under the laws of Hong
Kong,
section 8 (2) shall apply to such an individual or body
corporate
.
No direction under section 6 (2) shall apply to any vessel
of Her
sty's navy or to any ship not forming part of Her Majesty's navy
which
ngs to Her Majesty or is held by any person on behalf of or for
the
fit of the Crown in right of Her Majesty's Government in the
United
dom or Her Majesty's Government in Hong Kong, and no action shall
be
n under section 6 (4) or (5) as respects any such vessel or ship.
hipping casualties
The powers conferred by this section may be exercised where--
an accident has occurred to or in a ship; and
in the opinion of the Governor--
oil, or any substance other than oil, from the ship will or may
cause
ution on a large scale in Hong Kong or in the waters of Hong Kong;
if the ship is one referred to in section 5 (2), the
danger of
ution is grave and imminent; and
) the exercise of the powers conferred by this section is
urgently
ed.
For the purpose of preventing or reducing pollution, or the
risk of
ution, the Governor may give directions as respects the ship or
its
o--
to the owner of the ship, or to any person in possession or control
of
ship; or
to the master of the ship; or
to any salvor in possession of the ship, or to any person who is
the
ant or agent of any such salvor, and who is in charge of the
relevant
age operation.
Directions under subsection (2) may require the person to whom
they
given to take, or refrain from taking, any action of
any kind
soever, and without limiting the generality of the
foregoing the
ctions may require--
that the ship is to be, or is not to be, moved--
to or from a specified place, area or locality;
over a specified route; or
that any oil or other cargo is to be, or is not to be, unloaded
or
harged; or
that specified salvage measures are to be, or are not to be, taken.
If in the opinion of the Governor the powers conferred by
subsection
are, or have proved to be, inadequate for the purpose, the
Governor
for the purpose of preventing or reducing pollution, or the risk
of
ution, take, as respects the ship or its cargo, any action of any
kind
soever, and without limiting the generality of the
foregoing the
rnor may--
do anything he has power to require to be done by a direction
under
ection (2);
cause operations to be undertaken for the sinking or
destruction of
ship, or any part of it, of a kind which is not within the means
of
person to whom he may give such a direction;
cause operations to be undertaken which involve taking over
control of
ship.
The powers of the Governor under subsection (4) may also be
exercised
uch persons as may be authorized in that behalf by the Governor.
A person concerned in complying with directions given, or in
action
n, under this section shall use his best endeavours to avoid risk
to
n life.
Nothing in this section shall derogate from or affect any
right or
r of the Government existing apart from this section whether
under
rnational law or otherwise.
Any action taken as respects a ship which is under arrest
or as
ects the cargo of such a ship, being action taken under a
direction
n under subsection (2), or under subsection (4) or (5)--
does not constitute contempt of court; and
shall not constitute a ground or cause of action in legal
proceedings
ituted against the Government.
In this section--
ident" includes the loss, stranding, abandonment of or damage
to a
; "any substance other than oil" means--
any substance specified in an order made under subsection (10);
and
any other substance which is liable to create a hazard to
human
th, to harm living resources and marine life, to damage
amenities or
nterfere with other legitimate uses of the sea;
cified", in relation to a direction under subsection (2),
means
ified in the direction.
The Governor may, by order published in the Gazette,
specify any
tance for the purposes of the definition of "any substance other
than
in subsection (9).
irections; right to recover in respect of unreasonable loss or
damage
If any action taken under a direction under section 6 (2), or
under
ion 6 (4) or (5)--
was not reasonably necessary to prevent or reduce pollution or,
as may
ppropriate, the risk of pollution; or
was such that the good it did or was likely to
do was
roportionately less than the expense incurred, or damage suffered,
as
sult of the action,
rson incurring expense or suffering damage as a result of the
action,
f himself having taken the action, shall be entitled to
claim and
ver compensation from the Government.
In determining whether subsection (1) applies in a particular
case,
unt shall be taken of--
the extent and risk of pollution if the action had not been taken;
the likelihood of the action being effective; and
the extent of the damage which has been caused by the action.
Any reference in this section to the taking of any action
includes a
rence to a compliance with a direction not to take some
specified
on.
ffences in relation to section 6
A person to whom a direction is given under section 6 (2) who fails
to
ly with any requirement of the direction, commits an offence.
A person who wilfully obstructs any person who is--
acting on behalf of the Governor in connection with the
giving or
ice of a direction under section 6 (2);
acting in compliance with such a direction; or
acting under subsection (4) or (5) of that section,
its an offence.
In proceedings for an offence under subsection (1), it shall
be a
nce for the accused to prove that--
he used all due diligence to secure compliance with the direction;
or
he had reasonable cause for believing that such compliance would
have
lved a serious risk to human life.
A person who commits an offence under this section is liable-
-
on conviction upon indictment, to a fine of $5,000,000;
on summary conviction, to a fine of $500,000.
ervice of directions under section 6
If the Governor is satisfied that a company or other body
corporate is
one to which section 338 or 356 of the Companies Ordinance (Cap.
32)
ies so as to authorize the service of a direction on that body
under
er of those sections, he may give a direction under section 6 (2)--
to that body, as the owner of, or the person in possession or
control
a ship, by serving the direction on the master of the ship; or
to that body, as a salvor, by serving the direction on the person
in
ge of the salvage operations.
For the purpose of giving or serving a direction under section
6 (2)
r on any person on a ship, a person acting on behalf of the
Governor
l have the right to go on board the ship.
Enforcement of fines
e a fine imposed in proceedings against the owner or master of
a ship
an offence under this Part is not paid at the time ordered by
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