It is the responsibility of personnel to determine the correct level. Opened or needle-punctured single-dose containers must be used within one hour if opened in worse than ISO Class 5 air quality and remaining contents discarded. Opened single-dose ampuls must be discarded and may not be stored for any time period. The BUD for opened or entered multiple-dose containers is 28 days, unless otherwise specified by the manufacturer. Additionally, in Multiple-dose and single-dose sterile products or CSPs for use as multiple-dose applications, combining is forbidden. The section on hazardous drugs is aimed at protecting handlers from exposure to certain drugs during preparation.
It recommends PECs that do not recirculate air. Of course, waste disposal should be according to state and federal regulations. Highly particulate generating materials, like lead containers, are required to be used for the protection of handlers. ISO Class 8 air is permitted because it is hard to maintain air cleanliness with all of the lead shielding being used. Unpreserved allergen extracts must fully comply with , but most allergen extracts are highly preserved. Preparations using preserved allergen extracts are exempt from certain aspects of USP under certain conditions involving:.
The related revisions deal with environmental designs and primary engineering control areas, including CAIs barrier isolators , HEPA filters, buffer and anterooms, and cleanrooms. They clarify ISO cleanliness requirements and placement of equipment in compounding facilities. For questions or assistance with regard to indoor air quality and infection control for hospitals, contact Tom Petersen, P. Your email address will not be published. Notify me of follow-up comments by email. Notify me of new posts by email.
Based on a presentation by Tom N. Petersen, P. Medium-Risk Level occurs in an ISO Class 5 environment and involves complex procedures, like bulk compounding, which could occur over an extended period. It also includes using pooled sterile commercial products for multiple patients or for one patient multiple times, as in Chemotherapy or pain management administered by an infusion device Low-risk level compounding occurs in an ISO Class 5 environment and involves only a few basic, steps.
It could apply in reconstituting single-dose vials of antibiotics, simple transfers of sterile products or preparing hydration solutions. This category is for those products that are low risk and will be administered within 12 hours of compounding. Compounding does not include making copies of commercially available drug products, as this is not allowed by law.
Pharmaceutical compounding is performed or supervised by a pharmacist licensed by a state board of pharmacy see question below on legal oversight of compounding versus manufacturing. Manufacturing is the mass production of drug products that have been approved by the Food and Drug Administration FDA. These products are sold to pharmacies, health care practitioners, or others who are authorized under state and federal law to resell them. While most pharmacies offer some level of compounding, most compounding is done in pharmacies that have made the investment in equipment and training to do so safely and efficiently.
The preparations offered by these compounding pharmacies can be nonsterile ointments, creams, liquids, or capsules that are used in areas of the body where absolute sterility is not necessary or sterile usually intended for the eye, or injection into body tissues or the blood.
All licensed pharmacists learn during their training and education to perform basic compounding. In addition, most pharmacies have some compounding tools, such as a mortar and pestle for grinding materials, graduated cylinders for measuring liquids, balances for weighing solids, spatulas for mixing materials, and ointment slabs on which to work. With such tools and through applying their knowledge, all pharmacists routinely prepare nonsterile compounded preparations when requested by prescribers. Of the approximately 56, community-based pharmacies in the United States, about 7, pharmacies specialize in compounding services.
This means the pharmacists in those facilities spend most or all of their time compounding special preparations for patients. Preparations made in these pharmacies are more likely to include both sterile and nonsterile dosage forms. Compounding also takes place in hospital pharmacies and at other health care facilities.
The practice of compounding is regulated by state boards of pharmacy.
Community and hospital compounding pharmacists are allowed exemptions to the Federal Food, Drug, and Cosmetic Act of if they comply with the regulations outlined in Section A. All pharmacists and pharmacies engaged in compounding are subject to oversight by both federal and state authorities.
Pharmacists engaged in compounding are expected to follow applicable standards and regulations for the types of preparations that are compounded. Controlled substances include narcotics such as hydrocodone, amphetamines, and similar drugs, and drugs such as those used for anxiety and sleep disorders.
New Program Allows Pharmacists to Earn a Compounded Sterile Preparations Certificate
This private, nonprofit organization defines the chemical purity of drugs and also issues practice standards. USP develops standards for the identity, quality, strength, and purity of medicines, dietary supplements, and food ingredients that may be used in compounding preparations. These standards in particular are relevant to compounding pharmacists.
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It provides guidance on preventing microbial contamination and other variances in compounded sterile preparations, regardless of setting e. It describes categories of compounding simple, moderate, complex , defines concepts such as beyond-use date and stability, and provides criteria for compounding pharmacists to follow in preparing various drug preparations. This standard aims to promote worker safety pharmacists, pharmacy technicians, veterinarians, veterinary technicians, and many others , patient safety, and environmental protection.
This standard was published on February 1, , but will not be officially implemented until July 1, Compliance with these and other USP guidelines is considered the minimum standard of practice in pharmacy. Pharmacy Compounding Accreditation is a service of the Accreditation Council for Health Care ACHC that assesses the nonsterile and sterile pharmacy compounding process as defined by a specific set of standards that concentrate on the quality and consistency of medications produced.
A patient can receive compounded drugs from a typical community pharmacy or a specialty compounding pharmacy, or compounded drugs can be administered by doctors or other health professionals in clinics or medical offices. Patients should ask the person administering a medication or the pharmacist dispensing a prescription whether it was prepared in a compounding pharmacy or manufactured by a drug company.
If a prescription calls for a compounded drug, patients can ask whether the compounding pharmacy is accredited. Compounding is a central activity to the practice of pharmacy. Pharmacists who practice in the 7, pharmacies that specialize in compounding services have generally had advanced training in compounding after they graduated from pharmacy school.
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No state currently requires a particular type of training, and no nationally recognized specialty exists for pharmaceutical compounding. Specialized training in pharmacy compounding processes is available through several of the active pharmaceutical ingredient API suppliers serving the needs of the compounding pharmacy community. A health care provider will prescribe a compounded drug only when commercially available drug products do not meet your needs. If you do not understand why you have been prescribed a special formulation, ask your prescriber.
If you are concerned about taking a compounded drug and you and your prescriber agree that you can tolerate the commercially available drug, you may also ask if there is any evidence that your outcome will be better on the compounded formulation.
APhA has made available on this website the introductory chapter of a leading book it publishes on compounding pharmacy. Author Loyd V. Allen Jr. The FDA and CDC websites provide up-to-date information, lists of affected facilities and states, treatment guidelines, FAQ statements and other resources to assist health care providers and the public in addressing this issue. A number of things went wrong with these preparations.
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