Section 45Sec./Art. 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 ones COR in a pharmaceutical establishment where the pharmacist is not employed and practicing;

(c) Displaying of the pharmacists 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.