RA 10918 - https://www.lawphil.net/statutes/repacts/ra2016/ra_10918_2016.

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An Act Regulating and Modernizing the Practice of Pharmacy in the Philippines, Repealing for the Purpose Republic Act Numbered Five Thousand Nine Hundred Twenty-One
(R.A. No. 5921), Otherwise Known as the Pharmacy Law

Title Philippine Pharmacy Act

Objectives Section 3 - Objectives. This Act provides for and shall govern the:
(a) Standardization and regulation of pharmacy education;

(b) Administration of licensure examination, registration, and licensing of pharmacists;

(c) Supervision, control, and regulation of the practice of pharmacy in the Philippines;

(d) Development and enhancement of professional competence of pharmacists through

continuing professional development, research, and other related activities; and

(e) Integration of the pharmacy profession.

Section 4 - A person is deemed to be practicing pharmacy, within the meaning of this

Scope of the Practice of Pharmacy Act, when with or without a fee, salary, percentage or other rewards, paid or given
directly or indirectly, shall:

(a) Prepare, compound or manufacture, preserve, store, distribute, procure, sell, or

dispense, or both, any pharmaceutical product or its raw materials; or

(b) Render services, such as clinical pharmacy services, drug information services,
regulatory services, pharmaceutical marketing, medication management, or whenever
the expertise and technical knowledge of the pharmacist is required; or

(c) Engage in teaching scientific, technical, or professional pharmacy courses in a

school or college of pharmacy; or (d) Dispense pharmaceutical products in situations
where supervision of dispensing of pharmaceutical products is required; or

(e) Chemical, biological or microbiological analyses and assay of pharmaceutical

products, food/dietary supplements, health supplements, and cosmetics; or

(f) Physico-chemical analyses for medical devices used in aid of administration of

pharmaceutical products; or

(g) Administration of adult vaccines as approved by the Food and Drug Administration
(FDA): Provided, That they shall undergo the training on the safe administration of adult
vaccines and management of adverse event following immunization (AEFI) for
pharmacists and hold a certificate of training issued by an institution duly accredited by
the Professional Regulation Commission (PRC); Provided, further, That the safe
administration of vaccines be part of the higher education curriculum for pharmacists; or
 (h) Conduct or undertake scientific research in all aspects involving pharmaceutical
products and health care; or

(i) Provide other services where pharmaceutical knowledge is required.

Activities under paragraphs (a), (b), (c), (d) and (i) are exclusive to licensed
pharmacists. However, nothing herein shall be construed as requiring other persons
carrying out only the activities under paragraphs (e), (f), (g) and (h) to be licensed
pharmacists, subject to any qualification that is imposed by other laws with respect to
such particular activity.

All pharmacists are expected to abide by current standards such as the Philippine
Practice Standards for Pharmacists, Good Laboratory Practice, Good Distribution
Practice, Good Manufacturing Practice and Good Clinical Practice, which are deemed
vital in the performance of their roles and functions in different practice areas.

The Professional Regulatory Board of Pharmacy, hereinafter created, subject to the

approval of the PRC, as provided for by Republic Act No. 8981, otherwise known as the
"PRC Modernization Act of 2000", and in consultation with the integrated and
accredited professional organization (APO), may modify the above-enumerated acts,
services, or activities, as the need arises, in order to conform to the latest trends and
developments in the practice of the pharmacy profession: Provided, That such
modifications are consistent with the enumeration above.

Violations Article VI - Violations, Administrative Sanctions, and Procedures

Section 44. Revocation or Suspension of the Certificate of Registration and
Cancellation of Special/Temporary Permit.— The Board shall have the power, upon
notice and hearing, to revoke or suspend the COR of a registered pharmacist or to
cancel an STP of a foreign pharmacist on any of the following grounds:

(a) Violation of any provision of this Act, its rules and regulations, the Pharmacists’
Code of Ethics, Code of Technical Standards for the Professional Practice of the
Pharmacy Profession, Code of Good Governance and all other guidelines, policies and
regulatory measures of the Board and/or the PRC relating to the practice of the
pharmacy profession;

(b) Conviction of an offense involving moral turpitude by a court of competent

jurisdiction;

(c) Unprofessionalism, immorality, malpractice, incompetence, gross negligence, or

imprudence in the practice of the profession;

(d) Fraud or deceit in the acquisition of the COR, PIC or STP, or renewal thereof;

(e) Allowing the COR to be used or displayed in establishments where the pharmacist
is not actually employed and practicing;

(f) Addiction to alcoholic beverages or to any habit-forming drug rendering a pharmacist

 incompetent to practice the profession as provided for in Section 23 hereof;

(g) Aiding or abetting the illegal practice of a non-registered and licensed person;

(h) Insanity or any mental disorder that would render the person incompetent to practice
pharmacy;

(i) False, extravagant, or unethical advertisements and endorsements of

pharmaceutical products, pharmaceutical outlets and establishments where the
pharmacist’s name or the pharmacist’s professional organization and similar
information, or both, are used;

(j) Manufacture, sale, offering for sale of counterfeit, spurious, substandard and falsified
pharmaceutical products and committing other acts in violation of Republic Act No.
9165 and Republic Act No. 8203, otherwise known as the "Special Law on Counterfeit
Drugs";

(k) Illegal manufacture, sale, possession, dispensing of dangerous drugs and other acts
in violation of Republic Act No. 9165, and other applicable laws and issuances;

(l) Committing acts in violation of Section 6 of Presidential Decree No. 881, entitled
"Empowering the Secretary of Health to Regulate the Labeling, Sale and Distribution of
Hazardous Substances" and Section 11 of Republic Act No. 3720, as amended;

(m) Practicing pharmacy with a suspended COR or expired PIC;

(n) Unauthorized dispensing of pharmaceutical products through unregistered online

services or direct selling businesses; and

(o) Being found guilty of immoral, unprofessional, or dishonorable conduct by the

Board.

Provision Section 45. Penal Provisions. - Any person who shall commit any of the following acts
shall, upon conviction, be sentenced to pay a fine of not less than two hundred fifty
thousand pesos (₱250.000.00), but not exceeding five hundred thousand pesos
(₱500.000.00) or imprisonment of not less than one (1) year and one (1) day but not
more than six (6) years, or both, at the discretion of the court:

(a) Commission of any act in violation of Sections 30 and 31 of this Act;

(b) Allowing the display of one’s COR in a pharmaceutical establishment where the
pharmacist is not employed and practicing;

(c) Displaying of the pharmacist’s COR by pharmacy owners/operators in a

pharmaceutical establishment where the pharmacist is not employed and practicing;

(d) Dispensing or allowing the dispensing or offering for sale of prescription drugs or
pharmaceutical products in a place not licensed by the FDA as a pharmaceutical outlet;
(e) Dispensing of prescription and pharmacist-only OTC pharmaceutical products by a
person other than those under the direct and immediate supervision of a duly registered
and licensed pharmacist;

(f) Allowing the dispensing of prescription and pharmacist-only OTC pharmaceutical

products, without the direct and immediate supervision of a duly registered and licensed
pharmacist;

(g) Compounding and dispensing not in accordance with current Good Manufacturing
Practice, Good Laboratory Practice and Philippine Practice Standards for Pharmacists,
and such other standards and guidelines issued by the Board;

(h) Selling of prescription and pharmacist-only OTC drugs by manufacturers, importers,

and wholesalers to unlicensed pharmaceutical outlets and other establishments;

(i) Substituting prescription drugs which are not generically equivalent to what was on
the prescription, without the consent of the prescriber or not in accordance with
Republic Act No. 6675;

(j) Forcing, coercing, or intimidating a duly registered and licensed pharmacist to

compound or dispense medical and pharmaceutical products in violation of the
provisions of this Act;

(k) Preparing and compounding of pharmaceutical products in quantities greatly in

excess of single therapeutic doses, without the presence and supervision of a duly
registered and licensed pharmacist;

(l) Noncompliance with the labeling requirements for dispensed medicines by a

pharmaceutical outlet;

(m) Manufacturing and selling of pharmaceutical products under fraudulent name or

address, or both;

(n) Adulterating and misbranding of pharmaceutical products;

(o) Manufacturing and selling of unsafe, substandard and counterfeit pharmaceutical

products;

(p) Operating an unlicensed pharmaceutical outlet such as online pharmacy service or

direct selling not authorized by the FDA;

(q) Operating a Category A establishment which opens for business without a duly
registered and licensed pharmacist;

(r) Operating a Category B establishment without the supervision and oversight of a

duly registered and licensed pharmacist;

(s) Practicing pharmacy with an expired, suspended or revoked license;

 (t) Filling and refilling of prescription and pharmacist-only OTC pharmaceutical products
by a person other than a duly registered and licensed pharmacist without the direct and
immediate supervision;

(u) Dispensing prescription drugs and pharmacist-only OTC drugs by rural health units
without the supervision of a duly registered and licensed pharmacist; and

(v) All other acts or omissions analogous to the foregoing.

Other penalties Section 46. Other Penalties. - Any person who shall commit any of the following acts
shall, upon conviction, be sentenced to pay a fine of not less than one hundred
thousand pesos (₱100,000.00), but not exceeding two hundred thousand pesos
(₱200,000.00) or imprisonment of not less than thirty (30) days but not more than one
(1) year, or both, at the discretion of the court:

(a) Affixing of the title "RPh" by a person who is not a duly registered and licensed
pharmacist;

(b) Practicing the pharmacy profession in the Philippines without a valid COR, PIC or
STP;

(c) Non-indication of a pharmacist of his/her COR and professional tax receipt numbers
in official documents requiring such information;

(d) Refusal to display the COR of the pharmacist in a prominent and conspicuous place
in the establishment and outlet where the pharmacist is employed and practicing;

(e) Noncompliance by a duly registered and licensed pharmacist with the requirements
on the filling of prescription;

(f) Noncompliance by a duly registered and licensed pharmacist on the requirements for
partially-filled prescription;

(g) Selling of physician’s samples;

(h) Distribution of antimicrobials, including anti-TB drugs and other product

classification as may be prohibited by law as physician’s samples;

(i) Removal, erasure and alteration of mark or label of physician’s sample;

(j) Use of cipher, codes, or secret keys or unusual names or terms in prescriptions;

(k) Filling of prescriptions where cipher, codes, or secret keys or unusual names or
terms are used;

(l) Noncompliance with labeling requirements for dispensed medicines;

(m) Noncompliance with the requirements on the keeping of record books by a

 pharmaceutical outlet;

(n) Employment of personnel in a pharmacy or pharmaceutical operation without the

required training and certification;

(o) Refusal of a non-pharmacist owner/operator of a pharmaceutical outlet to undergo

training and certification;

(p) Refusal by the owner/operator to allow and require duly registered and licensed
pharmacists and pharmacy support personnel to undergo CPD, training and
certification;

(q) Rendering dispensing-related services by non-pharmacists in a pharmaceutical

outlet without undergoing the required training and certification;

(r) Dispensing pharmaceutical products in medical missions without the supervision of a

duly registered and licensed pharmacist;

(s) Noncompliance with the required training and certification of professional service or
medical representatives or professional service representatives, pharmacy technicians,
pharmacy assistants, pharmacy aides, pharmacy clerks, and other medicine handlers
of pharmaceutical products. Both the medical representatives or professional service
representatives, pharmacy technicians, pharmacy assistants, pharmacy aides,
pharmacy clerks, or medicine handlers and the pharmaceutical establishment and
outlet emploving any such individual shall be held jointly liable; and

(t) Violation of any provision of this Act and its rules and regulations not aforementioned
above. Any person, other than the citizens of the Philippines, having been found guilty
of any violation as provided for in this section and the preceding section shall, after
having paid the fine or having served the sentence, or both, when so adjudged, shall
also be subject to immediate deportation.

The penalties and liabilities herein provided shall be without prejudice to other
sanction/s that may be imposed for violation of other applicable laws, policies, rules and
regulations.

The owner/operator of the pharmaceutical establishments/outlets and the duly

registered and licensed pharmacists/pharmacy support personnel are jointly liable for
the willful violation of any provision of this Act.

Definition of Terms Adulterated/Deteriorated pharmaceutical products refer to pharmaceutical products

unfit for human consumption, following the standards of quality or purity of which, are
as those stated in the United States Pharmacopeia/National Formulary and Philippine
Pharmacopeia in its latest edition or any standard reference for drugs and medicines
which are given official recognition as well as those provided for in Republic Act No.
3720, otherwise known as the "Food, Drug, and Cosmetic Act", as amended, and
Republic Act No. 9711, known as the "Food and Drug Administration Act of 2009";
 RA 5921 - https://lawphil.net/statutes/repacts/ra1969/ra_5921_1969.html

Title AN ACT REGULATING THE PRACTICE OF PHARMACY AND SETTING

STANDARDS OF PHARMACEUTICAL EDUCATION IN THE PHILIPPINES AND FOR
OTHER PURPOSES.

Objectives Section 1. Objectives. This Act provides for and shall govern (a) the standardization
and regulation of pharmaceutical education; (b) the examination for registration of
graduates of schools of pharmacy and (c) the supervision, control and regulation of the
practice of pharmacy in the Philippines.

Violations and Penalties Section 40. Penal provisions. Any person who shall violate any of the provisions of
Sections twelve, twenty-four, twenty-five, twenty-six, twenty-seven and twenty-nine of
this Act or any person who shall make false representation to procure a registration
certificate as pharmacist for himself or for another; or any person who shall allow
anyone in his employ who is not a registered pharmacist to engage in the practice of
pharmacy; or any person who shall falsely display within the establishment the
certificate of registration of a pharmacist who is not actually and regularly employed
therein as such or to act as a dummy for any alien or an unqualified person for the
purpose of opening and operating a retail drugstore; shall, upon conviction thereof, be
sentenced to a fine of not less than one thousand pesos but not exceeding four
thousand pesos or to an imprisonment of not less than six months and one day but not
more than four years, in the discretion of the court.

Section 41. Other penalties. Any pharmacist who shall violate any of the provisions of
Sections twenty-eight, thirty, thirty-one, thirty-two, thirty-three, thirty-four, thirty-five,
thirty-seven and thirty-eight of this Act or any pharmacist after his certificate of
registration has been lawfully suspended or revoked, who continues to engage in the
practice of pharmacy, shall, upon conviction thereof, be sentenced to a fine of not less
than one hundred pesos but shall not exceed five hundred pesos or to an imprisonment
of not less than thirty days but not more than four months, in the discretion of the court.

Any person other than citizens of the Philippines having been found guilty of any
violation as provided for in this and the preceding section shall, after having paid the
fine or having served his sentence or both when so required be also subject to
deportation.

Adulterated and Misbranded Drug or Devices Section 29. Responsibility for quality of drugs. In cases of drugs, pharmaceuticals
or poisons sold in their original packings, the seal of which has not been broken or
tampered with, the liability that may arise because of their quality and purity , rests upon
the manufacturer or in his absence, upon the importer, the distributor, representative or
dealer who was responsible for their distribution or sale.

It shall be unlawful for any reason, whoever, to manufacture, prepare, sell or administer
any prescription, drug, pharmaceutical or poison under any fraudulent name, direction
or pretense or to adulterate any drug, pharmaceutical, medicine or poison so used, sold
or offered for sale. Any drug, pharmaceutical, medicine or poison shall be held to be
adulterated or deteriorated within the meaning of this section if it differs from the
standard of quality or purity given in the United States Pharmacopoeia or National
 Formulary, both in their latest edition or, in lieu thereof, in any standard reference for
drugs and medicines given official recognition; and those which fall within the meaning
as provided for in the Food, Drug and Cosmetic Act, (Republic Act Numbered
Thirty-seven hundred twenty).

Powers and Functions of the Board and FDA Section 11. Powers and duties of the Board. The Board of Pharmacy, conformably
with the provisions of this Act is vested with authority:

(a) To examine applicants for the practice of pharmacy;

(b) To issue certificates of registration or pharmacists.

(c) To reprimand any pharmacist or to suspend or revoke his certificate of registration

on the grounds as provided for in Section thirteen hereof, after a formal administrative
investigation has been conducted by it.

(d) To promulgate from time to time the necessary rules and regulations for the effective
enforcement of this Act, subject to the approval of the President upon advice of the
Commissioner of Civil Service;

(e) To study the conditions affecting the practice of pharmacy in the Philippines;

(f) To check the employment of qualified personnel in drug stores, hospital pharmacies,
drug or pharmaceutical laboratories, cosmetic laboratories and similar establishments
for which the Board may designate inspectors from the Board of Pharmacy; and

(g) To encourage the development of botanical gardens and their inspection particularly
the propagation of Philippine medicinal plants with the cooperation of the Department of
Agriculture and Natural Resources.

Scope of Practice of Pharmacist Section 23. Definition of practice of pharmacy. A person shall be deemed to be
practicing pharmacy within the meaning of this Article, who shall, for fee, salary,
percentage or other reward paid or given directly to himself or indirectly through
another, prepare or manufacture, analyze, assay, preserve, store, distribute or sell any
medicine, drug, chemicals, cosmetics, pharmaceuticals, devices or contrivances used
in pursuance thereof; or render pharmaceutical service in any office or drug and
cosmetic establishment where scientific, technological or professional knowledge of
Pharmacy is applied; or engage in teaching scientific, technological or professional
pharmacy subject in a college of pharmacy; or conduct or undertake scientific
pharmaceutical research for biological and bacteriological testings and examinations.

However, persons performing executive managerial or administrative functions and

their subordinate personnel employed in the pharmaceutical laboratories referred to in
the second paragraph of Section twenty-seven hereof shall not be considered for
purposes of this definition, considered persons in the practice of pharmacy.

Section 24. Prerequisite for the practice of pharmacy. No person shall engage in the
practice of pharmacy in the Philippines unless he is at least twenty-one years of age,
has satisfactorily passed the corresponding examination given by the Board of
Pharmacy, and is a holder of a valid certificate of registration duly issued to him by said
 Board.

RA 10912
An Act Mandating and Strengthening the Continuing Professional Development Program for All Regulated Professions, Creating Continuing Professional Development Council,
and Appropriating Funds Therefor, and for Other Related Purposes

Title This Act shall be known as the "Continuing Professional Development Act of 2016".

Objectives -

Violations and Penalties -

Adulterated and Misbranded Drug or Devices -

Powers and Functions of the Board and FDA Section 6. Powers, Functions and Responsibilities of the PRC and the
Professional Regulatory Boards (PRBs).— The PRC and the PRBs shall undertake
the overall implementation of the CPD Programs, and for this purpose, shall:

(a) Organize CPD Councils for each of the regulated professions and promulgate
guidelines for their operation;

(b) Review existing and new CPD Programs for all of the regulated professions;

(c) Formulate, issue, and promulgate guidelines and procedures for the implementation
of the CPD Programs;

(d) Coordinate with the academe, concerned government agencies, and other
stakeholders in the implementation of the CPD Programs and other measures provided
under this Act; and

(e) Coordinate with concerned government agencies in the development of

mechanisms and guidelines, in the grant and transfer of credit units earned from all the
learning processes and activities, pursuant to this Act.

Section 7. CPD Council. - There is hereby created a CPD Council in each of the
regulated professions, which shall be under the supervision of the concerned PRB.
Every CPD Council shall be composed of a chairperson and two (2) members.

The chairperson of the CPD Council shall be the member of the PRB so chosen by the
PRB concerned to sit in the CPD Council.

The first member shall be the president or officer of the AIPO/APO duly authorized by
its Board of Govemors/Trustees. In the absence of the AIPO/APO, the PRB concerned
shall submit within ten (10) working days from notification of such absence, a list of
three (3) recommendees from the national professional organizations. The PRC shall
designate the first member within thirty (30) days from receipt of the list.
 The second member shall be the president or officer of the national organization of
deans or department chairpersons of schools, colleges or universities offering the
course requiring the licensure examination. In the absence of such organization, the
PRB concerned shall submit, within ten (10) working days from notification of such
absence, a list of three (3) recommendees from the academe. The PRC shall designate
the second member within twenty (20) working days from receipt of the list.

The term of office of the chairperson of the CPD Council shall be coterminous with
his/her incumbency in the PRB unless sooner replaced by the PRB concerned through
a resolution, subject to the approval of the PRC. The first and second members shall
have a term of office of two (2) years unless sooner replaced through a resolution by
the AIPO/APO concerned or the organization of deans or heads of departments,
respectively. However, members of the CPD Council who are appointed by the PRC
may be replaced before the end of the two (2)-year period, upon the recommendation
of the PRB through a resolution.

Section 8. Powers, Functions and Responsibilities of the CPD Council. - The CPD
Council for each profession shall:

(a) Ensure the adequate and appropriate provision of CPD Programs for their
respective profession;

(b) Evaluate and act on applications for accreditation of CPD Providers and their CPD
Programs;

(c) Monitor and evaluate the implementation of the CPD Programs;

(d) Assess and/or upgrade the criteria for accreditation of CPD Providers and their CPD
Programs on a regular basis;

(e) Develop mechanisms for the validation, accreditation and recognition of

self-directed learning, prior/informal learning, online learning, and other learning
processes through professional work experience;

(f) Conduct researches, studies and benchmarking for international alignment of the
CPD Programs;

(g) Issue operational guidelines, with the approval of the PRC and the PRB concerned;
and

(h) Perform such other functions related or incidental to the implementation of the CPD.

Section 9. Secretariat. - A CPD Council Secretariat is hereby created at the PRC

Central and Regional Offices to provide technical, administrative and operational
support to the CPD Councils and the PRBs in the implementation of the CPD
Programs. The CPD Council Secretariat shall be headed by an Executive Director to be
appointed by the PRC.

Scope of Practice of Pharmacist -

 RA 3720 - https://www.lawphil.net/statutes/repacts/ra1963/ra_3720_1963.html

N ACT TO ENSURE THE SAFETY AND PURITY OF FOODS, DRUGS, AND COSMETICS BEING MADE AVAILABLE TO THE PUBLIC BY CREATING THE FOOD AND
DRUG ADMINISTRATION WHICH SHALL ADMINISTER AND ENFORCE THE LAWS PERTAINING THERETO.

Title Section 1. This Act shall be known as the "Food, Drug, and Cosmetic Act."

Objectives Section 4. To carry out the provisions of this Act, there is hereby created an office to be
called the Food and Drug Administration in the Department of Health. Said
Administration shall be under the Office of the Secretary and shall have the following
functions, powers and duties:

(a) To administer and supervise the implementation of this Act and of the rules and
regulations issued pursuant to the same.

(b) To provide for the collection of samples of food, drug and cosmetic.

(c) To analyze and inspect food, drug and cosmetic in connection with the
implementation of this Act.

(d) To establish analytical data to serve as basis for the preparation of food, drug and
cosmetic standards, and to recommend standards of identity, purity, quality and fill of
container.

(e) To issue certificate of compliance with technical requirements to serve as basis for
the issuance of license and spot-check for compliance with regulations regarding
operation of food, drug and cosmetic manufacturers and establishments.

(f) To levy, assess and collect fees for inspection, analysis and testing of products and
materials submitted in compliance with the provisions of this Act.

(g) To certify batches of anti-biotic and anti-biotic preparations in compliance with the
provisions of this Act.

Section 5. The Food and Drug Administration shall have the following Divisions:

(a) Inspection and Licensing Division, which shall have charge of the inspection of food,
drug, and cosmetic establishments engaged in their manufacture and sale.

(b) Laboratory Division, which shall conduct all the tests, analyses and trials of products
covered by this Act.

Violations and Penalties CHAPTER VI

Prohibited Acts and Penalties

PROHIBITED ACTS

Section 11. The following acts and the causing thereof are hereby prohibited: (a) The
manufacture, sale, offering for sale or transfer of any food, drug, device or cosmetic that
is adulterated or misbranded.

(b) The adulteration or misbranding of any food, drug, device, or cosmetic.

(c) The refusal to permit entry or inspection as authorized by Section twenty-seven

hereof or to allow samples to be collected.

(d) The giving of a guaranty or undertaking referred to in Section twelve (b) hereof
which guaranty or undertaking is false, except by a person who relied upon a guaranty
or undertaking to the same effect signed by, and containing the name and address of,
the person residing in the Philippines from whom he received in good faith the food,
drug, device, or cosmetic or the giving of a guaranty or undertaking referred to in
Section twelve (b) which guaranty or undertaking is false.

(e) Forging, counterfeiting, simulating, or falsely representing or without proper authority

using any mark, stamp, tag label, or other identification device authorized or required by
regulations promulgated under the provisions of this Act.

(f) The using by any person to his own advantage, or revealing, other than to the
Secretary or officers or employees of the Department or to the courts when relevant in
any judicial proceeding under this Act, any information acquired under authority of
Section nine, or concerning any method or process which as a trade secret is entitled to
protection.

(g) The alteration, mutilation, destruction, obliteration, or removal of the whole or any
part of the labeling of, or the doing of any other act with respect to, a food, drug, device,
or cosmetic, if such act is done while such article is held for sale (whether or not the
first sale) and results in such article being adulterated or misbranded.

(h) The use, on the labeling of any drug or in any advertising relating to such drug, of
any representation or suggestion that an application with respect to such drug is
effective under Section twenty-one hereof, or that such drug complies with the
provisions of such section.

(i) The use, in labeling, advertising or other sales promotion of any reference to any
report or analysis furnished in compliance with Section twenty-six hereof.

PENALTIES

Section 12. (a) Any person who violates any of the provisions of Section eleven hereof
shall, upon conviction, be subject to imprisonment of not less than six months and one
day, but not more than five years, or a fine of not less than one thousand pesos, or both
such imprisonment and fine, in the discretion of the Court.

(b) No person shall be subject to the penalties of subsection (a) of this section (1) for
having sold, offered for sale or transferred any article and delivered it, if such delivery
was made in good faith, unless he refuses to furnish on request of the Board of Food
and Drug Inspection or an officer or employee duly designated by the Secretary, the
name and address of the person from whom he purchased or received such article and
copies of all documents, if any there be, pertaining to the delivery of the article to him;
 (2) for having violated Section eleven (a) if he established a guaranty or undertaking
signed by, and containing the name and address of, the person residing in the
Philippines from whom he received in good faith the article, or (3) for having violated
Section eleven (a), where the violation exists because the article is adulterated by
reason of containing a coal-tar color not permissible under regulations promulgated by
the Secretary under this Act, if such person establishes a guaranty or undertaking
signed by, and containing the name and address, of the manufacturer of the coal-tar
color, to the effect that such color is permissible, under applicable regulations
promulgated by the Secretary under this Act.

(c) Any article of food, drug, device, or cosmetic that is adulterated or misbranded when
introduced into the domestic commerce may be seized and held in custody pending
proceedings pursuant to Section twenty-six (d) hereof, without a hearing or court order,
when the Secretary has probable cause to believe from facts found by him or any
officer or employee of the Food and Drug Administration that the misbranded article is
dangerous to health, or that the labeling of the misbranded articles is fraudulent, or
would be in a material respect misleading to the injury or damage of the purchaser or
consumer.

Adulterated and Misbranded Drug or Devices CHAPTER VII

Definition and Standards for Food
Section 13. Whenever in the judgment of the Secretary such action will promote
honesty and fair dealing in the interest of consumers, he shall, upon recommendation of
the Food and Drug Administrator, promulgate regulations fixing and establishing for any
food, under its common or usual name so far as practicable, a reasonable definition
and standard of identity, a reasonable standard of quality, and/or reasonable standards
of fill of container: Provided, That no definition and standard of identity and no standard
of quality shall be established for fresh or dried fruits, fresh or dried vegetables.

ADULTERATED FOOD
Section 14. A food shall be deemed to be adulterated: (a) (1) If it bears or contains any
poisonous or deleterious substance which may render it injurious to health; but in case
the substance is not an added substance such food shall not be considered adulterated
under this clause if the quantity of such substance in such food does not ordinarily
render it injurious to health;

(2) if it bears or contains any added poisonous or added deleterious substance other
then one which is a pesticide chemical in or a raw agricultural commodity for which
tolerances have been established and it conforms to such tolerances;

(3) if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it

is otherwise unfit for food:

(4) if it has been prepared, packed, or held under unsanitary conditions whereby it may
have become contaminated with filth, or whereby, it may have been rendered injurious
to health;

(5) if it is, in whole or in part, the product of a diseased animal or of an animal which
has died otherwise than by slaughter;
(6) if its container is composed, in whole or in part, of any poisonous or deleterious
substance which may render the contents injurious to health.

(b) (1) If any valuable constituent has been, in whole or in part, omitted or abstracted
therefrom and same has not been substituted by any healthful equivalent of such
constituent;

(2) if any substance injurious to health has been added or substituted;

(3) if damage or inferiority has been concealed in any manner; and

(4) if any substance has been added thereto or mixed or packed therewith so as to
increase its bulk or weight, or reduce its quality or strength, or make it appear better or
of greater value than it is.

(c) If it bears or contains a coal-tar color other than one which is permissible under
existing regulations;

(d) If it is confectionery, and it bears or contains any alcohol or non-nutritive article or

substance except harmless coloring, harmless flavoring, harmless resinous glass less
coloring, harmless flavoring, harmless resinous glass not in excess of four-tenths of one
per centum, natural gum and pectin: Provided, That this paragraph shall not apply to
any confectionery by reason of its containing less than one-half of one per centum by
volume of alcohol derived solely from the use of flavoring extracts, or to any chewing
gum by reason of its containing harmless non-nutritive masticatory substances;

(e) If it is oleomargarine or margarine or butter and any of the raw material used therein
consists in whole or in part of any filthy, putrid or decomposed substance, or such
oleomargarine, margarine or butter is otherwise unfit for food.

MISBRANDED FOOD
Section 15. A food shall be deemed to be misbranded:

(a) If its labeling is false or misleading in any particular;

(b) If it is offered for sale under the name of another food;

(c) If it is an imitation of another food, unless its label bears in types of uniform size and
prominence, the word "imitation" and, immediately thereafter, the name of the food
imitated;

(d) If its container is so made, formed, or filled as to be misleading;

(e) If in package form unless it bears a label containing (1) the name and place of
business of the manufacturer, packer, distributor; and (2) an accurate statement of the
quantity of the contents in terms of weight, measure, numerial count: Provided, That
under clause (2) of this paragraph reasonable variations shall be permitted, and
exemptions as to small packages shall be established, by regulations prescribed by the
Secretary.

(f) If any word, statement, or other information required by or under authority of this Act
 to appear on the label or labeling is not prominently placed thereon with such
conspicuousness (as compared with other words, statements, designs, or devices, in
the labeling), and in such terms as to render it likely to be read and understood by the
ordinary individual under customary conditions of purchase and use.

(g) If it purports to be or is represented as a food for which a definition and standard of

identity has been prescribed unless (1) it conforms to such definition and standard, and
(2) its label bears the name of the food specified in the definition and standard, and,
insofar as may be required by such regulations, the common names of optional
ingredients (other than spices, flavoring, and coloring) present in such food.

(h) If it purports to be or is represented as

(1) A food for which a standard of quality has been prescribed by regulations as
provided by Section thirteen, and its quality falls below such standard, unless its label
bears, in such manner and form as such regulations specify, a statement that it falls
below such standard; or

(2) a food for which a standard or standards of fill of container have been prescribed by
regulations as provided by Section thirteen and it falls below the standard of fill of
container applicable thereto, unless its label bears, in such manner and form as such
regulations specify, statement that if falls below such standard.

(i) If it is not subject to the provisions of paragraph (g) of this section unless its label
bears (1) the common or usual name of the food, if there be any, and (2) in case it is
fabricated from two or more ingredients, the common or usual name of each such
ingredient; except that spices, flavorings, and colorings, other than those sold as such,
may be designated as spices, flavorings and colorings without naming each: Provided,
That to the extent that compliance with the requirements of clause (2) of this paragraph
is impracticable or results in deception or unfair competition, exemptions shall be
established by regulations promulgated by the Secretary.

(j) If it purports to be or is represented for special dietary uses, unless its label bears
such information concerning its vitamin, mineral and other dietary properties as the
Secretary determined to be, and by regulations prescribes as necessary in order fully to
inform purchasers as to its value for such uses.

(k) If it bears or contains any artificial flavoring, artificial coloring, or chemical

preservative, unless it bears labeling stating that fact: Provided, That to the extent that
compliance with the requirements of this paragraph is impracticable, exemptions shall
be established by regulations promulgated by the Secretary. The provisions of this
paragraph or paragraphs (g) and (i) with respect to artificial coloring shall not apply in
the case of butter, cheese or ice cream.

Powers and Functions of the Board and FDA Section 9. The Board of Food Inspection is hereby converted into the Board of Food
and Drug Inspection which shall consist of:

(a) A representative of the Department of Health to be designated by the Secretary of

Health, as Chairman;
 (b) A representative of the Department of Agriculture and Natural Resources;

(c) A representative of the Department of Commerce and Industry;

(d) An authorized designate of the Commissioner of Customs;

(e) An authorized representative of the Office of the Solicitor-General;

(f) A technical member to be designated by the Food and Drug Administrator with the
approval of the Secretary of Health.

(g) The President of the Philippine Medical Association of his authorized representative;

(h) The President of the Philippine Dental Association or his authorized representative;
and

(i) The President of the Philippine Pharmaceutical Association or his authorized

representative.

Each member of the Board as well as the Board secretary shall receive a per diem of
twenty pesos per meeting, hearing or investigation actually attended, but in no case
shall the total per diem exceed two hundred pesos each per month.

It shall be the duty of the Board, conformably with the rules and regulations, to hold
hearings and conduct investigations relative to matters touching the administration of
this Act, to investigate processes of food, drug and cosmetic manufacture and to submit
reports to the Food and Drug Administrator, recommending food and drug standards for
adoption. Said Board shall also perform such additional functions, properly within the
scope of the administration hereof, as may be assigned to it by the Food and Drug
Administrator. The decisions of the Board shall be advisory to the Food and Drug
Administrator.

Scope of Practice of Pharmacist (1) Drugs intended for use by man which:

(A) are habit-forming

(B) because of its toxicity or other potentiality for harmful effect, or the method of its use
is not safe for use except under the supervision of a practitioner licensed by law to
administer such drug;

(C) are new drugs whose application are limited to investigational use shall be
dispensed only (1) upon a written prescription of a practitioner licensed by law to
administer such drug, or (2) upon an oral prescription of such practitioner which is
reduced promptly to writing and filed by the pharmacist, or (3) by refilling any such
written or oral prescription if such refilling is authorized by the prescriber either in the
original prescription or by oral order which is reduced promptly to writing and filed by
the pharmacist. The act of dispensing a drug contrary to the provisions of this
paragraph shall be deemed to be an act which results in the drug being misbranded
while held for sale.
 RA 9711 - https://www.lawphil.net/statutes/repacts/ra2009/ra_9711_2009.html

AN ACT STRENGTHENING AND RATIONALIZING THE REGULATORY CAPACITY OF THE BUREAU OF FOOD AND DRUGS (BFAD) BY ESTABLISHING ADEQUATE
TESTING LABORATORIES AND FIELD OFFICES, UPGRADING ITS EQUIPMENT, AUGMENTING ITS HUMAN RESOURCE COMPLEMENT, GIVING AUTHORITY TO
RETAIN ITS INCOME, RENAMING IT THE FOOD AND DRUG ADMINISTRATION (FDA), AMENDING CERTAIN SECTIONS OF REPUBLIC ACT NO. 3720, AS AMENDED,
AND APPROPRIATING FUNDS THEREOF

Title Section 2. This Act shall be known as the "Food and Drug Administration (FDA) Act of
2009".

Objectives Section 4. This Act has the following objectives:

(a) To enhance and strengthen the administrative and technical capacity of the FDA in
the regulation of establishments and products under its jurisdiction;

(b) To ensure the FDA's monitoring and regulatory coverage over establishments and
products under its jurisdiction; and

(c) To provide coherence in the FDA's regulatory system for establishments and
products under its jurisdiction.

Violations and Penalties Section 10. Section 11, subsections (a), (b), (d), (g), (j),(k) and (l) of Republic Act
No. 3720, as amended, are hereby further amended to read as follows:

"SEC. 11. The following acts and the causing thereof are hereby prohibited:

"(a) The manufacture, importation, exportation, sale, offering for sale, distribution,
transfer, non-consumer use, promotion, advertising, or sponsorship of any health
product that is adulterated, unregistered or misbranded.

"(b) The adulteration or misbranding of any health product.

"x x x

"(d) The giving of a guaranty or undertaking referred to in Section twelve (b) hereof
which guaranty or undertaking is false, except by a person who relied upon a guaranty
or undertaking to the same effect, signed by, and containing the name and address of
the person or entity from whom he received in good faith the health products or the
giving of a guaranty or undertaking referred to in Section twelve (b) which guaranty or
undertaking is false.

"x x x

"(g) The alteration, mutilation, destruction, obliteration, or removal of the whole or any
part of the labeling of, or the doing of any other act with respect to health products if
such act is done while such article is held for sale (whether or not the first sale) and
results in such article being adulterated or misbranded Provided, That a retailer may
sell in smaller quantities, subject to guidelines issued by the FDA.
"x x x

"(j) The manufacture, importation, exportation, sale, offering for sale, distribution,
transfer, non-consumer use, promotion, advertisement, or sponsorship of any health
product which, although requiring registration, is not registered. with the FDA pursuant
to this Act.

"(k) The manufacture, importation, exportation, sale, offering for sale, distribution,
transfer, or retail of any drug, device or in-vitro diagnostic reagent; the manufacture,
importation, exportation, transfer or distribution of any food, cosmetic or
household/urban hazardous substance; or the operation of a radiation or pest control
establishment by any natural or juridical person without the license to operate from the
FDA required under this Act.

"(l) The sale, offering for sale, importation, exportation, distribution or transfer of any
health product beyond its expiration or expiry date, if applicable.

"x x x

"The prohibited acts mentioned herein shall cover all applicable health products."

Section 11. Section 12, subsection (a) of Republic Act No, 3720, as amended, is
hereby further amended to read as follows:

"SEC. 12. (a) Any person who violates any of the provisions of Section eleven hereof
shall, upon conviction, suffer the penalty of imprisonment ranging from one (1) year but
not more than ten (10) years or a fine of not less than Fifty thousand pesos
(P50,000.00) but not more than Five hundred thousand pesos (P500,000.00), or both,
at the discretion of the court: Provided, That if the offender is a manufacturer, importer
or distributor of any health product, the penalty of at least five (5) years imprisonment
but not more than ten (10) years and a fine of at least Five hundred thousand pesos
(P500,000.00) but not more than Five million pesos (P5,000,000.00) shall be imposed
Provided, further, That an additional fine of one percent (1%) of the economic
value/cost of the violative product or violation, or One thousand pesos (P1,000.00),
whichever is higher, shall be imposed for each day of continuing violation: Provided,
finally, That health products found in violation of the provisions of this Act and other
relevant laws, rules and regulations may be seized and held in custody pending
proceedings, without hearing or court order, when the director-general has reasonable
cause to believe from facts found by him/her or an authorized officer or employee of the
FDA that such health products may cause injury or prejudice to the consuming public.

"x x x

"Should the offense be committed by a juridical person, the Chairman of the Board of
Directors, the president, general manager, or the partners and/or the persons directly
responsible therefore shall he penalized.

"Should the offense be committed by a foreign national, he/she shall, in addition to the
 penalties prescribed, be deported without further proceedings after service of sentence.

"x x x."

Section 12. Section 26, subsections (c) and (d) of Republic Act No. 3720, as amended,
are hereby further amended and subsection (g) is hereby added thereto to read as
follows:

"x x x

"(c) Hearings authorized or required by this Act shall be conducted by the FDA.

"(d) Upon preliminary findings of the conduct of prohibited act/s, the director-general
shall issue the proper notices or orders to the person or persons concerned and such
person or persons shall be given an opportunity to be heard before the FDA.

"x x x

"(g) Both criminal and administrative actions may be instituted separately and
independent of one another."

Section 13. Section 29-A of Republic Act No. 3720, as amended, is hereby further
amended, and new subsections are added to read as follows:

"SEC. 29-A. Administrative Sanctions. - Where there is finding of prohibited actions and
determination of the persons liable thereto, after notice and hearing, the
director-general is empowered to impose one or more of the following administrative
penalties:

"(1) Cancellation of any authorization which may have been granted by the FDA, or
suspension of the validity thereof for such period of time as the director-general may
deem reasonable which shall not exceed one (1) year:

"(2) A fine of not less than Fifty thousand pesos (P50,000.00) but not more than Five
hundred thousand pesos (P500,000.00). An additional fine of not more than One
thousand pesos (P1,000.00) shall be imposed for each day of continuing violation; and

"(3) Destruction and/or appropriate disposition of the subject health product, and/or
closure of the establishment for any violation of this Act, as determined by the
director-general."

Adulterated and Misbranded Drug or Devices -

Powers and Functions of the Board and FDA Section 14. A new Section 30 and a new headnote "Additional Powers and
Functions of the Director-General" are hereby added to Republic Act No. 3720,
which shall read as follows:

"SEC. 30. The Director-General shall also exercise the following powers:

"(1) To hold in direct or indirect contempt any person who disregards orders or writs he
 or she issues and impose the appropriate penalties following the same procedures and
penalties provided in the Rules of Court;

"(2) To administer oaths and affirmations and issue subpoena duces tecum and
subpoena ad testificandum requiring the production of such books, contracts,
correspondence, records, statement of accounts and other documents and/or the
attendance and testimony of parties and witnesses as may be material to the
investigation conducted by the FDA;

"(3) To obtain information from any officer or office of the national or local governments,
government agencies and its instrumentalities;

"(4) To issue orders of seizure, to seize and hold in custody any article or articles of
food, device, cosmetics, household hazardous substances and health products that is
adulterated, counterfeited, misbranded or unregistered, or drug, in-vitro diagnostic
reagent, biologicals, and vaccine that is adulterated or misbranded, when introduced
into domestic commerce pending the authorized hearing under Republic Act No. 3720,
as amended, Executive Order No. 175 (1987), and Republic Act No. 7394, otherwise
known as the Consumers Act of the Philippines;

"(5) To call on the assistance of any department, office or agency and deputize
members of the Philippine National Police or any law enforcement agency for the
effective implementation of this Act; and

"(6) To exercise such powers and functions as may be necessary for the effective
implementation of this Act."

Scope of Practice of Pharmacist -

EO 175 - https://lawphil.net/executive/execord/eo1987/eo_175_1987.html

Sec. 1. The title of Republic Act No. 3720 is hereby amended to read as follows:

"An Act to Ensure The Safety And Purity of Foods and Cosmetics, And The Purity, Safety, Efficacy and Quality of Drugs and Devices Being Made Available To the
Public, Vesting The Bureau of Food and Drugs with Authority To Administer And Enforce the Laws Pertaining Thereto, And For Other Purposes"

Title "Sec. 1. This Act shall be known as the Foods, Drugs and Devices, and Cosmetics
Act".

Objectives -

Violations and Penalties Sec. 9. Section 12 of Republic Act No. 3720 is hereby amended to read as
follows:

"Sec. 12. (a) Any person who violates any of the provisions of Section eleven hereof
shall, upon conviction, be subject to imprisonment of not less than one year but not
 more than five years, or a fine of not less than five thousand pesos but not more than
ten thousand pesos, or both such imprisonment and fine, in the discretion of the Court.

Should the offense be committed by a juridical person, the Chairman of the Board of
Directors, the president, general manager, or the partners and/or the persons directly
responsible therefor shall be penalized.

(b) No person shall be subject to the penalties of subsection (a) of this section (1) for
having sold, offered for sale or transferred any article and delivered it, if such delivery
was made in good faith, unless he refuses to furnish on request of the Bureau or an
officer or employee duly designated by the Secretary, the name and address of the
person from whom he purchased or received such article and copies of all document, if
any there be, pertaining to the delivery of the article to him; (2) for having violated
Section 11 (a) if he established a guaranty or undertaking signed by, and containing the
name and address of, the person residing in the Philippines from whom he received in
good faith the article, or (3) for having violated Section eleven (a), where the violation
exists because the article is adulterated by reason of containing a color other than the
permissible one under regulations promulgated by the Secretary under this Act, if such
person established a guaranty or undertaking signed by, and containing the name and
address, of the manufacturer of the color, to the effect that such color is permissible,
under applicable regulations promulgated by the Secretary under this Act."

Adulterated and Misbranded Drug or Devices Sec. 10. Section 18 of Republic Act No. 3720 is hereby amended to read as
follows:

"Sec. 18. A drug or device shall be deemed to be adulterated: (a) (1) If it consists in
whole or in part of any filthy, putrid, or decomposed substances which may affects its
safety, efficacy or good quality or (2) if it has been manufactured, prepared or held
under unsanitary conditions whereby it may have been contaminated with dirt or filth or
whereby it may have been rendered injurious to health; or (3) if it is a drug or device
and its container is composed, in whole or in part, of any poisonous or deleterious
substance which may render the contents injurious to health; or (4) if it is a drug and it
bears or contains, for purposes of coloring only, any color other than a permissible one
as determined by the Secretary, taking into consideration standards of safety, efficacy
or good quality. lawphi1.net

(b) If it purports to be or is represented as a drug the name of which is recognized in an

official compendium, and its strength differs from or its safety, efficacy, quality or purity
falls below the standards set forth in such compendium, except that whenever tests or
methods of assay as are prescribed are, in the judgment of the Secretary, insufficient
for the making of such determination, the Secretary shall promulgate, upon
recommendation of the Director, regulations prescribing appropriate tests or methods of
assay in accordance with which such determination as to strength, safety, efficacy,
quality, or purity shall be made. No drug defined in an official compendium shall be
deemed to be adulterated under this paragraph because it differs from the standards of
strength, safety, efficacy, quality, or purity therefor set forth in such compendium, if its
difference in strength, safety, efficacy, quality or purity from such standards is plainly
stated in its label and approved for registration as such.
(c) If it is not subject to the provisions of paragraph (b) and its strength differs from, or
its efficacy, quality or purity falls below, that which it purports or is represented to
possess.

(d) If it is a drug or device and any substance has been mixed or packed therewith, or
any substance has been substituted wholly or in part thereof, so as to reduce its safety,
efficacy, quality, strength or purity. lawphi1.net

(e) If the methods used in, or the facilities or controls used for its manufacture or
holding do not conform to or are not operated or administered in conformity with current
good manufacturing practice to assure that such drug meets the requirements of this
Act as to safety, quality and efficacy, and has the identity and strength, and meets the
quality and purity characteristics, which it purports or is represented to possess."

Sec. 11. Section 19 of Republic Act No. 3720 is hereby amended to read as
follows:

"Sec. 19. A drug or device shall be deemed to be misbranded:

(a) If its labeling is false or misleading in any particular.

(b) If it is in package form unless it bears a label containing (1) the name and place of
business of the manufacture, importer, packer, or distributor; (2) an accurate statement
of the quantity of the contents in terms of weight, measure, or numerical count:
Provided, That reasonable variations shall be permitted and exemptions as to small
packages shall be established by regulations prescribed by the Secretary. lawphi1.net

(c) If any word, statement, or other information required by or under authority of this Act
to appear on the label or labeling is nor prominently placed thereon with such
conspicuousness (as compared with other words, statements, designs, or devises, in
the labeling) and in such terms as to render it likely to be read and understood by the
ordinary individual under customary conditions of purchase and use.

(d) If it is for use by man and contains any quantity of the narcotic or hypnotic
substance alpha-eucaine, barbituric acid, beta-eucaine, bromal, cannabis, cabromal,
chloral, coca, cocaine, codeine, heroin, marijuana, morphine, opium, paraldehyde,
peyote, or sulfonmethane; or any chemical derivative of such substance, which
derivative has been recommended by the Secretary, after investigation and by
regulations designated, as habit forming; unless its label bears the name, and quantity
or proportion of such substance or derivative and in juxtaposition therewith the
statement "Warning May be habit forming".

(e) If it is a drug and is not designated solely by a name recognized in an official

compendium unless its label bears (1) the common or usual name of the drug, if such
there be; and (2) in case it is fabricated from two or more ingredients; the common or
usual name of each active ingredient, including the quantity, kind and proportion of any
alcohol, and also including whether active or not, the name and quantity or proportion of
any bromides, ether, chloroform, acetanilid, acetophenetidin, amidopyrine, antipyrine,
atropine, hyoscine, hyoscyamine, arsenic, digitalis, digitalis glycosides, mercury,
ouabain, strophantin, strychnine, thyroid, or any derivative or preparation of any such
substances, contained therein: Provided, That where compliance with this paragraph is
 impracticable, exemptions shall, upon recommendation of the Director, be established
by regulations promulgated by the Secretary. lawphi1.net

(f) Unless its labeling bears (1) adequate directions for uses; and (2) such adequate
warnings against use in those pathological conditions or by children where its use may
be dangerous to health, or against unsafe dosage or methods or duration of
administration or application, in such manner and form as are necessary for the
protection of users: Provided, That where any requirement of clause (1) of this
paragraph, as applied to any drug or device, is not necessary for the protection of the
public health, the Secretary shall, upon recommendation of the Director, promulgate
regulations exempting such drug or device from such requirement.

(g) If it purports to be a drug the name of which is recognized in an official compendium,

unless it is packaged and labeled as prescribed therein: Provided, That the method of
packing may be modified with the consent of the Secretary. lawphi1.net

(h) If it has been found by the Secretary to be a drug liable to deterioration, unless it is
packaged in such form and manner, and its label bears a statement of such
precautions, as the Secretary shall by regulations require as necessary for the
protection of the public health.

(i) (1) If it is a drug and its container is so made, formed, or filled as to be misleading; or

(2) If it is an imitation of another drug; or

(3) If it is offered for sale under the name of another drug.

(j) If it is dangerous to health when used in the dosage, or with the frequency of
duration prescribed, recommended or suggested in the labeling thereof.

(k) If it is, or purports to be, or is represented as a drug composed wholly or partly of

any kind of penicillin, cephalosporins, amino glycosides, tetracycline, chloramphenicol,
erythromycin, or any other antibiotic drug, or any derivative thereof unless (1) it is from
a batch with respect to which a certificate of release has been issued pursuant to
Section twenty-two (a) and (2) such certificate of release is in effect with respect to such
drug: Provided, That this paragraph shall not apply to any drug or class of drugs
exempted by regulations promulgated under section twenty-two (a), (b) and (c)."

Powers and Functions of the Board and FDA -

Scope of Practice of Pharmacist -