Recalls, Market Withdrawals, & Safety Alerts Baxter Initiate Voluntary Recall of One Lot of Highly COncentrated Potassium Chloride Injection In The U.S. Due to Mislabeled Overpouch

Recalls, Market Withdrawals, & Safety Alerts Baxter Initiate Voluntary Recall of One Lot of Highly COncentrated Potassium Chloride Injection In The U.S. Due to Mislabeled Overpouch

High Importance: Electronic Product Reporting for Human Drug Compounding Outsourcing Facilities;

4164-01-P DEPARTMENT OF HEALTH AND HUMAN ...

www.ofr.gov/.../OFRUpload/OFRData/2014-27691_PI.pdf

2 hours ago - Electronic Product Reporting for Human Drug Compounding Outsourcing Facilities; ... must report information on the drugs they have compounded in Structured.

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4164-01-P

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1428]

Electronic Product Reporting for Human Drug Compounding Outsourcing Facilities; Draft

Guidance

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

SUMMARY: The Food and Drug Administration (FDA or the Agency) is announcing the

availability of a revised draft guidance entitled “Electronic Product Reporting for Human Drug

Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and

Cosmetic Act.” The revised draft guidance addresses provisions in the Federal Food, Drug, and

Cosmetic Act (the FD&C Act) added by the Drug Quality and Security Act (DQSA) and updates

reporting instructions for drug compounders that choose to register as outsourcing facilities.

Such compounders must report information on the drugs they have compounded in Structured

Product Labeling (SPL) format using FDA’s electronic submissions system. This revised draft

guidance supersedes a draft guidance entitled “Interim Product Reporting for Human Drug

Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and

Cosmetic Act.”

DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115 (g)(5)),

to ensure that the Agency considers your comments on this revised draft guidance, submit either

electronic or written comments on the revised draft guidance by [INSERT DATE 60 DAYS

AFTER DATE OF PUBLICATION IN THE FEDERAL REGISTER]. Submit either electronic

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or written comments concerning the collection of information proposed in the revised draft

guidance by [INSERT DATE 60 DAYS AFTER DATE OF PUBLICATION IN THE

FEDERAL REGISTER].

ADDRESSES: Submit written requests for single copies of the revised draft guidance document

to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug

Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD

20993-0002. Send one self-addressed adhesive label to assist that office in processing your

request. See the SUPPLEMENTARY INFORMATION section for electronic access to the

revised draft guidance.

Submit electronic comments on the revised draft guidance to http://www.regulations.gov.

Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug

Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Lysette Deshields, Center for Drug Evaluation

and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD

20993-0002, 301-796-3100.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a revised draft guidance for industry entitled

“Electronic Product Reporting for Human Drug Compounding Outsourcing Facilities Under

Section 503B of the Federal Food, Drug, and Cosmetic Act.” In the Federal Register of

December 4, 2013 (78 FR 72897), FDA issued a notice announcing the availability of an initial

draft of this guidance entitled “Interim Product Reporting for Human Drug Compounding

Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” That

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draft guidance addressed new provisions in the FD&C Act added by the DQSA and set forth an

interim submission method for human drug compounders that choose to register as outsourcing

facilities.

The comment period on the initial draft guidance ended on February 3, 2014. FDA

received six comments on the draft. In response to received comments or on its own initiative,

FDA made the following changes and updates in the revised draft guidance: (1) Modified the

scope of the guidance to refer to product reports submitted in SPL format; (2) clarified the

following elements required in a product report: “Strength of the active ingredient per unit,”

“package description,” and “number of individual units produced”; (3) included language that

discusses the time period during which outsourcing facilities must submit product reports; (4)

included the appropriate SPL document type category for outsourcing facilities submitting a

product report and a reference to detailed instructions on how to submit information using SPL;

(5) clarified that reports submitted under section 503B(b)(2) of the FD&C Act (21 U.S.C.

353b(b)(2)) are exempt from inspection unless the Secretary finds that such an exemption would

be inconsistent with the protection of the public health; and (6) made grammatical and other

minor editorial changes for clarity.

In some cases, received comments raised issues that were not directly pertinent to the

topics addressed in the draft. This revised draft guidance explains that registered outsourcing

facilities must provide reports to FDA on compounded drugs in SPL format using FDA’s

electronic submissions system. It supersedes the draft guidance entitled “Interim Product

Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the

Federal Food, Drug, and Cosmetic Act.”

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Section 503B(b)(2)(B) of the FD&C Act provides that a facility that elects to register

with FDA as an outsourcing facility is required to report to FDA information about the drugs

compounded at that outsourcing facility in the form and manner as FDA may “prescribe by

regulation or guidance.” Congress gave FDA explicit statutory authority to establish binding

requirements on this topic in guidance. Therefore, this guidance is not subject to the usual

restrictions in FDA's good guidance practice regulations (e.g., the requirements that guidances

not establish legally enforceable responsibilities and that guidances prominently display a

statement of the document's nonbinding effect); see 21 CFR 10.115(d)(1)).

As provided in section 503B of the DQSA, this revised draft guidance explains the form

and manner in which registered outsourcing facilities are required to submit drug reporting

information. This revised draft guidance, when finalized, will prescribe the form and manner for

submitting drug product reports to FDA under section 503B of the FD&C Act and will have

binding effect under section 503B(b)(2)(B). Until this draft guidance is finalized, FDA will

accept drug product reports submitted in accordance with the form and manner described in

FDA’s initial draft guidance on this subject. However, FDA strongly encourages outsourcing

facilities to submit drug product reports as described in this revised draft guidance.

Elsewhere in this issue of the Federal Register, FDA is making available a final guidance

on registration for human drug compounding outsourcing facilities under section 503B of the

FD&C Act.

II. Paperwork Reduction Act

Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520), Federal

Agencies must obtain approval from the Office of Management and Budget (OMB) for each

collection of information that they conduct or sponsor. “Collection of information” is defined in

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44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that

members of the public submit reports, keep records, or provide information to a third party.

Section 3506(c)(2)(A) of the PRA, 44 U.S.C. 3506(c)(2)(A), requires Federal Agencies to

provide a 60-day notice in the Federal Register for each proposed collection of information

before submitting the collection to OMB for approval. To comply with this requirement, FDA is

publishing this notice of the proposed collection of information set forth in this document.

With respect to the collection of information associated with this document, FDA invites

comments on the following topics: (1) Whether the proposed information collected is necessary

for the proper performance of FDA’s functions, including whether the information will have

practical utility; (2) the accuracy of FDA’s estimated burden of the proposed information

collected, including the validity of the methodology and assumptions used; (3) ways to enhance

the quality, utility, and clarity of the information collected; and (4) ways to minimize the burden

of information collected on the respondents, including through the use of automated collection

techniques, when appropriate, and other forms of information technology.

Under the revised draft guidance, registered outsourcing facilities must submit to FDA a

report identifying all drugs compounded by the facility during the previous 6-month period. The

report must be submitted upon initial registration as an outsourcing facility, once in June, and

once in December of each year. The report must include the following information for all drugs

compounded at the outsourcing facility during the previous 6-month period:

• The active ingredient and strength of active ingredient per unit

• The source of the active ingredient (bulk or finished)

• The National Drug Code (NDC) number of the source drug or bulk active

ingredient, if available

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• The dosage form and route of administration

• The package description

• The number of individual units produced

• The NDC number of the final product, if assigned

Product reports must be submitted to FDA electronically in SPL format, as described in

the revised draft guidance. Outsourcing facilities can request a waiver from the electronic

submission process by submitting a written request to FDA explaining why the use of electronic

means is not reasonable for them.

Based on our familiarity with outsourcing facilities, we estimate that annually a total of

approximately 50 outsourcing facilities (“number of respondents” in table 1, row 1) will submit

to FDA at the time of initial registration a report identifying all drugs compounded in the facility.

We also estimate that these outsourcing facilities will submit a total of approximately 50 reports

for compounded drugs containing the information specified in the draft guidance (“total annual

responses” in table 1, row 1). We estimate that preparing and submitting this information

electronically will take approximately 2 hours per report (“average burden per response” in table

1, row 1). We expect to receive no more than one waiver request from this electronic submission

process (“total annual responses” in table 1, row 2), and each request should take approximately

1 hour to prepare and submit to us (“average burden per response” in table 1, row 2).

We also estimate that a total of approximately 50 outsourcing facilities (“number of

respondents” in table 2, row 1) will submit to FDA a report twice each year identifying all drugs

compounded at the facility. We estimate that these outsourcing facilities will submit a total of

approximately 50 reports in December and 50 reports in June containing the information

specified in the draft revised guidance (“total annual responses” in table 2, row 1). We estimate

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that preparing and submitting this information electronically will take approximately 2 hours per

report (“average burden per response” in table 2, row 1). We expect to receive no more than one

waiver request from the electronic submission process (“total annual responses” in table 2, row

2), and each request should take approximately 1 hour to prepare and submit to us (“average

burden per response” in table 2, row 2).

Table 1.--Estimated One-Time Reporting Burden1

Product

Reporting for

Compounding

Outsourcing

Facilities

No. of

Respondents

No. of

Responses per

Respondent

Total Annual

Responses

Average Burden

per Response

Total Hours

Submission of

Initial Product

Report

50

1

50

2

100

Waiver Request

from Electronic

Submission of

Initial Product

Report

1

1

1

1

1

Total

101

1There are no capital costs or operating and maintenance costs associated with this collection of information.

Table 2.--Estimated Annual Reporting Burden1

Product

Reporting for

Compounding

Outsourcing

Facilities

No. of

Respondents

No. of

Responses per

Respondent

Total Annual

Responses

Average Burden

per Response

Total Hours

Submission of

December

Product Report

50

1

50

2

100

Submission of

June Product

Report

50

1

50

2

100

Waiver Request

from Electronic

Submission of

Product Reports

1

1

1

1

1

Total

201

1There are no capital costs or operating and maintenance costs associated with this collection of information.

III. Comments

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Interested persons can submit either electronic comments regarding this document to

http://www.regulations.gov or written comments to the Division of Dockets Management (see

ADDRESSES). It is only necessary to send one set of comments. Identify comments with the

docket number found in brackets in the heading of this document. Received comments can be

viewed at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through

Friday, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

Persons with access to the Internet may obtain the document at either

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm

or http://www.regulations.gov.

Dated: November 18, 2014.

Leslie Kux,

Associate Commissioner for Policy.

[FR Doc. 2014-27691 Filed 11/21/2014 at 8:45 am; Publication Date: 11/24/2014]

Ohio Legislation Relating to State Board of Pharmacy, Controlled Substances and Compounds

LSC 130 1714-7 130th General Assembly Regular Session ...

search-prod.lis.state.oh.us/.../cm_amend_Sub%20HB378_HB378Sub.pdf

13 hours ago - (2) The state board of pharmacy may impose a fine of not more than five thousand ... (1) Dangerous drugs that are compounded or used for the purpose of  

Express Scripts, CVS Health formulary changes affect one in two Americans: harmaceutical manufacturers are in a must play position to have any chance at maintaining a presence in the brand medication market. Posted by Chris Hanson-Ehlinger on Fri, Sep 05, 2014 @ 12:20 PM

In August CVS Caremark (now CVS Health) and Express Scripts released their formulary restrictions, effective January 2015. CVS Health and ESI, which together cover nearly half of all Americans, make formulary decisions that influence roughly 150 million covered lives. Thus, pharmaceutical manufacturers are in a must play position to have any chance at maintaining a presence in the brand medication market.

Here are the highlights of each PBM’s formulary changes and their potential impact on your plan and participants.

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Question of the Day November 21, 2014 How many compounding pharmacies have on-line surveys, questions or online assessments for consumers to answer and then get back results on what might be wrong with them such as adrenal fatigue, hormone issues etc.? Is this a form of practicing medicine without a licence?

New lawsuits filed in connection with meningitis outbreakAn attorney said PainCare gave "bargain-basement medicine" to his clients, and it made them sick | Local News - WMUR Home

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Imprimis Pharmaceuticals, Inc. (IMMY) Thriving through the Art and Science of Compounding Pharmacy

Nov 20, 2014 - 23:54 GMT

If one were to begin a discussion on the history and future of pharmacy, they would not be able to proceed very far without addressing the prominent role pharmacy compounding has played and will play within the industry. Woven throughout thousands of years of history, the pharmacist was the one individual in society who carried the knowledge to prepare drugs from vegetable, animal … (continue reading)

2014 Summer Newsletter USP 800 Summary - Oklahoma Society of Health-System Pharmacists

2014 Summer Newsletter USP 800 Summary - Oklahoma Society of Health-System Pharmacists

Question of the Day November 20, 2014 Does anyone know what happened regarding this complaint filed by Joe Landers at Weatherford Compounding Pharmacy that an employee had stole trade secrets? Was it dismissed? Investigated? Charges Filed?

1300015902 THEFT OF TRADE 

SECRETS

801 Santa Fe Dr Wed, Apr/24 02:42 PM 

Sat, Apr/27 02:42 PM On 04/27/2013 at approximately 1442hrs, I, Officer P. Tumlin 

was dispatched to Weatherford Police Department in 

reference to a theft. Upon arrival I spoke to the complainant 

who was identified as Joe Landers, W/M, age 61. Landers 

reported that a previous employee of his business had 

obtained formulas specific to his pharmacy, and had 

transmitted said information to an outside party without his 

effective consent. 

A theft of trade secrets report was completed. No further 

information at this time.

Complainant: Joe M. 

Landers W/M 61Victim: 

Weatherford Compounding 

Pharmacy

SOURCE FOUND HERE

Letter in Support of FDA Enforcement of Compounding Law November 20, 2014 Drug Safety Project Pew Foundation

November 20, 2014 

Drug Safety Project

On November 20, The Pew Charitable Trusts—joined by the American Public Health Association, the Biotechnology Industry Organization, the Generic Pharmaceutical Association, the Pharmaceutical Research and Manufacturers of America, and Trust for America’s Health—sent a letter to the Food and Drug Administration (FDA) supporting their enforcement of federal law on drug compounding. 

Contaminated compounded steroid injections from a single pharmacy in Massachusetts in 2012 and 2013 were associated with 751 illnesses and 64 deaths across multiple states. Federal law, as updated by the Drug Quality and Security Act of 2013,  will help prevent a repeat of this tragedy, but only if FDA is free to proactively enforce against illegal compounding activity.

Download the Letter (PDF)