New Publication Helps Compounding Practitioners Ensure the Quality of Customized Preparations

June 26, 2012

To help ensure the quality of compounded medicines, the U.S. Pharmacopeial Convention (USP) has launched USP on Compounding: A Guide for the Compounding Practitioner, an electronic publication that includes all the compounding-related general chapters from the United States Pharmacopeia and the National Formulary (USP-NF).

Rockville, MD (PRWEB) June 26, 2012

To help ensure the quality of compounded medicines, the U.S. Pharmacopeial Convention(USP) has launched USP on Compounding: A Guide for the Compounding Practitioner, an electronic publication that includes all the compounding-related general chapters from the United States Pharmacopeia and the National Formulary (USP-NF). Compounding is the special preparation of a prescribed medicine. While compounding has been a traditional way of delivering medicines to patients for centuries, the practice has reemerged and grown steadily over the past two decades. This results from a variety of factors including special patient needs for customized therapies (e.g., allergen-free medications, nonstandard doses, and individualized parenteral nutrition), the need to access drugs or dosage forms withdrawn from the market for reasons other than safety or efficacy, and drug shortages.

USP on Compounding will be available for purchase through the USP store. Additionally, USP has partnered with the International Academy of Compounding Pharmacists (IACP) to sell copies directly to IACP members through the organization’s website (http://www.iacprx.org). USP on Compounding is offered as a 12-month electronic subscription in PDF format and will be updated with the release of each new USP-NF edition and supplement. Compounding practitioners in the US should be familiar with Federal and State requirements regarding standards in USP-NF and—by extension, USP on Compounding—to assure compliance with applicable requirements.

“As the need for good quality compounded medications grows, it’s important for compounding practitioners to have easy access to the standards that best support their practice,” said Roger L. Williams, M.D., USP’s chief executive officer. “This new publication will provide compounding pharmacists with the information they need in one location, enabling them to work more efficiently. Additionally, we are pleased to be offering this resource through IACP, which will allow direct access to the publication through the organization most compounding pharmacists look to for information.”

“As the healthcare system recognizes the value and importance of customized medication therapies to meet unique patient needs, the ancient art of compounding has transformed into a sophisticated, science based practice,” said David G. Miller, R.Ph., IACP’s executive vice president and chief executive officer. “IACP is proud to be a partner with USP in the launch of this new resource that gives pharmacists the standards, guidelines, and tools they need to advance their patient care services.”

USP on Compounding includes five compounding-related General Chapters:

•795 Pharmaceutical Compounding—Nonsterile Preparations: Provides guidance on applying good compounding practices in the preparation of nonsterile compounded formulations for dispensing and/or administration to humans or animals.

•797 Pharmaceutical Compounding—Sterile Preparations: Provides practice and quality standards for compounding sterile preparations.

•1160 Pharmaceutical Calculations in Prescription Compounding: Provides general guidance and assistance to pharmacists in performing the necessary calculations when preparing or compounding any pharmaceutical drug.

•1163 Quality Assurance in Pharmaceutical Compounding: Describes a quality assurance program as a system of steps and actions that must be taken to ensure the maintenance of proper standards in compounded preparations.

•1176 Prescription Balances & Volumetric Apparatus: Provides information about acceptable balances and volumetric apparatus (e.g., burets, pipets, cylinders, conical graduates, medicine droppers) used to weigh or measure medicinal and other substances required in prescriptions or in other pharmaceutical compounding.

In addition, USP on Compounding contains 46 supporting General Chapters referenced in the compounding-related chapters.

For more information, please visit http://www.usp.org or email mediarelations (at) usp (dot) org.

USP—Advancing Public Health Since 1820

The United States Pharmacopeial Convention (USP) is a scientific, nonprofit, standards-setting organization that advances public health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods. USP’s standards are recognized and used worldwide. For more information about USP visithttp://www.usp.org.

For the original version on PRWeb visit: http://www.prweb.com/releases/prwebUSPonCompounding/MM/prweb9639081.htm

U.S. Marshals seized misbranded drugs in Maine

FDA NEWS RELEASE

 

For Immediate Release: June 6, 2012

Media Inquiries: Pat El-Hinnaway, 301-796-4763, patricia.el-hinnawy@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA

U.S. Marshals seized misbranded drugs in MainePortland company promoted their products for disease diagnosis, treatment 

On May 31, 2012, at the request of the U.S. Food and Drug Administration, U.S. Marshals seized drug products from Global Biotechnologies, Inc., of Portland, Maine, pursuant to a warrant issued by the U.S. District Court for the District of Maine.

 

According to the complaint, the company has made claims on its website, in promotional materials, and on the products’ labels that its products can diagnose, cure, mitigate, treat or prevent human diseases. The company’s products, including Glucanol, Healthy Trac, Immunol, and Lactopril, meet the FDA definition of drugs because Global Biotechnologies promoted them to treat diseases. However, the company failed to provide adequate directions for use for its drug products, causing those products to be misbranded drugs in violation of the Federal Food, Drug and Cosmetic Act.

 

“The public relies on the FDA to keep companies from claiming that their products improve medical conditions or diseases,” said Armando Zamora, acting director, office of enforcement, in the Office of Regulatory Affairs. “Using these products in the mistaken belief that they will cure a disease – especially when they cannot do so – represents a danger to the public’s health.”

 

Earlier, the FDA sent a warning letter to Global Biotechnologies advising the company that making treatment claims on its labels, promotional materials and websites caused the products to be unapproved new drugs and misbranded drugs in violation of the Federal, Food, Drug and Cosmetic Act. At that time, the company committed to removing drug claims cited in the warning letter from its labeling. However, during a recent inspection, the FDA found that the company had continued to make illegal claims that cause their products to be misbranded drugs.

 

No illnesses have been associated to date with Global Biotechnologies’ products. Illnesses or adverse events related to use of these products should be reported to the FDA at caers@fda.hhs.gov or by calling 240-402-2405.

 

For more information:

• FDA Warning Letter, Feb. 8, 2006

 

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation and for regulating tobacco products.

CDER Sponsored Meetings, Conferences and Workshops

Meetings, Conferences, & Workshops (Drugs)

The following are meetings, conferences, and workshops sponsored or co-sponsored by the Center for Drug Evaluation and Research (CDER):

Upcoming 

• FDA Small Business Regulatory Education for Industry (REdI) Conference Spring 2012, June 19-20, 2012
• DIA/FDA: Revitalizing Productivity in Drug Development, October 23, 2012, 5151 Pooks Hill Road, Bethesda, MD. Meeting
• The Regulatory Convergence, October 26–30, 2012, Seattle, WA. 
• CDER Forum for International Drug Regulatory Authorities, November 5-9, 2012, College Park, MD. 
• PDA Pharmaceutical Quality Systems (ICHQ10) Conference, November 15-16, 2012
•  

For more information on these meetings, click here.

FDA Guidelines Regarding Drug Inspections

The FDA website contains the following guidance regarding drug inspections:

5.5 - DRUGS

 5.5.1 - DRUG INSPECTIONS

Authority for inspection is discussed in IOM 2.2. FD&C Act Sections 501(a)-(d) [21 U.S.C. 351(a)-(d)] describe the ways in which a drug may be or may become adulterated. Section 502 of the FD&C Act [21 U.S.C. 352] does the same, with respect to misbranding. Section 505 of the FD&C Act [21 U.S.C. 355] requires that new drugs be approved by FDA. Therefore, the purposes of a drug inspection are:

1. To evaluate a firm's adherence to the concepts of sanitation and good manufacturing practice; i.e.,production and control procedures include all reasonable precautions to ensure the identity, strength, quality, and purity of the finished products;
2. To identify deficiencies that could lead to the manufacturing and distribution of products in violation of the Act, e.g., non-conformance with Official Compendia, super/sub potency, substitution;
3. To determine whether a firm is distributing drugs that lack required FDA approval including counterfeit or diverted drugs;
4. To obtain correction of those deficiencies;
5. To determine if new drugs are manufactured by the same procedures and formulations as specified in the New Drug Application documents;
6. To determine the drug labeling and promotional practices of the firm;
7. To assure the firm is reporting NDA field alerts as required by 21 CFR 314.81 and Biological Product Deviation Reports (BPDRs) for therapeutic biological products as required by 21 CFR 600.14;
8. To determine if the firm is complying with the requirements of the Prescription Drug Marketing Act (PDMA) and regulations; and
9. To determine the disposition of Drug Quality Reports (DQRS) received from the Division of Compliance Risk Management and Surveillance/CDER; and
10. To determine if the firm is complying with postmarket Adverse Drug Experience reporting requirements as required by 21 CFR sections 310.305 (prescription drugs without approved NDA/ANDA), 314.80, 314.98, and 314.540 (application drug products), and 600.80 (therapeutic biological products), and Section 760 of the FD&C Act (non-application nonprescription products) [21 U.S.C. 379aa].

 5.5.1.1 - Preparation and References

Become familiar with current programs related to drugs. Determine the nature of the assignment, i.e., a specific drug problem or a routine inspection, and if necessary, consult other district personnel, such as chemists, microbiologists, etc., or center personnel, such as office of compliance staff. Review the district files of the firm to be inspected including:

1. Establishment Inspection Reports,
2. District Profiles,
3. OTC monographs and other pertinent references for non-application products,
4. Drug Applications (New, Abbreviated and Investigational) and the Knowledge Transfer Memo, if the Center has provided it for a specific pre-approval inspection,
5. Therapeutic Biologics License Applications,
6. Sample results,
7. Complaints and Recalls,
8. Regulatory files,
9. Drug Quality Reports (DQRs), NDA Field Alert Reports (FARs), and Biological Product Deviation Reports (BPDRs), 
10. Drug Registration and Listing 

During this review identify products which:

1. Are difficult to manufacture,
2. Require special tests or assays, or can not be assayed,
3. Require special processes or equipment, and
4. Are new drugs and/or potent low dosage drugs.
5. Are misbranded, unapproved, fraudulent, or compounded drugs containing ingredients that have been withdrawn or removed from the market for safety reasons.

Review the factory jacket, FACTS OEI and registration/listing data, and all complaint reports which are marked follow-up next inspection. These complaints are to be investigated during the inspection and discussed with management. See IOM 5.2.7.

Become familiar with current regulations and programs relating to drugs, CP 7356.002, et al. When making GMP inspections, discuss with your supervisor the advisability of using a microbiologist, analyst, engineer, or other technical personnel to aid in evaluating those areas of the firm germane to their expertise. Review the FD&C Act, Chapter V, Drugs and Devices. Review parts of 21 CFR 210/211 applicable to the inspection involved and Bioavailability (21 CFR 320). In the case of APIs, review FD&C Act section 501(a)(2)(B) [21 U.S.C 351(a)(2)(b)] and the ICH industry guideline entitled "Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients."

Review the current editions of the United States Pharmacopeia (USP), and Remington's Pharmaceutical Sciences for information on specific products or dosage forms. For compounding pharmacies, review USP Chapters 795 and 797. IOM 1.10.3 also provides a link to a consolidated list of pertinent guides and guidelines which may be applicable during drug inspections.

Review 21 CFR 203 "Prescription Drug Marketing", 21 CFR 205 "Guidelines for State Licensing of Rx Drug Distributors", and CP 7356.022, Enforcement of the Prescription Drug Marketing Act (PDMA).

Before conducting drug preapproval inspections (CP 7346.832) it is important to be familiar with the application and coordinate accomplishment of Center goals communicated by (1) inspectional memos, (2) pre-inspection briefings, and/or (3) Center participation on the inspection team.

Before conducting an inspection that may involve postmarketing adverse drug experience reporting, you should review 21 CFR Sections 310.305, 314.80, 314.98, 314.540, and 600.80, Section 760 of the FD&C Act[21 U.S.C. 379aa], CP 7353.001, and the training video, 'Field Investigators: Adverse Drug Effects (ADE) Detectives,' available online at http://www.fda.gov/Training/ForHealthProfessionals/ucm091001.htm.

The Office of Manufacturing and Product Quality (OMPQ) in CDER has established two mechanisms for you to obtain technical assistance before, during, or after an inspection: 

1. Office of Manufacturing and Product Quality (OMPQ) Subject Contacts.  This list contains the names and phone numbers of OMPQ individuals identified as technical specialists in various areas.
2. Questions and Answers on Current Good Manufacturing Practices for Drugs (http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm124740.htm).  This forum is intended to provide timely answers to questions about the meaning and application ofCGMPs for human, animal, and biological drugs, and to share these widely.  These questions and answers generally clarify statements of existing requirements or policy.

 5.5.1.2 - Inspectional Approach

Follow Compliance Program Guidance Manual (CP) 7356.002 and others as appropriate when conducting CGMP inspections.  In-depth inspection of all manufacturing and control operations is usually not feasible or practical. A risk-based systems audit approach is recommended in which higher risk, therapeutically significant, medically necessary, and difficult to manufacture drugs are covered in greater detail during an inspection. (Note: The status of a drug as medically necessary is determined by CDER, Office of New Drugs, Drug Shortages; They can be reached at 301-796-1300 and via email - drugshortages@fda.hhs.gov) The latter group includes, but is not limited to, time release and low dose products, metered dose aerosols, aseptically processed drugs, and formulations with components that are not freely soluble.

CP 7356.002 incorporates the systems-based approach to conducting an inspection and identifies six (6) systems in a drug establishment for inspection: Quality, Facilities and Equipment, Materials, Production, Packaging and Labeling and Laboratory Control Systems.  The full inspection option includes coverage of at least four (4) of the systems; the abbreviated inspection option covers of at least two (2) systems. In both cases,  CP 7356.002, indicates the Quality System be selected as one of the systems being covered.  During the evaluation of the Quality System it is important to determine if top management makes science-based decisions and acts promptly to identify, investigate, correct, and prevent manufacturing problems likely to, or have led to, product quality problems.

When inspecting drug manufacturers marketing a number of drugs meeting the risk criteria, the following may help you identify suspect products:

1. Reviewing the firm's complaint files early in the inspection to determine relative numbers of complaints per product.
2. Inspecting the quarantine, returned, reprocessed, and/or rejected product storage areas to identify rejected product.
3. Identifying those products which have process control problems and batch rejections via review of processing trends and examining reviews performed under 21 CFR 211.180(e).
4. Reviewing summaries of laboratory data (e.g., laboratory workbooks), OOS investigations, and laboratory deviation reports.

 5.5.1.3 - CDER Bio-research Monitoring

Bio-research monitoring (BIMO) assignments for drugs will generally be issued by the Center for Drug Evaluation and Research (CDER) (see IOM 5.5.6).

 5.5.2 - DRUG REGISTRATION & LISTING

Registration and listing is required whether or not interstate commerce is involved. See Exhibit 5-12 and IOM 2.9.1.1 for additional information.

Two or more companies occupying the same premises and having interlocking management are considered one establishment and usually will be assigned a single registration number. See IOM 5.1.1.11 - Multiple Occupancy Inspections for additional information.

Independent laboratories providing analytical or other laboratory control services on commercially marketed drugs must register.

FACTS will indicate if the establishment is registered for the current year. If you determine registration and listing is required, advise your supervisor. After checking for past registration, cancellation, etc., the district will provide the firm with the proper forms and instructions.

Each establishment is required to list with FDA every drug in commercial distribution, whether or not the output of such establishment or any particular drug so listed enters interstate commerce.  During the establishment inspection, you should remind the firm of its responsibilities for ensuring its drug listing accurately reflects the current product line and updating its listing as necessary to include all product changes, NDC changes, and discontinuations in accordance with 21 CFR 207. If registration and listing deficiencies are found, document it in your EIR, collect a documentary sample and/or contact your supervisor.

 5.5.3 - PROMOTION AND ADVERTISING

21 CFR 202.1 which pertains only to prescription drugs, covers advertisements in published journals, magazines, other periodicals, and newspapers, and advertisements broadcast through media such as radio, television, and telephone communication systems. Determine what department or individual is responsible for promotion and advertising and how this responsibility is demonstrated. Ascertain what media (radio, television, newspapers, trade journals, etc.) are utilized to promote products.

Do not routinely collect examples of current advertising. Advertising should be collected only on assignment, or if, in your opinion, it is clearly in violation of Section 502(n) of the FD&C Act [21 U.S.C. 352 (n)] or 21 CFR 202.1.