Briefer On RA 10918

RA 10918 otherwise known as the Philippine Pharmacy Act
I. Who are deemed to be engaged in the practice of Pharmacy (sec.4)

A. The following activities exclusive to licensed pharmacists:
1.Preparation, compounding or manufacture, and even storage, distribution procurement, sale or
dispensing of any pharmaceutical product or its raw materials
2.Clinical pharmacy services, drug information, pharmaceutical marketing, medication management
3. Teaching of pharmacy courses in schools
4.Dispensing pharmaceutical products in situations where supersivion is required
5. All other services where pharmaceutical knowledge is required.
The fifth defined activity is a catch-all provision to cover for all other instances that do not specifically
fall under the enumerations
B. The following are likewise deemed engaged in the practice but may be undertaken by nonlicensed pharmacists, but is still however subject to other qualifications under other laws:
1.Chemical, biological or microbiological analyses and assay of pharmaceutical products,
food/dietary supplements, health supplements and cosmetics
2.Physisco-chemical analyses for medical devices used in aid of administration of pharmaceutical
products.
3. Administration of Adult Vaccines as approved by the FDA
4. Scientific research involving pharmaceutical products and health care.
Training
Pharmacy Aides, and Pharmacy Assistants(sec. 5)
- those who assist the pharmacists in the different aspects of pharmacy operation, with very minimal
degree of independence or decision making and without direct interaction with patients(Aides), or
with minimum degree of independence and decision making, and may have supervised interaction
with patients(Assistants)
Handling of Pharmaceutical Products by a Non-Pharmacist (sec.39)
- Must be certified by appropriate government agencies after undergoing an Accredited Training
Program.
These include pharmacy owners who are not pharmacists, medical representatives, pharmacy support
personnel, pharmacy technicians, pharmacy assistants, pharmacy aides, persons who assist in
any part of pharmacy operations or any other person performing functions involved in handling
pharmaceutical products.
Provisions on Adult Vaccines
1. Adult Vaccines refer to vaccines: (sec.5(b)
a. To be administered to patients aged 18 and above, such as cervical cancer, flu vaccines,
pneumococcal vaccines, and other pre-exposure prophylactic vaccines.
b. As defined by the Department of Health in an Administrative Issuance.
2. Pharmacists are required to: (sec 4(g); and sec. 40)
a. Undergo training for safe administration of adult vaccine and management of Adverse
Events Following Immunization (AEFI)
b. Hold a Certificate of Training issued by an institution accredited by the Professional
Regulation Commission
c. The training must form part of a higher education curriculum for pharmacists.
d. Before administration, the pharmacist must ensure that the vaccine to be administered shall
have a doctors prescription which is not more than 7 days old.
e. Pharmacists must submit a monthly vaccination report and AEFI report to the DOH regional
offices.
Distinction Between Adulterated and Counterfeit Pharmaceutical Products
Adulterated Pharmaceutical Products are those, following the standards of quality and purity, are unfit
for human consumption. -sec.5(c)
Counterfeit Pharmaceutical Products- on the other hand are those bearing misleading or fraudulent
writings or marks which are enumerated in the Act. One of which is when the product contains no
amount of or a different active ingredient, or less than 80% of the active ingredient it purports to
possess, including reduction of efficacy due to expiration-as distinguished from an adulterated drug.
sec.5(g)
II. Pharmacist Requirement (sec.31)
Category A Establishments/Outlets are those which are required to hire the direct and immediate
control and supervision of a duly registered and licensed pharmacist, per establishment.
Category B Establishments/Outlets are those which require only supervision and oversight of a duly
registered and licensed pharmacist.
The FDA, in coordination with the Board, and the approval of the PRC, may add to, delete, reclassify, or
modify the following list of establishments, as the need arises, in order to keep pace with the
developments in the pharmacy practice.
CATEGORY A
1. Selling or otherwise making available to the consuming public: prescription medicines,pharmacistonly over the counter (OTC) medicine,combination products classified as drugs accdg. to the
primary intended mode of action(medical device and drugs),
2. Those involved in that manufacture, import and export, distribution, and sale of combination products
3. Departments/Divisions/Units of establishments with the process involving the preparation,
manufacture, assay, regulation, product research and development, quality control, repacking,
importation and exportation, distribution, sale or transfer of pharmaceutical products, in quantities
greatly in excess of single therapeutic doses.
4. Government units, including local government, city, first to third class municipal health units, nongovernment organizations and/or associations involved in the procurement, distribution, dispensing,
cold storage.
A pharmacist working under category A are allowed to simultaneously work or render pharmacy
services in category B establishments. His maximum hours of work shall be determined by the board
in coordination with the FDA, and other agencies.
CATEGORY B
1.Those selling only household remedies and OTC drugs
2. Satellite institutional pharmacies providing medicines solely to employees of their respective
companies or the the dependents of such employees or both, or those with respect to a duly
registered organization or institution
3.Fourth to sixth class municipal health units involved in procurement, distribution, dispensing, and
storage of pharmaceutical products.
4. Institutions providing telepharmacy services
5. Non-traditional outlets of pharmaceutical products: Provided that no prescription medicines and

pharmacist-only OTC are sold.
Responsibility for Quality, Safety and Efficacy of Pharmaceutical Products
-Duty of the duly licensed and registered pharmacist of a pharmaceutical establishment and outlet to
ensure that pharmaceutical products conform to the standards under this Act and other pertinent Rules
and Regulations
-Owners, managers and pharmacists-in-charge shall be held jointly responsible with these
standards.
III. Regulation of the Practice of Pharmacy
Dispensing/Sale of Pharmaceutical Products
Provision on Dispensation in Emergency Cases(sec. 30)
Prescription and Pharmacist-only OTC Drugs can only be dispensed by a registered pharmacist,
except in emergency cases, where the services of a licensed pharmacist are not available.
A report shall be made to the supervising pharmacist within (24) hours after the occurrence of the
emergency so that product recording in the prescription books may be done.
Provision on Automatic Registration (sec.25)
1. The Certificates of Registration (COR), Special/Temporary Permits(STP), Professional Identifcation
Cards (PIC) held by persons in good standing shall remain effective.
2. All Pharmacists registered prior to the effectivity of this act shall automatically be registered, but
may be subject to future requirements.
Physicians Samples: must be indicated clearly on such drugs. Anti-TB, anti-microbials, others as
classified by the FDA, are prohibited to be sold as physicians samples.
Display of Certificate of Registration (sec. 29)
1. A pharmacist engaged in the practice, whether in private or as an employee, shall display the
original copy of ones COR in a prominent and conspicuous place in the drug establishment.
2. When a pharmacist is employed in Category B establishments, the duplicate copy of the
pharmacists COR shall be displayed therein.
No Pharmacist shall knowingly allow to be displayed in an establishment where one is not actually
employed as a professional pharmacist.
Label on Dispensed Medicines: (sec. 36)
Every box, bottle, or package of medicines compounded or dispensed by apharmacist, based on
prescription, the following must be indicated:
(1) Name of patient; (2) generic name; (3) brand name; (4) strength; (5) expiration date; (6) directions
for use;
(7)Name and address of the pharmacy; (8) name of the doctor, (9)dispensing pharmacist,
(10)Other requirements prescribed in the:
Phil Standards for Pharmacists and Dispensing Guidelines
RA 9502 Universally Accessible Cheaper and Quality Medicines Act
Its implementing RRs
Other guidelines as may be promulgated by the Board.

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RA 10918 otherwise known as the Philippine Pharmacy Act

I. Who are deemed to be engaged in the practice of Pharmacy (sec.4)

5. Non-traditional outlets of pharmaceutical products: Provided that no prescription medicines and

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