RA 9165

The Comprehensive Dangerous Drugs Act of 2002 and its

implementing rules and regulations
Introduction
 One of the greatest current concerns of the
government is the high incidence of the
use of prohibited drugs in the country.
The threat posed by prohibited drugs against
human dignity and the integrity of society is
malevolent and incessant.
 Such pernicious effect is felt not only by the
addicts themselves but also by their families.
 As a result, society's survival is endangered
because its basic unit, the family, is the
ultimate victim of the drug menace.
In pursuing an intensive and unrelenting
campaign against this social dilemma,
the government legislated R.A. No. 9165,
otherwise known as the Comprehensive
Dangerous Drugs Act of 2002. This law
mandates the Department of Health
(DOH) to license, accredit, establish
and maintain a drug test network and
laboratory, initiate, conduct, and support
scientific research on drugs and drug
control.
What is R.A. 9165?
It is a special penal law and consist of
102 sections.
Approved on June 7,2003.
Has repealed R.A. 6425( Dangerous
Drugs Act of 1972).
About R.A. 9165
 RepublicAct No. 9165 is a special penal law
and consists of 102 sections. However, only
certain sections that affect the practice of
medical technology will be discussed, such
as those covered by Article III of this law, as
amended.
 One of the most important mandates of this
law to the DOH is to license, accredit,
establish, and maintain the drug test
network and laboratory, and to initiate,
conduct, and support scientific research on
drugs and drug control.
About 9165
 Thus, in carrying out this task, the DOH promulgated
the Implementing Rules and Regulations
Governing the Accreditation of Drug Testing
Laboratories in the Philippines. At present, this is the
governing IRR with respect to the licensing and
accreditation of drug testing laboratories (DTLs).
 The objective of this IRR is to standardize the
procedure of drug testing services in the
Philippines among all stakeholders. It must also
implement a quality assurance program in DTLs
nationwide. The scope of this IRR covers both
government and private DTLs.
DTLs and their classifications
 DTLis a private or government facility that is
capable of testing a specimen to determine the
presence of dangerous drugs therein.
 DLTmay be classified into: ownership,
institutional character and service
capability.
 Ownership- government or private
 Institutional character- institution-based or
freestanding
 Servicecapability- screening laboratory or
confirmatory laboratory
Who is required to undergo drug
testing?
Drug test is no longer a requirement
when applying for a driver's license
 Under R.A. No. 10586, otherwise known as the Anti-Drunk
and Drugged Driving Act of 2013, it amended R.A. No.
9165 and expressly revoked the requirement of a drug
test as a prerequisite when applying for a driver's
license.
 Republic Act No. 10586 further states that only drivers in
vehicular accidents and persons believed to be driving
under the influence of alcohol, dangerous drugs and/or
other similar substances by apparent indications and
manifestations will be subjected to a mandatory drug
test as well as an alcohol test.
Supervision, management and
staffing
 Who may head a DTL?
Cont’d
 How many DTLs is a licensed physician allowed to
supervise?
a licensed physician is allowed to supervise at
least 10 DTLs
 Who is qualified to become a drug analyst?
 qualifiedprofessionals such as chemists,
MTs, pharmacists, or chemical engineers
may perform the tasks of a drug analyst.
 Who is an authorized specimen collector?
a specimen collector is a member of the
laboratory personnel who collects
specimens from a patient, client or subject.
Technical requirements and
Laboratory Equipment
DTL must comply with the
technical requirements,
including the necessary
laboratory equipment to acquire
a Certificate of Accreditation.
Screening laboratory
 Under Section 6, subsection 4-Technical
requirements for accreditation (see
annex A) of the IRR governing
accreditation of drug testing laboratories,
as revised.
 For laboratory equipment, a screening
laboratory must haveConfirmatory
Screening test
at least Examination
-
Immunoassay equipment ;or Basic equipment:

BFAD-registered drug testing kit; or -Refrigerator/freezer

a thin layer chromatography (TLC)

confirmatory laboratory
Screening test Confirmatory examination
Immunoassay equipment Gas Chromatography-Mass Spectrometer(GC-MS),
;or
BFAD-registered drug High-performance liquid chromatography- ass
testing kit; or spectrometer (HPLC-MS)
a thin layer or some such modern and accepted equipment
chromatography (TLC)
Basic equipment:
-laboratory oven
-analytical balance
-refrigerator
-freezer
-fumehood
-other necessary equipment based on the
procedure used
Floor area and Work area of a Drug
Testing Laboratory
Specimen and Specimen
Collection and Handling
What are the types of specimen that
may be submitted for a drug testing?

The following Blood,

specimens Fingernails,
maybe Saliva,
submitted for Scalp hair,
drug test: Sweat(patch)
Urine,
And tissue
What is chain of custody?
 Chain of custody refers to procedures to
account for each specimen by tracking its
handling and storage from point to point
of collection to final disposal.
 These steps require the confirmation of the
applicant’s identity and a custody and
control form(CCF) must be used from the
time of collection to receipt by the
laboratory.
 Within the laboratory, an appropriate chain
of custody record must account for samples
until disposal.
URINE AS A MOST COMMON TYPE
OF SAMPLE SPECIMEN
It is mainly used for it is readily
available in conducting drug test.
Quantity of urine to be collected:
Atleast 60ml- if single container is
used OR
30ml in two (2) separate containers
for split specimen.
BASIC STEPS IN COLLECTING URINE SPECIMEN
FOR DRUG TESTING
 a. The Client/Donor/Subject removes all unnecessary outer
garments (sush as coat or jacket, after which, he/she will be
subjected to a bodily search.
 b. The Authorized Specimen collector directs the
Client/Donor/Subject to empty his/her pockets and check items
that may be used to adulterate the specimen.
 c. The Client/Donor/Subject washes and dries hands prior to
collection. After washing hands, the Client/Donor/Subject must
remain in the presence of the Authorized Sppecimen Collector
and must not have access to anything that could be used to
affect the specimen.
 d. The Authorized Specimen Collector either gives or
allows the Client/Donor/Subject to select the collection
container from available supplies. The specimen is
opened in full view of the Client/Donor/Subject.
 e. The Authorized Specimen Collector directs the
Client/Donor/Subject to go to the toilet facility for
urination and to provide at least 60-ml either collected in
single or split specimen.
 f.The Authorized Specimen Collector shall observe
closely the entire collection procedure and take note of
the conduct and demeanor of the Client/Donor/Subject
for attempts of substitution, adulteration and dilution of
specimen.
 g. A tampered specimen is sent to the laboratory for validity
testing and the Authorized Specimen Collector shall document the
tampering on the CCF with appropriate remarks. The Authorized
Specimen Collector shall instruct the Client/Donor/Subject to
provide another urine sample immediately under direct observed
collection. The second specimen shall also be sent for examination
 h. After the Client/Donor/Subject hands the specimen, the
Authorized Specimen collector must measure the temperature,
check volume and inspect its characteristics.
 i. The Atuhorized Specimen collector and Client/Donor/Subject
must keep the specimen in full view at all times prior to sealing of
all specimen containers.
 j. A tamper-evident label must be used to secure the entire
specimen container.
 k. Both Authorized Specimen Collector and Client/Donor/Subject
must affix their signature on the seal together with the date and
time of collection.
 l. The Authorized Specimen Collector must complete steps 1 and 2
and initiates step 4 of CCF.
 m. The Client/Donor/Subject must affix his/her signature at step 5 of
the CCF. The Authorized Specimen Collector may ask the
Client/Donor/Subject to list any prescription, medication he/she may
have taken for the past two weeks at the back of the CCF (Analyst
copy). Authorized Specimen Collector shall distribute each copy
asrequired.
 n. In case of specimen collection at a remote site and transport via a
courier/mail, the specimen container together with the CCF chall be
placed ina a sealed, labeled and secured transparent plastic bag.
CRITERIA FOR SPECIMEN REJECTION THAT ARE
NON-CORRECTABLE

 a.Incompatibility of the ID number on the specimen

received by the laboratory with the number on the
CCF
 b. Absence of ID number on the specimen
 c.No printed Authorized Specimen Collector’s name
and signature on the CCF.
 d.Broken or tampered seal on the specimen
container.
 e. Insufficient quantity of specimen.
Reporting
What is a Screening Test?
A rapid test performed to establish
potential/presumptive positive result.
A test to eliminate negative
specimens from further consideration
and to identify the presumptively
positive specimens that requires
confirmatory testing.
 What is a Confirmatory Test?
 An analytical procedure used 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.

 NOTE: the 2 most abused prohibited

drugs in the Philippines are shabu and
marijuana.
Accreditation
 Accreditation refers to the formal authorization
issued by the DOH to an individual, partnership,
corporation, or association which has complied
with all licensing requirements and accreditation
requirements as prescribed In manual of
operations for drug testing laboratories released
by the DOH.
 Authorized drug testing shall be done by any
government forensic laboratories or by any of
the drug testing laboratories accredited and
monitored by the DOH to safeguard the quality
of test results.
As the mandate of law, it follows that
all DTLs must first be accredited
before performing drug tests.
*confirmatory laboratory- valid for
2years.
*screening laboratory- valid for 1
year.
* for renewal of certificate- must be
file within 90days before the expiry
date
Owners must file DOH will check the
Issuance of the
the minimum due compliance of
Certificate of
requirements to the owner of the
Accreditation
the DOH laboratory
 *theHFSRB or CHD has the authority to
monitor accredited DTLs
 *HFSRB has the authority to investigate
and may suspend and revoke the
accreditation of DTLs.
 Iffound to be in violation of the rules and
regulations during the survey or on a
monitoring visit, the HFSRB may
immediately preventively suspend
the operation of the said laboratory. The
preventive suspension shall not be
more than 60 days.
 ifthe penalty imposed by the HFSRB is
revocation of accreditation, a DTL
whose COA has been revoked may re-
apply for a new one upon compliance
with the requirements and/or the
correction of the deficiency or violation
that caused the revocation.
* may file the appeal to the secretary
of health within 15days from receipt.
violations

Issuance of a false or fraudulent

drug test result may be a ground for
suspension or revocation of license.
Imprisonment: 6years and 1 day to
12 years
Fine: 100,000.00 to 500,000.00