Compounding

Destruction of Unwanted Medications 1. What are my options for disposing of unwanted medications? A small number of medicines may be especially harmful if taken by someone other than the person for whom the medicine was prescribed. Many of these medicines have specific disposal instructions on their labeling or patient information leaflet. Are there guidelines in place for proper disposal of unwanted medications? The following guidelines were developed to encourage the proper disposal of medicines and help reduce harm from accidental exposure or intentional misuse after they are no longer needed: Follow any specific disposal instructions on the prescription drug labeling or patient information that accompanies the medicine.

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USP > expiration dating to ensure that finished preparations have the expected potency, purity, quality and characteristics at least until the labeled expiration date.

Terminology To get started in this article, there are some terms that should be defined. Prescriptions and over-the-counter medicines and other healthcare products sold in the United States are required to follow the standards in the USP-NF. The USP also sets standards for food ingredients and dietary supplements. Chapters in the USP that are listed as below are considered enforceable, while chapters enumerated as or greater are considered guidelines.

USP – USP Chapter , Pharmaceutical Compounding-Nonsterile Preparations, codifies the rules pharmacists and pharmacy technicians must follow when compounding nonsterile formulations intended for humans and animals. USP Chapter describes the procedures and requirements for compounding sterile preparations and sets the standards that apply to all settings in which sterile preparations are compounded.

USP – USP Chapter , Pharmaceutical Calculations in Prescription Compounding, provides general information on the mathematical concepts required for compounding pharmaceutical preparations. The BOP sets standards, roles, and requirements for pharmacy personnel and practice setting in their state.

Alabama Board of Pharmacy

Destruction of Unwanted Medications 1. What are my options for disposing of unwanted medications? A small number of medicines may be especially harmful if taken by someone other than the person for whom the medicine was prescribed. Many of these medicines have specific disposal instructions on their labeling or patient information leaflet. Are there guidelines in place for proper disposal of unwanted medications?

The following guidelines were developed to encourage the proper disposal of medicines and help reduce harm from accidental exposure or intentional misuse after they are no longer needed:

If a drug component has an assigned expiration date, the pharmacist cannot extend the supplier’s expiration date by means of re-testing. If a drug component is labeled with a retest date, the material can be re-tested in compliance with specifications to ensure that it is still suitable for use.

Relates to State Board of Pharmacy, relates to sterile compounding, relates to permits. The bill contains the following provisions. The bill provides a definition for “compounding pharmacy” and describes sterile compounding pharmacies and non sterile compounding pharmacies. Beginning with appointments made on or after January 1, , the bill adds a physician and an advanced practice registered nurse to the Maine Board of Pharmacy, decreases the number of pharmacist members from 5 to 3.

MN H Pharmacy Regulation Pending – Carryover Changes licensing requirements for pharmacies, drug manufacturers, and wholesale drug distributors, requires all licensed pharmacies to comply with federal laws and state laws and rules related to operation of a pharmacy, requires out-of-state pharmacies dispensing drugs to residents of Minnesota to comply with federal laws related to operation of a pharmacy. MN H Health Pending – Carryover Relates to health, changes licensing requirements for businesses regulated by the Board of Pharmacy, clarifies requirements for compounding, makes changes to the prescription monitoring program.

MN S Health Pending – Carryover Relates to health, changes licensing requirements for businesses regulated by the Board of Pharmacy, clarifies requirements for compounding, makes changes to the prescription monitoring program. MS S State Board of Pharmacy Registration Failed Defines the term non-traditional compounding pharmacy and require all legal entities engaging in this practice to register with the state board of pharmacy.

UT S 14 Pharmacy Practice Act Enacted Amends the Pharmacy Practice Act, defines research using pharmaceuticals, exempts research using pharmaceuticals from licensure to engage in the practice of pharmacy, telepharmacy, or the practice of a pharmacy technician, exempts research using pharmaceuticals from licensure to act as a pharmacy, makes technical corrections.

VA H Compounding Pharmacies Enacted Relates to compounding pharmacies, clarifies the definition of compounding and adds a requirement for a current inspection report for registration or renewal of a registration for a nonresident pharmacy, provides that the compounding of an inordinate amount of a preparation where there is not historical pattern of prescriptions to support an expectation of receiving a valid prescription for the preparation shall constitute manufacturing of drugs.

Search courtesy of StateNet. No cases were reported within Massachusetts. Published by Compounding Compliance service, a private consulting entity.

Alabama Board of Pharmacy

While both the boards are accredited by the American Society Of Hospital Pharmacists ASHP , the PTCB is preferred by a majority of pharmacy technicians as well as employers as it has been around for a long time and therefore widely recognized. Certification earned from either of the boards widens employment opportunities and can help in giving a rise to the salary of a Pharmacy Technician PT.

The following information is a step by step guide, taking you through entire process of certification: The PTCB established in , is a private national organization which provides certification to qualified pharmacy technician, thus promoting skilled pharmacy technicians, ensuring safe patient care to pharmacy customers.

Since their inception they have certified over , as of Dec.

Compunding. Question Answer; Non sterile compounding: Solutions and suspensions, Ointments and creams, suppositories and capsules not called expiration date-date is initiated at the time of compounding. USP Chapter Beyond use date for prescription with two or more active ingredients take the earlier of these.

The Board also supplies the answers, which is a terrific idea to educate pharmacists and the public and to ensure more compliance with the rules and regulations in Oregon. The questions and answers can be found by clicking here or by reading below: FAQ for Division 45 1. Do I need to follow the rules set forth in division 45 if I do simple compounding like magic mouthwash or mixing 2 creams in my retail pharmacy?

Simple and infrequent compounding using non-sterile commercial components to fill a single prescription for a non-sterile product is classified as Category 1 compounding. The Board states that Category 1 compounding is not considered compounding for all intensive purposes. When does category 1 compounding become category 2? When the compounding becomes complex multiple ingredients, etc… , requires complex calculations, a scale is needed to weigh ingredients, if it requires alterations of the original dosing form making capsules, etc… , or changes in the route of administration making suppositories, etc….

Any of these requirements would result in a compound that is no longer classified as category 1. Can you make a compound without a prescription? OAR You may compound a reasonable amount of drug product without a prescription, but you must be anticipating prescriptions for what you are compounding or you must be distributing the product under the Shared Pharmacy Services agreement as defined in OAR Does division 45 apply to nuclear pharmacies?

Radiopharmaceuticals have their own guidelines and are exempt from division

A History: ’s Word of the Year

It is an opportunity for us to reflect on the language and ideas that represented each year. So, take a stroll down memory lane to remember all of our past Word of the Year selections. Change It wasn’t trendy , funny, nor was it coined on Twitter , but we thought change told a real story about how our users defined Unlike in , change was no longer a campaign slogan.

But, the term still held a lot of weight. Here’s an excerpt from our Word of the Year announcement in

The beyond-use date is not later than the intended duration of therapy or 30 days, whichever is earlier. Assign a beyond-use date of either intended duration of therapy or 30 days, whichever is earlier.

Classification of air cleanliness. For example, particles of 0. Barrier isolators provide a suitable environment by restricting any ambient air from the work chamber. These systems are not as sensitive to external environments as the HEPA-filtered unidirectional airflow units. Several aspects of barrier isolation and filtered unidirectional airflow in work environment must be understood and practiced in the compounding process. Policies and procedures for maintaining and working in the prescribed conditions for aseptic processing must be prepared, updated, maintained, and implemented and are determined by the scope and risk levels of the activities undertaken in the SP compounding operation.

In general, the CSP work environment is designed to have the cleanest work surfaces horizontal or vertical clean benches, biological safety cabinets, or isolators located in a buffer area, which is preceded by an anteroom that provides a clean area for donning personnel barriers, such as hair covers, gloves, gowns, or full clean-room attire. The class limit of the buffer or core room has to be demonstrably better than that of ambient air to reduce the risk of contaminants being blown, dragged, or otherwise introduced into the filtered unidirectional airflow environment.

For example, strong air currents from opened doors, personnel traffic, or air streams from the heating, ventilating, and air-conditioning systems can easily disrupt the unidirectional, columnar airflow in the open-faced workbenches. The operators may also introduce disruptions in flow by their own movements and by the placement of objects onto the work surface. Measuring, weighing, mixing, and other manipulations of nonsterile in-process CSPs are also performed in air quality of at least ISO Class 8 see Table 1.

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In particular, pharmacists must offer to discuss the unique drug therapy regimen of each Medicaid recipient when filling prescriptions for them. Such discussions must include matters that are significant in the professional judgment of the pharmacist. The information that a pharmacist may discuss with a patient is found in the enumerated list below.

Name and description of the medication. Dosage form, dosage, route of administration, and duration of drug therapy. Special directions and precautions for preparation, administration, and use by the patient.

Our Rules still state both, so we need to change our Rules so they betterreflect what USP statesand that is only actives. Trip willtalk with Board in June concerning this issue.

What is USP ? Widely agreed to improve the safety of the compounding environment and the products produced in that environment, USP is mandated by some state boards of pharmacy and recommended by others. Sterile compounding environments designed, built, and operated in compliance with USP are considered by most pharmaceutical professionals as state-of-the-art. However, its requirements also extend to architectural and environmental areas. Consequently, hospital design, construction and operations professionals should also become familiar with it.

Far-reaching regulation USP is a far-reaching regulation that governs a wide range of pharmacy policies and procedures. It is designed both to cut down on infections transmitted to patients through pharmaceutical products and to better protect staff working in pharmacies in the course of their exposure to pharmaceuticals. Many pharmacies fit this description. Moreover, many large hospitals have several pharmacies—a main one and several satellite pharmacies—that will be affected.

Understanding the meaning of expiration dates on drug labels

Protect fromabsorption of carbon dioxide. Calcium Hydroxide, saturated at 25Shake an excessof calcium hydroxide with water, and decant at 25 beforeuse. Protect from absorption of carbon dioxide.

Ms. Sherpa clarified the difference between USP and regarding sterile and non-sterile products. Dr. Paulsen discussed that irrespective of the regulations, it has been typical practice to record the lot number and expiration date of the drug when preparing a batch.

Understanding the meaning of expiration dates on drug labels by Michael R. December 24, Drug manufacturers are required to stamp an expiration date on their products. On over-the-counter OTC medicines, the expiration date is often printed on the label or carton under “EXP” or stamped without ink into the bottom of a bottle, carton, or the crimp of a tube.

But what does the expiration date mean? Is a medicine still safe to take after its expiration date? Will it cause harm or just not work after its expiration date? Neither fully explains what the expiration date means. Actually, it’s the date up until which the drug manufacturer can guarantee that the medicine is fully potent and safe to take based on scientifically-sound product testing.

It is usually expressed by month and year. The product can legally be used or dispensed until the last day of the stated month and year. How the product is stored is important. As you might expect, temperature, humidity, proper sealing can all affect the stability of products. Expiration date testing by manufacturers is done under prescribed conditions. Expiration dates are typically conservative to make sure you get what you paid for—a fully potent and safe medicine.

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Pharmaceutical Specialties, Inc. USP > In the absence of stability information that is applicable to a specific drug and preparation, the following maximum beyond-use dates are recommended for nonsterile compounded drug preparations remaining until the product’s expiration date or 6 months.

It is intended to provide public portions of communications within the General Committee of Revision and public notice of proposed new and revised standards of the USP and NF and to afford opportunity for comment thereon. The organization of PF includes, but is not limited to, the following sections. Supplements Supplements to official text are published periodically and include text previously published in PF, which is ready to be made official.

Reagent Standards The proper conduct of the Pharmacopeial tests and assays and the reliability of the results depend, in part, upon the quality of the reagents used in the performance of the procedures. Unless otherwise specified, reagents are to be used that conform to the specifications set forth in the current edition of Reagent Chemicals published by the American Chemical Society. Where such ACS reagent specifications are not available or where for various reasons the required purity differs, compendial specifications for reagents of acceptable quality are provided see Reagents, Indicators, and Solutions.

These are supplied by USP when they might not be generally commercially available or because they are necessary for the testing and are available only to the originator of the tests or assay. Where a test or an assay calls for the use of a compendial article rather than for a USP Reference Standard as a material standard of reference, a substance meeting all of the compendial monograph requirements for that article is to be used.

Units of Potency For substances that cannot be completely characterized by chemical and physical means, it may be necessary to express quantities of activity in biological units of potency, each defined by an authoritative, designated reference standard.

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