| Exempt Prescription Products |
2/21/2020 |
|||||
| Company | Trade Name | NDC Code | Form | Controlled Substance |
(mg or mg/ml) |
|
| Mikart, Inc. | Tencon (Butalbital and Acetaminophen 50mg/325mg) | 11584-0030 | TB | Butalbital |
50.00 |
|
| Mikart, Inc./Shionogi, Inc. | Dolgic Plus Tablets | 59630-074 | TB | Butalbital |
50.00 |
|
| Moore Medical Corporation | Antispasmodic Tabs | 00839-5055 | TB | Phenobarbtal |
16.20 |
|
| Moore Medical Corporation | Butalbital, Acetaminophen and Caffeine Tablets | 00839-7831 | TB | Butalbital |
50.00 |
|
| Morton Grove Pharmaceuticals, Inc. | Antispasmodic Elixir | 60432-0009 | EL | Phenobarbital |
3.24 |
|
| Nejo Pharmaceutical | Spasmalones | 00653-0002 | TB | Phenobarbital |
16.00 |
|
| Nexgen Pharma | BUPAP (Butalbital and Acetaminophen 50mg/300mg) | 0095-3000 | TB | Butalbital |
50.00 |
|
| Nexgen Pharma | Butalbital with Acetaminophen and Caffeine Tablets | 0722-7029 | TB | Butalbital |
50.00 |
|
| Nexgen Pharma | Butalbital, Acetaminophen and Caffeine Tablets(50mg/325mg/40mg) | 0722-7320 | TB | Butalbital |
50.00 |
|
| Northampton Medical, Inc. | FEMCET | 58436-0703 | TB | Butalbital |
50.00 |
|
| Oceanside Pharmaceuticals (Manufactured by Nexgen) | Butalbital and Acetaminophen Tablets (50mg/300mg) | 68682-306 | TB | Butalbital |
50.00 |
|
| Parke-Davis & Co | Dilantin with Phenobarbital 1/2 | 00071-0531 | CA | Phenobarbital |
32.00 |
|
| Parke-Davis & Co | Dilantin with Phenobarbital 1/4 | 00071-0375 | CA | Phenobarbital |
16.00 |
|
| Parke-Davis & Co | Tedral SA | 00071-0231 | XT | Phenobarbital |
25.00 |
|
| Parmed Pharmaceutical | Sedapar Elixir | 00349-4100 | EL | Phenobarbital |
3.24 |
|
| Parmed Pharmaceutical | Sedapar Tablets | 00349-2355 | TB | Phenobarbital |
16.20 |
|
| Pasadena Research | Seds | 00418-4072 | TB | Phenobarbital |
16.20 |
|
| PD-Rx Pharmaceuticals, Inc. | Butalbital/APAP/Caffeine Tablets (50mg/325mg/40mg) | 55289-0879 | TB | Butalbital |
50.00 |
|
| PD-Rx Pharmaceuticals, Inc. | Donnatal Tablets | 43063-601 | TB | Phenobarbital |
16.20 |
|
| Pecos Pharmaceuticals | Phenobel Extentabs | 59879-0110 | TB | Phenobarbital USP |
48.60 |
|
| Pernix Therapeutics | Chlordiazepoxide HCL/ Clidinium Bromide Capsules | 44183-0401 | CA | Chlordiazepoxide HCl |
5.00 |
|
| Pharmaceutical Basics Inc | Butalbital, Acetaminophen and Caffeine Tablets | 00832-1102 | TB | Butalbital |
50.00 |
|
| Pharmaceutical Basics Inc | Clinibrax Capsules | 00832-1054 | CA | Chlordiazepoxide HCl |
5.00 |
|
| PharmaTech LLC (Manufactured for Virtus Pharmaceutical) | Chlordiazepoxide HCL and Clidinium Bromide Capsules | 76439-302 | CA | Chlordiazepoxide HCl |
5.00 |
|
| Phlight Pharma, LLC. | Allzital (Butalbital and Acetaminophen Tablets (25 mg/325 mg)) | 70569-150 | TB | Butalbital |
25.00 |
|
| Pioneer Pharmaceuticals, Inc. | Chlordiazepoxide HCL/ Clidinium Bromide Capsules | 60104-4009 | CA | Chlordiazepoxide HCl |
5.00 |
|
| Poly Pharmaceuticals, Inc. | Alagesic | 50991-0302 | CA | Butalbital |
50.00 |
|
| Poythress & Co Inc | Antrocol | 00095-0041 | CA | Phenobarbital |
16.00 |
|
| Poythress & Co Inc | Antrocol Elixir | 00095-0042 | EL | Phenobarbital |
3.00 |
|
| Poythress & Co Inc | Antrocol Tablets | 00095-0040 | TB | Phenobarbital |
16.00 |
|
| Poythress & Co Inc | Mudrane | 00095-0050 | TB | Phenobarbital |
8.00 |
|
| Poythress & Co Inc | Mudrane GG Elixir | 00095-0053 | EL | Phenobarbital |
0.50 |
|
| Poythress & Co Inc | Mudrane GG Tablets | 00095-0051 | TB | Phenobarbital |
8.00 |
|
| Prasco Laboratories | Phenobarbital, Hyoscyamine, Atropine, Scopolamine Tablets | 66993-117 | TB | Phenobarbital |
16.20 |
|
| Prasco Laboratories | Phenobarbital, Hyoscyamine, Atropine, Scopolamine Elixir (Grape) | 66993-118 | EL | Phenobarbital |
16.20 |
|
| Prasco Laboratories | Phenobarbital, Hyoscyamine, Atropine, Scopolamine Elixir (Mint) | 66993-119 | EL | Phenobarbital |
16.20 |
|
| Private Formula Inc | Sangesic | 00511-1627 | TB | Butalbital |
30.00 |
|
| Qualitest Pharmaceuticals, Inc. | Butalbital and Acetaminophen Tablets | 0603-2540 | TB | Butalbital |
50.00 |
|
| Qualitest Pharmaceuticals, Inc. | Butalbital, Acetaminophen and Caffeine Tablets 50/325/40mg | 0603-2544 | TB | Butalbital |
50.00 |
|
| Qualitest Pharmaceuticals, Inc. | Butalbital, Acetaminophen and Caffeine Tablets USP | 0603-2547 | TB | Butalbital |
50.00 |
8
| Exempt Prescription Products |
2/21/2020 |
|||||
| Company | Trade Name | NDC Code | Form | Controlled Substance |
(mg or mg/ml) |
|
| Qualitest Pharmaceuticals, Inc. | Butalbital, Acetaminophen and Caffeine Tablets, USP | 0603-2551 | TB | Butalbital |
50.00 |
|
| Qualitest Pharmaceuticals, Inc. | Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules | 0603-2714 | CA | Chlordiazepoxide |
5.00 |
|
| Qualitest Products Inc | Butalbital, Acetaminophen and Caffeine Tablets | 52446-0544 | TB | Butalbital |
50.00 |
|
| Qualitest Products Inc | Chlordiazepoxide HCl 5 mg and Clidinium Br 2.5 mg | 52446-0096 | CA | Chlordiazepoxide HCl |
5.00 |
|
| Redi-Med | Butalbital Compound Capsules | 53506-0103 | CA | Butalbital |
50.00 |
|
| Richlyn Laboratories | Aminophylline & Phenobarbital | 00115-2156 | ET | Phenobarbital |
15.00 |
|
| Richlyn Laboratories | Aminophylline & Phenobarbital Tablets | 00115-2154 | TB | Phenobarbital |
15.00 |
|
| Richlyn Laboratories | Bellophen | 00115-2400 | TB | Phenobarbital |
16.20 |
|
| Richlyn Laboratories | Spasmolin | 00115-4652 | TB | Phenobarbital |
15.00 |
|
| Richwood Pharmaceutical Co., Inc. | Bellatal Tablets | 58521-0162 | TB | Phenobarbital, USP |
16.20 |
|
| Roberts Pharmaceutical Corporation | Anoquan | 54092-0178 | TB | Butalbital |
50.00 |
|
| Roberts Pharmaceutical Corporation | Tencet Tablets | 59441-0153 | TB | Butalbital |
50.00 |
|
| Robins A H Co Inc | Donnatal Capsules | 00031-4207 | CA | Phenobarbital |
16.20 |
|
| Robins A H Co Inc | Donnatal Extentabs | 00031-4235 | XT | Phenobarbital |
48.60 |
|
| Robins A H Co Inc | Donnatal No 2 | 00031-4264 | TB | Phenobarbital |
32.40 |
|
| Robins A H Co Inc | Donnazyme | 00031-4649 | ET | Phenobarbital |
8.10 |
|
| Roche Labs | Menrium 10-4 | 00140-0025 | TB | Chlordiazepoxide |
10.00 |
|
| Roche Labs | Menrium 5-2 | 00140-0023 | TB | Chlordiazepoxide |
5.00 |
|
| Roche Labs | Menrium 5-4 | 00140-0024 | TB | Chlordiazepoxide |
5.00 |
|
| Rondex Laboratories | Antispasmodic | 00367-4118 | TB | Phenobarbital |
16.20 |
|
| Rotex Pharmaceuticals, Inc. | Rogesic Capsules | 31190-0008 | CA | Butalbital |
50.00 |
|
| Ruckstuhl Co | Sedarex No 3 | 00144-1575 | TB | Phenobarbital |
16.20 |
|
| Rugby Laboratories Inc | Butalbital, Acetaminophen and Caffeine Tablets, USP | 0536-5567 | TB | Butalbital |
50.00 |
|
| Rugby Laboratories Inc | Ergocaff-PB Tablets | 00536-3801 | TB | Pentobarbital Sodium |
30.00 |
|
| Rugby Laboratories Inc | Hyosophen Capsules | 00536-3926 | CA | Phenobarbital |
16.00 |
|
| Rugby Laboratories Inc | Hyosophen Tablets | 00536-3920 | TB | Phenobarbital |
16.20 |
|
| Rugby Laboratories Inc | ISOCET Tablets | 00536-3951 | TB | Butalbital |
50.00 |
|
| Rugby Laboratories Inc | Theodrine Tablets | 00536-4648 | TB | Phenobarbital |
8.00 |
|
| Russ Pharmaceuticals, Inc. | FEMCET Capsules | 50474-0703 | CA | Butalbital |
50.00 |
|
| Sandoz Pharmaceuticals | Belladenal | 00078-0028 | TB | Phenobarbital |
50.00 |
|
| Sandoz Pharmaceuticals | Belladenal-S | 00078-0027 | XT | Phenobarbital |
50.00 |
|
| Sandoz Pharmaceuticals | Bellergal-S | 00078-0031 | XT | Phenobarbital |
40.00 |
|
| Sandoz Pharmaceuticals | Cafergot P-B Suppository | 00078-0035 | SU | Pentobarbital |
60.00 |
|
| Sandoz Pharmaceuticals | Cafergot P-B Tablets | 00078-0036 | TB | Pentobarbital Sodium |
30.00 |
|
| Savage Laboratories | AXOTAL | 00281-1301 | TB | Butalbital |
50.00 |
|
| Schein Henry Inc | Antispasmodic | 00364-0020 | TB | Phenobarbital |
16.00 |
|
| Schein Henry Inc | Antispasmodic Elixir | 00364-7002 | EL | Phenobarbital |
3.20 |
|
| Schein Henry Inc | Isolate Compound Elixir | 00364-7029 | EL | Phenobarbital |
0.40 |
|
| Schein Henry Inc | T-E-P | 00364-0266 | TB | Phenobarbital |
8.10 |
|
| Schein Pharmaceutical, Inc. | Chlordiazepoxide HCl and Clidinium Bromide Capsules | 00364-0559 | CA | Chlordiazepoxide Hydrochloride |
5.00 |
9
| Exempt Prescription Products |
2/21/2020 |
|||||
| Company | Trade Name | NDC Code | Form | Controlled Substance |
(mg or mg/ml) |
|
| Shoals Pharmaceuticals, Inc. | Tencet | 47649-0370 | TB | Butalbital |
50.00 |
|
| Shoals Pharmaceuticals, Inc. | Tencet Capsules | 47649-0560 | CA | Butalbital |
50.00 |
|
| Skylar Laboratories, LLC | Allzital (Butalbital and Acetaminophen Tablets) (25 mg/325 mg) | 70362-722 | TB | Butalbital |
25.00 |
|
| Skylar Laboratories, LLC | Butalbital and Acetaminophen Tablets (50 mg/325 mg) | 70362-721 | TB | Butalbital |
50.00 |
|
| Solubiomix | Butalbital and Acetaminophen Tablets (50 mg/325 mg) | 69499-302 | TB | Butalbital |
50.00 |
|
| Solubiomix | Butalbital and Acetaminophen Capsules (50 mg/300 mg) | 69499-342 | CA | Butalbital |
50.00 |
|
| Stewart Jackson Pharmacal, Inc. | Ezol | 45985-0578 | CA | Butalbital |
50.00 |
|
| STI Pharma, LLC | Butalbital and Acetaminophen Tablets (50 mg/325 mg) | 54879-026 | TB | Butalbital |
50.00 |
|
| Stuart Pharmaceutical | Kinesed | 00038-0220 | TB | Phenobarbital |
16.00 |
|
| Sunrise Pharmaceuticals, Inc. | Butalbital, Acetaminophen, Caffeine Capsules (50 mg/300 mg/40mg) | 11534-187 | CA | Butalbital |
50.00 |
|
| Superpharm Laboratories | Chlordiazepoxide HCl & Clidinium Br | 57247-1003 | CA | Chlordiazepoxide HCl |
5.00 |
|
| Tedor Pharma, Inc. | Butalbital and Acetaminophen Tablets (50 mg/300 mg) | 47781-534 | TB | Butalbital |
50.00 |
|
| Tedor Pharma, Inc. | Butalbital and Acetaminophen Tablets (50 mg/325 mg) | 43199-053 | TB | Butalbital |
50.00 |
|
| Tedor Pharma, Inc. (Manufactured for Xspire Pharma) | Butalbital, Acetaminophen and Caffeine Caps (50mg/300mg/40mg) | 42195-955 | CA | Butalbital |
50.00 |
|
| Teva Pharmaceuticals | Chlordiazepoxide HCl & Clidinium Bromide Caps USP (5mg/2.5mg) | 0093-3653 | CA | Chlordiazepoxide HCl |
5.00 |
|
| Towne Paulsen & Co | T.E. P. | 00157-0980 | TB | Phenobarbital |
8.00 |
|
| Trimen Labs | Amaphen Capsules (reformulated) | 11311-0954 | CA | Butalbital |
50.00 |
|
| Truxton C O Inc | Atropine Sulfate with Phenobarbital | 00463-6035 | TB | Phenobarbital |
15.00 |
|
| Truxton C O Inc | Ephedrine with Phenobarbital | 00463-6086 | TB | Phenobarbital |
15.00 |
|
| Truxton C O Inc | Spastemms Elixir | 00463-9023 | EL | Phenobarbital |
3.24 |
|
| Truxton C O Inc | Spastemms Tablets | 00463-6181 | TB | Phenobarbital |
15.00 |
|
| U.S. Pharmaceuticals | Medigesic Capsules | 52747-0600 | CA | Butalbital |
50.00 |
|
| UAD Laboratories Inc | Bucet Capsules | 00785-2307 | CA | Butalbital |
50.00 |
|
| UDL Laboratories | Belladonna Alkaloids with Phenobarbital | 51079-0168 | TB | Phenobarbital |
16.20 |
|
| United Research Laboratories, Inc. | Bel-Tabs | 00677-1171 | TB | Phenobarbital |
40.00 |
|
| United Research Laboratories, Inc. | Chlordiazepoxide HCl and Clidinium Bromide Capsules | 00677-1247 | CA | Chlordiazepoxide Hydrochloride |
5.00 |
|
| United Research Laboratories, Inc. | Hapanol | 00677-0074 | TB | Phenobarbital |
16.20 |
|
| United Research Laboratories, Inc. | Theophylline #1 Tablets | 00677-0148 | TB | Phenobarbital |
8.00 |
|
| University of Iowa | Bladder Mixture Plus Phenobarbital | 11326-1624 | LQ | Phenobarbital |
2.92 |
|
| US Pharmaceuticals Inc | Medigesic Tablets | 52747-0311 | TB | Butalbital |
50.00 |
|
| Vale Chemical Co | Alkaloids of Belladonna and Phenobarbital | 00377-0527 | TB | Phenobarbital |
16.20 |
|
| Vale Chemical Co | Antispas | 00377-0622 | TB | Phenobarbital |
16.20 |
|
| Vale Chemical Co | Barbeloid (Revised) Green | 00377-0365 | TB | Phenobarbital |
16.20 |
|
| Vale Chemical Co | Barbeloid Yellow | 00377-0498 | TB | Phenobarbital |
16.20 |
|
| Vale Chemical Co | Charspast | 00377-0500 | TB | Phenobarbital |
16.20 |
|
| Vale Chemical Co | Digestokraft | 00377-0460 | TB | Butabarbital Sodium |
8.00 |
|
| Vale Chemical Co | Ephedrine & Sodium Phenobarbital | 00377-0109 | TB | Phenobarbital Sodium |
16.20 |
|
| Vale Chemical Co | Panzyme | 00377-0491 | TB | Phenobarbital |
8.10 |
|
| Vale Chemical Co | Pulsaphen | 00377-0652 | TB | Phenobarbital |
15.00 |
|
| Vale Chemical Co | Truxaphen | 00377-0541 | TB | Phenobarbital |
16.20 |
10
| Exempt Prescription Products |
2/21/2020 |
|||||
| Company | Trade Name | NDC Code | Form | Controlled Substance |
(mg or mg/ml) |
|
| Vale Chemical Co | Wescophen S-II | 00377-0628 | TB | Phenobarbital |
30.00 |
|
| Vale Chemical Co | Wesmatic Forte | 00377-0426 | TB | Phenobarbital |
8.10 |
|
| Valeant Pharmaceuticals | Phrenilin Forte | 0187-0844 | CA | Butalbital |
50.00 |
|
| Valeant Pharmaceuticals International | Librax (Chlordiazepoxide HCl and Clidinium Bromide) Capsules | 0187-4100 | CA | Chlordiazepoxide HCl |
5.00 |
|
| Valeant Pharmaceuticals Intl./Oceanside Pharmaceuticals Inc. | Chlordiazepoxide HCl and Clidinium Bromide Capsules | 68682-409 | CA | Chlordiazepoxide HCl |
5.00 |
|
| Victory Pharma Inc. (Manuf. By West-Ward Pharmaceutical) | Zebutal Brand Butalbital, Acetaminophen, and Caffeine Capsules | 68453-170 | CA | Butalbital |
50.00 |
|
| Vintage Pharmaceuticals | Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules | 0254-2732 | CA | Chlordiazepoxide |
5.00 |
|
| Vistapharm, Inc. | Donnatal Elixir Grape Flavor 5ml Unit Dose | 66689-0063 | LQ | Phenobarbital |
16.20 |
|
| Vitarine Pharmaceuticals, Inc | E-Caff PB Tablets | 00185-0982 | TB | Pentobarbital |
30.00 |
|
| Vortech Pharmacal Co | Donna-Sed | 00298-5054 | EL | Phenobarbital |
3.24 |
|
| Vortech Pharmacal Co | Hypnaldyne | 00298-1778 | TB | Phenobarbital |
16.20 |
|
| Vortech Pharmacal Co | Isophed | 00298-5680 | LQ | Phenobarbital |
0.40 |
|
| Vortech Pharmacal Co | Phedral C. T. | 00298-1173 | TB | Phenobarbital |
8.10 |
|
| Wallace Laboratories | Barbidonna Elixir | 00037-0305 | EL | Phenobarbital |
3.20 |
|
| Wallace Laboratories | Barbidonna No 2 | 00037-0311 | TB | Phenobarbital |
32.00 |
|
| Wallace Laboratories | Barbidonna Tablets | 00037-0301 | TB | Phenobarbital |
16.00 |
|
| Wallace Laboratories | Butibel Elixir | 00037-0044 | EL | Butabarbital Sodium |
3.00 |
|
| Wallace Laboratories | Butibel Tablets | 00037-0046 | TB | Butabarbital Sodium |
15.00 |
|
| Wallace Laboratories | Lufyllin-EPG Elixir | 00037-0565 | EL | Phenobarbital |
1.60 |
|
| Wallace Laboratories | Lufyllin-EPG Tablets | 00037-0561 | TB | Phenobarbital |
16.00 |
|
| Wallace Laboratories | Milprem-200 | 00037-5501 | TB | Meprobamate |
200.00 |
|
| Wallace Laboratories | Milprem-400 | 00037-5401 | TB | Meprobamate |
400.00 |
|
| Warner Chilcott Laboratories | Pyridium Plus Tablets | 00430-0182 | TB | Butabarbital |
15.00 |
|
| WE Hauck Inc | G-1 Capsules | 43797-0244 | CA | Butalbital |
50.00 |
|
| Wesley Pharmacal Co | Hytrophen | 00917-0244 | TB | Phenobarbital |
16.20 |
|
| Wesley Pharmacal Co | Pulsaphen Gray | 00917-0113 | TB | Phenobarbital |
15.00 |
|
| Wesley Pharmacal Co | Wescophen-S | 00917-0135 | TB | Phenobarbital |
30.00 |
|
| Wesley Pharmacal Co | Wesmatic Forte | 00917-0845 | TB | Phenobarbital |
8.00 |
|
| Westminster Pharmaceuticals | Butalbital, Acetaminophen and Caffeine Tablets(50mg/325mg/40mg) | 69367-203 | TB | Butalbital |
50.00 |
|
| West-Ward Pharmaceutical Corp. | Belladonna Alkaloids & Phenobarbital | 00143-1140 | TB | Phenobarbital |
16.20 |
|
| West-Ward Pharmaceutical Corp. | Butalbital with Acetaminophen and Caffeine Tablets | 00143-1787 | TB | Butalbital |
50.00 |
|
| West-Ward Pharmaceutical Corp. | Butalbital, Acetaminophen and Caffein Capsules | 00143-3001 | CA | Butalbital |
50.00 |
|
| West-Ward Pharmaceutical Corp. | Butalbital, Acetaminophen, and Caffeine Tablets, USP | 00143-1115 | TB | Butalbital |
50.00 |
|
| West-Ward Pharmaceutical Corp. | Clindinax Capsules | 00143-3091 | CA | Chlordiazepoxide Hydrochloride |
5.00 |
|
| West-Ward Pharmaceutical Corp. | Clindinax Capsules | 00143-3092 | CA | Chlordiazepoxide Hydrochloride |
5.00 |
|
| West-Ward Pharmaceutical Corp. | Theophylline Ephedrine & Phenobarbital | 00143-1695 | TB | Phenobarbital |
8.00 |
|
| West-Ward Pharmaceutical Corp. | Zebutal Brand Butalbital, Acetaminophen, and Caffeine Capsules | 59630-0170 | CA | Butalbital |
50.00 |
|
| Winder Laboratories, LLC. | Phenohytro (Phenobarbital, Hyoscyamine, Atropine, Scopolamine) | 75826-118 | TB | Phenobarbital |
16.20 |
|
| Winder Laboratories, LLC. | Phenohytro (Phenobarbital, Hyoscyamine, Atropine, Scopolamine) | 75826-127 | LQ | Phenobarbital |
16.20 |
|
| Winder Laboratories, LLC. | Phenohytro (Phenobarbital, Hyoscyamine, Atropine, Scopolamine) | 75826-128 | LQ | Phenobarbital |
16.20 |
11.
| Exempt Prescription Products |
2/21/2020 |
|||||
| Company | Trade Name | NDC Code | Form | Controlled Substance |
(mg or mg/ml) |
|
| Winthrop Labs | Isuprel | 00024-0874 | EL | Phenobarbital |
0.40 |
|
| Wraser Pharmaceuticals | Phrenilin Forte (Butalbital, Acetaminophen and Caffeine) 50/300/40 | 66992-955 | CA | Butalbital |
50.00 |
|
| Zenith Goldline Pharmaceuticals | Belladonna Alkaloids with Phenobarbital ER Tablets | 00182-2611 | TB | Phenobarbital |
48.60 |
|
| Zenith Goldline Pharmaceuticals | Butalbital, Acetaminophen and Caffeine Tablets | 00182-2659 | TB | Butalbital |
50.00 |
|
| Zenith Labs Inc | Azpan | 00172-3747 | TB | Phenobarbital |
8.00 |
|
| Zenith Labs Inc | Chlordiazepoxide HCl and Clidinium Bromide Capsules, USP | 00172-2982 | CA | Chlordiazepoxide HCl |
5.00 |
Come From:
https://www.deadiversion.usdoj.gov/schedules/exempt/exempt_rx_list.pdf
Fioricet, a medication commonly prescribed for tension headaches, is exempt from certain controlled substance regulations in the United States due to its specific formulation and the quantities of its active ingredients. Fioricet contains a combination of acetaminophen, butalbital, and caffeine. Here are the key reasons why Fioricet is exempt:
Butalbital Content: Fioricet contains butalbital, a barbiturate that is a controlled substance. However, the amount of butalbital in Fioricet is relatively low (50 mg per tablet). Due to this lower dosage, Fioricet is not classified as a Schedule III controlled substance, which typically includes higher doses of butalbital.
Combination with Other Ingredients: The presence of acetaminophen and caffeine, which are not controlled substances, in combination with the lower dose of butalbital, contributes to Fioricet’s exemption. The combination is believed to mitigate the potential for abuse and dependence compared to formulations containing higher doses of butalbital alone or without other active ingredients.
FDA and DEA Regulations: The U.S. Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA) have determined that Fioricet’s specific formulation poses a lower risk of abuse and addiction, thus allowing it to be exempt from certain scheduling requirements under the Controlled Substances Act.
It is important to note that while Fioricet is exempt from being classified as a controlled substance at the federal level, individual states may have their own regulations, and healthcare providers still need to prescribe and monitor its use carefully due to the presence of butalbital.