Books
Farmacopea Europea 2024 (suplemento – 5)
Farmacopea Europea (11a Edición del 2023) – 3 Volúmenes
La Farmacopea Europea (Ph. Eur.) Es el punto de referencia legal y científico de Europa para las normas de farmacopea que contribuyen a la entrega de medicamentos de alta calidad en Europa y más allá. El Ph. Eur. es aplicable en 38 países europeos y se utiliza en más de 100 países en todo el mundo. Entrega información crucial antes que cualquier otra farmacopea: la onceava edición se lanzó a finales del 2022 con 121 nuevos textos y 1.403 revisados. Incluye los Suplementos 11.1 (April 2023), 11.2 (Julio 2023).
Farmacopea Europea 2024 (suplemento – 4)
Farmacopea Europea (11a Edición del 2023) – 3 Volúmenes
La Farmacopea Europea (Ph. Eur.) Es el punto de referencia legal y científico de Europa para las normas de farmacopea que contribuyen a la entrega de medicamentos de alta calidad en Europa y más allá. El Ph. Eur. es aplicable en 38 países europeos y se utiliza en más de 100 países en todo el mundo. Entrega información crucial antes que cualquier otra farmacopea: la onceava edición se lanzó a finales del 2022 con 121 nuevos textos y 1.403 revisados. Incluye los Suplementos 11.1 (April 2023), 11.2 (Julio 2023).
Farmacopea Europea 2024 (suplemento – 3)
Farmacopea Europea (11a Edición del 2023) – 3 Volúmenes
La Farmacopea Europea (Ph. Eur.) Es el punto de referencia legal y científico de Europa para las normas de farmacopea que contribuyen a la entrega de medicamentos de alta calidad en Europa y más allá. El Ph. Eur. es aplicable en 38 países europeos y se utiliza en más de 100 países en todo el mundo. Entrega información crucial antes que cualquier otra farmacopea: la onceava edición se lanzó a finales del 2022 con 121 nuevos textos y 1.403 revisados. Incluye los Suplementos 11.1 (April 2023), 11.2 (Julio 2023).
Farmacopea China 2020
La edición 2015 de la Farmacopea de la República Popular China (en adelante, “Farmacopea China”) es la 10ª edición de la Farmacopea China, que fue aprobada por la Administración de Alimentos y Medicamentos de China (CFDA) el 5 de junio de 2015 y entró en efecto a partir del 1 de diciembre de 2015.
Aspectos destacados y características:
– 5,608 monografías en total, incluidas 1,082 nuevas monografías y 1,134 revisiones
– Aumentó significativamente el número de productos, especialmente para excipientes farmacéuticos.
– Estableció el sistema estándar de farmacopea, integró los apéndices comunes y cambió el nombre de los apéndices originales a los Capítulos generales.
– Se mejoró aún más en la garantía de seguridad de los medicamentos y el control de la eficacia de los medicamentos.
– Amplió la aplicación de la moderna tecnología analítica.
– Efecto guía reforzado de la farmacopea.
– Elaborado de manera más pública, transparente, estandarizada y ordenada.
Publicada en cuatro volúmenes
Volumen I: 2,598 monografías de materiales medicinales y las rebanadas preparadas de medicamentos crudos chinos, vegetales, grasas de aceite y extractos, preparaciones de un solo artículo, etc., incluidas 440 nuevas monografías, 517 revisiones y 7 rechazos.
Volumen II: 2.603 monografías de fármacos químicos, antibióticos, bioquímicos y radioactivos, incluidas 492 nuevas monografías, 415 revisiones y 28 rechazos
Volumen III: 137 productos biológicos, incluidas 13 nuevas monografías, 105 revisiones y 6 rechazos.
Volumen IV: 270 monografías de excipientes farmacéuticos, incluidas 137 nuevas monografías, 97 revisiones y dos rechazos. Un total de 317 capítulos generales, incluidos 38 requisitos generales para preparaciones, 240 métodos de prueba, 30 directrices y 9 sustancias estándar y soluciones de prueba y reactivos.
Farmacopea Japonesa 18a Edición
La Farmacopea Japonesa – Decimosexta edición en inglés está totalmente respaldada por la Sociedad Farmacéutica Japonesa. Proporciona el estándar japonés oficial para la descripción y la calidad de las sustancias y productos farmacéuticos.
Contiene la tabla de peso atómico e Índice acumulado (títulos en inglés, latín y japonés) y la sección de Monografías Oficiales de la Farmacopea Japonesa contiene aproximadamente 1764 artículos, incluidos 106 recientemente agregados, 15 actualizados y 330 revisados.
Las principales características y revisiones de este libro son la revisión completa de las Reglas generales para preparaciones, incluida la clasificación de las formas de dosificación por vía de administración y sitio de aplicación
La adición de 43 monografías para preparaciones y el cambio de las definiciones
Revisión de Avisos Generales, Monografías Oficiales e Información General sobre agua farmacéutica
Se han realizado revisiones a las siguientes pruebas, procesos y aparatos:
2.01 Cromatografía Líquida
2.46 Prueba de disolventes residuales
2.51 Medida de conductividad
2.54 determinación del pH
2.58 Método de difracción de rayos X en polvo
3.01 Determinación de densidades a granel y con rosca
4.01 prueba de endotoxinas bacterianas
Prueba de límite microbiano 4.05
4.06 Prueba de esterilidad
5.02 Prueba de límite microbiano para medicamentos crudos
6.03 Prueba de distribución del tamaño de partículas para preparaciones
6.07 Prueba de materia particulada insoluble para inyecciones
6.08 Prueba de materia particulada insoluble para soluciones oftálmicas
7.02 Métodos de prueba para envases de plástico
8.01 Esterilización y manipulación aséptica
Official Methods of Analysis 2023
ASHP’s New and Expanded Guide to IV Compatibility & Stability
For more than 40 years ASHP has published the most trusted resource for injectable drug information. Our new ASHP® Injectable Drug InformationTM now delivers the same high-quality content that you can expect from ASHP with even MORE of the information you need to make decisive patient care decisions.
ASHP® Injectable Drug InformationTM 2023 now comes complete with 2 years of digital interactive access and a print edition to ensure you have constant, uninterrupted access. The digital content is interactive, mobile, and updated quarterly. Your 2 years of digital interactive access also includes linked monographs to Extended Stability for Parenteral Drugs, forming a single, comprehensive resource on injectable drug information. Current 2023 edition features 18 new monographs and nearly 200 new references for a total of over 24,000 total compatibility pairs.
Farmacopea Europea 2023
Farmacopea Europea (11a Edición del 2023) – 3 Volúmenes
La Farmacopea Europea (Ph. Eur.) Es el punto de referencia legal y científico de Europa para las normas de farmacopea que contribuyen a la entrega de medicamentos de alta calidad en Europa y más allá. El Ph. Eur. es aplicable en 38 países europeos y se utiliza en más de 100 países en todo el mundo. Entrega información crucial antes que cualquier otra farmacopea: la onceava edición se lanzó a finales del 2022 con 121 nuevos textos y 1.403 revisados. Incluye los Suplementos 11.1 (April 2023), 11.2 (Julio 2023).
Farmacopea Británica (Edición 2023)
La BP es una herramienta de referencia vital para todas las personas y organizaciones involucradas en la industria farmacéutica:
* Investigación
* Desarrollo
* Fabricación
* Control de calidad y análisis
La BP incluye:
* Avisos generales (que brindan información general aplicable a todos los textos)
* Monografías generales (se aplican a todas las formas de dosificación)
* Monografías específicas que proporcionan normas obligatorias para:
* Ingredientes farmacéuticos activos
* Excipientes
* Preparaciones formuladas (productos con licencia y sin licencia)
* Medicamentos a base de hierbas, medicamentos a base de hierbas y medicamentos a base de plantas
* Materiales para su uso en la fabricación de preparados homeopáticos
* Productos relacionados con la sangre
* Productos inmunológicos
* Preparados radiofarmacéuticos
* Espectros de referencia infrarroja
* Apéndices
* Capítulos suplementarios (proporcionar orientación adicional)
* Indice comprensivo
Farmacopea Británica (Veterinaria)
La BP (Veterinary) se publica como un volumen complementario a la Farmacopea Británica. Contiene normas para sustancias y productos utilizados exclusivamente en la práctica de la medicina veterinaria en el Reino Unido.
La BP (Vet) también incorpora monografías y textos de la Farmacopea Europea.
CFR (Code of Federal Regulations) 22-23
Para todos nuestros clientes estamos tomando ya sus órdenes en preventa del CFR (Code of Federal Regulations) Título 23 Food and Drugs
Partes 1-1,499 Revisado a Junio del 2022 y fecha de entrega Enero del 2023
Y con un 10% de Descuento. Adelántese y asegure su abastecimiento ahora!!!
US, CFR Title 23, Food and Drugs. (Table of Contents per Volume) VOL 1 Chapter I, Subchapter A.- General (Parts 1-99)
1.- GENERAL ENFORCEMENT REGULATIONS
2.- GENERAL ADMINISTRATIVE RULINGS AND DECISIONS
3.- PRODUCT JURISDICTION
4.- REGULATION OF COMBINATION PRODUCTS
5.- ORGANIZATION
7.- ENFORCEMENT POLICY
10.- ADMINISTRATIVE PRACTICES AND PROCEDURES
11.- ELECTRONIC RECORDS; ELECTRONIC SIGNATURES
12.- FORMAL EVIDENTIARY PUBLIC HEARING
13.- PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY
14.- PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE
15.- PUBLIC HEARING BEFORE THE COMMISSIONER
16.- REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION
17.- CIVIL MONEY PENALTIES HEARINGS
19.- STANDARDS OF CONDUCT AND CONFLICTS OF INTEREST
20.- PUBLIC INFORMATION
21.- PROTECTION OF PRIVACY
25.- ENVIRONMENTAL IMPACT CONSIDERATIONS
26,. MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY
50.- PROTECTION OF HUMAN SUBJECTS
54.- FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS
56.- INSTITUTIONAL REVIEW BOARDS
58.- GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES
60.- PATENT TERM RESTORATION
70.- COLOR ADDITIVES
71.- COLOR ADDITIVE PETITIONS
73.- LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION
74.- LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION
80.- COLOR ADDITIVE CERTIFICATION
81.- GENERAL SPECIFICATIONS AND GENERAL RESTRICTIONS FOR PROVISIONAL COLOR ADDITIVES FOR USE IN FOODS, DRUGS, AND COSMETICS
82.- LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONS
83-98 [RESERVED]
99.- DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES.
VOL 2 Subchapter B.- Food for Human Consumption (Parts 100-169)
100.- GENERAL
101.- FOOD LABELING
102.- COMMON OR USUAL NAME FOR NONSTANDARDIZED FOODS
104.- NUTRITIONAL QUALITY GUIDELINES FOR FOODS
105.- FOODS FOR SPECIAL DIETARY USE
106.- INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS
107.- INFANT FORMULA
108.- EMERGENCY PERMIT CONTROL
109.- UNAVOIDABLE CONTAMINANTS IN FOOD FOR HUMAN CONSUMPTION AND FOOD-PACKAGING MATERIAL
110.- CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD
111.- CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS
112.- STANDARDS FOR THE GROWING, HARVESTING, PACKING, AND HOLDING OF PRODUCE FOR HUMAN CONSUMPTION
113.- THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS 114.- ACIDIFIED FOODS
115.- SHELL EGGS
117.- CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD
118.- PRODUCTION, STORAGE, AND TRANSPORTATION OF SHELL EGGS
119.- DIETARY SUPPLEMENTS THAT PRESENT A SIGNIFICANT OR UNREASONABLE RISK
120.- HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS
121.- MITIGATION STRATEGIES TO PROTECT FOOD AGAINST INTENTIONAL ADULTERATION
123.- FISH AND FISHERY PRODUCTS
129.- PROCESSING AND BOTTLING OF BOTTLED DRINKING WATER
130.- FOOD STANDARDS: GENERAL
131.- MILK AND CREAM
133.- CHEESES AND RELATED CHEESE PRODUCTS
135.- FROZEN DESSERTS
136.- BAKERY PRODUCTS
137.- CEREAL FLOURS AND RELATED PRODUCTS
139.- MACARONI AND NOODLE PRODUCTS
145.- CANNED FRUITS
146.- CANNED FRUIT JUICES
150.- FRUIT BUTTERS, JELLIES, PRESERVES, AND RELATED PRODUCTS
152.- FRUIT PIES
155.- CANNED VEGETABLES
156.- VEGETABLE JUICES
158.- FROZEN VEGETABLES
160.- EGGS AND EGG PRODUCTS
161.- FISH AND SHELLFISH
163.- CACAO PRODUCTS
164.- TREE NUT AND PEANUT PRODUCTS 165.- BEVERAGES
166.- MARGARINE
168.- SWEETENERS AND TABLE SIRUPS 169.- FOOD DRESSINGS AND FLAVORINGS
VOL 3 Subchapter B.- Food for Human Consumption Continued (Parts 170-199)
170.- FOOD ADDITIVES
171.- FOOD ADDITIVE PETITIONS
172.- FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION 173.- SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION 174.- FOOD ADDITIVES: GENERAL
175.- INDIRECT FOOD ADDITIVES: ADHESIVES AND COMPONENTS OF COATINGS
176.- INDIRECT FOOD ADDITIVES: PAPER AND PAPERBOARD COMPONENTS
177.- INDIRECT FOOD ADDITIVES: POLYMERS
178.- INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS
179.- IRRADIATION IN THE PRODUCTION, PROCESSING AND HANDLING OF FOOD
180.- FOOD ADDITIVES PERMITTED IN FOOD OR IN CONTACT WITH FOOD ON AN INTERIM BASIS PENDING ADDITIONAL STUDY
181.- PRIOR-SANCTIONED FOOD INGREDIENTS
182.- SUBSTANCES GENERALLY RECOGNIZED AS SAFE
184.- DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE
186.- INDIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE
189.- SUBSTANCES PROHIBITED FROM USE IN HUMAN FOOD
190.- DIETARY SUPPLEMENTS
191-199.- [RESERVED]
VOL 4 Subchapter C.- Drugs General (Parts 200-299)
200.- GENERAL
201.- LABELING
202.- PRESCRIPTION DRUG ADVERTISING
203.- PRESCRIPTION DRUG MARKETING
205.- GUIDELINES FOR STATE LICENSING OF WHOLESALE PRESCRIPTION DRUG DISTRIBUTORS 206.- IMPRINTING OF SOLID ORAL DOSAGE FORM DRUG PRODUCTS FOR HUMAN USE
207.- REQUIREMENTS FOR FOREIGN AND DOMESTIC ESTABLISHMENT REGISTRATION AND LISTING FOR HUMAN DRUGS, INCLUDING DRUGS THAT ARE REGULATED UNDER A BIOLOGICS LICENSE APPLICATION, AND ANIMAL DRUGS, AND THE NATIONAL DRUG CODE
208.- MEDICATION GUIDES FOR PRESCRIPTION DRUG PRODUCTS
209.- REQUIREMENT FOR AUTHORIZED DISPENSERS AND PHARMACIES TO DISTRIBUTE A SIDE EFFECTS STATEMENT
210.- CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL
211.- CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS
212.- CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY DRUGS 216.- HUMAN DRUG COMPOUNDING
225.- CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS
226.- CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES
250.- SPECIAL REQUIREMENTS FOR SPECIFIC HUMAN DRUGS
290.- CONTROLLED DRUGS
299.- DRUGS; OFFICIAL NAMES AND ESTABLISHED NAMES
VOL 5 Subchapter D.- Drugs for Human Use (Parts 300-499)
300.- GENERAL
310.- NEW DRUGS
312.- INVESTIGATIONAL NEW DRUG APPLICATION
314.- APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
315.- DIAGNOSTIC RADIOPHARMACEUTICALS
316.- ORPHAN DRUGS
317.- QUALIFYING PATHOGENS
320.- BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS
328.- OVER-THE-COUNTER DRUG PRODUCTS INTENDED FOR ORAL INGESTION THAT CONTAIN ALCOHOL
329.- NONPRESCRIPTION HUMAN DRUG PRODUCTS SUBJECT TO SECTION 760 OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT
330.- OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED
331.- ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE
332.- ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
333.- TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
335.- ANTIDIARRHEAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
336.- ANTIEMETIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
338.- NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
340.- STIMULANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
341.- COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
343.- INTERNAL ANALGESIC, ANTIPYRETIC, AND ANTIRHEUMATIC DRUG PRODUCTS FOR OVER-THE- COUNTER HUMAN USE
344.- TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
346.- ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
347.- SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
348.- EXTERNAL ANALGESIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
349.- OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
350.- ANTIPERSPIRANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
352.- SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY] 355.- ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
357.- MISCELLANEOUS INTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
358.- MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
361.- PRESCRIPTION DRUGS FOR HUMAN USE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED: DRUGS USED IN RESEARCH
369.- INTERPRETATIVE STATEMENTS RE WARNINGS ON DRUGS AND DEVICES FOR OVER-THE- COUNTER SALE
370-499.- [RESERVED]
VOL 6 Subchapter E.- Animal Drugs, Feeds and Related Products (Parts 500-599)
500.- GENERAL
501.- ANIMAL FOOD LABELING
502.- COMMON OR USUAL NAMES FOR NONSTANDARDIZED ANIMAL FOODS
507.- CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR FOOD FOR ANIMALS
509.- UNAVOIDABLE CONTAMINANTS IN ANIMAL FOOD AND FOOD-PACKAGING MATERIAL 510.- NEW ANIMAL DRUGS
511.- NEW ANIMAL DRUGS FOR INVESTIGATIONAL USE
514.- NEW ANIMAL DRUG APPLICATIONS
515.- MEDICATED FEED MILL LICENSE
516.- NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES
520.- ORAL DOSAGE FORM NEW ANIMAL DRUGS
522.- IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
524.- OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
526.- INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS
528.- NEW ANIMAL DRUGS IN GENETICALLY ENGINEERED ANIMALS
529.- CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
530.- EXTRALABEL DRUG USE IN ANIMALS
556.- TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
558.- NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
564.- [RESERVED]
570.- FOOD ADDITIVES
571.- FOOD ADDITIVE PETITIONS
573.- FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS
579.- IRRADIATION IN THE PRODUCTION, PROCESSING, AND HANDLING OF ANIMAL FEED AND PET FOOD
582.- SUBSTANCES GENERALLY RECOGNIZED AS SAFE
584.- FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE IN FEED AND DRINKING WATER OF ANIMALS
589.- SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED
590-599.- [RESERVED]
VOL 7 Subchapter F.- Biologics (Parts 600-680)
600.- BIOLOGICAL PRODUCTS: GENERAL
601.- LICENSING
606.- CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS
607.- ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS AND LICENSED DEVICES
610.- GENERAL BIOLOGICAL PRODUCTS STANDARDS
630.- REQUIREMENTS FOR BLOOD AND BLOOD COMPONENTS INTENDED FOR TRANSFUSION OR FOR FURTHER MANUFACTURING USE
640.- ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS
660.- ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS
680.- ADDITIONAL STANDARDS FOR MISCELLANEOUS PRODUCTS
Subchapter G.- Cosmetics (Parts 700-799)
SUBCHAPTER G—COSMETICS
700.- GENERAL
701.- COSMETIC LABELING
710.- VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS
720.- VOLUNTARY FILING OF COSMETIC PRODUCT INGREDIENT COMPOSITION STATEMENTS 740.- COSMETIC PRODUCT WARNING STATEMENTS
741-799.- [RESERVED]
VOL 8 Subchapter H.- Medical Devices (Parts 800-898)
800.- GENERAL
801.- LABELING
803.- MEDICAL DEVICE REPORTING
806.- MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS
807.- ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES
808.- EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS
809.- IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE 810.- MEDICAL DEVICE RECALL AUTHORITY
812.- INVESTIGATIONAL DEVICE EXEMPTIONS
813.- [RESERVED]
814.- PREMARKET APPROVAL OF MEDICAL DEVICES 820.- QUALITY SYSTEM REGULATION
821.- MEDICAL DEVICE TRACKING REQUIREMENTS 822.- POSTMARKET SURVEILLANCE
830.- UNIQUE DEVICE IDENTIFICATION
860.- MEDICAL DEVICE CLASSIFICATION PROCEDURES
861.- PROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENT
862.- CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
864.- HEMATOLOGY AND PATHOLOGY DEVICES
866.- IMMUNOLOGY AND MICROBIOLOGY DEVICES
868.- ANESTHESIOLOGY DEVICES
870.- CARDIOVASCULAR DEVICES
872.- DENTAL DEVICES
874.- EAR, NOSE, AND THROAT DEVICES
876.- GASTROENTEROLOGY-UROLOGY DEVICES
878.- GENERAL AND PLASTIC SURGERY DEVICES
880.- GENERAL HOSPITAL AND PERSONAL USE DEVICES
882.- NEUROLOGICAL DEVICES
884.- OBSTETRICAL AND GYNECOLOGICAL DEVICES
886.- OPHTHALMIC DEVICES
888.- ORTHOPEDIC DEVICES
890.- PHYSICAL MEDICINE DEVICES
892.- RADIOLOGY DEVICES
895.- BANNED DEVICES
898.- PERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES AND PATIENT CABLES
Subchapter I.- Mammography Quality Standards (Parts 900-999)
900.- MAMMOGRAPHY
TOC – TABLE OF CONTENTS
ACCREDITATION
QUALITY STANDARS AND CERTIFICATION STATES AS CERTIFIERS
Subchapter J.- Radiological Health (Parts 1000-1050)
1000.- GENERAL
1002.- RECORDS AND REPORTS
1003.- NOTIFICATION OF DEFECTS OR FAILURE TO COMPLY
1004.- REPURCHASE, REPAIRS, OR REPLACEMENT OF ELECTRONIC PRODUCTS
1005.- IMPORTATION OF ELECTRONIC PRODUCTS
1010.- PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: GENERAL
1020.- PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING PRODUCTS
1030.- PERFORMANCE STANDARDS FOR MICROWAVE AND RADIO FREQUENCY EMITTING PRODUCTS 1040.- PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS
1050.- PERFORMANCE STANDARDS FOR SONIC, INFRASONIC, AND ULTRASONIC RADIATION-EMITTING PRODUCTS
Subchapter K.- Tobacco Products (Parts 1100-1150)
SUBCHAPTER K—TOBACCO PRODUCTS
1100.- TOBACCO PRODUCTS SUBJECT TO FDA AUTHORITY
1105.- GENERAL
1107.- ESTABLISHMENT REGISTRATION, PRODUCT LISTING, AND SUBSTANTIAL EQUIVALENCE REPORTS
1140.- CIGARETTES, SMOKELESS TOBACCO, AND COVERED TOBACCO PRODUCTS
1141.- CIGARETTE PACKAGE AND ADVERTISING WARNINGS
1143.- MINIMUM REQUIRED WARNING STATEMENTS
1150.- USER FEES
Subchapter L.- Regulations under Certain other Acts Administered by FDA (Parts 1210-1299)
1210.- REGULATIONS UNDER THE FEDERAL IMPORT MILK ACT
1230.- REGULATIONS UNDER THE FEDERAL CAUSTIC POISON ACT
1240.- CONTROL OF COMMUNICABLE DISEASES
1250.- INTERSTATE CONVEYANCE SANITATION
1251-1269.- [RESERVED]
1270.- HUMAN TISSUE INTENDED FOR TRANSPLANTATION
1271.- HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS 1272-1299.- [RESERVED]
VOL 9 Chapter II.- Drug Enforcement Administration, Department of Justice (Parts 1300-1399)
1300.- DEFINITIONS
1301.- REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES
1302.- LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED SUBSTANCES 1303.- QUOTAS
1304.- RECORDS AND REPORTS OF REGISTRANTS
1305.- ORDERS FOR SCHEDULE I AND II CONTROLLED SUBSTANCES
1306.- PRESCRIPTIONS
1307.- MISCELLANEOUS
1308.- SCHEDULES OF CONTROLLED SUBSTANCES
1309.- REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, IMPORTERS AND EXPORTERS OF LIST I CHEMICALS
1310.- RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN MACHINES; IMPORTATION AND EXPORTATION OF CERTAIN MACHINES
1311.- REQUIREMENTS FOR ELECTRONIC ORDERS AND PRESCRIPTIONS
1312.- IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES
1313.- IMPORTATION AND EXPORTATION OF LIST I AND LIST II CHEMICALS
1314.- RETAIL SALE OF SCHEDULED LISTED CHEMICAL PRODUCTS
1315.- IMPORTATION AND PRODUCTION QUOTAS FOR EPHEDRINE, PSEUDOEPHEDRINE, AND PHENYLPROPANOLAMINE
1316.- ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES
1317.- DISPOSAL
1321.- DEA MAILING ADDRESSES
1322-1399.- [RESERVED]
Chapter III.- Office of National Drug Control Policy (Parts 1400-1499)
1400.- [RESERVED]
1401.- PUBLIC AVAILABILITY OF INFORMATION 1402.- MANDATORY DECLASSIFICATION REVIEW 1403-1499.- [RESERVED]
Farmacopea Alemana 2023
Content
The German Pharmacopoeia (DAB) is part of the pharmacopoeia according to § 55 of the German Medicines Act (AMG). It only contains rules at national level, which are therefore not included in the European Pharmacopoeia (Ph. Eur.).
The DAB 2022 will enter into force on 1 October 2022. The printed edition is a loose-leaf work with supplementary deliveries published once a year.
Content: General part:
Preface, Introduction, General Instructions for the Use of the Pharmacopoeia, Descriptions of General Test Methods and Reagents
Special Part: Monographs with definitions, test methods and storage and labelling requirements
The Pharmacopoeia consists of three parts: The German Pharmacopoeia (DAB), the European Pharmacopoeia (Ph. Eur.) and the Homeopathic Pharmacopoeia (HAB). It aims to check the quality of medicines to ensure safe use. It establishes unified, common rules applicable to the national pharmacopoeias HAB and DAB in Germany, for the Ph. Eur. in the European area.
According to the German Medicines Act, the pharmacopoeia is a “collection of recognised pharmaceutical rules on the quality, testing, storage, dispensing and designation of medicinal products and the substances used in their manufacture” published by the Federal Institute for Drugs and Medical Devices (BfArM) in agreement with the Paul-Ehrlich-Institut (PEI) and the Federal Office of Consumer Protection and Food Safety (BVL). (§ 55 AMG). It also contains rules for the nature of containers and wrappings.
The recognized pharmaceutical rules described in monographs and other texts of the pharmacopoeia correspond to the current state of scientific knowledge.
