to respective owner NCII

Transcription

1 to respective owner NCII

2 Course Orientation, House Rules and Pharmaceutics 2 (PMC2) Pre-laboratory discussion BSP 3B BSP 3C BSP 3F BSP 3I BSP 3J BSP 3L WF 14:00 17:00 TTH 10:30 13:30 MS 13:00 16:00 TTH 07:00 10:00 MS 07:00 10:00 WF 10:00 13:00

3 Course Orientation Syllabus Requirements House Rules Laboratory Rules Pharmaceutics 2 (PMC2) AO 55 s.1988: Requirements for Labelling Materials of Pharmaceuticals AO 109 s.1969 Prescription Drug Label Symbol BSP 3B BSP 3C BSP 3F BSP 3I BSP 3J BSP 3L WF 14:00 17:00 TTH 10:30 13:30 MS 13:00 16:00 TTH 07:00 10:00 MS 07:00 10:00 WF 10:00 13:00

4 Course Orientation

5 Course Objective At the end of the course the students should be able to: 1. Cognitive: Practice and apply the principles of the GxP s, with particular emphasis on GDP, GMP, GPP in the production of pharmaceuticals, cosmetics and veterinary products. 2. Psychomotor: Dispense, manufacture, label and package a pharmaceutical, cosmetic, and veterinary product, in adherence and compliance to GxP s. 3. Affective: Appreciate the pharmacist s social professional responsibilities in helping restore or maintain the health of men and animals and of the high moral and ethical standards that are required of the pharmacy profession.

6 Manufacture of Drugs, Cosmetics and Veterinary Medicine 5 unit subject: 3 lecture, 2 laboratory The course familiarizes the students with the concept of cgmp involved in pharmaceutical manufacture. Acquisition of the basic knowledge in the regulatory and technical requirements of the Food and Drugs Administration in the production of Drugs, Cosmetics and Veterinary products. PRE-REQUISITE: Pharm.5 Biopharmaceutics and Pharmacokinetics

7 Requirements: During preparation day: 1. Complete PPI 2. Task tag To be passed after each preparation day 30mins. before end of session (10) 1. One (1) fully accomplished answer sheet per group (45) 2. Preparation *** 3. Index card To be passed on the 2 nd meeting before the final examination (1 st period of session): 1. An advertisement in a form of a commercial. 30 second commercial for 5 preparations (2min 30sec) (any preparation) (CD burned) 2. A portfolio of your preparations.

8 Criteria for preparations: Each preparation is equivalent to 50 points. Part 1: Secondary packaging Design - 3 Readability - 2 Adherence to AO 55 and AO * Capability to carry primary container - 3 * Part 2: Primary packaging Design - 3 Readability - 2 Adherence to AO 55 and AO * Appropriateness of container - 5 * Part 3: Content (depends on preparation) - 15 Part 4: Package insert Readability - 2 Content - 5

9 Class Participation Each laboratory session day: Attendance: (grace period of 15 min. PST) Present: 2 pts. Late: 0.5 pt. (up to 30 min. only) Absent: 0 pt. *in final computation of grade, an excess of 0.5 is not rounded off to 1

10 Class Participation Each laboratory session day: Deduction guide: No/improper use of head cap: - 2 No/improper use of face mask: - 2 * No gloves: - 2 No shoe cap: - 1 With jewellery/nail polish/facial hair - 1/ part/pc No/improper use of lab gown: - no experiment No task tag - 1 *Sitting while course of experiment - 2 Cluttered worktable - 5 *not applicable to labeller Deduction procedure: 1. Random inspection 2. Deduction to members = Deduction to inspector 3. Deduction to inspector = Deduction to inspector 4. Above guide is to be applied on the total score

11 Class Participation Each preparation day: Deduction guide: Late submission - 5 per 10mins. Deduction procedure: 1. Submission is 30 min. before end of session. 2. Deduction applies to the total grade on preparation

12 Class Participation Each preparation day: Maximum total possible score: Preparation: 50 pts. Answer sheet: 10 pts. Attendance: 2 pts.. 62 pts.

13 Reminders: 20% absences, consecutive or non-consecutive: automatic unofficially drop.

14 Criteria for project 50 points 10 Originality 20 Adherence to current laws governing advertisement of 20 Content *late submission deduction guide applies

15 Materials needed/group Tissue / lint-free tissue Mantle Masking tape Permanent marker Dishwashing liquid/hand soap Rags Sando bag

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17 to respective owner NCII

18 Course Orientation, House Rules and Pharmaceutics 2 (PMC2) Pre-laboratory discussion BSP 3B BSP 3C BSP 3F BSP 3I BSP 3J BSP 3L WF 14:00 17:00 TTH 10:30 13:30 MS 13:00 16:00 TTH 07:00 10:00 MS 07:00 10:00 WF 10:00 13:00

19 Course Orientation Syllabus Requirements House Rules Laboratory Rules Pharmaceutics 2 (PMC2) AO 55 s.1988: Requirements for Labelling Materials of Pharmaceuticals AO 109 s.1969 Prescription Drug Label Symbol BSP 3B BSP 3C BSP 3F BSP 3I BSP 3J BSP 3L WF 14:00 17:00 TTH 10:30 13:30 MS 13:00 16:00 TTH 07:00 10:00 MS 07:00 10:00 WF 10:00 13:00

20 House Rules

21 Course Complete PPI Before Session: 1. Anteroom 2. Proper hand washing During Session: 1. No sitting 2. Maintain cleanliness of workplace Orientation Process: Inspector with all members: a. Dispensing/Weighing b. Compounding c. Labelling ** inspector must make sure to supervise all task. Follow laboratory manual. After session policy 1. CLAYGO Pre-laboratory discussion: 1 st meeting per week Measurements and preparation for manufacturing order 1 st meeting per week Post-laboratory discussion: Week before examination *Expect 2 M.O. per preparation day.

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23 to respective owner NCII NCII

24 Course Orientation, House Rules and Pharmaceutics 2 (PMC2) Pre-laboratory discussion BSP 3B BSP 3C BSP 3F BSP 3I BSP 3J BSP 3L WF 14:00 17:00 TTH 10:30 13:30 MS 13:00 16:00 TTH 07:00 10:00 MS 07:00 10:00 WF 10:00 13:00

25 Course Orientation Syllabus Requirements House Rules Laboratory Rules Pharmaceutics 2 (PMC2) AO 55 s.1988: Requirements for Labelling Materials of Pharmaceuticals AO 109 s.1969 Prescription Drug Label Symbol BSP 3B BSP 3C BSP 3F BSP 3I BSP 3J BSP 3L WF 14:00 17:00 TTH 10:30 13:30 MS 13:00 16:00 TTH 07:00 10:00 MS 07:00 10:00 WF 10:00 13:00

26 AO 55 s.1988: Requirements for Labelling Materials of Pharmaceuticals

27 Requirements for labelling materials of pharmaceutical products Formulated by DOH with accordance to RA 3720 with amendments from EO 175 and RA 6675

28 Label on immediate container, and other printed materials that are incorporated with the product at the time of purchase. E.g. Wrapper cartons, leaflet/package insert.

29 refers to, which mean any pharmaceutical or biological intended to be used in the Dx, cure, mitigation and Tx or prevention of dse in human or affect the structure or any fx of the. human body..

30 proprietary or trade name assigned to the product by the drug establishment

31 refers to the identification of drugs and medicines by their scientifically and internationally recognized active ingredients determined by the FDA of the DOH

32 classification of the product based on the Tx action as specified in the product registration

33 refers to the name(s) and amount(s) of active medicinal ingredients per dosage unit expressed in the METRIC system

34 the approved clinical use of the product based on substantial and scientifically supported evidence of the safety and efficacy of the drug in the given dosage form

35 pharmaceutical form of the preparation based on the official pharmacopoeia

36 the site and manner the product is to be introduced in or applied on the body

37 statements regarding the occurrence of potential hazards and side effects associated with use of the product and the limitation of its use

38 statements regarding the occurrence of potential hazards and side effects associated with use of the product and the limitation of its use

39 instruction and special care required in the use of the product to avoid undesired effects and to ensure the safe and effective use of the drug

40 products other than biological products means the date, in month and year, during which processing of the bulk product, from which goods are to be filled, is completed

41 refers to any distinctive combination of letters and/or numbers, assigned to a particular batch produced during a given cycle of manufacture. It permits production history of the batch including all stages of manufacture and control, to be traced and reviewed.

42 distinctive combinations of letters and/or numbers assigned to a particular lot, defined as a portion of the batch

43 date after which the product is not expected to retain its claimed safety, efficacy and quality or potency or after which it is not permissible to sell, distribute or use said product.

44 total amount/quantity/number of dosage form in a certain container of the product expressed in metric system

45 refers to prevailing specified range temperature, humidity and other environmental factors within optimal stability of the product is ensured based on laboratory data

46 part of the label that is most likely to be displayed, presented, shown or examined under customary condition of display for retail use

47 area or surface of the container/package where the display panel is located

48 first pack containing the individually wrapped products, strip blister packs

49 1. Name of the product (GN alone or with BN, as the case may be) 2. Dosage Form and strength 3. Pharmacologic Category 4. Rx symbol, in case of prescription drug 5. Name and complete address of manufacturer 6. Net Content 7. Formulation 8. Indication 9. Contraindication/s, Precaution/s, Warning/s 10. Mode of administration or Directions for use 11. Batch and Lot number 12. Exp. date and date of Mfg. 13. Registration number 14. Storage conditions 15. For Rx drugs: FOODS, DRUGS, DEVICES AND COSMETIC ACT PROHIBITS DISPENSING WITHOUT PRESCRIPTION

50 Must be in English or Filipino It should be Clearly and Prominently Displayed Readable with normal vision without straining Color contrast, position and spacing of the information must be taken into consideration in complying with the reqmt s

51 PRINCIPAL D I S P L A Y P A N E L MUST Contain the following: 1. Name of the product (GN alone or with BN, as the case may be) 2. Dosage Form and strength 3. Pharmacologic Category 4. Rx symbol, in case of prescription drug 5. Name & complete address of manufacturer 6. Net Content

52 PRINCIPAL D I S P L A Y P A N E L MUST Comprise 40% of the total surface of the container, except in the case of the rectangular container where the total area of the principal display panel must equal to the product of the height and width of the entire side of the container. For any other shaped container presenting an obvious principal display panel such as the top of a triangular or circular container, the size of the area shall consist of the entire top surface.

53 MUST CONTAIN THE FOLLOWING 1. Formulation 2. Indication (s) 3. Mode of Administration(s) and the Direction(s) for use 4. Batch and Lot number 5. Expiry/Expiration date of manufacture 6. Registration number 7. Storage Conditions 8. Rx notice for Rx drugs: FOODS, DRUGS, AND DEVICES AND COSMETIC ACT PROHIBITS DISPENSING WITHOUT PRESCRIPTION IMMEDIATE CONTAINER O U T S I D E O F T H E PRINCIPAL D I S P L A Y P A N E L

54 These informations shall appear on the other labelling materials such as inserts or leaflets or wrapper cartons.

55 GENERIC NAME Brand Name of Some Drug Specific requirements for the name of the product in labelling drug products IN ALL CASES, THE GENERIC NAME shall be the prominently printed element on the label, It is defined as the one with the highest point size among various printed elements on the label. It shall be enclosed exclusively by an outline box rendered in the same color as the generic name

56 GENERIC NAME Brand Name of Some Drug Specific requirements for the name of the product in labelling drug products The background color inside the box, against the GN is rendered, should be the same color as the background color outside the box, against which the BN is rendered

57 GENERIC NAME salt form Brand Name of Some Drug Specific requirements for the name of the product in labelling drug products IN ALL CASES, the GN shall be printed in full, NOT abbreviated and in accordance with the International Non-proprietary Name (INN). In cases the salt or specific chemical form of the drug needs to be indicated, this must be included inside the but in smaller font size

58 GENERIC NAME salt form Brand Name of Some Drug Specific requirements for the name of the product in labelling drug products GN and BN shall be of the same typeface, font and color GN shall appear immediately above the brand name and rendered in a point size bigger than the brand name

59 GENERIC NAME salt form Brand Name Specific requirements for the name of the product in labelling drug products If the BN is presented with a special typeface exclusively designed and used for it. The GN shall be rendered in HELVETICA MEDIUM or UNIVERSE MEDIUM be rendered while complying with the pertinent provisions presented earlier.

60 Active1 Active2 Brand Name of Some Drug Specific requirements for the name of the product in labelling drug products For products containing TWO (2) active ingredients: The GN of both active ingredients indicated within the box for generic name.

61 Active1 Active2 Brand Name of Some Drug Specific requirements for the name of the product in labelling drug products For products containing THREE or MORE active ingredients: An official name for the combination, which shall serve as the equivalent generic name, Shall be designated by a FDA committee of experts. Starting date at which the official name can be used shall be determined by FDA.

62 GENERIC NAME salt form Brand Name of Some Drug TABLET Dosage form shall be specified as: TABLETS, CAPSULES, SYRUPS, SUSPENSIONS, OINTMENTS, including special delivery system such as SUSTAINED-RELEASE, etc.

63 GENERIC NAME salt form Brand Name of Some Drug TABLET ANTIPYRETIC Shall conform to the category used in the PNDF. Drugs that cannot be classified under the said categories may be given a Tx category other than what appears in annex A of AO55 s.1988 subject to the approval of FDA taking into consideration current acceptable standards for Tx categories.

64 GENERIC NAME salt form Rx Brand Name of Some Drug TABLET ANTIPYRETIC It must be printed in contrasting color to the background on which it appears. Overprinting or superimposition of the Rx symbol is allowed PROVIDED that such will not result in obliterating or rendering less legible the other required label requirements. The Rx symbol should be printed in a type size no less than 1/5 of the height of the principal display panel.

65 GENERIC NAME salt form Rx Brand Name of Some Drug TABLET ANTIPYRETIC Manufactured and distributed by: Prime Laboratories Incorporated Km.44 Malolos City, Philippines Complete name and address of manufacturer and also trader, when applicable, must appear on the principal display panel.

66 60mL Rx GENERIC NAME salt form Brand Name of Some Drug TABLET ANTIPYRETIC Manufactured and distributed by: Prime Laboratories Incorporated Km.44 Malolos City, Philippines Net content shall indicate the total amount/quantity/number of the dosage form in a given container of the product expressed in metric system

67 Rx GENERIC NAME salt form Brand Name of Some Drug TABLET ANTIPYRETIC Manufactured and distributed by: Prime Laboratories Incorporated Km.44 Malolos City, Philippines 60mL Formulation: Brand name of Some Drug contains: Generic Name 50mg Active ingredients must be stated in their generic names (INN). The amounts of the active ingredients shall be expressed in the metric system/unit of potency. Salt or chemical forms must be stated, when applicable.

68 Rx GENERIC NAME salt form Brand Name of Some Drug TABLET ANTIPYRETIC Manufactured and distributed by: Prime Laboratories Incorporated Km.44 Malolos City, Philippines 60mL Formulation: Brand name of Some Drug contains: Generic Name 50mg Multiple components must be enumerated in decreasing pharmacologic activity. The coloring agent and other excipients used in the formulation that may cause hypersensitivity/adr must be indicated. Alcohol content must be expressed in percent.

69 Rx GENERIC NAME salt form Brand Name of Some Drug TABLET ANTIPYRETIC Manufactured and distributed by: Prime Laboratories Incorporated Km.44 Malolos City, Philippines 60mL Formulation: Brand name of Some Drug contains: Generic Name 50mg Indication: For patients with shall only be the approved clinical use of the product Based on approved FDA registration

70 Rx GENERIC NAME salt form Brand Name of Some Drug TABLET ANTIPYRETIC Manufactured and distributed by: Prime Laboratories Incorporated Km.44 Malolos City, Philippines 60mL Formulation: Brand name of Some Drug contains: Generic Name 50mg Indication: For patients with Contraindicated to Warning: Precaution: Full information regarding contraindications to the use of the product as well as precautions are to be observed in its administration and use must be provided.

71 Rx GENERIC NAME salt form Brand Name of Some Drug TABLET ANTIPYRETIC Manufactured and distributed by: Prime Laboratories Incorporated Km.44 Malolos City, Philippines 60mL Formulation: Brand name of Some Drug contains: Generic Name 50mg Indication: For patients with Contraindicated to Warning: Precaution: Warning statements as required and specified by FDA must be provided.

72 Rx GENERIC NAME salt form Brand Name of Some Drug TABLET ANTIPYRETIC Manufactured and distributed by: Prime Laboratories Incorporated Km.44 Malolos City, Philippines 60mL Formulation: Brand name of Some Drug contains: Generic Name 50mg Indication: For patients with Contraindicated to Warning: Precaution: In some cases, FDA may prescribe certain labelling information to be indicated on the label of certain drug product.

73 Mode of administration: 60mL Rx GENERIC NAME salt form Brand Name of Some Drug TABLET ANTIPYRETIC Manufactured and distributed by: Prime Laboratories Incorporated Km.44 Malolos City, Philippines Informations about the recommended dosage, including initial dose, usual dose, freq. interval, duration of Tx, dosage adjustment or other pertinent aspects of drug Tx must be given in full

74 Mode of administration: 60mL Dose: Rx GENERIC NAME salt form Brand Name of Some Drug TABLET ANTIPYRETIC Manufactured and distributed by: Prime Laboratories Incorporated Km.44 Malolos City, Philippines Dilution, reconstitution, preparation and administration must be provided. Separate directions for adults and children must be stated, and if not recommended for children, the dosage shall be clearly identified as adult dose.

75 Mode of administration: 60mL Dose: Rx GENERIC NAME salt form Brand Name of Some Drug TABLET ANTIPYRETIC Manufactured and distributed by: Prime Laboratories Incorporated Km.44 Malolos City, Philippines If the entire batch is MARKETED UNDER ONE COMPANY, ONLY THE BATCH NUMBER needs to be indicated. If batch is divided into several lots are MARKETED BY DIFFERENT COMPANIES, the LOT NUMBER and its CORRESPONDING BATCH NUMBER shall be indicated in every lot.

76 Mode of administration: 60mL Dose: BATCH: PLI Rx GENERIC NAME salt form Brand Name of Some Drug TABLET ANTIPYRETIC Manufactured and distributed by: Prime Laboratories Incorporated Km.44 Malolos City, Philippines Batch and/or Lot number must be printed on each strip of ten (10) blister units.

77 Mode of administration: 60mL Dose: BATCH: PLI EXP: 11/15 Rx GENERIC NAME salt form Brand Name of Some Drug TABLET ANTIPYRETIC Manufactured and distributed by: Prime Laboratories Incorporated Km.44 Malolos City, Philippines The expiry date shall be expressed in terms of the month and the year. In such cases, the last day of the month is assumed as the expiration date. For a drug that is reconstituted prior to use, a period of guaranteed efficacy must be specified at a given storage condition.

78 Mode of administration: 60mL Dose: BATCH: PLI EXP: 11/15 Rx GENERIC NAME salt form Brand Name of Some Drug TABLET ANTIPYRETIC Manufactured and distributed by: Prime Laboratories Incorporated Km.44 Malolos City, Philippines The EXP date shall be printed or embossed on the tin foil, blister and/or strip package.

79 Mode of administration: 60mL Dose: BATCH: PLI Reg: EWDF81238 EXP: 11/15 Rx GENERIC NAME salt form Brand Name of Some Drug TABLET ANTIPYRETIC Manufactured and distributed by: Prime Laboratories Incorporated Km.44 Malolos City, Philippines Reg. no. shall indicate the drug registration number and code assigned by FDA

80 Mode of administration: 60mL Dose: BATCH: PLI Reg: EWDF81238 EXP: 11/15 Store in cool dry place. Rx GENERIC NAME salt form Brand Name of Some Drug TABLET ANTIPYRETIC Manufactured and distributed by: Prime Laboratories Incorporated Km.44 Malolos City, Philippines Storage conditions appropriate for the product must be stated

81 In addition to requirements stated earlier: The name and proportion of any antimicrobial agent in the product Name any adjuvant in the product or any substance which, when administered with an antigen, modifies immune response to that antigen. Name of species of animal or organism from which the product has been prepared. For monoclonal antisera, the name of sp. Source or name of sp. of origin of hybridoma cell line used in the prep. of the product.

82 In addition to requirements stated earlier: For viral vac. Produced in animal cells or cell cultures, the name of the cell culture substrate, or the name of the species of animal and tissue used in the manufacture of the product, as well as the name of any residual antibiotic present in the product when applicable. Potency of biological products which needs to be prepared before use. Potency unit shall be the International Unit, approved by the FDA taking into consideration current acceptable standards. Date of manufacture pertaining to month and year.

83 In addition to requirements stated earlier: Name and quantity of all excipients in the product except for large volume injections. Statement of recommended routes of administration. If antimicrobial agent is not present in the product, the words USE ONLY ONCE or DISCARD ANY REMAINING PORTION or words to that effect. Where the contents of the container are to be used in one occasion only, the words SINGLE USE or SINGLE DOSE must be present. For conc. solution for injection, a direction not to administer the solution undiluted and directions for dilution must be present

84 In addition to requirements stated earlier: Name and quantities of all excipients and AI in the nominal volume of fluid in the container, listing in descending order of magnitude. If there is an amino acid present, a total amount of nitrogen in the nominal volume of fluid in container. Nominal osmolality Statement if the solution is nominally hypotonic or hypertonic Nominal ph of sol n Words SINGLE USE or SINGLE DOSE

85 In addition to requirements stated earlier: Label shall include the name and proportion of any antimicrobial agent present in product.

86 In addition to requirements stated earlier: The statement FOR EXTERNAL USE ONLY printed in red color must appear on the PDP of the label.

87 For products 10mL or less and enclosed in a primary pack. Label must contain: Name of product Company Logo Strength Mode of Admin Batch Number Expiry Date Must contain the informations required under general requirements and specific requirements (sections 2-5) (Name of Product Injections) When not practicable to set out particulars in full on a label on the container, particulars to in 9.1 (in red color) may be abbreviated, provided abbreviation is not ambiguous.

88 Product consist of individual dosage units Name of product Company name or logo Strength Expiry date For products in strip or blister packs Name of product Strength Expiry date must appear every 2 units Company name and Batch number every strip of 10 units Primary pack and other labelling materials must contain the requirements stated earlier.

89 There a container or primary pack containing products is enclosed in a transparent covering and the particulars which are required to be set out on the label on the container or primary pack are clearly visible through the transparent covering. Where products are made up or compounded by a pharmacist in a accordance with the individual prescription of a medicinal practitioner, dentist or veterinarian. Products donated by foreign agencies/person, the requirements of generic labelling may be waived except that the expiry date must be indicated.

90 The requirements do not apply for drugs used solely for investigational purpose and donated products by a foreign agency or person and in exceptional cases where the labelling provisions of this regulation are not appropriate. These exemption must be applied for and approved by FDA in case to case basis.

91 Manufacture, sale, offering for sale or transfer of any product that is misbranded. Forging, counterfeiting, simulating or falsely representing or using any mark, stamp, label or other identification device required under the regulation without proper authority. The alteration, mutilation, destruction, obliteration or removal of the whole or any part of the labelling of the product, if such act is done while such product is held for sale and results in such article being misbranded.

92 The use on the labelling of any product of any representation or suggestion that such product is approved by FDA or that complies with the provisions of this regulation, when in fact it does not. The use, in labelling of product of any reference to any FDA report or document without clearance from FDA

93 For violation of AO55 s.1988, any or the following sanctions after due notice and summary hearing may be imposed by the Secretary of Health - SUSPENSION or REVOCATION of the LTO of drug establishments and outlets and cancellation of Certificate of Product Registration. - IMPOSITION of ADMINISTRATIVE FINES of NOT LESS THAN 1,000 Php NOR MORE THAN 5,000 Php -Recall from the market of misbranded product(s) -Confiscation of violative product(s)

94 The imposition of sanctions stated earlier does not preclude the institution of appropriate criminal proceedings pursuant to Section 26 of RA3720, as amended and Section 12 of RA6675

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96 to respective owner NCII NCII

97 Course Orientation, House Rules and Pharmaceutics 2 (PMC2) Pre-laboratory discussion BSP 3B BSP 3C BSP 3F BSP 3I BSP 3J BSP 3L WF 14:00 17:00 TTH 10:30 13:30 MS 13:00 16:00 TTH 07:00 10:00 MS 07:00 10:00 WF 10:00 13:00

98 Course Orientation Syllabus Requirements House Rules Laboratory Rules Pharmaceutics 2 (PMC2) AO 55 s.1988: Requirements for Labelling Materials of Pharmaceuticals AO 109 s.1969 Prescription Drug Label Symbol BSP 3B BSP 3C BSP 3F BSP 3I BSP 3J BSP 3L WF 14:00 17:00 TTH 10:30 13:30 MS 13:00 16:00 TTH 07:00 10:00 MS 07:00 10:00 WF 10:00 13:00

99 AO 109 s.1969 Prescription Drug Label Symbol

100 All drugs which requires the prescription of a physician, dentist, veterinarian or any person authorized and licensed by law to prescribe must bear the symbol: Rx Prescription Drug Label Symbol R x

101 The symbol must be prominently placed on the PDP of the label and on any retail carton or wrapper for such container of each drug or pharmaceutical specialty. Prescription Drug Label Symbol R x

102 The symbol must be of contrasting color to the background on which it appears, with no particular color required and SHALL NOT BE LESS THAN 50% of the shorter dimension of a rectangular label or shorter diameter of an elliptical or nearby elliptical label and NOT LESS THAN 50% of the area of the PDP for any other shape of label. Prescription Drug Label Symbol R x

103 Overprinting and superimposition is allowed if the symbol meets the requirements indicated in these regulations and such overprinting or superimposition will not result in obliterating or rendering less legible the other required label statements. Prescription Drug Label Symbol R x

104 For products packed in foil or similar wrapper, the symbol shall appear on the foil and outer container from which they are removed for dispensing. Prescription Drug Label Symbol R x

105 For products with an outer retail container, the placement of the symbol is waived on the immediate label of the inner container; provided, however the inner container is not intended to be sold separately. Prescription Drug Label Symbol R x

106 In cases of ampules or other containers too small or otherwise unable to accommodate the label: If sold w/o an individual outer container, the symbol shall appear on the outer container from which they are removed for dispensing or use if with an outer retail container, the placement of the symbol is waived on the immediate label of the inner container, provided, however, the inner container is not intended to be sold separately. Prescription Drug Label Symbol R x

107 The symbol is not required on the retail carton or wrapper if it was easily visible through such carton or wrapper. Any drug or pharmaceutical specialty not subject to the placement of the symbol but whose labelling bears the symbol shall be deemed to be misleading. Prescription Drug Label Symbol R x

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109 to respective owner NCII