Ingredient Listing Qty. Unit NDC # Supplier. Sterile Preparation
|
|
|
- Scott Holt
- 6 years ago
- Views:
Transcription
1 2/8/2014; Page 1 SUGGESTED FORMULATION Ingredient Listing Qty. Unit NDC # Supplier Baclofen, USP g Cyclobenzaprine Hydrochloride, USP g Diclofenac Sodium, USP g Lidocaine Hydrochloride, USP Pentylene Glycol 1.75 ml Medisca VersaPro Cream Base SPECIAL PREPARATORY CONSIDERATIONS Ingredient-Specific Information Lot Number Expiry Date Light sensitive (protect from light whenever possible): Hygroscopic (protect from moisture whenever possible): Narrow Therapeutic Index Diclofenac Sodium Diclofenac Sodium, Pentylene Glycol Lidocaine Hydrochloride Preparatory Guidelines Non-Sterile Preparation Sterile Preparation Processing Error / Testing Considerations: Special Instruction: To account for processing error considerations during preparation, it is suggested to measure an additional 10 to 12% of the required quantities of ingredients. Protective apparel, such as a lab coat, disposable gloves, eyewear and face-masks should always be worn. Lidocaine Hydrochloride has a Narrow Therapeutic Index. This procedure requires the use of very small quantities of ingredients. All calculations and preparation techniques must be verified before dispensing the final product.
2 2/8/2014; Page 2 SUGGESTED PREPARATION (for 50 g) Weigh and / or measure the following ingredients when appropriate: Ingredient Listing Qty. Unit Multiplication factor (*) : Processing Error Qty. to measure Baclofen, USP g Cyclobenzaprine Hydrochloride, USP g Diclofenac Sodium, USP g Lidocaine Hydrochloride, USP Pentylene Glycol 1.75 ml Medisca VersaPro Cream Base Weigh / measure just prior to use. * Takes into account increased batch size conversions and density conversions, if required. 1. Ingredient quantification: Preparatory Instruction A. Determine the potency of Lidocaine Hydrochloride based on the certificate of analysis: 100% MINUS Water Content (from certificate of analysis) % DIVIDED BY 100 Quantity of water free Lidocaine Hydrochloride, in decimal MULTIPLY BY Assay on anhydrous basis result (from certificate of analysis) % DIVIDED BY 100 i. Potency of Lidocaine Hydrochloride, in decimal
3 2/8/2014; Page 3 2. Ingredient quantification: A. Determine the quantity (in g) of Lidocaine Hydrochloride to make a Lidocaine Hydrochloride 2% Topical Cream, batch size (50 g): Quantity of Lidocaine Hydrochloride required for 50 g g DIVIDED BY Potency of Lidocaine Hydrochloride (Step 1Ai) i. Quantity of Lidocaine Hydrochloride needed for 50 g g MULTIPLED BY Processing error adjustments (10 to 12%): 1.10 to 1.12 ii. Quantity of Lidocaine Hydrochloride needed plus processing error adjustments g
4 2/8/2014; Page 4 3. Ingredient quantification: A. Determine the actual quantity of VersaPro Cream Base to weigh for the required batch size (50 g): Total Weight of the batch g MINUS Total amount of other ingredients except Lidocaine Hydrochloride 5.20 g MINUS The weight of Lidocaine Hydrochloride (Step 2Ai) g i. Quantity of VersaPro Cream Base needed for 50 g g MULTIPLED BY Processing error adjustments (10 to 12%) 1.10 to 1.12 ii. Weight of VersaPro Cream Base required plus processing error adjustments g 4. Powder-liquid preparation: A. Combine and triturate the following ingredients together to form a fine homogeneous powder blend: -Baclofen -Cyclobenzaprine Hydrochloride -Diclofenac Sodium -Lidocaine Hydrochloride (amount determined in Step 2Aii) B. Levigate the fine, homogeneous powder blend (Step 4A) with the Pentylene Glycol. End result: Homogeneous paste-like dispersion.
5 2/8/2014; Page 5 5. Powder-liquid to medium integration: A. Incrementally add the homogeneous paste-like dispersion (Step 4B) to the VersaPro Cream Base (amount determined in Step 3Aii). Specifications: Continuously mix, using high-shear mixing techniques. End result: Homogeneous cream-like dispersion. B If the final result is gritty, pass it through the ointment mill until it becomes smooth and uniform. 6. Product transfer: Transfer the final product into the specified dispensing container (see Packaging requirements ).
6 2/8/2014; Page 6 SUGGESTED PRESENTATION Estimated Beyond-Use Date 30 days, as per USP. Packaging Requirements Tightly closed, light-resistant container with metered dose-measuring device. 1 Use as directed. Do not exceed prescribed dose. 6 Do not take with alcohol, sleep aids, tranquilizers or other CNS depressants. 2 Keep out of reach of children. 7 Cap tightly after use. Auxiliary Labels 3 Consult your health care practitioner if any other prescription or over-the-counter medications are currently being used or are prescribed for future use. 8 For external use only. 4 Keep in a dry place. 9 May impair mental and/or physical ability. Use care when operating a car or machinery. 5 Keep at room temperature (20 C 23 C). 10 Protect from light. Add any auxiliary labels specific to the API to the dispensing container as deemed necessary. IMPORTANT: - Small batch is prepared due to inherent potential of systemic toxicity. - Limits as to the total amount of product used should be established by a physician. Pharmacist Instructions - You should not apply this product to open wounds, areas of skin that are damaged or blistered, deep wounds, or large areas. - Continued application of this product might produce systemic side effects. Advise patient accordingly. IMPORTANT: DRUG-DRUG INTERACTION EXISTS BETWEEN BACLOFEN AND CYCLOBENZAPRINE HYDROCHLORIDE. TO BE DISPENSED AND ADMINISTERED ONLY UNDER THE CLOSE SUPERVISION OF THE PRESCRIBING PHYSICIAN. Contact your pharmacist in the event of adverse reactions. Patient Instructions IMPORTANT: - Do not cover the site of application. - The quantity of API administered is directly dependent on the quantity of product applied.
7 2/8/2014; Page 7 REFERENCES 1. Ointments, Creams, and Pastes. In: Allen, LV, Jr. The Art, Science and Technology of Pharmaceutical Compounding Third Edition. American Pharmaceutical Association; 2008: Baclofen. In: Sweetman SC, ed. Martindale: The Complete Drug Reference, 36 th Edition. London, England: The Pharmaceutical Press; 2009: Cyclobenzaprine Hydrochloride. In: Sweetman SC, ed. Martindale: The Complete Drug Reference, 36 th Edition. London, England: The Pharmaceutical Press; 2009: Diclofenac Sodium. In: Sweetman SC, ed. Martindale: The Complete Drug Reference, 36 th Edition. London, England: The Pharmaceutical Press; 2009: Lidocaine Hydrochloride. In: Sweetman SC, ed. Martindale: The Complete Drug Reference, 36 th Edition. London, England: The Pharmaceutical Press; 2009: Baclofen (Monograph). In: O Neil MJ. The Merck Index 14 th Edition. Whitehouse Station, NJ: Merck & Co, Inc.; 2006: Monograph # Cyclobenzaprine (Monograph). In: O Neil MJ. The Merck Index 14 th Edition. Whitehouse Station, NJ: Merck & Co, Inc.; 2006: Monograph # Lidocaine (Monograph). In: O Neil MJ. The Merck Index 14 th Edition. Whitehouse Station, NJ: Merck & Co, Inc.; 2006: Monograph # Baclofen. In: Trissel LA. Trissel s Stability of Compounded tions, 4th Edition. American Pharmaceutical Association; 2009: Diclofenac Sodium. In: Trissel LA. Trissel s Stability of Compounded tions, 4th Edition. American Pharmaceutical Association; 2009: Lidocaine Hydrochloride. In: Trissel LA. Trissel s Stability of Compounded tions, 4th Edition. American Pharmaceutical Association; 2009: Baclofen (Monograph). United States Pharmacopeia XXXVI / National ry 31. Rockville, MD. US Pharmacopeial Convention, Inc. 2013: Cyclobenzaprine Hydrochloride (Monograph). United States Pharmacopeia XXXVI / National ry 31. Rockville, MD. US Pharmacopeial Convention, Inc. 2013: Diclofenac Sodium (Monograph). United States Pharmacopeia XXXVI / National ry 31. Rockville, MD. US Pharmacopeial Convention, Inc. 2013: Lidocaine Hydrochloride (Monograph). United States Pharmacopeia XXXVI / National ry 31. Rockville, MD. US Pharmacopeial Convention, Inc. 2013: USP <795>. United States Pharmacopeia XXXVI / National ry 31. Rockville, MD. US Pharmacopeial Convention, Inc. 2013: 355. DISCLAIMER: MEDISCA NETWORK INC., HEREBY REFERRED TO AS 'THE NETWORK', HAS PROVIDED THE FORMULA AND INSTRUCTIONS ABOVE AS A MODEL FOR EDUCATIONAL PURPOSES ONLY ON THE BASIS OF THE RECOGNIZED COMPENDIA AND TEXTS REFERENCED AT THE END OF THIS DOCUMENT. THE NETWORK TAKES NO RESPONSIBILITY FOR THE VALIDITY OR ACCURACY OF THIS INFORMATION OR FOR ITS SAFETY OR EFFECTIVENESS, NOR FOR ANY USE THEREOF, WHICH IS AT THE SOLE RISK OF THE LICENSED PHARMACIST. ADJUSTMENTS MAY BE NEEDED TO MEET SPECIFIC PATIENT NEEDS AND IN ACCORDANCE WITH A LICENSED PRESCRIBER'S PRESCRIPTION. THE PHARMACIST MUST EMPLOY APPROPRIATE TESTS TO DETERMINE THE STABILITY OF THIS SUGGESTED FORMULA. THE NETWORK CANNOT BE HELD LIABLE TO ANY PERSON OR ENTITY CONCERNING CLAIMS, LOSS, OR DAMAGE CAUSED BY, OR ALLEGED TO BE CAUSED BY, DIRECTLY OR INDIRECTLY, THE USE OR MISUSE OF THE INFORMATION CONTAINED IN THIS SUGGESTED FORMULA. IN ALL CASES IT IS THE RESPONSIBILITY OF THE LICENSED PHARMACIST TO KNOW THE LAW, TO COMPOUND ANY FINISHED PRODUCT AND TO DISPENSE THESE PRODUCTS IN ACCORDANCE WITH FEDERAL AND STATE LAW.
Lidocaine Hydrochloride 2%, Metronidazole 2%, Misoprostol % Topical Ointment (Suspension, 30 g) Ingredient Listing Qty. Unit NDC # Supplier
6/18/2015; Page 1 SUGGESTED FORMULATION Ingredient Listing Qty. Unit NDC # Supplier Lidocaine Hydrochloride, USP Metronidazole, USP 0.600 g Misoprostol 1% Dispersion, USP 0.072 g Ethoxy Diglycol 3.0 ml
Ingredient Listing Qty. Unit NDC # Supplier TBD. Sterile Preparation
8/16/2018; Page 1 SUGGESTED FORMULATION Acyclovir, USP Ingredient Listing Qty. Unit NDC # Supplier Mineral Oil (Light), NF 3.0 ml Polyox TM WSR-301 Oral Adhesive Paste* *Formula # F 006 397 available on
SUGGESTED FORMULATION. Lot Number. Expiry Date. Ingredient Listing Qty. Unit NDC # Supplier
9/17/2016; Page 1 SUGGESTED FORMULATION Ingredient Listing Qty. Unit NDC # Supplier Aloe Vera (Powder) (Freeze Dried) 0.200 g Tacrolimus 5% Stock Powder Blend 0.600 g Ethoxy Diglycol 1.0 ml Medisca U-Mild
Ingredient Listing Qty. Unit NDC # Supplier
3/4/2015; Page 1 SUGGESTED FORMULATION Ingredient Listing Qty. Unit NDC # Supplier Lidocaine, USP 3.000 g Prilocaine, USP 3.000 g Tetracaine, USP 1.200 g Stevia Powder 0.10 g Butylated Hydroxytoluene (BHT),
Ingredient Listing Qty. Unit NDC # Supplier ml
8/28/2016; Page 1 SUGGESTED FORMULATION Ingredient Listing Qty. Unit NDC # Supplier Progesterone 0.25%/Spironolactone 0.5% Stock Solution 5.00 ml Medisca Foamil Base 45.00 g Alcohol (95%), USP q.s. to
Ingredient Listing Qty. Unit NDC # Supplier. Sterile Preparation
6/22/2014; Page 1 SUGGESTED FORMULATION Ingredient Listing Qty. Unit NDC # Supplier Estradiol 1% Stock Powder Blend 2.000 g Estriol (Micronized), USP 0.080 g Medisca CapsuBlend -H TBD Sodium Chloride,
Hydrocortisone 2%, Hydroquinone 6%, Kojic Acid 4%, Salicylic Acid 4%, Tretinoin 0.01% Topical Gel (Suspension, 20 g)
8/22/2016; Page 1 SUGGESTED FORMULATION Ingredient Listing Qty. Unit NDC # Supplier Tretinoin 2% Stock Solution 0.10 ml Hydrocortisone (Micronized), USP 0.400 g Hydroquinone, USP 1.200 g Kojic Acid 0.800
Ingredient Listing Qty. Unit NDC # Supplier g. Sterile Preparation
Note: Glucosamine Sulfate Potassium Chloride 1267 mg is equivalent to Glucosamine 750 mg. 11/8/2016; Page 1 SUGGESTED FORMULATION Ingredient Listing Qty. Unit NDC # Supplier Chondroitin Sulfate Sodium,
Ingredient Listing Qty. Unit NDC # Supplier. Sterile Preparation
4/23/2015; Page 1 SUGGESTED FORMULATION Ingredient Listing Qty. Unit NDC # Supplier Nifedipine, USP 0.975 g Silica Gel (Micronized) 0.75 g Medisca SPG Supposi-Base 189.06 g SPECIAL PREPARATORY CONSIDERATIONS
Ingredient Listing Qty. Unit NDC # Supplier g
8/16/2018; Page 1 SUGGESTED FORMULATION Ingredient Listing Qty. Unit NDC # Supplier Lidocaine, USP 0.400 g Stevia Powder 0.10 g Polyox TM WSR-301 Topical Adhesive Powder* 9.50 g *Formula # F 007 422 available
Methimazole 5 mg Oral Chewable Treats (Solid Suspension, 60 x 1 ml Treats) FIN F v2. Ingredient Listing Qty. Unit NDC # Supplier
11/23/2015; Page 1 SUGGESTED FORMULATION Ingredient Listing Qty. Unit NDC # Supplier Methimazole, USP 0.300 g Tuna Flavor 1.50 g Glycerin, USP** 6.0 ml Chew-A-Treat Compound A 22.80 g Chew-A-Treat Compound
Ingredient Listing Qty. Unit NDC # Supplier. q.s. to ml
12/20/2018; Page 1 SUGGESTED FORMULATION Ingredient Listing Qty. Unit NDC # Supplier, USP 10 MU Sucrose, NF 23.00 g Propylene Glycol, USP 7.0 ml Medisca Oral Mix (Flavored Suspending Vehicle) 50.0 ml Medisca
Fluoxetine Hydrochloride 5.6 mg Oral Chewable Treats (Solid Suspension, 60 x 1 ml Chewable Treats)
4/11/2015; Page 1 Note: Fluoxetine Hydrochloride 5.6 mg is equivalent to Fluoxetine 5 mg. SUGGESTED FORMULATION Ingredient Listing Qty. Unit NDC # Supplier Fluoxetine Hydrochloride, USP 0.336 g Glycerin
Ingredient Listing Qty. Unit NDC # Supplier
7/12/2015; Page 1 SUGGESTED FORMULATION Ingredient Listing Qty. Unit NDC # Supplier Tramadol Hydrochloride, EP 0.300 g Stevia Powder 0.15 g Glycerin, USP** 3.0 ml Beef Flavor (Powder) 2.00 g Chew-A-Treat
Disclosure. Objectives. Objectives. Introduction. Introduction. Non-Sterile Compounding/Calculations
49th Annual Meeting Non-Sterile Compounding/ Sunil Jambhekar, B. Pharm., M.S., Ph.D Professor, Pharmaceutical Sciences LECOM Bradenton, School of Pharmacy Bradenton, FL 34211 Disclosure I do not have a
905 UNIFORMITY OF DOSAGE UNITS
Change to read: 905 UNIFORMITY OF DOSAGE UNITS [ NOTE In this chapter, unit and dosage unit are synonymous. ] To ensure the consistency of dosage units, each unit in a batch should have a drug substance
247 CMR BOARD OF REGISTRATION IN PHARMACY
247 CMR 18.00: NON-STERILE COMPOUNDING Section 18.01: Authority and Purpose 18.02: Non-Sterile Compounding Process 18.03: Non-Sterile Compounding Facility 18.04: Non-Sterile Compounding Equipment 18.05:
The Therapeutic Goods Act (1989)
EDUCATION PRACTICE UPDATE Assigning expiry dates to compounded medications First published in the Australian Journal of Pharmacy, Vol. 99, No.1169, February 2018, pp.72-76. Reproduced and distributed by
History Note: Authority G.S ; ; ; Eff. May 1, 1997; Amended Eff. January 1, 2015; March 1, 2013.
21 NCAC 46.1412 PHYSICAL REQUIREMENTS A health care facility pharmacy shall have sufficient floor space allocated to it to ensure that drugs are prepared in sanitary, well lighted, and enclosed places.
Q&A for submission of applications for prequalification of Zinc Sulfate tablets and Zinc Sulfate oral liquid (solution)
Q&A for submission of applications for prequalification of Zinc Sulfate tablets and Zinc Sulfate oral liquid (solution) This document should not be treated as a comprehensive guideline; it serves as a
Guidance for Pharmacists on Extemporaneous Dispensing
Guidance for Pharmacists on Extemporaneous Dispensing Pharmaceutical Society of Ireland Version 1 June 2015 Contents 1. Introduction 2 2. Legislative Basis and Implications 3 3. Guidance 4 3.1 Key Responsibilities
COMPOUNDING WITH PHLOJEL Ultra (PU) Slab & Spatula or mortar & pestle
COMPOUNDING WITH PHLOJEL Ultra (PU) 1. Diclofenac sodium (DCF) 2 20%w/w Slab & Spatula or mortar & pestle S & S: Place the required amounts of PU and DCF on the slab in separate locations. Add a portion
The Pharmacy Board of Australia s
Stability vs suitability of compounded preparations: customisation with appropriate compromise Rebecca O Grady BPharm, GradCertPharmPrac, MPS In customising preparations to the individual needs of the
6/7/2017 CHANGES IN PHARMA REGULATIONS HOW IT AFFECTS THE OR NURSE DISCLOSURE OBJECTIVES
CHANGES IN PHARMA REGULATIONS HOW IT AFFECTS THE OR NURSE John Karwoski, RPh, MBA DISCLOSURE I, John Karwoski, RPH, MBA have business relationships with the companies MOBIUS THERAPEUTICS, LLC, Cubex, and
Challenges in Reporting Compounded Drugs to the PMP/PDMP
Challenges in Reporting Compounded Drugs to the PMP/PDMP Katie Busroe, RPh Pharmacy Inspections and Investigations Supervisor Kentucky Board of Pharmacy Disclosures Katie Busroe has reported that she has
Student Practical Guide (1) Milk of Magnesia
School of Pharmacy Student Practical Guide (1b) Milk of Magnesia Facilitators Dr Mark Hewitt M.Hewitt@wlv.ac.uk Required Resources Pre-work: Read this guide Dr Rebecca Butler Rebecca.Butler@wlv.ac.uk Compulsory:
Residual Solvents: FDA/ Regulatory Perspective
Rosa Motta Compliance Officer Residual Solvents: FDA/ Regulatory Perspective PDA/USP Residual Solvents Conference January 18-19, 2007 1 Outline Laws and regulations governing the compliance requirements
MATERIAL SAFETY DATA SHEET
MATERIAL SAFETY DATA SHEET SECTION 1 - CHEMICAL PRODUCT(S) AND COMPANY IDENTIFICATION Supplier Name and address: Genlantis, A division of Gene Therapy Systems, Inc. 10190 Telesis Court San Diego, CA 92121
Model Standards for Pharmacy Compounding of Non-Sterile Preparations
Model Standards for Pharmacy Compounding of Non-Sterile Preparations Published with the Guidance Document For Pharmacy Compounding of Non-Sterile Preparations National Association of Pharmacy Regulatory
LIQUID PREPARATIONS FOR ORAL USE. Final text for addition to The International Pharmacopoeia (November 2007)
November 2007 LIQUID PREPARATIONS FOR ORAL USE Final text for addition to The International Pharmacopoeia (November 2007) This monograph was adopted at the Forty-second WHO Expert Committee on Specifications
Draft Guidance for Pharmacists on Extemporaneous Dispensing. Version 1
1. Introduction Draft Guidance for Pharmacists on Extemporaneous Dispensing Version 1 The purpose of this guidance is to assist pharmacists in discharging their legal and professional obligations to patients
Vol. 41(1) [Jan. Feb. 2015] (P) \\uspnetapp2\share\share\uspnf\printq\pager\xmlin\lyc_ _m99989.xml. Nov.
![Vol. 41(1) [Jan. Feb. 2015] (P) \\uspnetapp2\share\share\uspnf\printq\pager\xmlin\lyc_ _m99989.xml. Nov.](/thumbs/91/104519687.jpg "Vol. 41(1) [Jan. Feb. 2015] (P) \\uspnetapp2\share\share\uspnf\printq\pager\xmlin\lyc_ _m99989.xml. Nov.")
Vol. 41(1) [Jan. Feb. 2015] (P) \\uspnetapp2\share\share\uspnf\printq\pager\xmlin\lyc_20141121103705_m99989.xml Nov. 21, 2014 10:37:09 BRIEFING General Notices and Requirements, USP 38 NF 33 page 1. The
LubriTose Mannitol Michael Crowley, Director of R&D, Excipients
LubriTose Mannitol Michael Crowley, Director of R&D, Excipients Introduction Michael Crowley Director of R&D Excipients 158 St. Highway 320 Norwich, NY 13815 PH 315-802-5970 Michael.Crowley@Kerry.com 2
Stability Study of Hydralazine HCl Oral Solutions Compounded in Humco Oral Vehicles to Determine a Beyond-use Date
Stability Study of Hydralazine HCl Oral Solutions Compounded in Humco Oral Vehicles to Determine a Beyond-use Date Pradeep Gautam, MS* 1, Troy Purvis, PhD 1 Address correspondence to Pradeep Gautam, HUMCO
SLEEP AIDS - LABELLING STANDARD
SLEEP AIDS - LABELLING STANDARD CATEGORY: DESCRIPTION: Sleep Aids An over-the-counter drug (tablet, capsule, caplet, powder, or elixir form) that is useful for the relief of occasional sleeplessness by
CATEGORY IV MONOGRAPH. Athlete's Foot Treatments
CATEGORY IV MONOGRAPH Athlete's Foot Treatments I) Description: This monograph applies to products in cream, ointment, lotion, gel, powder, spray powder, aerosol liquid, solution, foam, or soap form intended
Chapter 8. Nonsterile Pharmaceutical Compounding. Paradigm Publishing, Inc. 1
Chapter 8 Nonsterile Pharmaceutical Compounding Paradigm Publishing, Inc. 1 The Need for Compounding Before large-scale pharmaceutical manufacturing, pharmacists compounded most prescriptions. Compounding
SAFETY DATA SHEET. Oxycodone Hydrochloride (CII) Capsule, 5mg, 100 count bottle NDC
SAFETY DATA SHEET SECTION 1 - IDENTIFICATION Product Identification: Oxycodone Hydrochloride (CII) Capsule, 5mg, 100 count bottle NDC 64950-901-10 Recommended use and restrictions: Oxycodone Hydrochloride
ANTACID LABELLING STANDARD
ANTACID LABELLING STANDARD CATEGORY: DESCRIPTION: Antacid Single and multiple ingredient drugs, containing medicinal ingredients suitable for self-medication, which are intended to relieve symptoms such
General Concepts in the European Pharmacopoeia. Anne-Sophie Bouin European Pharmacopoeia Department, EDQM, Council of Europe
General Concepts in the European Pharmacopoeia Anne-Sophie Bouin European Pharmacopoeia Department, EDQM, Council of Europe General notices Anne-Sophie Bouin, 28/10/09 2009 EDQM, Council of Europe, All
Calculations. Doses and Dosage Regimens. Pharmacy Technician Training Systems Passassured, LLC
Calculations Doses and Dosage Regimens Pharmacy Technician Training Systems Passassured, LLC Calculations, Doses and Dosage Regimens Calculations, Doses and Dosage Regimens Objectives Expressions of Dose
Compounding Medication Regulations
Association of Professors of Dermatology 2016 Annual Meeting Swissôtel, Chicago, IL Compounding Medication Regulations Christopher Bichakjian, MD Professor of Dermatology Comprehensive Cancer Center and
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
ISENTRESS raltegravir 400 mg tablet What is in this leaflet This leaflet answers some common questions about ISENTRESS. It does not contain all the available information. It does not take the place of
STANDARDS FOR PHARMACY COMPOUNDING OF NON-STERILE PREPARATIONS
STANDARDS FOR PHARMACY COMPOUNDING OF NON-STERILE PREPARATIONS ACKNOWLEDGEMENTS The standards in this document are based on the Model Standards for Pharmacy Compounding of Non-Sterile Preparations developed
Prime Asthma Relief Refill NDC
Prime Asthma Relief Refill NDC15343-104-40 Epinephrine Inhalation Bronchodilator, OTC DrNaturalHealing, Inc. 111 McCoy Street Milford, DE 19963 USA 1 EPINEPHRINE INHALATION FOR ORAL INHALATION ONLY ACTIVE
LABELLING STANDARD ANTIFUNGALS (TOPICAL)
LABELLING STANDARD ANTIFUNGALS (TOPICAL) I) Description: This labelling standard applies to products in cream, ointment, lotion, gel, powder, spray powder, aerosol liquid, solution, foam, or soap form
Food Fortification Regulations, 2016 (Gazetted on 24 October, 2016) ARRANGEMENT OF SECTIONS PART I PRELIMINARY
Statutory Instrument 120 of 2016 Food Fortification Regulations, 2016 (Gazetted on 24 October, 2016) [Cap 15:05 Section 1 Title 2 Interpretation ARRANGEMENT OF SECTIONS PART I PRELIMINARY 3 Inspection
Established in Locally Owned & Independently Operating. Physicians, Nurse Practitioners, Physician Assistants
Established in 1987 Locally Owned & Independently Operating Physicians, Nurse Practitioners, Physician Assistants Please Fax all Compounding RX s to: Fax: 630.530.0295 For assistance call: 855.770.6313
COMMENTS. Submitted by The International Pharmaceutical Aerosol Consortium
COMMENTS on a draft Guidance for Industry Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products Chemistry, Manufacturing, and Controls Documentation (Docket No. 99D-1454) Submitted by
GUIDELINES FOR EFFECTIVENESS TESTING OF OTC ANTIPERSPIRANT DRUG PRODUCTS. The Food and Drug Administration (FDA) is offering
GUIDELINES FOR EFFECTIVENESS TESTING OF OTC ANTIPERSPIRANT DRUG PRODUCTS 1. BACKGROUND. The Food and Drug Administration (FDA) is offering suggested guidelines for testing the effectiveness of an OTC antiperspirant
GOVERNMENT OF REPUBLIC OF TRINIDAD AND TOBAGO MINISTRY OF HEALTH CHEMIST- FOOD AND DRUGS DIVISION NEW DRUG SUBMISSION FORM
GOVERNMENT OF REPUBLIC OF TRINIDAD AND TOBAGO MINISTRY OF HEALTH CHEMIST- FOOD AND DRUGS DIVISION NEW DRUG SUBMISSION FORM Guidelines: In order to expedite the processing of your New Drug Submissions,
NEPHROCHECK Calibration Verification Kit Package Insert
NEPHROCHECK Calibration Verification Kit Package Insert Manufactured for Astute Medical, Inc. 3550 General Atomics Ct. Building 2 San Diego, CA 92121 USA Intended Use The NEPHROCHECK Calibration Verification
VITAMIN D. Proper name(s): Vitamin D (Sweetman 2007; IOM 2003; O Neil et al. 2001)
VITAMIN D Date: August 16, 2007 Proper name(s): Vitamin D (Sweetman 2007; IOM 2003; O Neil et al. 2001) Common name(s): Vitamin D, vitamin D 2, vitamin D 3 (Sweetman 2007; IOM 2003; O Neil et al. 2001)
Stability Of Extemporaneously Prepared Oral Liquid Formulations Part XI
CPE CREDIT 1.0 Current & Practical Compounding Information for the Pharmacist VOLUME 20 NUMBER 1 Grant funding provided by Perrigo Pharmaceuticals Goal: To provide information on the occurrence, causes
Pharmaceutical Calculations
Pharmaceutical Calculations Introduction Pharmaceutical calculations dealing with: Expressions of concentration Master formulae to working quantities Changing concentrations Small quantities ( trituration)
Government Gazette Staatskoerant
Government Gazette Staatskoerant REPUBLIC OF SOUTH AFRICA REPUBLIEK VAN SUID-AFRIKA Regulation Gazette No. 10054 Regulasiekoerant Vol. 581 Pretoria, 15 November 2013 No. 37032 N.B. The Government Printing
Drugs with Handling Concerns Due to Reproductive Risk
PL Detail-Document #280513 This PL Detail-Document gives subscribers additional insight related to the Recommendations published in PHARMACIST S LETTER / PRESCRIBER S LETTER May 2012 Drugs with Handling
"Understanding USP 71 Sterility Tests and Extending BUD"
"Understanding USP 71 Sterility Tests and Extending BUD" ERIC S. KASTANGO, M BA, RPH, FASHP CLINICAL IQ, LLC JULY 10, 2013 Disclaimer Although I am an Expert Consultant to the USP, I am speaking today
MATERIAL SAFETY DATA SHEET
MATERIAL SAFETY DATA SHEET 1. IDENTIFICATION OF THE SUBSTANCE AND THE COMPANY Material Divalproex Sodium Delayed-Release Tablets USP 125 mg, 250 mg & 500 mg Manufacturer Lupin Limited Mumbai 400 098 INDIA
INTERNATIONAL PHARMACOPOEIA MONOGRAPH ON LIQUID PREPARATIONS FOR ORAL USE
RESTRICTED INTERNATIONAL PHARMACOPOEIA MONOGRAPH ON LIQUID PREPARATIONS FOR ORAL USE REVISED DRAFT FOR DISCUSSION World Health Organization 2007 All rights reserved. This draft is intended for a restricted
Recall Guidelines. for Chinese Medicine Products
Recall Guidelines for Chinese Medicine Products April 2018 Recall Guidelines for Chinese Medicine Products Chinese Medicines Board Chinese Medicine Council of Hong Kong Compiled in September 2005 1 st
INTRODUCTION. Asthma Drug Delivery - 1
Asthma Drug Delivery Laboratory Experiment Developed by: Alex Jannini, David Krause, Heather Malino and Kevin Sweeney, Rowan University, Department of Chemical Engineering Edited by: C. Stewart Slater
ANIMAL HEALTH DIVISION. Technologies & Services
ANIMAL HEALTH DIVISION Technologies & Services Friulchem AH division is a fully compliant with the EU cgmp. Since 2007, it is a dedicated finished product manufacturer and R&D service provider for the
Medicines Improve your Understanding and your Health
Medicines Improve your Understanding and your Health Lung Health Patient Education Day 2015 Marina Lyne Pharmacist, Launceston General Hospital What we will discuss Medicines how they work Potential interactions
Regulatory Status FDA-approved indications: Emend is a substance P/neurokinin 1 (NK1) receptor antagonist, indicated: (1-2)
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.50.05 Section: Prescription Drugs Effective Date: April 1, 2017 Subject: Emend Page: 1 of 6 Last Review
REVISION OF MONOGRAPH ON TABLETS. Tablets
March 2011 REVISION OF MONOGRAPH ON TABLETS Final text for addition to The International Pharmacopoeia This monograph was adopted by the Forty-fourth WHO Expert Committee on Specifications for Pharmaceutical
Taking the guesswork out of supplying multi-compartment compliance aids: do pharmacists
1 2 Taking the guesswork out of supplying multi-compartment compliance aids: do pharmacists require further guidance on medication stability? 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24
Introduction to Compounding INTRODUCTION. L earning Objectives CHAPTER
CHAPTER 9 Introduction to Compounding L earning Objectives INTRODUCTION Webster s New World Dictionary defines the word compound as a verb meaning 1. to mix or combine, 2. to make by combining parts, and
Curraheen, Co.Cork. Disclaimer: The information contained within this policy is accurate and up-to-date at date of approval.
Curraheen, Co.Cork. SOP Title: Management of Transdermal Patches SOP No: 19 Version number: 2 Date of Re-approval: 28 th July, 2015 Revision due: 28 th July, 2018 Index Code No: CLIN041/SOP NO 19 Disclaimer:
USP NF General Chapter <905> Uniformity of Dosage Units
USP NF General Chapter Uniformity of Dosage Units Type of Posting: Explanatory Note Posting Date: 20 Apr 2007 This explanatory note is intended to clarify the steps taken by USP to address issues
American Emu Association. Certified Emu Oil Program
Table of Contents Part 1. Frequently Asked Questions... 3 Part 2. AEA Certified Fully Refined Seal & Verbiage Usage Requirements... 5 Section A. Program Requirements... 5 Section B. Product Labeling Requirements...
SECTION PRESCRIPTIONS
SECTION.1800 - PRESCRIPTIONS 21 NCAC 46.1801 EXERCISE OF PROFESSIONAL JUDGMENT IN FILLING PRESCRIPTIONS (a) A pharmacist or device and medical equipment dispenser shall have a right to refuse to fill or
Assessment of Low Dose Content Uniformity of Indomethacin in Excipient Blends Using FT-Raman Mapping Spectroscopy
Starch 1500 Application Data Partially Pregelatinized Maize Starch Assessment of Low Dose Content Uniformity of Indomethacin in Excipient Blends Using FT-Raman Mapping Spectroscopy OBJECTIVE To characterize
LABELING - SKIN OF PRODUCT Arun. N 1 Kadibagil vinay R 2 Ganti basavaraj Y 3 PG Scholar,
Review Article International Ayurvedic Medical Journal ISSN:2320 5091 LABELING - SKIN OF PRODUCT Arun. N 1 Kadibagil vinay R 2 Ganti basavaraj Y 3 PG Scholar, Associate Professor, Associate Professor &
REGULATORY REQUIREMENTS FOR REGISTRATION OF HEALTH SUPPLEMENTS IN MALAYSIA
REGULATORY REQUIREMENTS FOR REGISTRATION OF HEALTH SUPPLEMENTS IN MALAYSIA TAN JAS MIN National Pharmaceutical Regulatory Agency Ministry of Health Malaysia Email address: tanjasmin@npra.gov.my ORGANISATION
A. General Appearance
TABLET EVALUATION To design tablets and later monitor tablet production quality, quantitative evaluations and assessments of a tablet s chemical, physical, and bioavailability properties must be made.
Preparation of TAMIFLU for Oral Suspension. Emergency Compounding of an Oral Suspension from TAMIFLU Capsules (Final Concentration 15 mg/ml)
Preparation of TAMIFLU for Oral Suspension It is recommended that TAMIFLU for Oral Suspension be constituted by the pharmacist prior to dispensing to the patient: 1. Tap the closed bottle several times
SCIENTIFIC DISCUSSION
This part reflects the scientific knowledge and the information about this product available at the time of prequalification. Thereafter, updates may have become necessary which are included in parts 1
NEPHROCHECK Liquid Control Kit Package Insert
NEPHROCHECK Liquid Control Kit Package Insert Manufactured for Astute Medical, Inc. 3550 General Atomics Ct. Building 2 San Diego, CA 92121 USA Intended Use The NEPHROCHECK Liquid Controls are used for
Change to read: BRIEFING
BRIEFING Dibasic Calcium Phosphate Dihydrate, USP 29 page 359. The Japanese Pharmacopoeia is the coordinating pharmacopeia for the international harmonization of the compendial standards for the Dibasic
Compounding Pharmacy Pharmacy s Past, Present & Future
Compounding Pharmacy Pharmacy s Past, Present & Future David G. Miller, RPh Executive Vice President & CEO International Academy of Compounding Pharmacists 1 Compounding Pharmacy Pharmacy s Past, Present
USP Perspective on Atypical Actives November 29, 2017
USP Perspective on Atypical Actives November 29, 2017 USP Excipients Stakeholder Forum USP Perspective on Atypical Actives Catherine Sheehan, M.S., M.S. Senior Director, Science Excipients Outline Role
Understand Medication and Prescriptions
Workbook 1 Understand Medication and Prescriptions Accountability Storage Administration Prescription Supply Legislation Level 2 Certificate in Understanding the Safe Handling of Medicines 1 L4W 2013 Information
Formulation and evaluation of immediate release salbutamol sulphate
5 Formulation, optimization and evaluation of immediate release layer of salbutamol sulphate Salbutamol is moderately selective beta (2)-receptor agonist similar in structure to terbutaline and widely
Medicines. Let s Talk About. health literacy. wisconsin. A division of Wisconsin Literacy, Inc.
Let s Talk About Medicines Supported by a grant from the Wisconsin Department of Health Services Minority Health Program wisconsin health literacy A division of Wisconsin Literacy, Inc. What is a pharmacy?
COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE ON THE PHARMACEUTICAL QUALITY OF INHALATION AND NASAL PRODUCTS
European Medicines Agency Inspections London, 16 February 2005 Doc Ref.: EMEA/CHMP/QWP/49313/2005 corr. COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE ON THE PHARMACEUTICAL QUALITY OF
What Do IACP Members Think?
What Do IACP Members Think? Results of a National Survey of Compounding Practitioners February 27, 2013 Final Summary Results What Do Compounders Think? National Survey of 2,857 pharmacists and technicians
LUPIN LIMITED SAFETY DATA SHEET. Section 1: Identification. Vancomycin Hydrochloride Capsules USP 125 mg and 250 mg. Lupin Limited Goa INDIA
LUPIN LIMITED SAFETY DATA SHEET Section 1: Identification Section 1, Identification Material Manufacturer Distributor Vancomycin Hydrochloride Capsules USP 125 mg and 250 mg Lupin Limited Goa 403 722 INDIA
Quality, Safety and Sourcing in Unlicensed Medicines
Quality, Safety and Sourcing in Unlicensed Medicines with Andrew Trouton Managing Director, UL Medicines Agenda Welcome What is an unlicensed medicine? When should you consider using an unlicensed medicine?
SCIENTIFIC DISCUSSION. Lopinavir and Ritonavir 200 mg/50 mg Tablets * Name of the Finished Pharmaceutical Product:
SCIENTIFIC DISCUSSION Name of the Finished Pharmaceutical Product: Manufacturer of Prequalified Product: Active Pharmaceutical Ingredients (APIs): Pharmaco-therapeutic group (ATC Code): Therapeutic indication:
Food supplement manufacture
Food supplement manufacture Nick Bennett BSc. RNutr April 2018 1 Introduction There are many different product formats available Liquids, powders, tablets, capsules etc Many different types of machine
Why and how does a pharmaceutical company take the risk to use novel excipients?
Why and how does a pharmaceutical company take the risk to use novel excipients? M. Sherry Ku, Ph.D. CSO, Anchen Pharmaceuticals Irvine, CA Excipient Fest, May 5, 2010 Puerto Rico Global Excipient Acceptability
THE NOTIFICATION OF MINISTRY OF PUBLIC HEALTH NO. 158 [B.E (1994)] Supplementary Food for Infants and Young Children
![THE NOTIFICATION OF MINISTRY OF PUBLIC HEALTH NO. 158 [B.E (1994)] Supplementary Food for Infants and Young Children](/thumbs/90/101635137.jpg "THE NOTIFICATION OF MINISTRY OF PUBLIC HEALTH NO. 158 [B.E (1994)] Supplementary Food for Infants and Young Children")
THE NOTIFICATION OF MINISTRY OF PUBLIC HEALTH NO. 158 [B.E. 2537 (1994)] Re Supplementary Food for Infants and Young Children Whereas it is deemed appropriate to improve the Notification of Hin i s t r"j,"
NATURAL HEALTH PRODUCT FUNGAL PROTEASE
NATURAL HEALTH PRODUCT FUNGAL PROTEASE This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLAs) and labels for natural health product market
RULES OF THE TENNESSEE BOARD OF PHARMACY CHAPTER DRUG DONATION REPOSITORY PROGRAM TABLE OF CONTENTS
RULES OF THE TENNESSEE BOARD OF PHARMACY CHAPTER 1140-17 DRUG DONATION REPOSITORY PROGRAM TABLE OF CONTENTS 1140-17-.01 Definitions 1140-17-.02 Purpose 1140-17-.03 Eligibility Criteria for Program Participation
Prescribing and Dispensing Drugs
STANDARDS & GUIDELINES Prescribing and Dispensing Drugs TABLE OF CONTENTS Standards and guidelines inform practitioners and the public of CDSBC s expectations for registrants. This document primarily contains
KEYWAX WX1014 RUBBER WAX CONCENTRATE
PRODUCT DESCRIPTION ADVANTAGES KEYWAX WX1014 RUBBER WAX CONCENTRATE (TYPICAL PROPERTIES) These should not be considered as specifications. KEYWAX WX1014 is a is a blend of 15% polyisobutylene rubber in
PRODUCT MONOGRAPH FLUNARIZINE. Flunarizine Hydrochloride Capsules. 5 mg Flunarizine/Capsule THERAPEUTIC CLASSIFICATION
1 PRODUCT MONOGRAPH FLUNARIZINE Flunarizine Hydrochloride Capsules 5 mg Flunarizine/Capsule THERAPEUTIC CLASSIFICATION Selective Calcium-Entry Blocker INFORMATION FOR THE PATIENT Please read this Information
CARD/MAIL/PRE-APPROVAL/PREFERRED RIDER FOR PRESCRIPTION DRUG [INSURANCE] [Policy]holder: Group Policy No: Effective Date:
![CARD/MAIL/PRE-APPROVAL/PREFERRED RIDER FOR PRESCRIPTION DRUG [INSURANCE] [Policy]holder: Group Policy No: Effective Date:](/thumbs/79/80269988.jpg "CARD/MAIL/PRE-APPROVAL/PREFERRED RIDER FOR PRESCRIPTION DRUG [INSURANCE] [Policy]holder: Group Policy No: Effective Date:")
RIDER FOR PRESCRIPTION DRUG [INSURANCE] [Policy]holder: Group Policy No: Effective Date: CARD/MAIL/PRE-APPROVAL/PREFERRED The Prescription Drug Coverage under this Rider [replaces] [supplements] the Prescription
E-CIGARETTE AND VAPORIZER GENERAL & PRODUCTS LIABILITY APPLICATION
E-CIGARETTE AND VAPORIZER GENERAL & PRODUCTS LIABILITY APPLICATION NOTICE: THE POLICY FOR WHICH THIS APPLICATION IS MADE IS A CLAIMS MADE AND REPORTED POLICY. THIS POLICY APPLIES ONLY TO ANY CLAIM FIRST