Pharmacy compounding

SEC. 503. EXEMPTIONS AND CONSIDERATION FOR CERTAIN DRUGS, DEVICES. AND BIOLOGICAL PRODUCTS SEC. 503A. PHARMACY COMPOUNDING. 

Proposal to Withdraw Approval of Two New Drug Applications and One Abbreviated New Drug Application Terfenadine, Hoechst Marion Rousssel, Inc and Baker Norton Pharmaceuticals, Fed Regist., Docket No. 96N-0512, 1997, 1998. Part 216 Pharmacy Compounding, Drug Products Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness, Cite 216.24. 

Pharmacy compounding is specifically allowed under the federal Food, Drug and Cosmetic Act (FDCA) (21 U.S.C. 353A). Pharmacists who compound a drug product for an identified individual patient based on the... 

Pharmacy compounding, 214-215 Pharmacy curriculum, 211 Pharmacy education, 210-212 Pharmacy error, 216-218 Pharmacy practice systems, 217 Pharmacy profession opportunities for, 209-210 pharmacogenomics and, 207-208... 

Documents of special importance in providing guidelines and standards for pharmaceutical compounding include the National Association of Boards of Pharmacy s "Good Compounding Practices Applicable to State Licensed Pharmacies " the USP 27/NF 22 Chapter 795, "Pharmacy Compounding — Nonsterile Preparations " and Chapter 797, "Pharmacy Compounding — Sterile Preparations " as well as numerous other portions of the USP/NF. 

The following are summaries of the lengthy Chapter 795, "Pharmacy Compounding — Nonsterile Preparations," and Chapter 797, "Pharmacy Compounding — Sterile Preparations, in the USP/NF."... 

USP Chapter 795 "Pharmacy Compounding — Nonsterile Preparations" is divided into the following nine sections ... 

USP Chapter 797 Pharmacy Compounding — Sterile Preparations is divided into the following fen categories ... 

The guidelines published in the USP 24/NF 19 Chapter (795), Pharmacy Compounding [18] state that ... 

Establishes an entire new programme to control pharmacy compounding. 

The practical aspects of pharmacy—compounding, dosage forms, and sundry manipulations of an extensive materia medica— were complex and not as simplistic and haphazard as often assumed by modern analysts. 

Fig. 3). (HEPA filters used in pharmaceutical and pharmacy-compounding applications rarely exceed 99.99%.) Expressed another way, the HEPA filter is capable of trapping and retaining 999,700-999,900 of every 1,000,000 particles smaller and larger than 0.3 pm in diameter. 

Prior to choosing a BSC for any pharmaceutical manufacturing or pharmacy compounding operation, all risks should be assessed by a qualified process engineer, safety officer, or industrial hygienist, ensuring that the equipment meets occupational safety as well as process requirements. 

Class II BSC. The Class II BSC (Fig. 9) provides product, personnel, and environmental protection, and is the most common BSC employed in pharmaceutical manufacturing and pharmacy-compounding operations. The Class II BSC has several subclassifications, based upon cabinet ventilation design (Table 1). The Class II BSC (Fig. 8), the most widely used by hospital and home-care pharmacies, features a front access opening with carefully maintained inward airflow for replacement of air exhausted from the cabinet, a HEPA-filtered vertical laminar flow airstream within the entire work area, and HEPA-filtered exhaust air. The vertical laminar flow airstream and front access opening are common to all Class II cabinets, although LAF velocities and patterns, HEPA filter sizes and position, ventilation rates, and cabinet exhaust methods vary considerably in different designs (Fig. 7). 

On the regional level, regional control laboratories (as a part of the State Institute for Drug Control) are responsible for drug control among wholesalers eind pharmacies, especially for pharmacy-compounded drugs. 

USP-NF monographs include assays and various analytical methods—identification, dissolution, content uniformity, etc. USP-NF also provides guidance and standards on biotechnology, radiopharmaceuticals, pharmacy compounding, and pharmaceutical waters. General chapters outline requirements for microbiological, biological, chemical, and physical tests and assays. 

Establishes an entire new programme to control pharmacy compounding. Reauthorises a clinical pharmacology programme in FDA. 

For more information on pharmacy compounding, try the FDA s Web site at www.fda.gov/cder/pharmcomp/... 

Carrier materials and degradable matrices can be produced from PHAs and are desired in many fields, such as agriculture, food technology, or pharmacy. Compounds that can be released from these matrices at controlled rates include drugs, hormones, pesticides, antibiotics, dyestuffs, or fiavours [111]. 

---