The Punjab Drugs Rules, 2007 Se TRS v Beclomethasone vi Hydrocortisone Ls: Hormones : 5 } i Vasopressin Vi Finasteride fi Desmopressin Vii Finasteriode iii Stanozolol Vili Somatropin iv Nandrolone, ix Testosterone v -Mesterolone x Progestrogens ‘SCHEDULE H] [See Tule 23] GOOD STORAGE AND DISTRIBUTION PRACTCETO BE FOLLOWED BY THE LICENCE? AND A PUBLIC SECTOR INSTITUTION OR A PRIVATE ORGANIZTION . A good storage Practice is e part of the quality of the Pharmaceutical Or medical product” through various activities ut. different levels related to Storage and distribution Operations, A Pharmacy, medici! Store and distributor shall follow the good storage practice and supply chain Management acvordingly / detailed below: 1. At each sale op Storage site i.e. 4 distributor, wholesuler, Velerinary, food Products, cosmetics, chemicals, disinfectants and cleaning Materials to eliminate the risk of cross Contamination. 33 The shall be Proper cleanliness and hygiene. The humidity and temperature shalt be maintained within acceptable limits Of respective products, ; 1. Ins. by Nutification No. $.0. (DC) 8142003 (4-97) (P), dater 20.1.2014. .790 . The Punjab Drugs Rules, 2007 4. goods and muterials:shall be stored off the floor, suitably spaced to permit ventilation, cleaning and inspection. - a; The dispensing equipment of pharmacy including temperature and humidity monitoring devices and scale shall be validated. 6. The vehicles deployed to distribute, store, or handle drugs | “shall be properly designed and equipped to ensure protection from different environmental and weather conditions. ~ Narcotic, psychotropic drugs and radioactive substances shall be stored’separately with proper record keeping. 8. The starting material and products used in the dispensing pharmacy shall be isolated and be properly labeled in a way which prevents mix-up-and cross contribution. OY Tt will be ensured that pharmaceuticals products due to expire first are sold and /or distributed first (FEFO). 10. _ Adequate controls shall be in place to prevent the sale «/ distribution of expired products. 11. Expired, broken or damaged items shall kept/stored : separately, properly labeled and 12 Thermo labile products shall be. kept in refrigerator with Proper temperature recording device like thermometer, and its temperature shall be monitored to ensure its consistency within the required limits. ' 13. Storage. conditions for products and materials shall be in compliance with the labeling instructions and requirements. 14 All-the medicines must be kept on racks and shelves. To allow access for cleaning and to avoid harbouring pests. The stores may be arranged in the store room-and shelves as per following general SUE EUIS pallets are being. used, stake the carton: ° At least 10 cm (4 inches) off the floor; ° At least 30 cm (1 foot) away from the walls and other . stacks; andThe Punjab Drugs Rules, 2007 : 794 Not more than 2.5 m (8 feet) high. Products shall be protected from excessive climatic conditions during storage and transport such as heat, frost, moisture and direct sunlight, Buildings shall be kept free of vermin, insects, birds & other pests. a Temperature above 40° C degree and relative humidity above 70% are considered to be the extremes of temperature arid humidity respectively. Drugs products that must be stored under defined conditions ‘require appropriate storage instructions. Unless atherwise specifically stated, deviation may be tolerated only during _Short terms interruptions or during local transportation. It is important to follow the manufacturer’s recommended storage conditions printed on label all products: Store frozen: Some products, like certain vaccines, need to be transported within a cold chain and stored at -20° C (4° F). Frozen storage is normally for longer-term storage at higher level facilities; * Store at 2-8° € (36° - 46° F): Some products are very heat sensitive but must not be frozen. These are usually kept in the first and second part of the refrigerator and never in the freezer. This temperature is appropriate for sonIng vaccines for a short period of time: "Keep cool: Store between 8°-15° Ca5"59°P) * Store at room temperature: Store at ambient temperature: Store at the surrounding temperature. This term is not widely used due to significant variation in ambient temperatures. It mean,s “room temperature” or normal storage conditions, with means storage in dry, clean, well-ventilated area at room temperatures between 15° to 26° C (59°-77°F) or up to 30°792 nN wo 24. 25. The Punjab Drugs Rules, 2007 C, deperiding on climatic conditions. Protect from moisture no more than 60% relative humidity, =foteet from moisture In normal “Storage condition: to be provided to the patients in a light-resistant. container, There shall not be any leaks from roofs of Storage sites, The storage facil 'y shall be clean and free trom litter, dust and pests, Adequate . precautions shall be taken against spillage and breakage, attack by microorganism and Toss contamination, The manufacturer, importers shall ensure the deliveries only to authorized retailers, Wholesalers or distributors under a valid warranty under the law. For all supplies a document shall be enclosed making it Possible to identity the stocks to ascertain the date, the name and pharmaceutical firm of the medicinal product, quantity supplied, the name and address of the suppler and addressee, The medicinal products shall be transported in such a way that: (a) their idemtification is not fost: (b) adequate precautions are taken against spillage, breakage or theft; and % ’ (C) . they are secure and Not subjected to unacceptable degree of heat, cold. light, moisture und such like other factors. Medicinal products fequiring controlled temperature Storage shall be transported by appropriately specialized means. Detective medicinal products which have been Tetuned shall be kept apart from saleable stock to Prevent sale/redistribution until a decision has been reached regarding the disposal.” —a. eee : The Punjab Drugs Rules, 2007 743 (a) the premises has proper and adequate facility for storage of drugs and for their protection from direct sunlight, dust or dirt, including refrigeration facility; (b). the premises is clean, hygienic and in tidy condition; (©) _ in the case of a licence of a pharmacy in which "preparation or compounding of a drug is undertaken, the premises has fulfilled the requirements contained in the Schedule F; (d) the covered area of the premises of a pharmacy is not be less than 140 square feet with minimum breadth of 8 feet in the front and height of 8:feet '[and, in case of - distributor minimum covered area shall not be less than=S00 square feet] and in case of a medical store, 96 square feet with minimum breadth of 8 feet and height of 8 feet; (e) the applicant is not a convict who has been sentenced for imprisonment for a period of one year or more or sentenced to pay fine of thirty thousand rupees or more for manufacturing or selling spurious drugs; and . (f) a person who is registered under section 24(1)(a) of Ms : the Pharmacy Act 1967 (XI of 1967) has agreed to personally supervise the sale of drugs for licence in Form 9 (pharmacy) *fand Form 11 (Distributor)] and a person -who is registered under section 24(1)(a) & (b) ~ of the said Act has agreed to supervise sale of drugs for licence in Form 10 (medical store). *[Provided that provision of this rule for the licences already issued shall come into force after ten years from the notification of these rules]. “ 4@Q) _ The licensing authority shall not issue a licence without inspection report of the Secretary of the Provincial Board or the Secretary of the District Board or the Inspector of the area.] ° 1, Ins. by Notification No. SO(DC) 814/2003 (A-97) (P), dated 20.1.2014. 2. _ Ins. by Notification No. SO(DC) 814/2003 (A-97) (P), dated 20.1.2014, 3. Proviso added by Notification No. SO(DC) 814/2003 (A-97) (P), dated 2.1,2010. b 4. Subs. by Notification No, SO(DC) 814/2003 (A-97) (P), dated 20.1.2014. © te ee ee te ee