Juris Pink PDF
Juris Pink PDF
Juris Pink PDF
JURISPRUDENCE
239. Prescription without specification of the generic name of the prescribed product is a violation of RA _________.
A. 5921
B. 6675
C. 6425
D. 3720
240. The ultimate objective of PNDP is/are to provide
A. low-cost high quality drugs
B. free consultation from the physician
C. high quality but expensive drug
D. both A & B
241. __________ means any substance which has a flash point at or below negative six and six-tenths degrees
centigrade as determined by the Tagliabue Open Club tester
A. extremely flammable
B. combustible
C. both A & B
D. neither A & B
242. ___________ contains the rules and regulations to implement dispensing requirements under the Generics Act
of 1988.
A. AO. No. 63
B. AO. No. 64
C. AO. No. 65
D. AO. No. 66
243. Which of the following is the Dangerous Drugs?
A. LSD
B. MDMA
C. both A & B
D. NOTA
244. This means any substance which on contact with living tissue will cause destruction of tissue by chemical
action.
A. corrosive
B. bleaching agent
C. disinfectant
D. irritant
245. This a substance which on immediate, prolonged or repeated contact with normal living tissue will induce local
inflammatory action.
A. corrosive
B. irritant
C. disinfectant
D. bleaching agent
246. RA. 7394 was signed into a law on
A. April 13, 1992
B. Feb. 7, 1992
C. Sept. 13, 1992
D. April 7, 1992
247. RA. 6675 was signed into a law on
A. Sept. 23, 1998
B. Sept. 13, 1998
C. Sept. 4, 1998
D. Sept. 30, 1998
248. RA. 7432 was signed into a law on
A. Feb.7, 1992
B. April 7, 1992
C. Feb. 13, 1998
D. April 13, 1992
249. Which of the following does not required a prescription?
A. finasteride
B. ibuprofen 200mg
C. zafirlukast
D. esomeprazole
250. EO. No.______ institutionalizes the Continuing Professional Education ( CPE ) Programs of the various
Professional regulatory Boards ( PRBs ) under the supervision of the Philippine Regulatory Commission.
A. 851
B. 265
C. 266
D. 267
251. Inspection Section and Licensing Section are under what organizational unit of BFAD?
A. Regulation Division I
B. Regulation Division II
C. Product Services Division
D. Laboratory Services Division
252. Cash collection and Disbursement Section, and Personnel Section are under what organizational unit of
BFAD?
A. Product Services Division
B. Laboratory Services Division
C. Legal, Information and Compliance Division
D. Administrative Division
253. This BFAD organizational unit plans, directs, organizes, and controls the activities of the Bureau with the
assistance of the Divisions and Units under it.
A. Office of the Director
B. Regulation Division I
C. Regulation Division II
D. Product Services Division
254. The Laboratory Services Division Of BFAD includes
A. food
B. toxicology
C. cosmetic
D. household hazardous substance
255. The Division in BFAD that certifies batches of antibiotics
A. Product Services
B. Laboratory services
C. Legal, Information, and Compliance
D. Administrative
256. This is the Division of the BFAD that provides assistance to person/establishment in complying with BFAD legal
requirements.
A. Laboratory Services
B. Legal, Information, and Compliance
C. Product Services
D. Regulation Division I
257. The Laboratory Division of BFAD has the duty of
A. testing, analyzing, and doing trials on submitted products
B. inspection of drug outlets
C. taking samples from different drug establishment
D. assist in the of factual evidences
258. This order prescribes the conditions and requirements for good manufacturing practice applied to premises,
equipment, personnel, product and warehouse.
A. AO. No. 202
B. AO. No. 220
C. AO. No. 221
D. AO. No. 223
259. CGMP means
A. current general manufacturing process
B. current good manufacturing procedure
C. current good manufacturing practice
D. current good manufacture practice
260. CGMP assures drug meets the requirements of the act as to
A. safety
B. identity
C. strength
D. purity
E. AOTA
261. Equipment used for manufacturing, processing, packing, labeling, testing and control of drugs must be
A. of suitable size
B. absorptive
C. non-reactive
D. both A & C
262. Test for components
A. Microbiological test
B. Test for heavy metals
C. Microscopic examination
D. all of the above
263. The amount of reserve sample of all active ingredients to be kept for all required test in the laboratory to be
performed are
A. 5×
B. 2x
C. 3x
D. 4x
264. Approved records of components which must be maintained for future reference
A. name of customer
B. lot component
C. date and amount received
D. batch uniformity
265. Production record must be kept for
A. 2 years after expiration of the product
B. 2 years after batch distribution is completed
C. 1 year after batch distribution is complied
D. 2 years before expiration date
266. Each critical step in production process must be performed and checked by _________ competent and
responsible individual
A. 1
B. 3
C. 4
D. 2
267. Laboratory controls are required for
A. finished products
B. in process drug
C. components
D. all of the above
268. This mean any ingredient intended for use in the manufacturing of drugs, including those that may not appear
in the finished product.
A. component
B. raw material
C. inactive ingredient
D. both A & B
E. both A & C
269. This means a batch or any portion of a batch of a drug produced by continuous process, an amount of drug
produced in a unit time or quantity in a manner that assures its uniformity and either case which is identified by a
distinctive lot number and has uniform character and quality within specified limits.
A. lot
B. lot number
C. control number
D. none of the above
270. This means any distinctive combination of letters or numbers, or both by which the complete history of the
manufacture, control, packaging, and distribution of a batch or lot of a drug is determined.
A. lot
B. lot number
C. control number
D. A & B
E. B & C
271. According to AO. No. 42, the test for alcohol content in quality control requirements should not more than ___
A. 15%
B. 10%
C. 20%
D. 30%
272. This is the required test for suppositories and pessaries
A. weight variation
B. dissolution
C. melting point
D. boiling point
273. Ointments, creams, and other semi-solid preparations are tested for
A. impalpability
B. homogeneity
C. melting point
D. all of the above
274. Validity of the initial registration for herbal and traditional drugs
A. 5 years
B. 2 years
C. 1 years
D. 3 years
275. Herbal and Traditional drugs must be registered with the
A. DOH
B. DTI
C. BFAD
D. DDB
276. This means any drugs Establishment that procures raw materials, active ingredients and/or finished products
from local establishments for local distribution on wholesale basis.
A. importer
B. exporter
C. wholesaler
D. drug trader
277. This means any organization or company involved in the manufacture, importation, repacking, and/or
distribution of drugs or medicines.
A. drug establishment
B. drug outlet
C. drug manufacturer
D. drug trader
278. This a drug which has been used for at least 5 years and involving at least 5,000 patients.
A. investigational drugs
B. tried and tested drugs
C. established drugs
D. none of the above
279. This a drug whose safety and efficacy has been demonstrated through long years of general use and can be
found in current official USP-NF, and other internationally recognized pharmacopeias.
A. investigational drugs
B. new drug
C. established drugs
D. none of the above
280. This refers to a new chemical or structural modification of tried and tested or established drug proposed to be
used for a specific therapeutic indication.
A. investigational drug
B. new drug
C. both A & B
D. neither A or nor B
281. This refers to a new chemical or structural modification of tried and tested or established drug proposed to be
used for a specific therapeutic indication, which has undergone adequate clinical pharmacology Phase I, II, III
studies but which needs further Phase IV Clinical Pharmacology Studies before it can be given regular registration
A. investigational drug
B. new drug
C. both A & B
D. neither A nor B
282. This is also refer to as the Price Act
A. RA. 7581
B. RA. 8203
C. RA. 7432
D. RA. 6425
283. The requirements for labeling materials is under what Administrative Order?
A. AO. No. 51
B. AO. No. 52
C. AO. No. 54
D. AO. No. 55
284. __________ refers to the instructions and special care required in the use of product to avoid undesired effects
and to ensure the safe and effective use of the drug.
A. Precautions
B. Contraindications
C. Warning
D. none of the above
285. This refers to statements regarding the occurrence of potential hazards and side effects associated with the
use of the product and limitation of its use.
A. Precautions
B. Contraindications
C. Warning
D. none of the above
286. This refers to a statement regarding the conditions wherein the use of the product may cause harm to the
patient.
A. Precautions
B. Contraindications
C. Warning
D. none of the above
287. __________ refers to the classification of the product based on its therapeutic action.
A. dosage form
B. mode of action
C. formulation
D. pharmacologic category
288. Pursuant to AO. No. 55, s. 1988, the alcohol content in the formulation shall be expressed in _______
A. mg%
B. %
C. ml
D. v/v
289. The net content shall indicate the total amount/quantity/number of dosage form in a given container of the
product expressed in _______
A. Arabic numeral
B. avoirdupois
C. metric system
D. roman numeral
290. What type of font was specified for printing the Generic name if the name of the product is presented using a
special typeface exclusively designed for it?
A. Arial
B. Helvetica medium
C. universe medium
D. both A & B
E. both B & C
291. Expiry date expressed in terms of
A. month and day
B. month and year
C. day and year
D. year, day and month
292. If the expiry date of the product is indicated as “January 2005”, the expiry date of the product is assumed to be
A. January 1, 2005
B. January 15, 2005
C. January 20, 2005
D. January 31, 2005
293. __________ indicates the number given by BFAD for the product code.
A. manufacture date
B. expiry date
C. registration number
D. lot number
294. Drugs with multiple components must be arranged in order of _________
A. decreasing pharmacologic activity
B. increasing pharmacologic activity
C. alphabetically
D. according to the amount of use
295. _________ contains the active ingredient and quantity of drug per dosage unit.
A. dosage form
B. mode of administration
C. formulation
D, pharmacologic category
296. Additional information for injections
A. recommended routes of administration
B. ”use only one” or “discard the remaining portion” if an anti-microbial agent is not included in the product
C. both A & B
D. Neither A nor B
297. Which of the following is exempted in the labeling requirement?
A. product for external use
B. product placed in small container
C. drugs for investigational purposes
D. large volume injections
298. The word “single use” must be included in the label for
A. biological products
B. individually wrapped products
C. large volume injections
D. small containers
299. In accordance to Administrative order No. 56, s. 1989, the initial License to Operate has a ______ years.
A. 5
B. 2
C. 1
D. 3
300. Under Administrative Order No. 56, s. 1989, the renewal of the License to Operate has a ______years
A. 5
B. 1
C. 2
D. 3