BOARD REGULATION No. 2
Series of 2003
IMPLEMENTING RULES AND REGULATIONS GOVERNING
ACCREDITATION OF DRUG TESTING
LABORATORIES IN THE PHILIPPINES
Section 1
Scope
These rules and
regulations embodied herein shall apply to all government and private drug
testing laboratories in the Philippines.
Section 2
Authority
These rules and
regulations are issued to implement the provisions of Republic Act 9165:
“Comprehensive Dangerous Drugs Act of 2002” consistent with Executive
Order 102 series 1999: “Redirecting the Functions and Operations of the
Department of Health.”
Section 3
Definition of Terms
Accreditation refers to the formal authorization issued by the DOH
to an individual, partnership, corporation or association which has complied
with all licensing requirements (input/structural standards) and accreditation
requirements (process standards and outcome/output/impact standards) as
prescribed in the Manual of Operations for Drug Testing Laboratories issued by
the DOH.
Act refers to Republic Act No. 9165, “The Comprehensive
Dangerous Drugs Act of 2002.”
Applicant refers to the owner or head of a laboratory that is
applying for the issuance of accreditation.
Applications Service
Provider refers to third party
entities that manage and distribute software–based services and solutions to
customers across a wide area network from a central data center.
Bureau refers to the Bureau of Health Facilities and Services
of the DOH. It shall exercise the regulatory function.
Bureau Director refers to the director of the Bureau of Health
Facilities and Services.
Chain of Custody refers to procedures to account for each specimen by
tracking its handling and storage from point of collection to final disposal.
These procedures require that the applicant’s identity is confirmed and that a
Custody and Control Form is used from of collection to receipt by the laboratory.
Within the laboratory, appropriate chain of custody records must account for
the samples until disposal.
Custody and Control
Form refers to the form used to
document the procedures from time of collection until receipt by the
laboratory.
CHD refers to the Center for Health Development, which is
the DOH Regional Field Office.
Client/Donor refers to the individual from whom a specimen is
collected.
Confirmatory Test refers to the analytical procedures to identify and
quantify the presence of a specific drug or metabolite, which is independent of
the initial test and which uses a different technique and chemical principle
from that of the screening test in order to ensure reliability and accuracy.
Cut Off refers to the concentration level set to determine
whether the sample is positive or negative for the presence of a drug.
Dangerous Drugs include those listed in the schedule annexed to the
Act and its implementing rules and regulations.
DOH refers to the Department of Health
Laboratory refers to a private or government facility that is
capable of testing a specimen to determine the presence of dangerous drugs
therein.
NRL refer to the National Reference Laboratory for
Environmental and Occupational Health, Toxicology and Micronutrient Assay
designated by the Secretary of Health. It is a laboratory capable of doing
screening and confirmatory laboratory services, training and surveillance and
external quality assurance program for laboratory tests. Whenever the drug
testing laboratory is challenged, the NRL shall make the final decision.
Procedure Manual refers to the written document giving detailed steps
to be followed when undertaking a particular task.
Screening Test refers to a test to eliminate negative specimen from
further consideration and to identify the presumptively positive specimen that
requires confirmatory testing.
Secretary refers to the Secretary of Health
Specimen refers to the body fluid that is collected from a
person.
Section 4
Classification of Drug
Testing Laboratories
Drug testing
laboratories shall be classified according to:
1.
Ownership
a. Government – operated and maintained partially or wholly by the
national, provincial, city or municipal government, or other political unit, or
by any department, division, board or agency thereof.
b. Private – privately owned, established and operated with
funds through donation, principal, investment or other means, by any
individual, association or organization.
2.
Institutional Character
a. Institution–based – a laboratory that is located within the premises
and operates as part of an institution (e.g. hospital, medical facilities for
overseas workers and seafarers).
b. Freestanding – a laboratory that is located outside the premises
of an institution and operated independently.
3.
Service Capability
a. Screening Laboratory – a laboratory capable of performing screening tests.
b. Confirmatory Laboratory – a laboratory capable of performing qualitative and
quantitative examinations of dangerous drugs from the specimen.
Section 5
Client/Donor of Drug
Testing Laboratories
As enumerated and
described in R.A. 9165 Article III Section 36, the following persons shall
undergo drug testing:
Mandatory Drug Testing
a. Applicants for driver’s license
b. Applicants for firearm license
c. Officers and members of the military, police and other law enforcers
d. Persons charged before the prosecutor’s office with a criminal offense
having an imposable penalty of imprisonment of not less than six (6) years and
one (1) day
e. Candidates for public office whether appointee or elected both in the
national or local government
f. Persons apprehended or arrested for violating the provisions of this
Act
Random Drug Testing
a. Students of secondary and tertiary schools
b. Officers and employees of public and private offices whether domestic
or overseas
Section 6
Technical Requirements
for Accreditation
The laboratory to be able
to secure a DOH certificate of accreditation must comply with the following
technical requirements:
1.
Physical plant
a. Screening Laboratory – shall have at least twenty (20) square meters in floor area. The
work area must be ten (10) square meters with exhaust fan, sink and storage
cabinet
b. Confirmatory Laboratory – shall have at least sixty (60) square meters in
floor area. The clinical work area must be thirty (30) square meters with
exhaust fan, sink, stock room and instrumentation room.
A
laboratory of whatever category shall have within its premises an area which
can receive or accommodate at least five (5) prospective client/donors at a
given time, hand washing facility, toilet facility, and stall for the orderly
collection of specimen
A
DOH–licensed hospital or non–hospital based Secondary or Tertiary Category
Clinical Laboratory which intends to put up a Screening Laboratory for Drug
Testing, need not provide an additional twenty square meters to its existing
floor area. It shall only designate an area for drug testing within the
clinical laboratory.
2. Headship of the Laboratory
The
screening laboratory shall be headed by a licensed physician with certification
in Clinical Pathology from the Philippine Board of Pathology or certification
in Clinical Laboratory Management Training conducted by the DOH.
The
maximum number of screening laboratories a physician trained in Clinical
Laboratory Management can handle is ten (10), provided that they are physically
feasible (within 5 kilometers radius) to supervise.
In
cases where the screening drug–testing laboratory is a division, section or
unit of a Clinical Laboratory, it shall be headed either by a licensed
physician, chemist, medical technologist, pharmacist or chemical engineer.
The
confirmatory laboratory shall be headed by a licensed physician certified in
Clinical Pathology by the Philippine Board of Pathology with at least two (2)
years of active laboratory experience in analytical toxicology or a licensed
chemist with at least a Master’s Degree in Chemistry, Biochemisry or a branch
of Chemistry and at least two (2) years of active laboratory experience in
analytical chemistry.
The
head of the laboratory shall have a training and/or experience in the theory
and practice of the procedures used in laboratories, resulting in his or her thorough
understanding of quality control procedures and practices; the review,
interpretation and reporting of test results; the maintenance of chain of
custody and proper remedial actions to be taken in response to test systems
being out of control limits or quality control results.
The
laboratory head shall have the overall responsibility for the professional,
organizational, educational and administrative activities of the drug testing
facility.
3.
Personnel
A
laboratory shall have the following technical staff:
a. Screening Laboratory – shall have either a full time licensed chemist, medical
technologist, pharmacist or chemical engineer with appropriate training in
screening test procedures for dangerous drugs. The DOH shall recognize the
training program.
b. Confirmatory Laboratory – shall have a full time licensed chemist, who has
successfully completed extensive and appropriate training in chromatography,
spectroscopy, and either a medical technologist, pharmacist or chemical
engineer with appropriate training in the screening test procedure for
dangerous drugs. The DOH shall recognize the training program. The laboratory
staff of Confirmatory Laboratory shall be required to pass a proficiency test,
which is to be established and administered by the NRL.
A
laboratory shall have administrative or non–technical personnel who shall have
the necessary training and skills for the tasks assigned to them.
4.
Laboratory Equipment
A
laboratory shall be required to have the following equipment:
a. Screening Laboratory – shall have the necessary equipment or kit for screening tests in
addition to the basic equipment. (refer to Annex A)
b. Confirmatory Laboratory – shall have the necessary equipment for screening,
qualitative and quantitative examinations in addition to the basic equipment.
Annex
A: Minimum Technical Requirements
|
Service
|
Confirmatory Laboratory
|
Screening Laboratory
|
|
Screening Test
|
Immunoassay equipment or
BFAD registered drug
testing kit
Or
Thin Layer
Chromatography (TLC)
|
Immunoassay equipment or
BFAD registered drug
testing kit
Or
Thin Layer
Chromatography (TLC)
|
|
Confirmatory
Examination
|
Gas Chromatography –
Mass Spectrometer
(GC – MS)
High Performance Liquid
Chromatography – Mass
Spectrometer
(HPLC – MS)
or some such modern and
accepted equipment
|
|
|
|
Basic equipment:
Laboratory oven
Analytical balance
Refrigerator
Freezer
Fumehood
Other necessary
equipment based on the procedure used
|
Basic equipment
Refrigerator/Freezer
|
5.
Information Technology Requirements
a. The laboratory shall maintain a set of information technology equipment
whose specification shall conform to the minimum requirement set by the DOH.
b. The laboratory shall have access to one duly authorized Application
Service Provider (ASP) approved and maintained by the DOH selected through
competitive bidding following existing government rules and regulations. The
DOH shall formulate the Terms of Reference / Request for Proposal for the
selection of the Application Service Provider subject to the approval of the
Dangerous Drugs Board.
6. Records
The
laboratory shall maintain a record of all its personnel. These records shall
include the resume of training and experience, certification or license,
incident reports (if any) and such other information, which will establish the
competence of the employees.
The
laboratory must maintain and make available for an agreed period, documentation
of all aspects of the testing process involved in the generation of a positive
result.
The
required documentation must include:
a. Training records on all individuals authorized to have access to
samples
b. Custody and Control Forms
c. Quality assurance/quality control records
d. All data including calibration curves and any calculations used in
determining test results.
e. Reports
f. Records of performance testing and computer generated data
The
laboratory will be required to maintain documents for any sample under legal
challenge for a further agreed period.
7. Security
A
laboratory shall have security measures to control access to the premises and
to ensure that only authorized personnel handle or have access to specimens or
can gain access to laboratory processes or to areas where records are stored.
With the exception of duly authorized representative of the Bureau, all
authorized visitors, maintenance and service personnel shall be escorted at all
times while inside the laboratory. The laboratory shall maintain a record that
indicates the date, time of entry and exit and purposes of entry of non–employees.
8. Chain of custody
A
laboratory shall use documented chain of custody procedures to maintain control
and accountability of specimens. The date and purpose shall be recorded on an
appropriate Custody and Control Form each time a specimen is handled or
transferred and every individual the chain shall be identified. Accordingly,
authorized collection staff shall be responsible for each specimen in their
possession and shall sign and complete the Custody and Control Forms.
The
minimum information required on the Custody and Control Form is the following:
a.
Information identifying the specimen
b.
Date and time of collection
c.
Name of testing laboratory
d.
Name and signature of all individuals who had custody of the sample during
the collection process.
9. Storage of Laboratory Reports and Specimens
Reports
pertaining to specimens shall be kept by the testing laboratory for a minimum
period to be determined by the DOH. Specimens with confirmed positive test
results, which are not challenged within fifteen (15) days after receipt, shall
be discarded. A specimen may be kept for a maximum of one (1) year upon
request.
10. Test levels
The
Bureau, until such time that the NRL is established and operational shall
require each laboratory to submit its protocol indicating the initial cut–off
levels in screening specimens to determine whether they are negative or for
confirmation of the presence of dangerous drugs. The acceptability of the cut
off levels shall depend on the methods used by the laboratory, its equipment
and registered testing kits.
11. Procedure Manual
A
laboratory shall have a procedure manual validated by the NRL which shall
include the principles of each test, the preparation of reagents, standards and
controls, calibration procedures, derivation of results, linearity of methods, sensitivity
of the methods, cut–off values, mechanisms for reporting results, control
criteria for unacceptable specimens and results, remedial actions to be taken
when the test systems are outside of acceptable limits, reagents expiration
dates, references and quality control measures. Copies of all procedures and
dates on which they are in effect shall be maintained as part of the manual.
12. Equipment and Instruments
Volumetric
pipettes and measuring devices shall be certified for accuracy or be checked by
gravimetric, colorimetric or other verification procedures by the Department of
Science of Technology – Industrial Technology Development Institute. Automatic
pipettes and dilutors shall be checked for accuracy and reproducibility before
being place in service and checked periodically. Thereafter, there shall be
written procedures for instruments set–up and normal operations, a schedule for
checking critical operating characteristics, tolerance limits for acceptable
function checks, and instructions for major troubleshooting and repair.
Preventive maintenance records shall be kept.
13. Calibrators and Controls
Laboratory
calibrators and controls shall be prepared using pure drug reference materials,
stock standard solutions obtained from other laboratories, or standard
solutions obtained from commercial manufacturers. The calibrators and controls
shall be properly labeled as to content and concentration. The standards (e.g.
pure reference standards, stock standard solutions, purchased standards) shall
be labeled with the following: date received (if applicable); date prepared or
opened; date placed in service and expiration date.
14. Urine Specimen Collection,
Handling and Disposal
The
laboratory shall follow the DOH prescribed guidelines in the collection,
handling and disposal of urine specimens. Universal precaution shall be observed
at all times.
15. Laboratory Report
a. Screening test result form – the test result of an accredited laboratory shall
be in the form prescribed by the DOH.
b. Signatory of test result – all test results shall bear the signature of the
analyst and head of laboratory.
c. Reporting test results – a screening test result shall be reported as
negative or positive. A confirmatory test shall report the presence or absence
and the identity of the drug/metabolite tested as well as its concentration.
The
original copy of the test result form shall be given to the client/donor
immediately upon its completion. All specimens with positive screening test
results shall be submitted for confirmation before a final report will be
issued immediately to the DOH and the requesting agency. The drug–testing
laboratory shall retain once copy.
The
test results that are forwarded to the DOH shall include the membrane of the
registered drug testing kit in the case of screening tests and a copy of the
chromatogram in the case of confirmatory tests.
d.
Access to laboratory test results – the drug test result and the records shall be
confidential subject to the usual accepted practices to protect the confidentiality
of the test results.
16. Proficiency Testing
a. The NRL shall conduct a continuing assessment of the proficiency of
Screening and Confirmatory Laboratories. All procedures associated with the
handling and testing of the proficiency – testing sample shall to the greatest
extent possible to carried out in a manner identical to that applied to routine
specimens, unless otherwise specified.
b. Results of proficiency test
The
laboratory shall submit to the NRL the results of the test performed on the
unknown sample within three (3) weeks after the receipt of the test sample.
Said results shall be kept confidential.
c. Failure to pass proficiency test
A
laboratory that fails to pass proficiency test conducted by the NRL shall be
given another test not earlier than one (1) month after the failed test.
However, failure to pass proficiency test shall result in the suspension of its
accreditation. Such suspension shall be lifted only after passing the second
proficiency test. Failure to pass the second proficiency test shall result in
the revocation of its accreditation.
Section 7
Validity of the Test
Result
The drug test certificates
on tests performed by accredited drug testing centers shall be valid for one
(1) year period from the date of issue, which may be used for other purposes.
Section 8
Allowable Service Fees
The drug–testing
laboratory may collect a reasonable service fee for the performed examination,
which shall not be greater than the maximum allowable service fee prescribed by
the DOH. The maximum allowable service fees shall be adjusted from time to
time.
Section 9
Procedural Guidelines
for Accreditation
The applicant shall follow
these procedures for application of initial certificate of accreditation:
1. Applicant accomplishes the required documents and submits them to the
Bureau or CHD for endorsement to the Bureau. Upon filing of application, the
applicant pays the corresponding fees to the Cashier of the DOH in person, or
through postal money order.
Documentary
Requirements:
a. BHFS Application Form – filed either at the Bureau or CHD
b. Letter of Endorsement to the Bureau Director (if filed at the CHD)
c. DTI/SEC Registration (for private laboratory)
Enabling
Act (for national government laboratory)
Approved
Board Resolution (for local government laboratory)
d. Mayor’s Permit
e. One (1) set of Floor Plan showing specific location of equipment and
work areas required, appropriately dimensioned, properly identified and
completely labeled. It shall be signed and sealed by an architect or engineer.
f. List of Personnel, notarized, including photocopies of current PRC
identification card and certificates of training
g. List of Equipment with specifications
h. Contract of Lease (if facility is rented)
i. Procedure Manual
j. Custody and Control Form
The
following requirements shall be submitted within the first six (6) months of
operation after issuance of initial certificate of accreditation:
a. Documentation of Quality Control Program (for screening laboratory)
b. Certification for Quality Standard System from DOH–recognized
certifying body (for confirmatory laboratory)
2. The Bureau conducts survey on site to determine compliance with
standards and technical requirements of accreditation.
3. The Bureau approves or disapproves the issuance of certificate of
accreditation.
a. If approved, the Bureau registers the laboratory and issues an initial
certificate of accreditation to the applicant upon deposit of twenty thousand
pesos (P20,000) cash bond.
b. If disapproved, the Bureau sends the findings and recommendations to
the applicant for compliance. Failure to comply within fifteen (15) days shall
be a ground for denial of the application. Hence, the applicant has to re–file
his application and pays the required accreditation fees.
Section 10
Accreditation Fees
1. The following schedule of fees for initial and renewal of accreditation
shall be paid to the Cashier of the DOH.
Accreditation
Fees
a.
Confirmatory laboratory P
10,000
b.
Screening laboratory P
5,000
The
initial certificate of accreditation of private drug testing laboratories shall
be issued upon deposit of twenty thousand pesos (P20,000) cash bond per
laboratory.
2. The Bureau is authorized to adjust the accreditation fees from time to
time.
Section 11
Content of Certificate
of Accreditation
The certificate of
accreditation shall state on its face the name of the owner and head of the
laboratory, the classification and validity period. It shall be signed by the
Bureau or CHD Director.
Section 12
Validity
The certificate of
accreditation shall be valid for a period of two (2) years for Confirmatory
Laboratory and one (1) year for a Screening Laboratory.
Section 13
Renewal Certificate of
Accreditation
1. Application for renewal of accreditation shall be filed ninety (90)
days before the expiry date to the Bureau or CHD under whose jurisdiction the
laboratory is located.
2. The applicant shall follow the following procedures for renewal of
certificate of accreditation:
a. Applicant accomplishes the required documents and submits them to the
Bureau or CHD. Upon filing of application, the applicant pays the corresponding
fees for renewal to the Cashier of the Bureau or CHD in person, or through
postal money order.
Documentary
requirements:
(1) Notarized: Application for
Renewal of Certificate of Accreditation
(2) Notarized List of Personnel
(3) List of Equipment/Instrument
(4) Current Certificate of
Accreditation
(5) Current Mayor’s Permit
(6) Documentation of Chain of Custody
(7) Current Certification for Quality
Standard System (renewed yearly) – for Confirmatory Laboratory
(8) Current Proficiency Test Result
(renewed yearly)
b.
The Bureau or CHD conducts survey to determine compliance with
standards and technical requirements for accreditation.
c. The Bureau or CHD approves or disapproves renewal of certification of
accreditation
(1) If approved, the Bureau or CHD
renews the certificate of accreditation
(2) If disapproved, the Bureau or CHD
sends the findings and recommendations to the applicant for compliance. Failure
to comply within fifteen (15) days shall be a ground for suspension/revocation
of accreditation.
Section 14
Monitoring of
Laboratories
The Bureau or CHD may
conduct an on–site monitoring visits of accredited laboratories. The monitoring
visits shall be conducted unannounced. The monitoring visits shall document the
overall quality of the laboratory setting.
Section 15
Terms and Conditions of
Accreditation
1. An accreditation shall be granted in accordance with prescribed
accreditation requirements and on the basis of specific conditions and
limitations established during survey.
2. An accreditation that is not renewed on the expiry date shall be
considered lapsed and registration shall be cancelled. A new application for
the issuance of accreditation shall be required before a laboratory can be
allowed to operate.
3. The accreditation as herein granted as well as any right under the
accreditation cannot be assigned or otherwise transferred directly or
indirectly to any party.
4. The Bureau shall be notified of any change in management name or
ownership. In cases of transfer of location, a new application for
accreditation shall be required.
5. Failure to report in writing within fifteen (15) days of any
substantial change in the condition of the laboratory (e.g. changes in the
physical plant, equipment or manpower) may be a basis for the suspension or
revocation of the accreditation.
6. A separate accreditation shall be required for all laboratories or
branches maintained in separate premises under the same management.
7. The accreditation shall be placed in an area readily seen by the
public. A copy of the rules and regulations shall be readily available for
guidance of all personnel of the laboratory.
Section 16
Violations
Violations of this
Implementing Rules and Regulations shall include among others the commission of
the following acts:
1. Issuance of false or fraudulent drug test results.
2. Failure to protect the confidentiality of drug test results.
3. Failure to participate or pass the proficiency testing.
4. Conviction of the owner or manager of a laboratory for any criminal
offense committed as an incident to the operation of the laboratory.
5. Failure to refer the positive screening test results to a Confirmatory
Laboratory.
6. Any other cause which materially affects the ability of the laboratory
to ensure the full reliability and accuracy of drug tests and the accurate
reporting of results.
7. Failure on the part of the medical facility to submit documentation of
Quality Control Program (for screening laboratory) and certification of Quality
Standard System from a DOH–recognized certifying body (for confirmatory
laboratory) within six (6) months of operation after issuance of initial
certificate of accreditation will cause revocation of the initial certification
of accreditation.
8. Refusal to allow survey, monitoring of a laboratory by the Bureau or
CHD at an appropriate time.
9. Any act which is contrary to the accepted clinical laboratory
practices.
Commission or omission of
any of the aforementioned acts shall be a ground for suspension/ revocation of
certificate of accreditation without prejudice to the filing of any criminal
action under Section 32 of R.A. 9165.
Section 17
Suspension or
revocation of Certificate of Accreditation
The Bureau on its own or
based on complaint, shall investigate and after due hearings may suspend or
revoke the accreditation of a laboratory for such period and under such terms
as may be necessary to ensure the full reliability and accuracy of drug tests
and the accurate reporting of test results.
If upon survey or
monitoring visits, the drug testing laboratory is found to be violating the
rules and regulations as well as other violations stipulated under Section 17,
the Bureau may immediately preventively suspend the operation of the said
laboratory. Preventive suspension shall not be more than sixty (60) days.
Section 18
Reapplication for
Certificate of Accreditation
A laboratory whose
Certificate of Accreditation has been revoked may reapply for the issuance of a
new one upon compliance with the requirements established hereunder and/or the
correction of the deficiency or violation, which resulted in the revocation.
Section 19
Appeal
Any laboratory or any of
its personnel aggrieved by the decision of the Bureau may, within fifteen (15)
days after receipt of the notice of decision, file a notice of the appeal with
the Office of Secretary, and serve a copy of the notice of appeal to the
Bureau. Thereupon, the Bureau shall promptly certify and file a copy of the
decision, including the transcript of the hearings on which the decision is
based with the Office of the Secretary for review and consideration.
Section 20
Penal Provisions
Any person authorized or
accredited under this Act and its implementing rules to conduct examination or
test, who issues false or fraudulent drug test result knowingly, willfully or
through gross negligence, shall suffer the penalty of imprisonment ranging from
six (6) years and one (1) day to twelve (12) years and a fine ranging from one
hundred thousand pesos (P100,000) to five hundred thousand pesos (P 500,000).
Further, revocation of license to practice shall be recommended to the
Professional Regulation Commission.
Section 21
Transitory Provisions
Until such time that the
NRL that the NRL for toxicology of the DOH is established and operational, the
DDB – Laboratory shall act as the NRL.
In administrative regions
where are no Gas Chromatography – Mass Spectrometer (GCMS) nor High Performance
Liquid Chromatography – Mass Spectrometer (HPLC – MS) equipment currently
available, all DDB licensed drug testing laboratories using High Performance
Liquid Chromatography may be allowed to operate as Confirmatory Laboratory
using such machine provided that its photo diode array is not more than two (2)
years. In the absence of GC – MS and HPLC with photodiode array of not more
than two years. In the absence of GC – MS and HPLC with photodiode array of not
more than two years, licensed drug – testing laboratories using Thin Layer
Chromatography (TLC) may be allowed to perform confirmatory tests.
In the event that a confirmatory
laboratory with GC–MS or HPLC–MS is accredited by the DOH in administrative
regions where they were not earlier available, use of HPLC with photo – diode
array of not more than two years or TLC shall be allowed only for a maximum
period of ninety (90) days from receipt of notice of such accreditation from
the DOH, which notice must be sent within then (10) days from approval.
In the event that a
confirmatory laboratory with HPLC with a photo diode array of not more than two
years is accredited by the DOH in administrative regions where GC–MS or HPLC is
not available, use of TLC shall be allowed only for a minimum period of ninety
(90) days from receipt of notice of such accreditation from DOH, which notice
must be sent within ten (10) days from approval.
When modern and accepted
methods for confirmatory testing emerge, the DOH shall immediately conduct
technical studies and submit recommendations to the DDB for appropriate action.
The use of DDB validate
drug testing kits shall be allowed until December 31, 2003. Thereafter, only
Bureau of Food and Drugs registered kits shall be used.
Manual processing of
necessary documents shall be done in facilities where Application Service
Provider (ASP) is not available.
These rules and regulations
shall be subject for review annually.
Section 23
Separability
In the event that any
section, paragraph, sentence, clause or word of this order is declared invalid
for whatever, any reason, other provisions thereof shall not be affected
thereby.
Section 24
Effectivity
These rules and
regulations shall take effect upon approval of the Dangerous Drugs Board and
publication in a newspaper of general circulation.
ADOPTED and APPROVED this
27th of June, 2003 at Camp Crame, Quezon City.
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