Where To Purchase Paregoric (Page 2)

I've used Paregoric for 15 years and can't find it. Is there anywhere in the U.S. or other countries where this can be purchased?

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When my son was an infant the Dr presribed paregoric for him because he was throwing up his milk. So I would put a few drops in his bottle. Worked like a charm. I had a huge bottle left over. I was shoved to the back of the bathroom closet, forgot all about it.

Eight years ago my husband passed away from cancer, so I started cleaning out his medicines and came across the paregoric and thought it usless since it was from 1978. Poured it out and took all the cancer drugs to the pharmacy to be disposed of. When I told my pharmacist about it she said OMG! I thought I was in trouble because I poured it out, she said you poured out liquid gold that you can't get anymore. It never goes bad.

So the Brazil angle is interesting. My son goes fishing there every couple years with about 10 of his friends. So maybe that might be an option if any one knows of someone that goes there. Ask around in your community, it's more popular than people realize.

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A family member mentioned how we used to take paregoric as kids and I googled it. Now I know it's off the market. Seriously, though, you must not criticize the FDA. After all, in order to get on the FDA you have to have been thrown out of Freddie Mac for stupidity!LOL.

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OUR LIQUID GOLD, GONE! I HAVE A PROBLEM WITH MSG, HOW ABOUT TAKING THAT OFF THE MARKET. I CAN NO LONGER GO OUT TO EAT. FDA U-SUCK. WE NEED TO RALLY, CONTACT EVERYONE WE CAN, FDA, DR. PHILL. DR. OZ, THE DOCTORS ETC. FDA IN THEIR REPORT AS TO WHY, " IT'S A NEW DRUG NOT RESEARCHED" BULLSHIP, MUST BE A YOUNEN THAT WROTE THE REPORT. THE NAME OF THE FDA MEMBER IS IN THE REPORT, I THINK WE ALL NEED TO MAKE A CALL! OR MAYBE TO MRS. OBAMA, SHES A MOTHER. MAYBE SHE CAN HELP.

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GYPSEY, GOOD FOR YOU, DO YOU NEED A NEW BEST FRIEND WITH THE SAME INTERESTS? LOL

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I was able to buy it over the counter in Freeport Grand Bahama about 15 years ago. I recently went on a cruise to Nassau in the Bahamas and tried a couple of local drug stores with no luck. Perhaps Freeport might be better. I do remember the product was made in Jamaica though so if anyone knows anyone who travels to Jamaica, you can ask.

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I would be one who would gladly protest the taking off the market of one drup that allowed me not to be afraid to leave the bathroom. I've tried many other drugs to no avail and I don't know anyone going over seas. If you could send me a protest letter, I'd glad sign it.

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Carol, I WISH I NEW HOW TO PUT THAT TOGETHER. MAYBE IF WE ALL SENT E-MAILS TO THE FDA IT WOULD HELP. IF YOU GO TO THE WEB SITE POSTED AT THE BOTTOM ID THE NAME OF THE FDA REP. TO CONTACT. I WILL SEND ONE SOON.
fda.gov/ICECI/EnforcementActions/WarningLetters/ucm219984.htm

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CAROL, I JUST SENT A LETTER TO THE FDA STATING MY DISPLEASURE (EVERYONE'S) AS TO THE DISCONTINUATION OF PAREGORIC. SO I GUESS WE'LL SEE IF ANYONE REPLY'S.

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I am just devastated that Paregoric is no longer available, I too have taken this wonder drug for as long as I can remember. Never left home with out it. Now I can just never leave home, THANKS A WHOLE LOT FDA... I AGREE YOU SUCK!! I am still searching for a way to get my Liquid Gold!

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Laura, I would be glad to know if you have had any reply from FDA?

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That's wonderful, Laura. I'm glad someone, such as yourself, has notified the FDA about taking this drug (and our "normal" life away. Please keep me posted and thanks...beyond words....for stepping forward for all of us sufferers!

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well folks this is what i got from the FDA!

-----Original Message-----
From: [email protected] [mailto:[email protected]]
Sent: Thursday, February 16, 2012 7:52 PM
To: CDER DRUG INFO
Subject: DrugInfo Comment Form FDA/CDER Site

Feb 19 (7 days ago)

to me
Dear Laura:

Thank you for your message to the Center for Drug Evaluation and Research (CDER), one of the seven centers within the Food and Drug Administration (FDA).

Although tincture of opium products have been around for a long time, there are no opium tincture products FDA approved. Such unapproved drugs are subject to our Unapproved Drug Initiative. Please allow me to provide you with some background on this initiative.

The Federal Food, Drug, and Cosmetic Act (the Act) requires that drugs marketed in the United States be shown to be both safe and effective prior to marketing. The FDA's evidence-based system of drug approval plays an essential role in ensuring that drugs meet these requirements. The regulatory process provides vital public health benefits by assisting consumers to avoid drugs that are ineffective or carry risks that outweigh their benefits.

The mission of CDER is to promote and protect the public health by ensuring that safe and effective drugs are available to Americans. FDA's drug approval process ensures that drugs have been shown to be safe, effective, of suitable quality and purity, and properly labeled.
To more fully understand why unapproved drugs continue to be marketed, it is helpful to understand the background of drug regulation in the United States. Prior to 1906, there was no drug regulation of any kind in this country. Legislation passed in that year and subsequently amended in 1938 mandated, for the first times in our history, that drugs marketed in the United States carry accurate labeling, make no false claims, and be approved for safety. Additional legislation passed in 1962 required that all marketed drugs also be approved for efficacy (intended therapeutic effect when used as directed and labeled). This legislation established that efficacy be evaluated and confirmed for all drugs introduced into the marketplace after 1938.

Since drugs approved between 1938 and 1962 were approved for safety only, Congress directed FDA to complete efficacy evaluations of drugs approved within this time span, all of which remained on the market during the evaluation period. These initial evaluations took several years to complete, during which time thousands of additional drugs entered the market. Many of these drugs were not assessed for safety and efficacy and were considered unapproved products that were therefore marketed illegally. This continues to be the case for certain drugs, including tincture of opium drugs that have not been evaluated through any of the FDA approval mechanisms or have not sought a formal exemption from the FDA.

To address this issue in a proactive, organized, and comprehensive manner, the FDA launched its unapproved drugs initiative in 2006. The principal goal of this effort is to either remove unapproved drugs from the market or have manufacturers of those products submit the necessary information for FDA evaluation. In tandem with the initiative launch, the Agency issued its final Compliance Policy Guide ("Marketed Unapproved Drugs-Compliance Policy Guide," available online at: fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070290.pdf, which outlines FDA enforcement policies aimed at bringing unapproved drugs into the approval process in a rational and fair manner.

The FDA is using a risk-based enforcement program in order to concentrate its resources on those products that pose the greatest threat to public health, and to avoid imposing undue burdens on consumers and health care professionals or unnecessarily disrupting the market. Please visit the following website for further information about the initiative and Agency priorities: fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/ucm118990.htm.

The FDA has taken numerous enforcement actions against companies that market unapproved drugs. A list of companies and products that have been successfully targeted by enforcement action under the unapproved drugs initiative can be found at:
fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/default.htm. You may notice that tincture of opium is not on the "Enforcement Actions by Drug Class" list and that Hi Tech is not on the "Enforement Actions by Firm" list. It appears that this drug and company were not specificily target, but such actions were a result of GMP violations observed via a routine inspection fda.gov/ICECI/EnforcementActions/WarningLetters/2010/ucm219984.htm.

In addition to the specific enforcement actions listed above, the Agency has been working with many manufacturers of unapproved drugs to encourage voluntary compliance with the drug approval requirements. As a result, numerous manufacturers are now actively pursuing approval for their unapproved drugs. In addition, some unapproved drugs have also been voluntarily discontinued by manufacturers. The Agency intends to systematically and responsibly ensure that all products on the U.S. drug market become compliant with current FDA approval requirements for safety and efficacy.

The Agency will continue to ensure that all prescription drugs are safe, effective, high quality, and properly labeled by encouraging companies to comply with FDA approval requirements. We ask your support in this important initiative.

Sincerely,

Division of Drug Information
D202D

This communication is consistent with 21 CFR 10.85 (k) and constitutes an informal communication that represents our best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.

For up-to-date drug information, follow the FDA's Division of Drug Information on Twitter twitter.com/fda_drug_info

CDER has made it easier for small business to interact with the Agency via our Small Business Assistance contacts:

E-mail: [email protected]
Phone: 866-405-5367 or 301-796-6707
Website: fda.gov/smallbusinessdrugs

WIDGET: fda.gov/Drugs/ucm153379.htm

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Thanks Laura for sharing you reply from the FDA. After reading this, does it mean there is a chance after we all suffer for years to come it could be approved again?

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I HAVE NO CLUE! WE'LL ALL HAVE TO KEEP WORKING ON IT.

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I can only agree with you that there is nothing that works as well for diarrhea, especially when it is caused by an intestinal or stomach flu. I have Irritable Bowel Syndrome, and have constant difficulties between diarrhea and constipation. My Dr. says that is part of the illness. But a stomach flu is not an often occurrence. When I do have it, NOTHING stops the diarrhea & the stomach ache. Paragoric did. I hate that it can't be found anymore.

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Here's a prayer that the manufacture of Paregoric will get it approved thru the FDA. Does any one know who the manufacture is? I will call them if I can find out.

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I hope that the manufacture of Paregoric will get it approved through the FDA. Does any one know who the manufacture is? I will call them if I can find out.

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Laura hope this will help, this is the manfg. Hi-Tech Pharmacal Co., Inc. 6/28/10

Department of Health and Human Services' logoDepartment of Health and Human Services
Public Health Service
Food and Drug Administration
New York District
158-15 Liberty Ave
Jamaica, NY 11433


June 28, 2010

WARNING LETTER NYK-2010-21

VIA UPS

David Seltzer, President/CEO
Hi-Tech Pharmacal Co., Inc.
369 Bayview Avenue
Amityville, NY 11701

Dear Mr. Seltzer:

During our October 21, 2009 through December 3, 2009 inspection of your pharmaceutical manufacturing facility located at 369 Bayview Avenue, Amityville, NY 11701, Investigators from the Food and Drug Administration (FDA) identified significant violations of Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals, Title 21, Code of Federal Regulations, Parts 210 and 211. These violations cause your drug products to be adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 351(a)(2)(B)] in that the methods used in, or the facilities or controls used for their manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with CGMP.

In addition, your firm manufactures a prescription drug without an approved application. As described below, this drug is an unapproved new drug without an approved application, and by introducing it into interstate commerce, you are in violation of sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d) and 355(a)]. This unapproved new drug is misbranded pursuant to section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], and by introducing it into interstate commerce you are in violation of section 301(a) of the Act [21 U.S.C. § 331(a)].

Specific violations observed during the inspection include, but are not limited, to the following:

CGMP Violations

1. Your firm failed to establish laboratory control mechanisms to include the detennination of conformance to applicable written specifications for the acceptance of each lot within each shipment of components used in the manufacture, processing, packing, or holding of drug products [21 C.F.R.§ 211.160(b)(1)].

For example, lot 26910 of Prednisolone API failed to meet the acceptance specifications for two unknown impurities and was released. This lot was used to manufacture (b)(4) distributed lots of Prednisolone Oral Solution drug product. Your firm's out of specification (OOS) investigation (b)(4) states the initial samples of this lot yielded OOS results for two unknown impurities. Although the lot was re-sampled and retested as a part of the OOS investigation, results from the retest failed and your firm failed to reject the lot as required by your SOP P-14-04. Your firm continued to resample and retest until test results met the acceptance specifications. Your firm's investigation report attributed the OOS results to probable glassware contamination or instability of the sample solution, even though there was no scientific evidence to support these conclusions. Furthermore, your firm's own laboratory management stated that glassware contamination and instability of solutions did not cause the OOS result in an email dated February 18, 2009.

2. Your firm has not established scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure drug products conform to appropriate standards of identity, strength, quality, and purity [21 C.F.R. § 211.160(b)].

For example,

a. Your firm failed to perform residual solvent testing for (b)(4) drug products (including Paregoric Liquid USP and Prednisolone Oral Solution USP) which used API's that were manufactured using solvents that are required to be limited in drug products.

b. Your firm failed to dry in-house reference standards or determine the water content of those standards before use in analyzing your drug products. Your firm uses in-house reference standards on an "as-is" basis without drying or determining water content before use. Your firm then assigns the in-house reference standards an "as-is" purity factor with a one year expiration date as required by your SOP QC-057-05. However, there is no data to demonstrate that these "as-is" purity factors will remain accurate over the one-year expiry period of the standard. Your use of these "as-is" purity factors have resulted in erroneous assay calculations for your drug products.

For example, your firm failed to determine the anhydrous purity factor of Riboflavin 5' Phosphate Sodium (Vitamin B2), Lot 26630 standard as required by your SOP. Your firm used the anhydrous purity factor from the supplier's certificate of analysis (COA), which became the "as-is" reference standard. Because you used this "as-is" purity factor instead of drying the standard or using a loss-on-drying factor, your calculations for the assay of Poly-Vitamin Drops, Lot 602774 resulted in a (b)(4) % error.

c. Your firm failed to confirm the normality factors provided by suppliers for commercially prepared volumetric solutions. Your firm purchases commercially prepared volumetric solutions and uses the normality factors supplied on the certificates of analysis without verification testing to confirm the accuracy of the supplier's results.

3. Your firm has not recorded and justified any deviation from the written specifications, standards, sampling plans, test procedures or other laboratory control mechanisms [21 C.F.R. § 211.160(a)).

For example, your firm failed to follow your SOP QC-057-05 for expiration dating of "in-house" reference standards. Your firm uses Riboflavin 5' Phosphate Sodium (Vitamin B2) raw material as a standard for the analysis of Poly-Vitamin Drop products. It is classified as a non-compendial reference standard and assigned a two-year expiration date, even though this substance is a compendial (USP) product and should be assigned as a "in-house" standard with a one-year expiration date, according to your SOP.

4. Your firm failed to establish and document the accuracy, sensitivity, specificity, and reproducibility of test methods [21 C.F.R. § 211.165(e)].

For example,

a. Your firm failed to validate methods used for the assay analysis of six Poly-Vitamin Drop products, four Tri-Vitamin Drop products, and Sodium Fluoride Drops.

b. Your firm failed to include the following characteristics: accuracy, robustness, ruggedness and specificity in your validation of the UPLC assay method (b)(4) used for the analysis of Pyridoxine Hydrochloride (Vitamin B6), Riboflavin 5' Phosphate Sodium (Vitamin B2) and Thiamine Hydrochloride (Vitamin B1) in Poly-Vitamin Drop products.

c. Your firm failed to generate and document chromatographic data to support the validation of the analytical method (b)(4) used for determination of Urea in Urea Cream 40%. In addition, your firm failed to generate and document chromatographic data to support stress studies for Paregoric Liquid USP to demonstrate that the method is suitable for determining stability.

5. Your firm does not have adequate written procedures for production and process controls designed to assure that the drug products you manufacture have the identity, strength, quality, and/or purity they purport or are represented to possess [21 C.F.R. § 211.100].

Your firm failed to complete the process validation studies for the following four prescription drug products:

1. Tri-Vitamin Drops with Iron and Fluoride 0.25mg
2. Poly-Vitamin Drops with Fluoride 0.25mg
3. Tri-Vitamin Drops with Fluoride 0.50mg
4. Tri-Vitamin Drops with Fluoride 0.25mg

For example, there are no batch records with the original data and test results for the validation study of Poly-Vitamin Drops with Fluoride 0.25mg and Tri-Vitamin Drops with Fluoride 0.25mg. In addition, you implemented revisions to your master formula without adequate change control. Evaluation of the data and records associated with the manufacture of Poly-Vitamin Drops with Fluoride 0.25mg and Tri-Vitamin Drops with Fluoride 0.50mg was not available to assure that the changes made to the batch records (revisions to the master formula) do not impact the product quality.

6. Your firm does not have, for each batch of drug product, an appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release [21 C.F.R. § 211.165(a)].

For example, your firm failed to perform analytical testing for the following active ingredients to determine conformance to their assay specifications:

1. Vitamin D in Poly-Vitamin Drops with Iron and Poly-Vitamin Drops with Iron and Fluoride 0.25mg
2. Vitamin D and B12 in Poly-Vitamin Drops with Fluoride 0.50mg and Poly-Vitamin Drops with Fluoride 0.25mg

7. Your firm has not conducted at least one specific identity test and has not established the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals [21 C.F.R. § 211.84(d)(2)].

For example, your firm failed to establish the reliability of your suppliers' test results. Specifically, verification of a supplier's residual solvent test results for excipients is limited to testing of only one lot of material to confirm the accuracy of the supplier's test results.

Unapproved and Misbranded Prescription Drug

In addition to the CGMP violations, discussed above, you manufacture and market an unapproved new drug in violation of the Act at your facility. Based on the information your firm submitted to FDA's Drug Registration and Listing System and the information collected during the inspection, you manufacture the following prescription drug:

• Paregoric Liquid, USP (Anhydrous Morphine 2 mg, Alcohol 47.7%)

The above product is a drug within the meaning of Section 201 (g) ofthe Act, [21 U.S.C. 321(g)] because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases. Further, it is a "new drug" within the meaning of Section 201(P) of the Act [21 U.S.C. § 321(P)] because it is not generally recognized as safe and effective for its labeled uses. Under Sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d) and 355(a)] a new drug may not be introduced into or delivered for introduction into interstate commerce unless an application approved by FDA under either section 505(b) or (j) of the Act [21 U.S.C. § 355(b) or [j] is in effect for the drug. Based on our information, you do not have any FDA-approved applications on file for this drug product.

Additionally, under Section 301(a) of the Act [21 U.S.C. § 331(a)], it is prohibited to introduce into or deliver for introduction into interstate commerce a misbranded drug. The above product is misbranded because, as a prescription drug, adequate directions cannot be written for it so that a layman can use this product safely for its intended uses. Consequently, its labeling fails to bear adequate directions for use as required under Sections 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] and because it lacks a required approved application, it is not exempt from this requirement under 21 C.F.R. § 201.115.

The introduction or delivery for introduction into interstate commerce of adulterated and misbranded drugs or products without approved new drug applications violates Sections 301(a) and (d) of the Act [21 U.S.C. §§ 331(a) and (d)]. Therefore, you should discontinue manufacturing and distributing all of your unapproved drugs at all facilities immediately. We acknowledge the letter from your consultant, (b)(4) dated November 5, 2009, who provided your firm an opinion on the regulatory analysis of your products. Based on our information, you do not have any FDA-approved applications on file for those drug products.

The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facility. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence and the occurrence of other violations. It is your responsibility to assure compliance with all requirements of federal law and FDA regulations.

You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice including, without limitation, seizure and injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts. Additionally, FDA may withhold approval of requests for export certificates, or approval of pending drug applications listing your facility, until the above violations are corrected. FDA may re-inspect to verify corrective actions have been completed.

As stated above, you must cease manufacturing and distributing all your unapproved new drug products. Within fifteen working days of receipt of this letter, you should notify this office to arrange for a meeting to discuss the specific steps you have taken to correct the noted violations. Include an explanation of each step being taken to prevent the recurrence of violations and copies of supporting documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the date by which you will have completed the correction. We also request that you outline the action you are taking to discontinue the marketing of the unapproved drug product at your facility, or any other applicable drugs which you may market. Additionally, your response should state if you no longer manufacture or distribute products, and provide the date(s) and reason(s) you ceased production. Please note that if you are no longer marketing this (these) product(s), you must update the Drug Listing files in accordance with 21 C.F.R. § 207.30(a)(2).

Your reply should be sent to the following address: Compliance Branch, Food and Drug Administration, 158-15 Liberty Avenue, Jamaica, NY 11433. Attention: Lillian C. Aveta, Compliance Officer.


Sincerely,

/s/


Ronald M. Pace
District Director
New York District

Enclosure: Fonn FDA 483 dated December 3,2009



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im told nowhere in the us, but possibly in brazil

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Thank Laura

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