This document provides an overview of Ohio laws regarding pharmacy compounding. It defines different types of compounding and outlines legal requirements. Compounded drugs for administration by prescribers have specific limits, including only 5% of total sales, a 72-hour supply limit for prescribers, and labeling and record keeping rules. Compounding in a pharmacy for patient prescriptions requires following prescription and labeling rules, with limited batch preparation allowed based on routine orders.
The document provides an overview of the New Drug Application (NDA) process used in the United States to gain approval for new drugs. It discusses how the NDA process has evolved since 1938 to require evidence of both safety and efficacy. It also describes the various sections required in an NDA, including summaries of clinical data, chemistry and manufacturing, labeling, and safety information. The review process for an NDA by the FDA is also summarized, including timeframes for filing and reviewing an application.
This document provides an overview of Vineeth Kumar Ekbote's lab presentation on new drug applications (NDAs). The presentation covers what an NDA is, the goals and process of an NDA, the forms and contents required in an NDA submission, guidance documents for NDAs, and how NDAs are reviewed and approved by the FDA. The presentation also describes the various sections required in an NDA, including the application summary, chemistry and manufacturing controls, clinical data, and labeling.
Objectives
By completing the lesson, the pharmacist will be able to:
• Discuss the history of the REMS program
• Describe the elements of the REMS program
• Identify when a REMS might be used for a particular drug
• Identify REMS elements employed with medications dispensed in community pharmacy
• Discuss selection provision in Ohio law related to REMS requirements
505 b 2 strategy and Rx to otc switch market overview = ishan shuklaIshan Shukla
This document discusses regulatory pathways for switching drugs from prescription to over-the-counter status, including submitting an efficacy supplement to an approved NDA for a full switch or an NDA for a partial switch. It lists potential drugs that could be candidates for Rx-to-OTC switches due to upcoming patent expiries, and provides examples of switches that have occurred since 2000 along with their first-year OTC sales figures.
This white paper focuses on the 505(b)(2) New Drug Approval (NDA) regulatory pathway, which relies on the public literature of clinical studies and/or the FDA's filing of safety and efficacy data for a previously approved drug.
This document provides an overview of paper NDAs (new drug applications), which allowed generic drug companies to rely on published literature to demonstrate the safety and efficacy of reference drugs whose patents had expired. It discusses the history and implementation of paper NDAs, how they worked, and how they were replaced by the 505(b)(2) application pathway established by the Hatch-Waxman Act of 1984 to streamline the approval of generic drugs.
The document discusses the processes of investigational new drug (IND) application and new drug application (NDA).
The IND process allows testing of new drugs in humans to demonstrate safety and effectiveness prior to marketing. An NDA provides evidence of a drug's safety, effectiveness and quality for regulatory approval to market.
Developing a new drug takes an average of 15 years and huge costs. The IND contains pre-clinical data while the NDA has complete clinical trial results to prove a drug's risks outweigh its benefits and that its labeling and manufacturing are adequate. Regulatory agencies thoroughly review both applications to ensure a drug's quality and protect human subjects.
505(b)(2) new drug application (NDA) is one of three U.S. Food and Drug Administration (FDA) drug which was created by Hatch-Waxman Amendments of 1984, with 505(b)(2) referring to as a section of the Federal Food, Drug, and Cosmetic Act.
The document provides an overview of the New Drug Application (NDA) process used in the United States to gain approval for new drugs. It discusses how the NDA process has evolved since 1938 to require evidence of both safety and efficacy. It also describes the various sections required in an NDA, including summaries of clinical data, chemistry and manufacturing, labeling, and safety information. The review process for an NDA by the FDA is also summarized, including timeframes for filing and reviewing an application.
This document provides an overview of Vineeth Kumar Ekbote's lab presentation on new drug applications (NDAs). The presentation covers what an NDA is, the goals and process of an NDA, the forms and contents required in an NDA submission, guidance documents for NDAs, and how NDAs are reviewed and approved by the FDA. The presentation also describes the various sections required in an NDA, including the application summary, chemistry and manufacturing controls, clinical data, and labeling.
Objectives
By completing the lesson, the pharmacist will be able to:
• Discuss the history of the REMS program
• Describe the elements of the REMS program
• Identify when a REMS might be used for a particular drug
• Identify REMS elements employed with medications dispensed in community pharmacy
• Discuss selection provision in Ohio law related to REMS requirements
505 b 2 strategy and Rx to otc switch market overview = ishan shuklaIshan Shukla
This document discusses regulatory pathways for switching drugs from prescription to over-the-counter status, including submitting an efficacy supplement to an approved NDA for a full switch or an NDA for a partial switch. It lists potential drugs that could be candidates for Rx-to-OTC switches due to upcoming patent expiries, and provides examples of switches that have occurred since 2000 along with their first-year OTC sales figures.
This white paper focuses on the 505(b)(2) New Drug Approval (NDA) regulatory pathway, which relies on the public literature of clinical studies and/or the FDA's filing of safety and efficacy data for a previously approved drug.
This document provides an overview of paper NDAs (new drug applications), which allowed generic drug companies to rely on published literature to demonstrate the safety and efficacy of reference drugs whose patents had expired. It discusses the history and implementation of paper NDAs, how they worked, and how they were replaced by the 505(b)(2) application pathway established by the Hatch-Waxman Act of 1984 to streamline the approval of generic drugs.
The document discusses the processes of investigational new drug (IND) application and new drug application (NDA).
The IND process allows testing of new drugs in humans to demonstrate safety and effectiveness prior to marketing. An NDA provides evidence of a drug's safety, effectiveness and quality for regulatory approval to market.
Developing a new drug takes an average of 15 years and huge costs. The IND contains pre-clinical data while the NDA has complete clinical trial results to prove a drug's risks outweigh its benefits and that its labeling and manufacturing are adequate. Regulatory agencies thoroughly review both applications to ensure a drug's quality and protect human subjects.
505(b)(2) new drug application (NDA) is one of three U.S. Food and Drug Administration (FDA) drug which was created by Hatch-Waxman Amendments of 1984, with 505(b)(2) referring to as a section of the Federal Food, Drug, and Cosmetic Act.
This document provides an overview of New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs). NDAs are required for new drugs and include extensive clinical trial data to prove safety and efficacy. The review process takes 12-15 years and is more expensive. ANDAs are for generic drugs and do not require new clinical trials, only proof of bioequivalence. The review process takes 1-2 years and is less expensive. Both application types provide information on chemistry, manufacturing, labeling, and clinical data in a standardized format.
The document provides information on India's drug regulatory system. It states that the Drug Controller General of India heads the Central Drug Standard Control Organisation, which regulates drugs in India. The objectives of the drug regulatory authority are to ensure medicinal products are of acceptable quality, safe, and effective. It also discusses new drug approval processes, definitions of new drugs, application forms and fees for various regulatory processes like clinical trials, manufacturing, and import of drugs.
The document provides information on the New Drug Application (NDA) process, including its history and requirements. An NDA application must include extensive information on chemistry, manufacturing, non-clinical and clinical studies, and statistical analysis to prove a drug's safety and efficacy. It undergoes review by the FDA including an advisory panel review before final approval or disapproval is granted.
The document discusses non-clinical drug development and the Investigational New Drug Application (IND) process. It explains that pre-clinical development involves determining a drug's safety profile before human clinical trials. An IND must be submitted to regulatory authorities for approval before testing an unapproved drug in humans. The IND contains information on pre-clinical data, clinical protocols, manufacturing, and other details to ensure the safety of trial participants. Regulators review the IND to verify reasonable safety before allowing clinical studies.
The document discusses the New Drug Application (NDA) process required by the FDA to approve marketing of new drugs in the US. It describes what an NDA is, its goals, forms and typical contents. An NDA includes extensive information on clinical trials, manufacturing, labeling and safety. It covers chemistry, non-clinical and clinical data. The review process can take 10 months for standard drugs or 6 months for priority drugs. The FDA uses various pathways like fast track or accelerated approval to expedite review of drugs that treat serious diseases.
The document discusses the FDA drug approval process and lists some drugs that have been withdrawn by the FDA. It describes the multi-phase approval process including pre-clinical testing in animals, followed by three phases of clinical trials in humans. It can take over a decade for a drug to be approved. Several drugs are mentioned that were withdrawn from the market due to serious safety issues discovered after approval, such as thalidomide causing birth defects, phenformin causing fatal lactic acidosis, and rofecoxib increasing heart attack and stroke risk.
The document provides an overview of the Investigational New Drug Application (IND) and New Drug Application (NDA) processes required by the FDA to develop and approve new drugs. It describes how developing a new drug takes 15 years and over $900 million on average. The IND allows testing of new drugs in humans and provides safety data, while the NDA provides all clinical trial data for the FDA to determine if the drug is safe and effective for approval. Both the IND and NDA are lengthy applications that require extensive non-clinical and clinical data to gain FDA approval to market a new prescription drug.
- The document presents information on the New Drug Application (NDA) process required by the FDA to obtain approval to market a new drug product in the United States.
- An NDA provides extensive data from non-clinical and clinical studies to establish the safety, efficacy, and appropriate labeling of the drug. It includes chemistry, manufacturing, and controls information as well as clinical data from Phase I-III trials.
- The goals of an NDA are to determine if the drug's benefits outweigh its risks, if its proposed labeling is appropriate, and if the methods used to manufacture and ensure the drug's quality are adequate.
The document discusses the requirements for a New Drug Application (NDA) submitted to the FDA for approval of a new pharmaceutical product. An NDA must provide extensive data on the chemistry, manufacturing, animal and human clinical studies of the drug to allow the FDA to determine if the drug is safe, effective and of adequate quality for approval. Guidance documents provide recommendations to applicants on the content and format of an NDA to streamline the review process.
This document provides an overview of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) submitted to regulatory agencies for drug approval. It describes the key differences between NDAs which are for new drugs and require clinical trials, and ANDAs which are for generic drugs and require bioequivalence testing. The document outlines the contents and review process for both NDAs and ANDAs and the steps involved in submitting and reviewing each type of application.
The new drug approval process involves several phases of laboratory and clinical testing that can take over a decade and cost hundreds of millions of dollars. Only about 1 in 1000 compounds that enter pre-clinical testing are approved for human testing. After pre-clinical animal testing, companies submit an Investigational New Drug (IND) application to the FDA to request permission for human clinical trials. If approved, the drug then enters three phases of clinical trials involving several hundred to thousands of human subjects to evaluate safety, efficacy, and proper dosing. If phase 3 trials are successful, companies submit a New Drug Application (NDA) to the FDA for review and potential approval allowing marketing and post-market safety surveillance.
This document discusses supplemental new drug applications (SNDA) which are submitted to the FDA for approval of changes to approved drugs. It defines what types of changes require an SNDA, including manufacturing changes, formulation changes, and labeling changes. It categorizes changes as major, moderate, or minor based on their potential impact on quality, safety, or efficacy. Major changes require prior approval, moderate changes require 30 days' notice, and minor changes are reported annually. Examples are provided for each category of change.
ABBREVIATED NEW DRUG APPLICATION (ANDA),INVESTICATION OF MEDICINAL PRODUCTS D...GOKULAKRISHNAN S
Introduction to ANDA
Regulations applied to ANDA process
Format and content of ANDA
ANDA approval process
Exclusivity
Hatch-Waxman amendments & 180 days exclusivity
Introduction to IMPD
Contents of IMPD
Introduction to IB
Contents of IB
CENTRAL DRUG STANDARD CONTROL ORGANISATION (CDSCO)Vijay Banwala
this ppt covers all quary about the CDSCO ( central drug standard control organisation ,drug controller gernal of india and the organisation strectures
this ppt provides you all detail about the CDSCO
This document discusses the requirements for manufacturing facilities and clinical trials in India according to Schedules M and Y of the Drugs and Cosmetics Rules. Schedule M outlines the good manufacturing practices and requirements for premises, plants, and equipment used in pharmaceutical production. It also discusses facility design aspects like clean surroundings, building facilities, lighting, ventilation, and storage areas. Schedule Y provides the guidelines for conducting clinical trials in India, including the various phases of trials from Phase 0 to Phase IV. It also discusses aspects like informed consent, ethics committee composition, and government facilities for expediting clinical trials.
Product registration and drug approval process in uskeerthi09
The document summarizes the key aspects of the new drug application (NDA) and abbreviated new drug application (ANDA) processes in the United States. It describes the requirements for NDAs, including the 20 sections that make up an NDA and the information contained within them. It also discusses ANDA requirements for generic drugs, such as bioequivalence studies and patent certifications that are part of the review process. The review processes for both NDAs and ANDAs by the FDA are also briefly outlined.
This document summarizes key aspects of non-clinical drug development. It discusses how non-clinical studies are performed in silico, in vitro, and in vivo to assess safety, efficacy, pharmacokinetics, and manufacturing viability before human clinical trials. It also describes the Investigational New Drug application process which is required to begin clinical trials in humans, and provides an overview of the New Drug Application submitted for marketing approval. The document concludes by outlining the contents of an Investigational Medicinal Products Dossier which forms the basis for approval of multinational clinical trials in the European Union.
This document discusses recommendations for post-approval changes to approved drug applications. It defines major, moderate, and minor changes and provides examples. Major changes require prior approval from the FDA before distribution. Moderate changes require submission of a supplement to the FDA either 30 days or 60 days before distribution depending on the type of change. Minor changes are described in annual reports. The document provides recommendations for changes in several areas including components and manufacturing processes, specifications, packaging, labeling, and multiple related changes. It also notes some of the major differences in requirements for changes to biological products versus drug products.
Holiday Gift Program Mc Gladrey Wmb 91212billybooe
The document provides options and pricing for McGladrey's holiday gift program. It includes gifts ranging in price from $25-$60+, such as cookie tins, popcorn tins, coffee gift sets, and towers of treats. For each gift, it provides details on contents, packaging, pricing at different quantities, setup and shipping fees. The gifts can be customized with the McGladrey logo or other imprints for an additional fee.
This document provides product specifications for several corporate polo shirt and sport shirt options. It describes the materials, features, sizing, imprint details, pricing, and production time for each item. The options include classic poly-cotton polos, moisture wicking pima and baby pique sport shirts, textured polyester sport shirts, Dri-Fit micro pique shirts, and luxury cotton Callaway polos. Pricing ranges from $17.50 to $55 per unit depending on the style and size.
Activate! is a full-service promotional marketing company founded in 1995. They have expertise in branded merchandise, marketing, and technology. Activate! utilizes value alliances for fulfillment, distribution, sourcing, and other services to reduce costs for customers. They provide various promotional products and services, as well as creative online stores and marketing programs. Activate! aims to drive business and create value through their unique business model and customer service.
This document provides an overview of New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs). NDAs are required for new drugs and include extensive clinical trial data to prove safety and efficacy. The review process takes 12-15 years and is more expensive. ANDAs are for generic drugs and do not require new clinical trials, only proof of bioequivalence. The review process takes 1-2 years and is less expensive. Both application types provide information on chemistry, manufacturing, labeling, and clinical data in a standardized format.
The document provides information on India's drug regulatory system. It states that the Drug Controller General of India heads the Central Drug Standard Control Organisation, which regulates drugs in India. The objectives of the drug regulatory authority are to ensure medicinal products are of acceptable quality, safe, and effective. It also discusses new drug approval processes, definitions of new drugs, application forms and fees for various regulatory processes like clinical trials, manufacturing, and import of drugs.
The document provides information on the New Drug Application (NDA) process, including its history and requirements. An NDA application must include extensive information on chemistry, manufacturing, non-clinical and clinical studies, and statistical analysis to prove a drug's safety and efficacy. It undergoes review by the FDA including an advisory panel review before final approval or disapproval is granted.
The document discusses non-clinical drug development and the Investigational New Drug Application (IND) process. It explains that pre-clinical development involves determining a drug's safety profile before human clinical trials. An IND must be submitted to regulatory authorities for approval before testing an unapproved drug in humans. The IND contains information on pre-clinical data, clinical protocols, manufacturing, and other details to ensure the safety of trial participants. Regulators review the IND to verify reasonable safety before allowing clinical studies.
The document discusses the New Drug Application (NDA) process required by the FDA to approve marketing of new drugs in the US. It describes what an NDA is, its goals, forms and typical contents. An NDA includes extensive information on clinical trials, manufacturing, labeling and safety. It covers chemistry, non-clinical and clinical data. The review process can take 10 months for standard drugs or 6 months for priority drugs. The FDA uses various pathways like fast track or accelerated approval to expedite review of drugs that treat serious diseases.
The document discusses the FDA drug approval process and lists some drugs that have been withdrawn by the FDA. It describes the multi-phase approval process including pre-clinical testing in animals, followed by three phases of clinical trials in humans. It can take over a decade for a drug to be approved. Several drugs are mentioned that were withdrawn from the market due to serious safety issues discovered after approval, such as thalidomide causing birth defects, phenformin causing fatal lactic acidosis, and rofecoxib increasing heart attack and stroke risk.
The document provides an overview of the Investigational New Drug Application (IND) and New Drug Application (NDA) processes required by the FDA to develop and approve new drugs. It describes how developing a new drug takes 15 years and over $900 million on average. The IND allows testing of new drugs in humans and provides safety data, while the NDA provides all clinical trial data for the FDA to determine if the drug is safe and effective for approval. Both the IND and NDA are lengthy applications that require extensive non-clinical and clinical data to gain FDA approval to market a new prescription drug.
- The document presents information on the New Drug Application (NDA) process required by the FDA to obtain approval to market a new drug product in the United States.
- An NDA provides extensive data from non-clinical and clinical studies to establish the safety, efficacy, and appropriate labeling of the drug. It includes chemistry, manufacturing, and controls information as well as clinical data from Phase I-III trials.
- The goals of an NDA are to determine if the drug's benefits outweigh its risks, if its proposed labeling is appropriate, and if the methods used to manufacture and ensure the drug's quality are adequate.
The document discusses the requirements for a New Drug Application (NDA) submitted to the FDA for approval of a new pharmaceutical product. An NDA must provide extensive data on the chemistry, manufacturing, animal and human clinical studies of the drug to allow the FDA to determine if the drug is safe, effective and of adequate quality for approval. Guidance documents provide recommendations to applicants on the content and format of an NDA to streamline the review process.
This document provides an overview of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) submitted to regulatory agencies for drug approval. It describes the key differences between NDAs which are for new drugs and require clinical trials, and ANDAs which are for generic drugs and require bioequivalence testing. The document outlines the contents and review process for both NDAs and ANDAs and the steps involved in submitting and reviewing each type of application.
The new drug approval process involves several phases of laboratory and clinical testing that can take over a decade and cost hundreds of millions of dollars. Only about 1 in 1000 compounds that enter pre-clinical testing are approved for human testing. After pre-clinical animal testing, companies submit an Investigational New Drug (IND) application to the FDA to request permission for human clinical trials. If approved, the drug then enters three phases of clinical trials involving several hundred to thousands of human subjects to evaluate safety, efficacy, and proper dosing. If phase 3 trials are successful, companies submit a New Drug Application (NDA) to the FDA for review and potential approval allowing marketing and post-market safety surveillance.
This document discusses supplemental new drug applications (SNDA) which are submitted to the FDA for approval of changes to approved drugs. It defines what types of changes require an SNDA, including manufacturing changes, formulation changes, and labeling changes. It categorizes changes as major, moderate, or minor based on their potential impact on quality, safety, or efficacy. Major changes require prior approval, moderate changes require 30 days' notice, and minor changes are reported annually. Examples are provided for each category of change.
ABBREVIATED NEW DRUG APPLICATION (ANDA),INVESTICATION OF MEDICINAL PRODUCTS D...GOKULAKRISHNAN S
Introduction to ANDA
Regulations applied to ANDA process
Format and content of ANDA
ANDA approval process
Exclusivity
Hatch-Waxman amendments & 180 days exclusivity
Introduction to IMPD
Contents of IMPD
Introduction to IB
Contents of IB
CENTRAL DRUG STANDARD CONTROL ORGANISATION (CDSCO)Vijay Banwala
this ppt covers all quary about the CDSCO ( central drug standard control organisation ,drug controller gernal of india and the organisation strectures
this ppt provides you all detail about the CDSCO
This document discusses the requirements for manufacturing facilities and clinical trials in India according to Schedules M and Y of the Drugs and Cosmetics Rules. Schedule M outlines the good manufacturing practices and requirements for premises, plants, and equipment used in pharmaceutical production. It also discusses facility design aspects like clean surroundings, building facilities, lighting, ventilation, and storage areas. Schedule Y provides the guidelines for conducting clinical trials in India, including the various phases of trials from Phase 0 to Phase IV. It also discusses aspects like informed consent, ethics committee composition, and government facilities for expediting clinical trials.
Product registration and drug approval process in uskeerthi09
The document summarizes the key aspects of the new drug application (NDA) and abbreviated new drug application (ANDA) processes in the United States. It describes the requirements for NDAs, including the 20 sections that make up an NDA and the information contained within them. It also discusses ANDA requirements for generic drugs, such as bioequivalence studies and patent certifications that are part of the review process. The review processes for both NDAs and ANDAs by the FDA are also briefly outlined.
This document summarizes key aspects of non-clinical drug development. It discusses how non-clinical studies are performed in silico, in vitro, and in vivo to assess safety, efficacy, pharmacokinetics, and manufacturing viability before human clinical trials. It also describes the Investigational New Drug application process which is required to begin clinical trials in humans, and provides an overview of the New Drug Application submitted for marketing approval. The document concludes by outlining the contents of an Investigational Medicinal Products Dossier which forms the basis for approval of multinational clinical trials in the European Union.
This document discusses recommendations for post-approval changes to approved drug applications. It defines major, moderate, and minor changes and provides examples. Major changes require prior approval from the FDA before distribution. Moderate changes require submission of a supplement to the FDA either 30 days or 60 days before distribution depending on the type of change. Minor changes are described in annual reports. The document provides recommendations for changes in several areas including components and manufacturing processes, specifications, packaging, labeling, and multiple related changes. It also notes some of the major differences in requirements for changes to biological products versus drug products.
Holiday Gift Program Mc Gladrey Wmb 91212billybooe
The document provides options and pricing for McGladrey's holiday gift program. It includes gifts ranging in price from $25-$60+, such as cookie tins, popcorn tins, coffee gift sets, and towers of treats. For each gift, it provides details on contents, packaging, pricing at different quantities, setup and shipping fees. The gifts can be customized with the McGladrey logo or other imprints for an additional fee.
This document provides product specifications for several corporate polo shirt and sport shirt options. It describes the materials, features, sizing, imprint details, pricing, and production time for each item. The options include classic poly-cotton polos, moisture wicking pima and baby pique sport shirts, textured polyester sport shirts, Dri-Fit micro pique shirts, and luxury cotton Callaway polos. Pricing ranges from $17.50 to $55 per unit depending on the style and size.
Activate! is a full-service promotional marketing company founded in 1995. They have expertise in branded merchandise, marketing, and technology. Activate! utilizes value alliances for fulfillment, distribution, sourcing, and other services to reduce costs for customers. They provide various promotional products and services, as well as creative online stores and marketing programs. Activate! aims to drive business and create value through their unique business model and customer service.
1) Physician assistants in Ohio can now prescribe under certain conditions, including completing education requirements and practicing under the supervision of a physician.
2) Physician assistants must complete a minimum of 65 hours of education in pharmacology, clinical training, and legal implications of prescribing. They must also complete a provisional period of prescribing under physician supervision.
3) Physician assistant prescriptions are limited to drugs in an approved formulary and standards of the supervising physician. Controlled substances are further restricted.
Bluegrass Social Media Preso For 2010 Nsmbillybooe
This presentation discusses how social media can impact businesses. It provides an overview of LinkedIn, including its growth and demographics. It notes how LinkedIn can be used to increase visibility, connections, search engine results and more. The presentation also outlines dos and don'ts for social media use, such as avoiding oversharing personal details or political views. It closes by emphasizing responding to feedback, connecting with audiences, and asking for help in developing a social media strategy.
The document summarizes the client work and partnerships over the past year in 3 sentences. It looks forward to continued growth together in 2013 and thanks clients for their support. The recap highlights key accomplishments and programs from 2012 that strengthened brands, grew market share, and helped clients' businesses.
This document provides information on Risk Evaluation and Mitigation Strategies (REMS) programs required by the FDA for certain prescription drugs. It discusses the history and elements of REMS, including medication guides, communication plans, elements to assure safe use, and implementation systems. The document then examines examples of specific REMS for isotretinoin (Accutane), testosterone topical, chantix, and suboxone, outlining the REMS elements employed for each drug commonly dispensed in community pharmacies.
Standardization of Excipients by Shubham WakdeShubham Wakde
This document discusses the standardization process for new excipients. It outlines the need to verify the intended use and properties of a new excipient. The standardization process involves evaluating the excipient's chemical and physical properties, impurity profile, and functionality. It also requires preclinical testing to establish the excipient's safety profile. International guidelines provide recommendations for the types of studies required for oral, topical, parenteral, and other routes of administration. Proper documentation of an excipient's characterization and specifications in monographs helps ensure consistent quality between batches.
This document discusses new drug applications (NDAs) and abbreviated new drug applications (ANDAs) submitted to the FDA for drug approval. It describes the goals and contents of an NDA, including clinical trial data and manufacturing information, as well as the multi-step review process. For ANDAs, the goals are to reduce drug costs and development time by allowing generics if they are equivalent to branded drugs. ANDAs must demonstrate bioequivalence but do not require new clinical trials. The document provides details on patent certification and approval processes for both NDA and ANDA submissions.
• Discuss Ohio’s new laws concerning use of opioids in minors
• Describe the documents and record keeping for opioid prescriptions
• Discuss Ohio’s donated drug repository program
• Describe record keeping for drug repository program
This document discusses new Ohio laws regarding opioid prescriptions for minors and Ohio's donated drug repository program. For minors, prescribers must now discuss risks of opioids and obtain consent forms when initially prescribing opioids. Pharmacists should be aware of these new requirements and may counsel patients on proper opioid use. Ohio's drug repository program allows donation of unused drugs to be dispensed to low-income patients, but drugs must be properly stored, sealed, and unexpired to be accepted. The program aims to improve access to medications for those in need.
The WHO Expert Committee on Specifications for Pharmaceutical Preparations met in October 2004 to consider matters concerning quality assurance of pharmaceuticals. Key topics discussed included proposed monographs for inclusion in The International Pharmacopoeia, quality specifications for antiretroviral and antituberculosis drugs, good manufacturing practices, inspection procedures, distribution standards, and guidelines for fixed-dose combination medicines. The Committee adopted several new standards and guidelines and made recommendations on advancing additional work in priority areas.
The document discusses guidelines from the International Conference on Harmonization (ICH) related to quality and specifications of pharmaceutical products. It describes several ICH Q guidelines including Q1 on stability testing, Q2 on analytical method validation, Q3 on impurities, Q4 on pharmacopoeial harmonization, and Q5 on biotechnological/biological products. Key points covered include requirements for stability testing protocols, validation of analytical methods, identification and qualification of impurities, harmonization of pharmacopoeial standards, and viral safety evaluation of cell-derived biopharmaceuticals.
This document discusses guidelines from the International Council for Harmonisation (ICH) for stability testing of drug substances and products. It provides guidance on topics such as the need for harmonized stability testing, types of stability testing, selection of batches and storage conditions for testing, and evaluation of stability data. The guidelines aim to establish a systematic approach to stability testing to ensure quality, safety and efficacy over a product's shelf life and recommend conditions for testing drug substances intended for various storage conditions.
manufacture of drugs - License. Drugs and cosmetic act 1940 and rules 1945Swarna kumari S
Manufacture of drugs - License. Drugs and cosmetic act 1940 and rules 1945. Licences are required for the manufacturing of following categories of drugs. PROHIBITED TO BE MANUFACTURED OR SOLD IN OUR COUNTRY. condition Precedent and condition subsequent
Introduction
Brief description of the drug and the therapeutic class to which it belongs
Chemical and pharmaceutical information
Animal Pharmacolog
Animal Toxicology
Human/Clinical Pharmacology phase I
Therapeutic exploratory trials (Phase II)
Therapeutic confirmatory trials (Phase III)
Special Studies Geriatrics, pediatrics, pregnant or nursing women
Regulatory status in other countries
Prescribing information
Samples and Testing Protocol/s
The document discusses the FDA approval process for new prescription medications and key regulations. It provides information about the FDA's role in evaluating safety and efficacy during drug development and monitoring after approval. The FDA is responsible for determining if benefits outweigh risks before approval and monitoring the drug afterward. However, the FDA has limited power to enforce post-marketing safety studies required of manufacturers.
AN OVERVIEW ON FIXED DOSE COMBINATIONS AND ITS REGULATIONS IN INDIA JAYA PRAKASH VELUCHURI
This document provides an overview of fixed dose combination drugs and regulatory requirements for FDCs in India. It discusses the classification of FDCs, clinical trial requirements, bioavailability and bioequivalence data requirements. It also addresses the reasons why 328 FDCs were banned in India, including that they were found to have no therapeutic justification and safer alternatives were available. Success factors for FDCs include addressing formulation challenges, patent feasibility, and physician considerations.
This document summarizes guidelines for stability testing according to ICH guidelines. The key points are:
1) ICH guidelines are most commonly accepted and provide information on stability testing in the EU, Japan, and US. Stability testing aims to provide evidence of how quality varies over time under different conditions.
2) The objectives of ICH are more economical use of resources, eliminating delays in global development and availability of medicines, and maintaining safeguards for quality, safety, and efficacy.
3) Stability topics covered by ICH include testing, validation, impurities, specifications, and manufacturing. This summary focuses on stability testing guidelines for new drug substances and products.
This document outlines the regulations for investigational new drugs as described in Part 312 of Title 21 of the Code of Federal Regulations. It discusses the requirements for investigational new drug applications (INDs), including the content that must be submitted in an IND. Key points covered include the phases of clinical investigation for a new drug, safety reporting requirements for INDs, protocols for amending an IND, and the conditions under which FDA can place a clinical hold, terminate an IND, or change a drug's status. The purpose is to ensure new drugs are properly evaluated for safety and effectiveness before being approved for marketing.
This document provides an overview of regulatory requirements for drugs and pharmaceuticals. It discusses drug regulation by international agreements and regulatory authorities like the FDA. The FDA is organized into centers responsible for drugs, biologics, devices and food. Applications like IND, NDA, ANDA are described which are required for investigational and approved drugs. The new drug approval process is outlined involving pre-clinical and clinical testing taking 10+ years. Key differences between NDA for new drugs and ANDA for generic drugs are summarized.
1. An Investigational New Drug (IND) application is required for testing an experimental drug in humans and must be submitted to regulatory agencies like the FDA for approval.
2. The IND application contains preclinical research data on animal and microbiological studies as well as clinical trial protocols, manufacturing information, and investigator details.
3. There are different types of INDs including commercial, non-commercial, emergency use, and treatment INDs which have varying requirements and purposes in the drug development process.
Scale up process and post marketing survilenceKAVITAAGRE
This document discusses scale up process approval changes and post marketing surveillance. It defines scale up as increasing batch size from research to production. It describes SUPAC guidelines which define levels of changes (minor, moderate, major) and required tests and documentation. The guidance provides recommendations for changes to composition, manufacturing site, batch size, and process. It also discusses post marketing surveillance methods like controlled trials, spontaneous reporting, cohort and case control studies to identify adverse drug effects. Manufacturers must establish standard operating procedures for post marketing surveillance.
Post-marketing safety surveillance, also known as post-marketing pharmacovigilance, is a critical process in monitoring the safety of pharmaceutical products after they have been approved and are available in the market. It involves the systematic collection, analysis, and evaluation of real-world data to identify and assess adverse events and other safety-related issues associated with medications. Here's an overview of how post-marketing safety surveillance detects adverse events
The document discusses the role and composition of a pharmacy and therapeutics committee in a hospital. The committee is responsible for advising on drug use, educating medical staff, and monitoring drug safety and adverse reactions. It is composed of physicians, pharmacists, nurses, and administrators. The committee establishes drug formularies, reviews new drugs, monitors adverse reactions, establishes guidelines for dangerous drugs, and ensures emergency drug supplies are available. It also reports defective drug products and reviews drug utilization in the hospital.
Students And Parents For Privacy vs School Directors Of Township High School District 211
No. 16 C 4945. United States District Court, N.D. Illinois, Eastern Division.
Findings of Fact
The DRE Protocol fails to produce an accurate and reliable determination of whether a suspect is impaired by drugs and by what specific drug he is impaired. The DRE training police officers receive does not enable DREs to accurately observe the signs and symptoms of drug impairment, therefore, police officers are not able to reach accurate and reliable conclusions regarding what drug may be causing impairment.
Conclusions of Law
The State failed to prove by a preponderance of the evidence that the drug evaluation and. Classification program is not new or novel and is generally accepted within the scientific community and, therefore, it is subject to analysis under Frye v. United States and Reed v. State. The drug evaluation and classification program does not survive a Frye/Reed challenge because it is not generally accepted as valid and reliable in the relevant scientific community which includes pharmacologists, neurologists, ophthalmologists, toxicologists, behavioral research psychologists, forensic specialists and medical doctors.
This document provides an overview of Ohio laws regarding pharmacy compounding. It defines different types of compounding and outlines legal requirements. Compounded drugs for administration by prescribers have specific limits, including only 5% of total sales, a 72-hour supply limit for prescribers, and labeling and record keeping rules. Compounding in a pharmacy for patient prescriptions requires following prescription and labeling rules, with limited batch preparation allowed based on routine orders.
Robert J. Garrity's pharmacist license was summarily suspended on February 8, 2001. He was found to have stolen controlled substances from CVS pharmacy on multiple occasions between December 2000 and January 2001 for his personal abuse and use. He admitted to being addicted to controlled substances. The Ohio State Board of Pharmacy revoked Garrity's pharmacist license based on findings that he committed felonies, gross immorality, dishonesty, was addicted to or abused drugs, and willfully violated drug laws.
- A new dietary ingredient (NDI) is defined as a dietary ingredient that was not marketed in the United States before October 15, 1994. Manufacturers and distributors must submit a notification to the FDA at least 75 days before marketing a dietary supplement containing an NDI.
- The notification must include a description of the NDI, the manufacturing process, a safety narrative explaining why the supplement is reasonably expected to be safe, and a description of the supplement and its conditions of use.
- Certain dietary ingredients that have been present in the food supply are exempt from the notification requirement if they have not been chemically altered. However, all dietary supplements containing an NDI, including exempt ones, must not cause the product
This document discusses requirements for pharmacy interns and preceptors in Ohio. It outlines the application process for becoming a registered intern, including educational and other requirements. Interns must complete a minimum of 1500 hours of supervised practical experience to qualify for licensure, which can be obtained in various pharmacy and non-traditional settings. Preceptors must be licensed pharmacists who supervise interns' training and ensure they gain experience in all aspects of pharmacy practice.
This document discusses the legal standard of "corresponding responsibility" that pharmacists have when dispensing prescriptions. A pharmacist must ensure each prescription is issued for a legitimate medical purpose by an authorized prescriber. While prescribers are responsible for proper prescribing, pharmacists have a duty to determine if a prescription is valid. The document outlines factors a pharmacist should consider to determine if a prescription has a legitimate medical purpose, such as prescription details, patient behavior, and prescriber characteristics. It also discusses legal cases and DEA guidance on prescribing and dispensing controlled substances. Overall, the document provides an overview of a pharmacist's legal responsibilities to validate prescriptions and factors that could indicate a prescription is not for a legitimate medical
This document discusses several standards related to controlled substances in pharmacy practice, including standards for mailing, destroying, faxing prescriptions for, and reporting loss of controlled substances. It provides details on the requirements for mailing controlled substances, destroying them according to state regulations, faxing prescriptions (which are allowed only in certain situations), standards for prescriptions by nurse practitioners, and requirements for reporting loss or theft of controlled substances to the DEA and state board of pharmacy. The document aims to review some common rules regarding controlled substances but does not present all state and federal regulations.
Mercurius is named after the roman god mercurius, the god of trade and science. The planet mercurius is named after the same god. Mercurius is sometimes called hydrargyrum, means ‘watery silver’. Its shine and colour are very similar to silver, but mercury is a fluid at room temperatures. The name quick silver is a translation of hydrargyrum, where the word quick describes its tendency to scatter away in all directions.
The droplets have a tendency to conglomerate to one big mass, but on being shaken they fall apart into countless little droplets again. It is used to ignite explosives, like mercury fulminate, the explosive character is one of its general themes.
Cell Therapy Expansion and Challenges in Autoimmune DiseaseHealth Advances
There is increasing confidence that cell therapies will soon play a role in the treatment of autoimmune disorders, but the extent of this impact remains to be seen. Early readouts on autologous CAR-Ts in lupus are encouraging, but manufacturing and cost limitations are likely to restrict access to highly refractory patients. Allogeneic CAR-Ts have the potential to broaden access to earlier lines of treatment due to their inherent cost benefits, however they will need to demonstrate comparable or improved efficacy to established modalities.
In addition to infrastructure and capacity constraints, CAR-Ts face a very different risk-benefit dynamic in autoimmune compared to oncology, highlighting the need for tolerable therapies with low adverse event risk. CAR-NK and Treg-based therapies are also being developed in certain autoimmune disorders and may demonstrate favorable safety profiles. Several novel non-cell therapies such as bispecific antibodies, nanobodies, and RNAi drugs, may also offer future alternative competitive solutions with variable value propositions.
Widespread adoption of cell therapies will not only require strong efficacy and safety data, but also adapted pricing and access strategies. At oncology-based price points, CAR-Ts are unlikely to achieve broad market access in autoimmune disorders, with eligible patient populations that are potentially orders of magnitude greater than the number of currently addressable cancer patients. Developers have made strides towards reducing cell therapy COGS while improving manufacturing efficiency, but payors will inevitably restrict access until more sustainable pricing is achieved.
Despite these headwinds, industry leaders and investors remain confident that cell therapies are poised to address significant unmet need in patients suffering from autoimmune disorders. However, the extent of this impact on the treatment landscape remains to be seen, as the industry rapidly approaches an inflection point.
share - Lions, tigers, AI and health misinformation, oh my!.pptxTina Purnat
• Pitfalls and pivots needed to use AI effectively in public health
• Evidence-based strategies to address health misinformation effectively
• Building trust with communities online and offline
• Equipping health professionals to address questions, concerns and health misinformation
• Assessing risk and mitigating harm from adverse health narratives in communities, health workforce and health system
Kosmoderma Academy, a leading institution in the field of dermatology and aesthetics, offers comprehensive courses in cosmetology and trichology. Our specialized courses on PRP (Hair), DR+Growth Factor, GFC, and Qr678 are designed to equip practitioners with advanced skills and knowledge to excel in hair restoration and growth treatments.
Adhd Medication Shortage Uk - trinexpharmacy.comreignlana06
The UK is currently facing a Adhd Medication Shortage Uk, which has left many patients and their families grappling with uncertainty and frustration. ADHD, or Attention Deficit Hyperactivity Disorder, is a chronic condition that requires consistent medication to manage effectively. This shortage has highlighted the critical role these medications play in the daily lives of those affected by ADHD. Contact : +1 (747) 209 – 3649 E-mail : sales@trinexpharmacy.com
Travel vaccination in Manchester offers comprehensive immunization services for individuals planning international trips. Expert healthcare providers administer vaccines tailored to your destination, ensuring you stay protected against various diseases. Conveniently located clinics and flexible appointment options make it easy to get the necessary shots before your journey. Stay healthy and travel with confidence by getting vaccinated in Manchester. Visit us: www.nxhealthcare.co.uk
Osteoporosis - Definition , Evaluation and Management .pdfJim Jacob Roy
Osteoporosis is an increasing cause of morbidity among the elderly.
In this document , a brief outline of osteoporosis is given , including the risk factors of osteoporosis fractures , the indications for testing bone mineral density and the management of osteoporosis
Promoting Wellbeing - Applied Social Psychology - Psychology SuperNotesPsychoTech Services
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1. Page 1 of 12
Pharmacy Compounding and Ohio Law1
2
Objectives3
After completing this lesson, the pharmacist will be able to:4
1. Differentiate between five different types of compounding.5
2. Describe legal requirements for preparing non-sterile Compounded Drugs for Administration6
to Patients by Prescribers.7
3. Describe legal requirements for preparing sterile Compounded Drugs for Administration to8
Patients by Prescribers.9
4. Discuss limits of preparing batches of compounded drugs.10
5. Discuss using a prescriber’s location as a pick-up-station.11
12
Introduction13
The matter of regulating compounding pharmacies (or compounding by pharmacies) and14
manufacturers recently gained renewed attention when an operation in Massachusetts allegedly15
prepared and distributed corticosteroids that were administered to patients who subsequently16
developed serious fungal infections. Some of these patients died. According to reports from the17
Centers for Disease Control and Prevention, the New England Compounding Center and its sister18
company (Ameridose) were involved in the production and eventual recall of19
methylprednisolone acetate (MPA) and other products in September 2012. Centers for Disease20
Control and Prevention. CDC responds to multistate outbreak of fungal meningitis and other21
infections. http://m.cdc.gov/en/HealthSafetyTopics/DiseasesConditions/Meningitis/current-22
situation Accessed November 10, 2012. The methylprednisolone was particularly prone to23
sterility concerns because it was produced without antimicrobial preservatives, a common24
practice for medications injected into the fluid of the central nervous system.25
26
The law regulating compounding includes a series of state and federal regulatory schemes.27
28
2. Page 2 of 12
Compounding Defined1
Ohio state law defines compounding in ORC 4729.01(C) as one or more of five activities.2
“Compounding” means the preparation, mixing, assembling, packaging, and labeling of one or3
more drugs in any of the following circumstances:4
Pursuant to a prescription issued by a licensed health professional authorized to prescribe5
drugs; [ORC 4729.01(C) (1)]6
Pursuant to the modification of a prescription made in accordance with a consult7
agreement; [ORC 4729.01(C) (2)]8
As an incident to research, teaching activities, or chemical analysis; [ORC 4729.01(C)9
(3)]10
In anticipation of orders for drugs pursuant to prescriptions, based on routine, regularly11
observed dispensing patterns; [ORC 4729.01(C) (4)]12
Pursuant to a request made by a licensed health professional authorized to prescribe drugs13
for a drug that is to be used by the professional for the purpose of direct administration to14
patients in the course of the professional’s practice, if all of the following apply: [ORC15
4729.01(C) (5)]16
(a) At the time the request is made, the drug is not commercially available regardless of17
the reason that the drug is not available, including the absence of a manufacturer for the18
drug or the lack of a readily available supply of the drug from a manufacturer.19
(b) A limited quantity of the drug is compounded and provided to the professional.20
(c) The drug is compounded and provided to the professional as an occasional exception21
to the normal practice of dispensing drugs pursuant to patient-specific prescriptions.22
23
Type of Compounding ORC Section Defined
Traditional Prescription ORC 4729.01(C) (1)
Consult agreement ORC 4729.01(C) (2)
Research ORC 4729.01(C) (3)
Batch ORC 4729.01(C) (4)
Prescriber for Direct Administration ORC 4729.01(C) (5)
24
3. Page 3 of 12
Compounded Drugs for Administration to Patients by Prescribers OAC 4729-9-251
In addition to complying with ORC 4729.01 (C) (5) as discussed above, compounded drugs must2
also comply with OAC 4729-5-25 and OAC 4729-9-25. The Board does not want to see3
pharmacies compounding drugs for administration to patients by prescribers as a major type of4
routine compounding practice. The pharmacy is limited to five percent (5%) of total5
compounding sales, within a twelve (12) month period. See OAC 4729-9-25 (A) (1).6
7
Which compounded drugs may be provided by a pharmacy to the prescriber? The pharmacy8
shall only provide those compounded drugs that are not commercially available to a prescriber9
which are needed: See OAC 4729-9-25 (A) (2).10
To treat an emergency situation; See OAC 4729-9-25 (A) (2) (a).11
For an unanticipated procedure for which a time delay would negatively affect a patient12
outcome; See OAC 4729-9-25 (A) (2) (b).13
For diagnostic purposes. See OAC 4729-9-25 (A) (2) (c).14
15
Board rules also limit the pharmacy to supplying an amount which will last the prescriber only16
seventy-two (72) hours – about three days. See OAC 4729-9-25 (B). The prescriber also may17
not have on hand more than a supply that will last the prescriber seventy-two (72) hours. The18
rule seems to place the burden on the prescriber for determining the amount that will last the19
prescriber for seventy-two (72) hours, since the rule reads that the amount “shall be determined20
by previous administration patters provided by a prescriber to the pharmacist.” See OAC 4729-21
9-25 (B). Indeed, it would be difficult if not impossible for a pharmacist alone to know or22
accurately estimate this amount.23
24
The seventy-two (72) hour supply limitation does not apply to the following supplied to a25
prescriber, meaning the following two categories of compounded preparations may be provided26
even if the supply may last more than seventy-two (72) hours:27
Small amounts sixty (60) grams or sixty (60) milliliters of non-sterile topical28
preparations. See OAC 4729-9-25 (B) (1).29
Non-sterile preparations intended to treat individuals in the event of an emergency. See30
OAC 4729-9-25 (B) (2).31
4. Page 4 of 12
1
Pharmacies may not sell a compounded drug to another pharmacy or wholesaler. See OAC2
4729-9-25 (C). “Sale” and “sell” include delivery, transfer, barter, exchange, or gift, or offer3
therefor, and each such transaction made by any person, whether as principal proprietor, agent,4
or employee. ORC 4729.01 (J). A prescriber may only administer compounded drugs directly to5
patients of the prescriber. Prescribers are not permitted to do any of the four acts: OAC 4729-9-6
25 (D)7
Dispense a compounded drug to a patient – administration is allowed. See OAC 4729-9-8
25 (D) (1)9
Sell a compounded drug to another prescriber. See OAC 4729-9-25 (D) (2)10
Sell a compounded drug to a pharmacy. See OAC 4729-9-25 (D) (3)11
Return a compounded drug to the supplying pharmacy. See OAC 4729-9-25 (D) (4)12
13
For compounded drugs provided to prescribers for patients, beyond-use dates are required. See14
OAC 4729-9-25 (E). For non-sterile compounded drugs, “testing pursuant to acceptable practice15
standards” is required. Two types of standards are provided:16
published peer reviewed pharmaceutical literature that have been critically reviewed by17
unbiased independent experts. See OAC 4729-9-25 (E) (1)18
current edition of an official compendium, such as the United States Pharmacopoeia19
(USP) or National Formulary (NF). See OAC 4729-9-25 (E) (1)20
Beyond-use dates for sterile compounded drugs must be determined by the compounding21
pharmacy through one of the two following types of standards:22
drug product testing pursuant to acceptable practice standards. See OAC 4729-9-25 (E)23
(2)24
United States Pharmacopoeia (USP) or National Formulary (NF) standards. OAC 4729-25
9-25 (E) (2)26
The standards account for level of risk of contamination by antimicrobials.27
The United States Pharmacopoeia (USP) or National Formulary (NF) standards are further28
refined to include low, medium, and high risk level compounded drug preparations as follows:29
Low Risk - beyond use date of not more than forty-eight (48) hours when stored at30
controlled room temperature at twenty to twenty-five degrees Celsius, or fourteen (14)31
5. Page 5 of 12
days when refrigerated at two to eight degrees Celsius, or forty-five days in solid frozen1
state at minus twenty-five to minus ten degrees Celsius. See OAC 4729-9-25 (E) (2) (a).2
An example of low risk preparations includes using sterile syringes with sterile needles3
to conduct single sterile dose transfers from the manufacturer’s original packaging such4
as bottles, bags and vials in an ISO Class 5 cleanroom. An ISO class 5 cleanroom5
contains at most 105
(or 100,000) particles per cubic meter. See OAC 4729-19-01 (A) (2).6
To give perspective, the ambient air outside in a typical urban environment contains7
35,000,000 particles per cubic meter.8
Medium Risk - beyond use date of not more than thirty (30) hours when stored at9
controlled room temperature at twenty to twenty-five degrees Celsius, or nine (9) days10
when refrigerated at two to eight degrees Celsius, or forty-five days in solid frozen state11
at minus twenty-five to minus ten degrees Celsius. See OAC 4729-9-25 (E) (2) (b). An12
example of medium risk preparations includes preparation of Total Parenteral Nutrition13
(TPN) solutions using automated or manual compounders.14
High Risk - beyond use date of not more than twenty-four (24) hours when stored at15
controlled room temperature at twenty to twenty-five degrees Celsius, or three (3) days16
when refrigerated at two to eight degrees Celsius, or forty-five days in solid frozen state17
at minus twenty-five to minus ten degrees Celsius. See OAC 4729-9-25 (E) (2) (c). An18
example of high risk preparations includes dissolving non-sterile bulk drug powders for19
solution preparation that will be terminally sterilized.20
Labeling a Compound Drug for Administration by Prescriber OAC 4729-9-25 (F) (1-10)21
The labeling of a compounded drug preparation must contain the following:22
(1) The statement “For direct patient administration only” displayed prominently;23
(2) The statement “Not for resale” displayed prominently;24
(3) Proper storage conditions;25
(4) Beyond use dates pursuant to OAC 4729-9-25 (E);26
(5) The name(s) of the active and inactive ingredients;27
(6) The amount or percentage of active drug ingredients;28
(7) The quantity of compounded drug provided;29
(8) The route of administration;30
6. Page 6 of 12
(9) The pharmacy name, address, and telephone number;1
(10) The pharmacy control number assigned to the compounded drug preparation.2
3
For a container that is too small, it is permissible for the labeling to omit the quantity of drug4
provided [OAC 4729-9-25 (F) (7)] and the notation “for direct patient administration only”5
[OAC 4729-9-25 (F) (1)]. In all cases, a complete label meeting the requirements of paragraph6
(F) of this rule must be applied to the outside container in which such compounded preparation is7
supplied. OAC 4729-9-25 (G).8
9
The sale of a compounded drug preparation to a prescriber is considered a wholesale sale as10
defined in section 4729.01 of the Revised Code. OAC 4729-9-25 (H). A pharmacy is required to11
follow record keeping requirements for wholesale sales. See OAC 4729-9-16 (H). The types of12
records include:13
source of the drugs, including the name and principle address of the seller or transferor,14
and the address of the location from which the drugs were shipped. OAC 4729-9-16 (H)15
(1) (a)16
identity and quantity of the drugs received and distributed or disposed of. OAC 4729-9-17
16 (H) (1) (b)18
dates of receipt and distribution of the drugs. OAC 4729-9-16 (H) (1) (c)19
system of records and procedures which prevent the sale or other distribution of20
dangerous drugs to any person not authorized by division (B) of section 4729.51 of the21
Revised Code. OAC 4729-9-16 (H) (1) (d)22
These records must be retained for at least three years. OAC 4729-9-16 (H) (2)23
24
Drugs Compounded in a Pharmacy for Dispensing to Patients OAC 4729-9-2125
Most community pharmacists are primarily concerned with compounding relatively small26
amounts of non-sterile preparations, for specific patients, having a prescription from a physician.27
These are typically oral or topical preparations provided directly to patients, not physicians.28
29
For all compounded prescriptions, the pharmacist must:30
Inspect and approve the compounding process. OAC 4729-9-21 (C) (1)31
7. Page 7 of 12
Perform the final check of the finished product. OAC 4729-9-21 (C) (2)1
Maintain all compounding records. OAC 4729-9-21 (D) (1)2
Ensure the proper maintenance, cleanliness, and use of equipment. OAC 4729-9-21 (D)3
(2)4
5
Personnel engaged in the compounding of drugs need to wear clean appropriate clothing – for6
protection and to prevent contamination. See OAC 4729-9-21 (E). The prescription must be7
compounded and dispensed only pursuant to a specific order for an individual patient issued by a8
prescriber. A limited quantity may be compounded in anticipation of prescription drug orders9
based on routine, regularly observed prescribing patterns. See OAC 4729-9-21 (F). Containers10
for compounded prescriptions dispensed must be labeled in the same matter as any other11
prescription medication dispensed. See OAC 4729-9-21 (G) and OAC 4729-5-16 [labeling of12
drugs dispensed on prescription].13
14
The pharmacist may need a substantial amount of chemicals and time to prepare a batch of some15
compounded medications. Likewise, the equipment and compounding process involved may16
dictate that compounding small quantities are simply impractical. For example, if a pharmacist17
wants to prepare medicated suppositories, a melt-able solid medium must be heated and melted18
in a receptacle. Active ingredients must be obtained, weighed, and added to the melted medium.19
The melted mixture must be poured into a suppository mold and allowed to cool. The cooled20
product must be removed from the mold. The mold and other equipment must be cleaned and21
stored. All this takes time. Suppose the mold may be adapted to form no less than one hundred22
(100) units at a time. Does the pharmacist have to postpone compounding activities until one or23
more prescriptions are in hand for exactly one hundred suppositories – and then compound only24
exactly one hundred suppositories?25
26
Fortunately, the answer is “no.” A limited quantity may be compounded in anticipation of27
prescription drug orders based on routine, regularly observed prescribing patterns. See OAC28
4729-9-21 (F). If a batch is made, the portion dispensed to patients and the stored portion must29
be labeled. See OAC 4729-9-21 (H). Labels for the stored medication must contain at least the30
following information:31
8. Page 8 of 12
The name, strength, and quantity of each drug used in the compounded prescription.1
OAC 4729-9-21 (H) (1)2
The identification of the repackager by name or by the final seven digits of its terminal3
distributor of dangerous drugs license number. OAC 4729-9-21 (H) (2)4
Pharmacy control number. OAC 4729-9-21 (H) (3)5
The pharmacy’s expiration date or beyond use date. OAC 4729-9-21 (H) (4)6
7
Using a Prescriber’s Location as a Pick-Up-Station See OAC 4729-5-108
Suppose the pharmacist wants to compound a drug for a patient that is not going to be picked up9
at the pharmacy. It is also not going to be administered to a patient by the prescriber. Can it be10
delivered to a prescriber’s office and picked up by a patient there? Yes. See OAC 4729-5-10.11
To offer this service, a request form (available on the Board website at12
http://pharmacy.ohio.gov/) must be completed and approved by the Board. Basically, there are13
five requirements for such a pick-up station:14
The site is appropriately licensed pursuant to Chapter 4729 of the Revised Code. See15
OAC 4729-5-10 (B) (1).16
The receipt, storage, control, and distribution of prescriptions or drugs are in the full and17
actual charge of a health care professional licensed pursuant to Ohio Revised Code18
Chapter 4715 [dentist], 4723 [nurse], 4729 [pharmacist], 4730 [physician assistant], 473119
[physician], or 4741 [veterinarian]. See OAC 4729-5-10 (B) (2).20
An appropriate recordkeeping system is in place that will provide accountability for21
proper receipt, delivery, and return of all prescription medications. See OAC 4729-5-1022
(B) (3).23
There is a documented method in place to ensure compliance with rule 4729-5-22 of the24
Administrative Code. See OAC 4729-5-10 (B) (4).25
The state board of pharmacy has approved the site for such activity due to clear and26
convincing evidence that delivery of prescription medication directly to the patient would27
result in:28
o Danger to public health or safety, [See OAC 4729-5-10 (B) (5) (a)] or29
o Danger to the patient without increased involvement by a health care professional30
in the patient’s drug therapy. [See OAC 4729-5-10 (B) (5) (b)]31
9. Page 9 of 12
CPE Quiz1
Questions – credit will be provided with correct responses to at least seven questions:2
1. The labeling of compounded drugs sold to physician for administration to a patient of the3
physician must contain name of patient.4
a) true5
b) false6
7
2. Compounding a drug in batches can be done in anticipation of prescriptions:8
a) Based on routine prescribing patterns9
b) Based on regularly observed patterns10
c) Based on buying patterns11
d) Both A and B are correct12
13
3. Compounding a drug in a pharmacy for administration to a patient by a prescriber is14
permitted when:15
a) The drug is commercially available – false16
b) The drug is provided as a principal source of income for the pharmacy – false17
c) A supply of the drug is not readily available from a manufacturer18
d) The drug is provided directly to the patient – false19
20
4. Compounding a drug in a pharmacy for administration to a patient by a prescriber is21
permitted when the compounded drug is to be used:22
a) To treat an emergency situation.23
b) For an unanticipated procedure for which a time delay would negatively affect a patient24
outcome.25
c) For diagnostic purposes.26
d) All of the above27
28
10. Page 10 of 12
5. Compounding a drug in a pharmacy for administration to a patient by a prescriber may be1
supplied in an amount that will last more than seventy-two (72) hours when:2
a) No more than sixty (60) grams of a non-sterile topical preparation is supplied to the3
prescriber.4
b) No more than sixty (60) milliliters of a non-sterile topical preparation is supplied to the5
prescriber.6
c) A non-sterile preparation intended to treat individuals in the event of an emergency is7
supplied to the prescriber.8
d) All of the above9
10
6. When labeling a compound drug for administration to a patient by a prescriber in a11
container that is too small to bear a complete label, the label must still include all but:12
a) the statement, “for direct patient administration only”13
b) the statement, “not for resale”14
c) the route of administration15
d) the pharmacy name16
17
7. A pharmacy is required to follow record keeping requirements for wholesale sales,18
including sales of a compounded drug preparation to a prescriber, including all except:19
a) source of the drugs20
b) collection of sales taxes and amounts21
c) identity and quantity of the drugs received and distributed or disposed of22
d) dates of receipt and distribution of the drugs23
24
8. When acting as a wholesaler, a pharmacy is required to retain records for sales of a25
compounded drug preparation to a prescriber for five years.26
a) True27
b) False28
29
11. Page 11 of 12
9. For all compounded prescriptions, the pharmacist must do all of the following except:1
a) Inspect and approve the compounding process2
b) Personally perform every step in the compounding process3
c) Maintain all compounding records4
d) Ensure the proper maintenance, cleanliness, and use of equipment5
6
10. For a limited quantity of drug compounded in anticipation of receiving a prescription,7
when a batch is made, the stored portion must be labeled with all but the following:8
a) The name, strength, and quantity of each drug used in the compounded prescription.9
b) The initials of the pharmacist.10
c) Pharmacy control number.11
d) The pharmacy’s expiration date or beyond use date.12
13
14
12. Page 12 of 12
Lesson number 036-368-13-001-H03 Answer Sheet: Expires April 18, 20151
Approved for one contact hour of Ohio Jurisprudence by the Ohio State Board of Pharmacy2
Pharmacy Compounding and Ohio Law3
Answer Sheet – circle the one best answer4
Question Answer Question Answer
1 True False 6 A B C D
2 A B C D 7 A B C D
3 A B C D 8 True False
4 A B C D 9 A B C D
5 A B C D 10 A B C D
5
Please return by mail with check for $20.00 payable to James Lindon at:6
Pharmacy Law, 35104 Saddle Creek, Avon, Ohio 44011-4907, 440-333-0011, 419-710-4925 (fax)7
You may also send payment via PayPal (account not needed) to JLindon@LindonLaw.com8
You may also send credit card number, expiration and CVV to JLindon@LindonLaw.com9
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Please fax or e-mail [circle one, please] my continuing education certificate to:11
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Pharmacist Name ___________________________________13
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Street Address _____________________________15
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City ________________________ State _________ Zip _______17
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E-Mail for CPE Certificate ___________________________________ Fax ______________________19
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Phone ___________________________________21
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Ohio Pharmacist License Number _____________________23
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NABP ID Number _____________________25
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After completing this lesson I can achieve the lesson objectives: Yes No27
This program was an effective way for me to learn: Yes No28
I liked the program’s format: Yes No29
This program fostered my mental participation: Yes No30
This was a “user-friendly” way for me to learn: Yes No31
I could sense some commercialism in this program: Yes No32
If yes, please describe: ______________________________________________33
The faculty quality was: Great OK Needs to Improve34
The learning material quality was: Great OK Needs to Improve35
How long did it take to complete this program? _______________________36
What other topics would you like to see? ____________________________37
Comments welcome: ____________________________________________38
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Any views expressed are not necessarily those of the author or Lindon & Lindon, LLC.40
Copyright 2013 James Lindon, Lindon & Lindon LLC (may freely copy and distribute, in whole)41